Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.8 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.25 (International Units/kg per International Units/dL). For joint bleeding, the circulating factor IX activity required is 40% to 60% for 1 to 2 days or longer if response is inadequate. For superficial muscle without neurovascular compromise, the circulating factor IX activity required is 40% to 60% for 2 to 3 days or longer if response is inadequate. For iliopsoas and deep muscle with neurovascular compromise or substantial blood loss, the circulating factor IX activity required is 60% to 80% for 1 to 2 days, then 30% to 60% for 3 to 5 days (sometimes longer as secondary prophylaxis during physiotherapy). For CNS/head bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 21 days. For throat and neck bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 14 days. For gastrointestinal bleeding, the circulating factor IX activity required is 60% to 80% for 7 to 14 days, then 30% (duration unspecified). For renal bleeding, the circulating factor IX activity required is 40% for 3 to 5 days. For deep lacerations, the circulating factor IX activity required is 40% for 5 to 7 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.8 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.25 (International Units/kg per International Units/dL). For joint bleeding, the circulating factor IX activity required is 40% to 60% for 1 to 2 days or longer if response is inadequate. For superficial muscle without neurovascular compromise, the circulating factor IX activity required is 40% to 60% for 2 to 3 days or longer if response is inadequate. For iliopsoas and deep muscle with neurovascular compromise or substantial blood loss, the circulating factor IX activity required is 60% to 80% for 1 to 2 days, then 30% to 60% for 3 to 5 days (sometimes longer as secondary prophylaxis during physiotherapy). For CNS/head bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 21 days. For throat and neck bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 14 days. For gastrointestinal bleeding, the circulating factor IX activity required is 60% to 80% for 7 to 14 days, then 30% (duration unspecified). For renal bleeding, the circulating factor IX activity required is 40% for 3 to 5 days. For deep lacerations, the circulating factor IX activity required is 40% for 5 to 7 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.43 (International Units/kg per International Units/dL). For joint bleeding, the circulating factor IX activity required is 40% to 60% for 1 to 2 days or longer if response is inadequate. For superficial muscle without neurovascular compromise, the circulating factor IX activity required is 40% to 60% for 2 to 3 days or longer if response is inadequate. For iliopsoas and deep muscle with neurovascular compromise or substantial blood loss, the circulating factor IX activity required is 60% to 80% for 1 to 2 days, then 30% to 60% for 3 to 5 days (sometimes longer as secondary prophylaxis during physiotherapy). For CNS/head bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 21 days. For throat and neck bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 14 days. For gastrointestinal bleeding, the circulating factor IX activity required is 60% to 80% for 7 to 14 days, then 30% (duration unspecified). For renal bleeding, the circulating factor IX activity required is 40% for 3 to 5 days. For deep lacerations, the circulating factor IX activity required is 40% for 5 to 7 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal). For joint bleeding, the circulating factor IX activity required is 40% to 60% for 1 to 2 days or longer if response is inadequate. For superficial muscle without neurovascular compromise, the circulating factor IX activity required is 40% to 60% for 2 to 3 days or longer if response is inadequate. For iliopsoas and deep muscle with neurovascular compromise or substantial blood loss, the circulating factor IX activity required is 60% to 80% for 1 to 2 days, then 30% to 60% for 3 to 5 days (sometimes longer as secondary prophylaxis during physiotherapy). For CNS/head bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 21 days. For throat and neck bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 14 days. For gastrointestinal bleeding, the circulating factor IX activity required is 60% to 80% for 7 to 14 days, then 30% (duration unspecified). For renal bleeding, the circulating factor IX activity required is 40% for 3 to 5 days. For deep lacerations, the circulating factor IX activity required is 40% for 5 to 7 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal). For joint bleeding, the circulating factor IX activity required is 40% to 60% for 1 to 2 days or longer if response is inadequate. For superficial muscle without neurovascular compromise, the circulating factor IX activity required is 40% to 60% for 2 to 3 days or longer if response is inadequate. For iliopsoas and deep muscle with neurovascular compromise or substantial blood loss, the circulating factor IX activity required is 60% to 80% for 1 to 2 days, then 30% to 60% for 3 to 5 days (sometimes longer as secondary prophylaxis during physiotherapy). For CNS/head bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 21 days. For throat and neck bleeding, the circulating factor IX activity required is 60% to 80% for 1 to 7 days, then 30% for 8 to 14 days. For gastrointestinal bleeding, the circulating factor IX activity required is 60% to 80% for 7 to 14 days, then 30% (duration unspecified). For renal bleeding, the circulating factor IX activity required is 40% for 3 to 5 days. For deep lacerations, the circulating factor IX activity required is 40% for 5 to 7 days.Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor bleeding (e.g., bruises, cuts or scrapes, uncomplicated joint hemorrhage), the circulating factor IX activity required is at least 20% to 30%; repeat dose every 12 hours until bleeding stops and healing is achieved (1 to 2 days). For moderate bleeding (e.g., nose bleeds, mouth and gum bleeds, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days, on average). For major bleeding (e.g., joint/muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding), the circulating factor IX activity should be at least 50% for at least 3 to 5 days (dose given twice daily), then maintained at 20% (dose given twice daily) until healing is achieved (up to 10 days). The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor bleeding (e.g., bruises, cuts or scrapes, uncomplicated joint hemorrhage), the circulating factor IX activity required is at least 20% to 30%; repeat dose every 12 hours until bleeding stops and healing is achieved (1 to 2 days). For moderate bleeding (e.g., nose bleeds, mouth and gum bleeds, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days, on average). For major bleeding (e.g., joint/muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding), the circulating factor IX activity should be at least 50% for at least 3 to 5 days (dose given twice daily), then maintained at 20% (dose given twice daily) until healing is achieved (up to 10 days). The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Safety and efficacy have not been established; however, per FDA-approved product labeling, anecdotal evaluation of use in pediatric patients younger than 17 years indicates no safety and efficacy differences between pediatric and adult populations. Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor bleeding (e.g., bruises, cuts or scrapes, uncomplicated joint hemorrhage), the circulating factor IX activity required is at least 20% to 30%; repeat dose every 12 hours until bleeding stops and healing is achieved (1 to 2 days). For moderate bleeding (e.g., nose bleeds, mouth and gum bleeds, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days, on average). For major bleeding (e.g., joint/muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding), the circulating factor IX activity should be at least 50% for at least 3 to 5 days (dose given twice daily), then maintained at 20% (dose given twice daily) until healing is achieved (up to 10 days). The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Safety and efficacy have not been established; however, per FDA-approved product labeling, anecdotal evaluation of use in pediatric patients younger than 17 years (exact age unspecified) indicates no safety and efficacy differences between pediatric and adult populations. Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor bleeding (e.g., bruises, cuts or scrapes, uncomplicated joint hemorrhage), the circulating factor IX activity required is at least 20% to 30%; repeat dose every 12 hours until bleeding stops and healing is achieved (1 to 2 days). For moderate bleeding (e.g., nose bleeds, mouth and gum bleeds, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days, on average). For major bleeding (e.g., joint/muscle hemorrhage, major trauma, hematuria, intracranial and intraperitoneal bleeding), the circulating factor IX activity should be at least 50% for at least 3 to 5 days (dose given twice daily), then maintained at 20% (dose given twice daily) until healing is achieved (up to 10 days). The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating level of factor IX by 1 International Unit/dL. For minor or moderate bleeding (e.g., uncomplicated hemarthrosis, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucous membrane), the circulating factor IX activity required is 30% to 60%; repeat every 48 hours if there is further evidence of bleeding. For major bleeding (e.g., iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 80% to 100%; consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Verify the target concentration has been achieved for major bleeds. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor or moderate bleeding (e.g., uncomplicated hemarthrosis, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucus membrane), the circulating factor IX activity required is 30% to 60%; repeat every 48 hours if there is further evidence of bleeding. For major bleeding (e.g., iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 80% to 100%; consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Verify the target concentration has been achieved for major bleeds. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.6 International Units/dL. Pediatric patients younger than 12 years, especially those younger than 6 years, may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor or moderate bleeding (e.g., uncomplicated hemarthrosis, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucus membrane), the circulating factor IX activity required is 30% to 60%; repeat every 48 hours if there is further evidence of bleeding. For major bleeding (e.g., iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 80% to 100%; consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Verify the target concentration has been achieved for major bleeds. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.8 +/- 0.2 International Units/dL (range: 0.4 to 1.2 International Units/dL). For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscle, soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for 1 to 2 days. For moderate bleeding (e.g., intramuscle or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins (approximately 2 to 7 days). For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.8 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.3 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.8 +/- 0.2 International Units/dL (range: 0.4 to 1.2 International Units/dL). For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscle, soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for 1 to 2 days. For moderate bleeding (e.g., intramuscle or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins (approximately 2 to 7 days). For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.8 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.3 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.7 +/- 0.3 International Units/dL (range: 0.2 to 2.1 International Units/dL). Compared to older patients, patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscle, soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for 1 to 2 days. For moderate bleeding (e.g., intramuscle or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins (approximately 2 to 7 days). For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.7 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.4 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.7 +/- 0.3 International Units/dL (range: 0.2 to 2.1 International Units/dL). Compared to older patients, patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscle, soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for 1 to 2 days. For moderate bleeding (e.g., intramuscle or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins (approximately 2 to 7 days). For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.7 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.4 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1.3 International Units/dL. For minor to moderate bleeding (e.g., uncomplicated hemarthrosis, muscle bleeding except iliopsoas, oral bleeding), the circulating factor IX activity required is 30% to 60%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until bleeding stops and healing is achieved. For major bleeding (e.g., life- or limb-threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal), the circulating factor IX activity required is 60% to 100%. Repeat dose every 48 to 72 hours for 7 to 14 days, until bleeding stops and healing is achieved; administer maintenance dose weekly. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1.3 International Units/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor to moderate bleeding (e.g., uncomplicated hemarthrosis, muscle bleeding except iliopsoas, oral bleeding), the circulating factor IX activity required is 30% to 60%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until bleeding stops and healing is achieved. For major bleeding (e.g., life- or limb-threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal), the circulating factor IX activity required is 60% to 100%. Repeat dose every 48 to 72 hours for 7 to 14 days, until bleeding stops and healing is achieved; administer maintenance dose weekly. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor to moderate bleeding (e.g., uncomplicated hemarthrosis, muscle bleeding except iliopsoas, oral bleeding), the circulating factor IX activity required is 30% to 60%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until bleeding stops and healing is achieved. For major bleeding (e.g., life- or limb-threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal), the circulating factor IX activity required is 60% to 100%. Repeat dose every 48 to 72 hours for 7 to 14 days, until bleeding stops and healing is achieved; administer maintenance dose weekly. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor to moderate bleeding (e.g., uncomplicated hemarthrosis, muscle bleeding except iliopsoas, oral bleeding), the circulating factor IX activity required is 30% to 60%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until bleeding stops and healing is achieved. For major bleeding (e.g., life- or limb-threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal), the circulating factor IX activity required is 60% to 100%. Repeat dose every 48 to 72 hours for 7 to 14 days, until bleeding stops and healing is achieved; administer maintenance dose weekly. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.98 International Units/dL. For minor bleeding (e.g., early bleeds, uncomplicated hemarthroses and superficial muscle bleeds except iliopsoas, other soft tissue), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for 1 to 3 days until healing is achieved. For moderate bleeding (hemarthrosis of longer duration, recurrent hemarthrosis, mucous membranes, deep lacerations, hematuria), the circulating factor IX activity required is 40% to 60%; repeat dose every 24 hours for 2 to 7 days until healing is achieved. For major bleeding (e.g., iliopsoas, deep muscle with neurovascular injury, substantial blood loss, CNS, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100%; repeat dose every 12 to 24 hours for 2 to 14 days until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.98 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.02 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.98 International Units/dL. For minor bleeding (e.g., early bleeds, uncomplicated hemarthroses and superficial muscle bleeds except iliopsoas, other soft tissue), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for 1 to 3 days until healing is achieved. For moderate bleeding (hemarthrosis of longer duration, recurrent hemarthrosis, mucous membranes, deep lacerations, hematuria), the circulating factor IX activity required is 40% to 60%; repeat dose every 24 hours for 2 to 7 days until healing is achieved. For major bleeding (e.g., iliopsoas, deep muscle with neurovascular injury, substantial blood loss, CNS, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100%; repeat dose every 12 to 24 hours for 2 to 14 days until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.98 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.02 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.79 International Units/dL. For minor bleeding (e.g., early bleeds, uncomplicated hemarthroses and superficial muscle bleeds except iliopsoas, other soft tissue), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for 1 to 3 days until healing is achieved. For moderate bleeding (hemarthrosis of longer duration, recurrent hemarthrosis, mucous membranes, deep lacerations, hematuria), the circulating factor IX activity required is 40% to 60%; repeat dose every 24 hours for 2 to 7 days until healing is achieved. For major bleeding (e.g., iliopsoas, deep muscle with neurovascular injury, substantial blood loss, CNS, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100%; repeat dose every 12 to 24 hours for 2 to 14 days until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.79 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.27 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.79 International Units/dL. For minor bleeding (e.g., early bleeds, uncomplicated hemarthroses and superficial muscle bleeds except iliopsoas, other soft tissue), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for 1 to 3 days until healing is achieved. For moderate bleeding (hemarthrosis of longer duration, recurrent hemarthrosis, mucous membranes, deep lacerations, hematuria), the circulating factor IX activity required is 40% to 60%; repeat dose every 24 hours for 2 to 7 days until healing is achieved. For major bleeding (e.g., iliopsoas, deep muscle with neurovascular injury, substantial blood loss, CNS, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100%; repeat dose every 12 to 24 hours for 2 to 14 days until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.79 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.27 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor spontaneous bleeding, the circulating factor IX activity required is 15% to 25%; administer a loading dose up to 20 to 30 International Units/kg IV once and repeat in 24 hours if necessary. For major trauma, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor spontaneous bleeding, the circulating factor IX activity required is 15% to 25%; administer a loading dose up to 20 to 30 International Units/kg IV once and repeat in 24 hours if necessary. For major trauma, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor spontaneous bleeding, the circulating factor IX activity required is 15% to 25%; administer a loading dose up to 20 to 30 International Units/kg IV once and repeat in 24 hours if necessary. For major trauma, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor bleeding, the circulating factor IX activity required is 20% to 30%; administer dose every 16 to 24 hours for 1 to 2 days or until bleeding stops and healing is achieved. For moderate bleeding, the circulating factor IX activity required is 20% to 30%; administer dose every 16 to 24 hours for 2 to 7 days or until bleeding stops and healing is achieved. For major bleeding, the circulating factor IX activity required is 30% to 50%; administer dose every 16 to 24 hours for 3 to 10 days or until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55314]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.9 International Units/dL. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscular or soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for at least 1 day until healing is achieved. For moderate bleeding (e.g., intramuscular or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours for 2 to 7 days until bleeding stops and healing is achieved. For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.9 International Units/dL of plasma (0.9% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.1 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.9 International Units/dL. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscular or soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for at least 1 day until healing is achieved. For moderate bleeding (e.g., intramuscular or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours for 2 to 7 days until bleeding stops and healing is achieved. For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.9 International Units/dL of plasma (0.9% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.1 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscular or soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for at least 1 day until healing is achieved. For moderate bleeding (e.g., intramuscular or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours for 2 to 7 days until bleeding stops and healing is achieved. For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.7 International Units/dL of plasma (0.7% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.4 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor bleeding (e.g., uncomplicated hemarthrosis, superficial muscular or soft tissue), the circulating factor IX activity required is 20% to 30%; repeat dose every 12 to 24 hours for at least 1 day until healing is achieved. For moderate bleeding (e.g., intramuscular or soft tissue with dissection, mucous membranes, hematuria), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours for 2 to 7 days until bleeding stops and healing is achieved. For major bleeding (e.g., pharyngeal, retropharyngeal, retroperitoneal, CNS), the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.7 International Units/dL of plasma (0.7% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.4 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the location and extent of bleeding and the patient's clinical condition. For minor and moderate bleeding (e.g., uncomplicated joint bleeds, minor muscular bleeds, mucosal or subcutaneous bleeds), a single 40 International Unit/kg IV dose should be sufficient; additional doses can be given if needed. For major bleeding (e.g., intracranial, retroperitoneal, iliopsoas, and neck bleeds with compartment syndrome and bleeds associated with a significant decrease in hemoglobin), administer 80 International Units/kg IV as a single dose; additional doses of 40 International Units/kg IV can be given if needed.[61991]

Dose and duration of treatment depend on the location and extent of bleeding and the patient's clinical condition. For minor and moderate bleeding (e.g., uncomplicated joint bleeds, minor muscular bleeds, mucosal or subcutaneous bleeds), a single 40 International Unit/kg IV dose should be sufficient; additional doses can be given if needed. For major bleeding (e.g., intracranial, retroperitoneal, iliopsoas, and neck bleeds with compartment syndrome and bleeds associated with a significant decrease in hemoglobin), administer 80 International Units/kg IV as a single dose; additional doses of 40 International Units/kg IV can be given if needed.[61991]

Dosage is variable. Limited data suggest an initial IV bolus followed by continuous IV infusion (adjusted to maintain factor IX activity concentrations 40% to 100% depending on clinical situation) has been shown to be safe and cost-effective. Protocols vary based on pharmacokinetics of the various factor IX products in each patient; many patients have had baseline pharmacokinetic studies performed prior to surgery. The continuous infusion dosage used in several studies was calculated by multiplying the clearance (mL/kg/hour) by desired factor IX increase at steady state (units/mL).[33446] [33448] In clinical trials, a total of 42 patients receiving 49 continuous infusions (38 for surgeries) over a range of 1 to 54 days experienced excellent or good hemostatic effect; the bolus dose ranged from 12.5 to 155 International Units/kg IV, and the continuous IV rate of infusion was 1.7 to 8.6 International Units/kg/hour. The goal factor IX concentrations ranged from 40% to 100%; monitoring of factor IX activity concentrations occurred 1 to 2 times/day.[33445] [33446] [33447] [33448]

Dosage is variable. Limited data suggest an initial IV bolus followed by continuous IV infusion (adjusted to maintain factor IX activity concentrations 40% to 100% depending on clinical situation) has been shown to be safe and cost-effective. Protocols vary based on pharmacokinetics of the various factor IX products in each patient; many patients have had baseline pharmacokinetic studies performed prior to surgery. The continuous infusion dosage used in several studies was calculated by multiplying the clearance (mL/kg/hour) by desired factor IX increase at steady state (units/mL).[33446] [33448] In clinical trials, a total of 42 patients receiving 49 continuous infusions (38 for surgeries) over a range of 1 to 54 days experienced excellent or good hemostatic effect; the bolus dose ranged from 12.5 to 155 International Units/kg IV, and the continuous IV rate of infusion was 1.7 to 8.6 International Units/kg/hour. The goal factor IX concentrations ranged from 40% to 100%; monitoring of factor IX activity concentrations occurred 1 to 2 times/day.[33445] [33446] [33447] [33448]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.8 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.25 (International Units/kg per International Units/dL). For minor surgery, the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80% for 1 to 5 days, depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, then 30% to 50% for 4 to 6 days, then 20% to 40% for 7 to 14 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.8 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.25 (International Units/kg per International Units/dL). For minor surgery, the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80% for 1 to 5 days, depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, then 30% to 50% for 4 to 6 days, then 20% to 40% for 7 to 14 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.43 (International Units/kg per International Units/dL). For minor surgery, the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80% for 1 to 5 days, depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, then 30% to 50% for 4 to 6 days, then 20% to 40% for 7 to 14 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal). For minor surgery, the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80% for 1 to 5 days, depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, then 30% to 50% for 4 to 6 days, then 20% to 40% for 7 to 14 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal). For minor surgery, the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80% for 1 to 5 days, depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, then 30% to 50% for 4 to 6 days, then 20% to 40% for 7 to 14 days. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[68659]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days on average). For major surgery, the circulating factor IX activity required is 50% to 100%; repeat every 12 hours for 7 to 10 days or until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days on average). For major surgery, the circulating factor IX activity required is 50% to 100%; repeat every 12 hours for 7 to 10 days or until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Safety and efficacy have not been established; however, per FDA-approved product labeling, anecdotal evaluation of use in pediatric patients younger than 17 years indicates no safety and efficacy differences between pediatric and adult populations. Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days on average). For major surgery, the circulating factor IX activity required is 50% to 100%; repeat every 12 hours for 7 to 10 days or until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Safety and efficacy have not been established; however, per FDA-approved product labeling, anecdotal evaluation of use in pediatric patients younger than 17 years (exact age unspecified) indicates no safety and efficacy differences between pediatric and adult populations. Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor surgery, the circulating factor IX activity required is 25% to 50%; repeat dose every 12 hours until healing is achieved (2 to 7 days on average). For major surgery, the circulating factor IX activity required is 50% to 100%; repeat every 12 hours for 7 to 10 days or until healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59768]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For minor surgery (including uncomplicated tooth extraction), the circulating factor IX activity required is 50% to 80%; a single infusion may be sufficient. Repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved. For major surgery, the circulating factor IX activity required is 60% to 100% (initial concentration); consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing in the postsurgical setting may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Consider determining the patient's in vivo recovery prior to elective major surgery and verify the target concentration has been achieved prior to surgery. The following formulas may be used to estimate the required dose or the expected in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required is 50% to 80%; a single infusion may be sufficient. Repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved. For major surgery, the circulating factor IX activity required is 60% to 100% (initial concentration); consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing in the postsurgical setting may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Consider determining the patient's in vivo recovery prior to elective major surgery and verify the target concentration has been achieved prior to surgery. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.6 International Units/dL. Pediatric patients younger than 12 years, especially those younger than 6 years, may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required is 50% to 80%; a single infusion may be sufficient. Repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved. For major surgery, the circulating factor IX activity required is 60% to 100% (initial concentration); consider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days. Due to the long half-life, the dose may be reduced and frequency of dosing in the postsurgical setting may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved. Consider determining the patient's in vivo recovery prior to elective major surgery and verify the target concentration has been achieved prior to surgery. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL) or Estimated Increment of Factor IX (International Units/dL or % of normal) = [Total Dose (International Units)/Body Weight (kg)] x Recovery (International Units/dL per International Unit/kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[56918]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.8 +/- 0.2 International Units/dL (range: 0.4 to 1.2 International Units/dL). For minor surgery (including dental extractions), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins, about 2 to 7 days. For major surgery, the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.8 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.3 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.8 +/- 0.2 International Units/dL (range: 0.4 to 1.2 International Units/dL). For minor surgery (including dental extractions), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins, about 2 to 7 days. For major surgery, the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.8 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.3 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.7 +/- 0.3 International Units/dL (range: 0.2 to 2.1 International Units/dL). Compared to older patients, patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (including dental extractions), the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins, about 2 to 7 days. For major surgery, the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.7 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.4 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating activity of factor IX by 0.7 +/- 0.3 International Units/dL (range: 0.2 to 2.1 International Units/dL). Compared to older patients, patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor surgery, the circulating factor IX activity required is 25% to 50%; repeat dose every 12 to 24 hours until bleeding stops and healing begins, about 2 to 7 days. For major surgery, the circulating factor IX activity required is 50% to 100%; repeat dose every 12 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.7 International Units/dL, the following formula may be used: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1.4 (International Units/kg per International Units/dL). In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[57019]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1.3 International Units/dL. For minor surgery (e.g., uncomplicated dental extraction), the circulating factor IX activity required is 50% to 80%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until healing is achieved. For major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100% (initial concentration). Repeat dose every 48 to 72 hours for 7 to 14 days or until bleeding stops and healing is achieved; administer maintenance dose 1 to 2 times per week. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1.3 International Units/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (e.g., uncomplicated dental extraction), the circulating factor IX activity required is 50% to 80%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until healing is achieved. For major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100% (initial concentration). Repeat dose every 48 to 72 hours for 7 to 14 days or until bleeding stops and healing is achieved; administer maintenance dose 1 to 2 times per week. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (e.g., uncomplicated dental extraction), the circulating factor IX activity required is 50% to 80%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until healing is achieved. For major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100% (initial concentration). Repeat dose every 48 to 72 hours for 7 to 14 days or until bleeding stops and healing is achieved; administer maintenance dose 1 to 2 times per week. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor surgery, the circulating factor IX activity required is 50% to 80%. A single dose should be sufficient; repeat as needed every 48 to 72 hours until healing is achieved. For major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal), the circulating factor IX activity required is 60% to 100% (initial concentration). Repeat dose every 48 to 72 hours for 7 to 14 days or until bleeding stops and healing is achieved; administer maintenance dose 1 to 2 times per week. The following formulas may be used to estimate the required dose or the in vivo peak increase in factor IX concentration: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x (Reciprocal of Recovery [International Units/kg per International Units/dL]) or Estimated Increment of Factor IX (International Units/dL or % of normal) = Dose (International Units) x Recovery (International Units/dL per International Unit/kg)/Body Weight (kg). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[60635]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.98 International Units/dL. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80%; repeat every 24 hours for 1 to 5 days depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, 30% to 50% for 4 to 6 days, and 20% to 40% for 7 to 14 days; repeat dose every 8 to 24 hours. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.98 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.02 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.98 International Units/dL. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80%; repeat every 24 hours for 1 to 5 days depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, 30% to 50% for 4 to 6 days, and 20% to 40% for 7 to 14 days; repeat dose every 8 to 24 hours. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.98 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.02 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.79 International Units/dL. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80%; repeat every 24 hours for 1 to 5 days depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, 30% to 50% for 4 to 6 days, and 20% to 40% for 7 to 14 days; repeat dose every 8 to 24 hours. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.79 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.27 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.79 International Units/dL. For minor surgery (including uncomplicated dental extraction), the circulating factor IX activity required preoperatively is 50% to 80% and postoperatively is 30% to 80%; repeat every 24 hours for 1 to 5 days depending on the type of procedure. For major surgery, the circulating factor IX activity required preoperatively is 60% to 80% and postoperatively is 40% to 60% for 1 to 3 days, 30% to 50% for 4 to 6 days, and 20% to 40% for 7 to 14 days; repeat dose every 8 to 24 hours. The following formula may be used to estimate the initial dose: Dose (International Units) = Body weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). To estimate the dose with an average incremental recovery of 0.79 International Units/dL, the following formula may be used: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.27 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[59514]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For major surgery, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For major surgery, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For major surgery, the circulating factor IX activity required is 25% to 50%; administer a loading dose up to 75 International Units/kg IV and repeat every 18 to 30 hours for up to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[62103]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 1 International Unit/dL. For surgery, the circulating factor IX activity required is 30% to 50% (for dental extractions, bring factor IX concentrations to 50% immediately prior to the procedure); repeat dose every 16 to 24 hours for 7 to 10 days. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x 1 (International Units/kg per International Units/dL). Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55314]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.9 International Units/dL. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for at least 1 day until healing is achieved. For major surgery (e.g., intracranial, intraabdominal, intrathoracic, joint replacement), the circulating factor IX activity required is 80% to 100%; repeat dose every 8 to 24 hours for 7 to 10 days, until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.9 International Units/dL of plasma (0.9% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.1 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.9 International Units/dL. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for at least 1 day until healing is achieved. For major surgery (e.g., intracranial, intraabdominal, intrathoracic, joint replacement), the circulating factor IX activity required is 80% to 100%; repeat dose every 8 to 24 hours for 7 to 10 days, until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.9 International Units/dL of plasma (0.9% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.1 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. For minor surgery (e.g., dental extraction), the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for at least 1 day until healing is achieved. For major surgery (e.g., intracranial, intraabdominal, intrathoracic, joint replacement), the circulating factor IX activity required is 80% to 100%; repeat dose every 8 to 24 hours for 7 to 10 days, until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.7 International Units/dL of plasma (0.7% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.4 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit/kg increases the circulating concentration of factor IX by 0.7 International Units/dL. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling. For minor surgery, the circulating factor IX activity required is 30% to 60%; repeat dose every 24 hours for at least 1 day until healing is achieved. For major surgery (e.g., intracranial, intraabdominal, intrathoracic), the circulating factor IX activity required is 80% to 100%; repeat dose every 8 to 24 hours for 7 to 10 days, until bleeding stops and healing is achieved. The following formula may be used to estimate the initial dose: Dose (International Units) = Body Weight (kg) x Desired Factor IX Rise (International Units/dL or % of normal) x Reciprocal of Recovery (International Units/kg per International Units/dL). For an incremental recovery of 0.7 International Units/dL of plasma (0.7% of normal), the dose is calculated as follows: Dose (International Units) = Body Weight (kg) x Desired Factor IX Increase (International Units/dL or % of normal) x 1.4 dL/kg. In previously treated patients, calculate the dose based on the patient's individual incremental recovery using serial factor IX activity assays, due to the wide range of interindividual differences in incremental recovery. Titrate the dose based on the patient's clinical response and individual pharmacokinetics (e.g., incremental recovery, half-life).[55148]

Dose and duration of treatment depend on the location and extent of bleeding and the patient's clinical condition. For minor surgery (e.g., dental procedures, skin biopsies), a single 40 International Units/kg IV dose given preoperatively should be sufficient; additional doses can be given if needed. For major surgery, administer 80 International Units/kg IV as a single dose preoperatively and 40 International Units/kg/dose IV as needed perioperatively for the management of bleeding. Repeat doses of 40 International Units/kg/dose IV every 1 to 3 days for the first week after surgery as needed; may extend dosing to once weekly after the first week until bleeding stops and healing is achieved.[61991]

Dose and duration of treatment depend on the location and extent of bleeding and the patient's clinical condition. For minor surgery (e.g., dental procedures, skin biopsies), a single 40 International Units/kg IV dose given preoperatively should be sufficient; additional doses can be given if needed. For major surgery, administer 80 International Units/kg IV as a single dose preoperatively and 40 International Units/kg/dose IV as needed perioperatively for the management of bleeding. Repeat doses of 40 International Units/kg/dose IV every 1 to 3 days for the first week after surgery as needed; may extend dosing to once weekly after the first week until bleeding stops and healing is achieved.[61991]

Dosage is variable. Limited data suggest an initial IV bolus followed by continuous IV infusion (adjusted to maintain factor IX activity concentrations 40% to 100% depending on clinical situation) has been shown to be safe and cost-effective. Protocols vary based on pharmacokinetics of the various factor IX products in each patient; many patients have had baseline pharmacokinetic studies performed prior to surgery. The continuous infusion dosage used in several studies was calculated by multiplying the clearance (mL/kg/hour) by desired factor IX increase at steady state (units/mL).[33446] [33448] In clinical trials, a total of 42 patients receiving 49 continuous infusions (38 for surgeries) over a range of 1 to 54 days experienced excellent or good hemostatic effect; the bolus dose ranged from 12.5 to 155 International Units/kg IV, and the continuous IV rate of infusion was 1.7 to 8.6 International Units/kg/hour. The goal factor IX concentrations ranged from 40% to 100%; monitoring of factor IX activity concentrations occurred 1 to 2 times/day.[33445] [33446] [33447] [33448]

Dosage is variable. Limited data suggest an initial IV bolus followed by continuous IV infusion (adjusted to maintain factor IX activity concentrations 40% to 100% depending on clinical situation) has been shown to be safe and cost-effective. Protocols vary based on pharmacokinetics of the various factor IX products in each patient; many patients have had baseline pharmacokinetic studies performed prior to surgery. The continuous infusion dosage used in several studies was calculated by multiplying the clearance (mL/kg/hour) by desired factor IX increase at steady state (units/mL).[33446] [33448] In clinical trials, a total of 42 patients receiving 49 continuous infusions (38 for surgeries) over a range of 1 to 54 days experienced excellent or good hemostatic effect; the bolus dose ranged from 12.5 to 155 International Units/kg IV, and the continuous IV rate of infusion was 1.7 to 8.6 International Units/kg/hour. The goal factor IX concentrations ranged from 40% to 100%; monitoring of factor IX activity concentrations occurred 1 to 2 times/day.[33445] [33446] [33447] [33448]

40 to 60 International Units/kg/dose IV twice weekly.[68659]

20 to 40 International Units/kg/dose IV twice weekly.[68659]

10 to 15 International Units/kg/dose IV twice weekly.[68659]

40 to 60 International units/kg/dose IV twice weekly.[68659]

20 to 40 International Units/kg/dose IV twice weekly.[68659]

10 to 15 International Units/kg/dose IV twice weekly.[68659]

50 International Units/kg/dose IV once weekly or 100 International Units/kg/dose IV once every 10 days. Adjust dose based on individual response.[56918]

50 International Units/kg/dose IV once weekly or 100 International Units/kg/dose IV once every 10 days. Adjust dose based on individual response.[56918]

60 International Units/kg/dose IV once weekly. Adjust dose based on individual response. Pediatric patients younger than 12 years, especially those younger than 6 years, may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery.[56918]

100 International Units/kg/dose IV once weekly. Adjust dosage (dose or frequency) based on individual response.[57019]

100 International Units/kg/dose IV once weekly. Adjust dosage (dose or frequency) based on individual response.[57019]

25 to 40 International Units/kg/dose IV every 7 days. Patients who are well-controlled on this regimen may be switched to 50 to 75 International Units/kg/dose IV every 14 days. Adjust dose based on individual response.[60635]

25 to 40 International Units/kg/dose IV every 7 days. Patients who are well-controlled on this regimen may be switched to 50 to 75 International Units/kg/dose IV every 14 days. Adjust dose based on individual response. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery.[60635]

40 to 55 International Units/kg/dose IV every 7 days. Adjust dose based on individual response. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery.[60635]

40 to 55 International Units/kg/dose IV every 7 days. Adjust dose based on individual response. Compared to adults, pediatric patients may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling.[60635]

40 to 70 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity.[59514]

40 to 70 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity.[59514]

35 to 75 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity.[59514]

35 to 75 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity. Specific neonatal dosing is not provided in the FDA-approved product labeling.[59514]

40 International Units/kg/dose IV once weekly.  Adjust dose based on individual patient's bleeding pattern and physical activity.[61991]

40 International Units/kg/dose IV once weekly.  Adjust dose based on individual patient's bleeding pattern and physical activity.[61991]

40 to 60 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity.[55148]

40 to 60 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity.[55148]

60 to 80 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery.[55148]

60 to 80 International Units/kg/dose IV twice weekly. Adjust dose based on individual patient's age, bleeding pattern, and physical activity. Compared to older patients, pediatric patients younger than 12 years may require a higher dose per kg bodyweight or more frequent dosing because they may have higher factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Specific neonatal dosing is not provided in the FDA-approved product labeling.[55148]