• Administer by a separate infusion line. Do not mix with other medications, fluids, or blood products. Do not mix different IVIG products.
• Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur; headache, nausea, vomiting, flushing, pulse rate, and blood pressure changes may be related to the rate of infusion. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
• Begin infusions at a low rate and gradually increase if patients are receiving IVIG for the first time, if there has been a prolonged interval between doses, or a different brand is used. Adverse reactions are more likely to occur in these situations.
• Ensure patients with pre-existing renal insufficiency are not volume depleted.[42655][42658][42955]

Asceniv:

• Asceniv is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter. Do not use any solution that has been frozen, heated, or shaken.
• Allow refrigerated product to come to room temperature before use and maintain at room temperature during administration.
• Do not mix with other IVIG products or other intravenous medications or fluids.
• No reconstitution is necessary.
• Do not dilute.
• If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags.
• The recommended initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 15 minutes; if tolerated, increase gradually every 15 minutes to a maximum rate of 8 mg/kg/minute (0.08 mL/kg/minute).
• For patients at risk of developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Consider discontinuation if renal function deteriorates.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[64039]

Bivigam 10%:

• Bivigam is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter.
• Allow product to come to room temperature before use and maintain at room temperature during administration; do not use any solution that has been frozen, heated, or shaken.
• Do not mix with other IVIG products or other intravenous medications or fluids.
• If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags. Discard any unused product; each vial is single-use only.
• Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 10 minutes. If no adverse reactions occur, the rate may be gradually increased every 20 minutes by 0.8 mg/kg/minute to a maximum of 6 mg/kg/minute.
• For patients judged to be at risk for renal dysfunction or thrombotic events, administer at the minimum infusion rate practicable, and consider discontinuation if renal function deteriorates.
• Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42658]

Carimune NF:

• Reconstitute with sterile water for injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection according to the manufacturer's directions.
• To aid in dissolution, vigorously swirl the vial; avoid shaking and foaming. Dissolution may take up to 20 minutes.
• The solution should be clear. Do not use if particulate matter is present.
• Solutions are stable for 24 hours under refrigeration if reconstituted in a sterile laminar flow hood. Bring to room temperature prior to administration. Otherwise, use promptly and discard unused portions. Do not freeze.
• The final concentration of the immunoglobulin solution to be administered is dependent on indication.
• Primary Immunodeficiency: In previously untreated patients, a 3% Immunoglobulin solution must be used for the initial IV infusion. If the initial infusion is well tolerated, higher concentrations may be used for subsequent infusions.
• Idiopathic Thrombocytopenic Purpura: A 6% immunoglobulin solution is recommended.
• Initial IV infusion rate is 0.5 mg/kg/minute for 30 minutes. If tolerated, the rate may be increased to 1 mg/kg/minute for the next 30 minutes. The infusion may then be gradually increased in a stepwise manner to a maximum of 2 mg/kg/minute for patients at risk of renal dysfunction or thromboembolic events and a maximum of 3 mg/kg/minute for all other patients. The mL/kg/minute infusion rate depends on the solution concentration.
• For patients at risk of acute renal failure, use the minimum practicable concentration and infusion rate.
• If side effects occur, stop or slow the infusion until symptoms subside.
• Filtering is not required, but if used, a pore size of 15 microns or larger will be less likely to slow infusion, especially with higher solution concentrations; 0.2 micron antibacterial filters may be used.
• Administer by a separate infusion line. Do not mix with other medications or fluids.[42654]

Flebogamma DIF 5% or 10%:

• No reconstitution necessary. Throw away unused product, as it does not contain preservatives. Do not use if turbid, contains particles, or was previously frozen.
• Do not dilute with IV fluids. Compatibility with drugs or solutions has not been established; do not mix with other IVIG products.
• If large doses are to be administered, several vials may be pooled using aseptic technique into an empty, sterile solution container. Discard any unused product; each vial is single-use only.
• Infuse immunoglobulin solutions through a dedicated IV line.[41552][41553]
• Flebogamma DIF 5% and 10% can be administered sequentially into a primary intravenous line containing 0.9% Sodium Chloride Injection or flushed with 0.9% Sodium Chloride Injection without causing precipitation or turbidity.[48515]
• Infusion rate dependent on immunoglobulin solution concentration.
• For the 5% Immunoglobulin solution, initial IV infusion rate is 0.5 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, the rate may be gradually increased to a maximum of 5 mg/kg/minute (0.1 mL/kg/minute).
• Dose titration to a maximum rate of less than 3 mg/kg/minute (0.06 mL/kg/minute) is recommended for patients at least 65 years of age or who are judged to be at risk of renal dysfunction. Infuse at the minimum infusion rate practicable for patients judged to be at risk for developing renal dysfunction or thromboembolic events.
• If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.[41552]
• For the 10% immunoglobulin solution, initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, the rate may be gradually increased to 4 mg/kg/minute (0.04 mL/kg/minute). If tolerated, the rate may be further increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
• Slower than recommended infusion rates may be utilized for the first 2 to 3 infusions. If no adverse reactions occur, the infusion rate may be gradually increased for subsequent infusions up to the maximum rate.
• Dose titration to a maximum rate of less than 4 mg/kg/minute (0.04 mL/kg/minute) is recommended for patients over 65 years of age or who are judged to be at risk of renal dysfunction. Infuse at the minimum infusion rate practicable in patients over 65 years of age, at risk of renal dysfunction, or at risk of thrombotic events; consider product discontinuation if renal function deteriorates.
• Patients who experience adverse reactions, either reduce the infusion rate in subsequent infusions or switch to the 5% immunoglobulin solution.[41553]
• Record lot numbers of the drug vials administered.
• Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[41552][41553]

Gammagard Liquid 10%:

• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear or slightly opalescent, colorless to pale yellow. Do not shake.
• No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
• Prior to use, allow solution to reach ambient room temperature. Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
• Use of an in-line filter is optional. Infuse through a dedicated line.
• Monitor vital signs throughout the infusion. Adverse reactions such as headaches, flushing, and changes in pulse rate and blood pressure may be related to the infusion rate; slow or stop the infusion if they occur. If symptoms subside promptly, infusion may be resumed at a lower rate that does not cause symptom recurrence.
• Initial and maximum infusion rates:
• Primary immunodeficiency: Initial IV infusion rate is 0.8 mg/kg/minute (0.5 mL/kg/hour) for 30 minutes. If no adverse reactions occur, rate may be gradually increased every 30 minutes to a maximum of 8 mg/kg/minute (5 mL/kg/minute).
• Multifocal motor neuropathy: Initial IV infusion rate is 0.8 mg/kg/minute (0.5 mL/kg/hour) and titrate, if tolerated, to a maximum of 9 mg/kg/minute (5.4 mL/kg/hour) as the maintenance infusion rate.
• For patients more than 65 years or who are at risk of renal dysfunction or thrombotic complications, dose titration to a maximum rate of less than 3.3 mg/kg/minute (less than 2 mL/kg/hour). Consider discontinuation if renal function deteriorates.
• Record the name and lot number of the product administered.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42655]

Gammagard S/D:

• NOTE: Manufacturer's directions for reconstitution must be read thoroughly before attempting to reconstitute this product.
• Both the diluent and the lyophilized powder should be at room temperature before reconstitution. The solution should be clear to slightly opalescent and colorless to pale yellow. Do not use solution if there are particles or discoloration.
• If prepared outside of a sterile laminar air flow hood, begin administration within 2 hours of reconstitution.
• If prepared in a sterile laminar air flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2 to 8 degrees C [36 to 46 degrees F]), begin administration within 24 hours of reconstitution.
• Using the supplied administration set, administer by a separate infusion line. Use the antecubital vein, if possible, especially for the 10% solution. Do not mix with other medications or fluids; do not mix with other IVIG products.
• If refrigerated, allow solution to reach room temperature prior to administration.
• Initial IV infusion rate for the 5% solution should begin at 0.0083 mL/kg/minute. If the patient does not experience any discomfort, the infusion rate may be gradually increased to a maximum of approximately 0.067 mL/kg/minute.
• If the highest rate for the 5% solution is tolerated, the 10% solution may be used with an initial rate of 0.0083 mL/kg/minute. If the patient does not experience any discomfort, the infusion rate may be gradually increased to a maximum rate of 0.133 mL/kg/minute.
• For patients at risk of renal dysfunction or thrombotic complications, infuse solution at the minimum practicable rate and gradually titrate up to a maximum rate of less than 0.067 mL/kg/minute for the 5% solution or less than 0.033 mL/kg/minute for the 10% solution.[42955]

Gammaked:

• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
  No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
• Allow solution to reach ambient room temperature prior to administration.
• Only 18 gauge needles should be used to penetrate the stopper for dispensing the product from the 10 mL vials; 16 gauge needles should only be used with the 25 mL vial sizes and larger. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
• Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
• The infusion line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
• Infuse using a separate infusion line. Do not mix with other IV medications, fluids, or other IVIG products.
• Avoid coadministration of Gammaked and heparin through a single lumen delivery device due to Gammaked and heparin incompatibility. Following Gammaked infusion, flush the IV line, delivery device, and/or heparin lock (Hep-Lock) with either 5% Dextrose Injection or 0.9% Sodium chloride Injection; do not flush with heparin.
• Initial (first 30 minutes) and maximum infusion rates:
• Idiopathic thrombocytopenic purpura (ITP) or primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
• Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 2 mg/kg/minute (0.02 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
• For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum infusion rate practicable. Discontinue the infusion if renal function deteriorates.
• If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[54820]

Gammaplex 5% or 10%:

• The solution should be clear or slightly opalescent and colorless. Do not use if solution is cloudy, discolored, or contains particulate matter. Do not shake or use if it has been frozen.
• Gammaplex should be at room temperature (up to 25 degrees C [77 degrees F]) at the time of administration. After piercing the cap, promptly administer; there are no preservatives, and it is for single use only. Dispose of partially used or unused product. If large doses are to be administered, several vials may be pooled using aseptic technique.
• Infuse using an infusion set and a separate infusion line. Do not mix with other IV medications (including 0.9% Sodium Chloride Injection) or other IVIG products. An infusion pump may be used to control the rate of administration.
• Initial and maximum infusion rates:
• For 5% product, initial IV infusion rate is 0.05 mg/kg/minute (0.01 mL/kg/minute) for 15 minutes. If well tolerated, the rate may be gradually increased every 15 minutes to a maximum of 4 mg/kg/minute (0.08 mL/kg/minute).
• For 10% product, initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 15 minutes. If well tolerated, the rate may be gradually increased every 15 minutes to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
• For patients judged to be at risk for renal dysfunction, thrombotic events, or volume overload, administer at the minimum infusion rate practicable, and discontinue if renal function deteriorates.
• Monitor vital signs throughout the infusion. If side effects occur, slow or stop the infusion. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient. The observation time of patients after administration may vary. If the patient has not received an IgG product, is switched from an alternative IVIG product, or has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42661][61745]

Gamunex-C:

• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
• No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
• Allow solution to reach ambient room temperature prior to administration.
• Only 18 gauge needles should be used to penetrate the stopper for dispensing the product from the 10 mL vials; 16 gauge needles should only be used with the 25 mL vial sizes and larger. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
• Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
• The infusion line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
• Infuse using a separate infusion line. Do not mix with other IV medications, fluids, or other IVIG products.
• Avoid coadministration of Gamunex-C and heparin through a single lumen delivery device due to Gamunex-C and heparin incompatibility. Following Gamunex-C infusion, flush the IV line, delivery device, and/or heparin lock (Hep-Lock) with either 5% Dextrose Injection or 0.9% Sodium chloride Injection; do not flush with heparin.
• Initial (first 30 minutes) and maximum infusion rates:
  • Idiopathic thrombocytopenic purpura (ITP) or primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
  • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 2 mg/kg/minute (0.02 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
  • For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum infusion rate practicable. Discontinue the infusion if renal function deteriorates.
• If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[51240]

Octagam 5% or 10%:

• Do not use if solution has discoloration, cloudiness, or particulate matter. Do not shake. Do not freeze or use solutions that have been frozen.
• No reconstitution necessary; Octagam should not be diluted.
• Use no larger than a 16 gauge needle. Do not insert the needle more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
• Bottles may be pooled under aseptic conditions into sterile infusion bags and administered within 8 hours after pooling.
• Allow refrigerated product to come to ambient room temperature before administration.
• If an in-line filter is used, the pore size should be 0.2 to 200 microns. Infuse through a dedicated line. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.[30276][57655]
• Initial and maximum infusion rates:
• For the 5% product, the initial IV infusion rate is 0.5 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, rate may be increased to 1 mg/kg/minute (0.02 mL/kg/minute) for the next 30 minutes. If tolerated, infusion may be further increased to 2 mg/kg/minute (0.04 mL/kg/minute) for the next 30 minutes.
• Do not exceed a maximum of 3.33 mg/kg/minute (0.07 mL/kg/minute).
• For geriatric patients and patients at risk for renal dysfunction or thrombosis, infuse at the minimum infusion rate practicable.[30276]
• For the 10% product, the initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, rate may be increased to 2 mg/kg/minute (0.02 mL/kg/minute) for the next 30 minutes. If tolerated, infusion may be further increased to 4 mg/kg/minute (0.04 mL/kg/minute) for the next 30 minutes. If tolerated, the infusion may be further increased to 8 mg/kg/minute (0.08 mL/kg/minute) for the next 30 minutes in patients with chronic immune thrombocytopenic purpura.
• Do not exceed a maximum of 4 mg/kg/minute (0.04 mL/kg/minute) in patients with dermatomyositis or 12 mg/kg/minute (0.12 mL/kg/minute) in patients with chronic immune thrombocytopenic purpura.
• For geriatric patients and patients at risk for renal dysfunction or thrombosis, infuse at the minimum infusion rate practicable, not to exceed 3.3 mg/kg/minute (0.03 mL/kg/minute).[57655]
• The IV infusion line may be flushed before and after administration of Octagam 5% or 10% with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
• Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate. Discontinue if renal function deteriorates.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[30276][57655]

Panzyga:

• No reconstitution necessary. Do not use if cloudy, turbid, contains particles, or was previously frozen. Do not freeze.
• Use no larger than a 16 gauge needle. Do not insert the needle more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
• Bottles may be pooled under aseptic conditions into sterile infusion bags and administered within 8 hours after pooling.
• Allow refrigerated product to come to room temperature before administration.
• If an in-line filter is used, the pore size should be 0.2 to 200 microns. Infuse through a dedicated line. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
• Initial and maximum infusion rates:
• Primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 14 mg/kg/minute (0.14 mL/kg/minute).
• Chronic immune thrombocytopenia (ITP): Initial IV infusion rate for chronic ITP is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
• Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 12 mg/kg/minute (0.12 mL/kg/minute).
• For patients who are at risk of renal dysfunction or thromboembolic complications, titrate, as tolerated, to a maximum rate of less than 3.3 mg/kg/minute (0.033 mL/kg/minute). Consider discontinuation if renal function deteriorates.
• Monitor vital signs during the infusion. If side effects occur, slow or stop the infusion until the symptoms subside. Restart the infusion at a lower rate that is comfortable for the patient.
• After administration, line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[63463]

Privigen:

• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
• No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection. Do not mix with other drugs or IVIG products.
• If large doses are to be administered, several vials may be pooled using aseptic technique and administered within 8 hours of pooling. Promptly use contents of each single-use vial; no preservatives are present.
• Administer via a separate IV infusion line, which may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection. An infusion pump may be used to control the administration rate.
• Initial and maximum infusion rates:
  • Primary immunodeficiency: Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
  • Chronic immune thrombocytopenia (ITP): Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 4 mg/kg/minute (0.04 mL/kg/minute).
  • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
  • For patients who are at risk of renal dysfunction, thromboembolic complications or volume overload, administer a minimum dose and infuse at the minimum infusion rate practicable. Discontinue therapy if renal function deteriorates.
  • For patients at risk of developing systemic reactions with rapid infusions (greater than 4 mg/kg/minute [0.04 mL/kg/minute]) of Privigen, begin the initial infusion at a slow rate (e.g., 0.5 mg/kg/minute [0.005 mL/kg/minute]) and gradually increase rate as tolerated. Systemic reactions may mimic symptoms of an inflammatory response or infection. Patients at risk of developing a systemic reaction include those that have not previously received Privigen or another immune globulin G (IgG) product or have not received it within the previous 8 weeks and those switching from another IgG product to Privigen.
• Monitor vital signs during the infusion. If side effects occur, slow or stop the infusion until the symptoms subside. Restart the infusion at a lower rate that is comfortable for the patient.
• Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42659]

Gammagard Liquid 10%:

• Gammagard Liquid may be given by subcutaneous infusion using a subcutaneous infusion pump.
• Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear or slightly opalescent, colorless to pale yellow. Do not shake.
• If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach ambient room temperature. Do not heat the product; the vials may take up to 60 minutes to reach room temperature.
• Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. If using a vented spike, it is not necessary to inject air into the vial. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
• Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing. Prime administration tubing to ensure no air is left in tubing or needles.
• Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
• Injection sites include the abdomen, thighs, upper arms, and/or lower back. Avoid bony areas, visible blood vessels, scars, and areas of inflammation, irritation, or infection. Rotate the injection site with each weekly administration. New infusion sites should be at least 2 inches from a previous site.
• Select the number of infusion sites based on the volume of the total dose.
• Patients weighing 40 kg and greater: do not exceed a volume of 30 mL per site. Determine the number of required infusion sites by dividing the total weekly dose (mL) by 30. Do not exceed a total of 8 simultaneous infusion sites.
• Patients weighing less than 40 kg: do not exceed a volume of 20 mL per site. Do not exceed a total of 8 simultaneous infusion sites.
• Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of a multi-needle administration set. Injection sites should be at least 2 inches apart.
• Firmly pinch at least 1 inch of skin between two fingers and insert the needle at a 90-degree angle subcutaneously using rapid motion. Tape the needle into place. Repeat the steps for each injection site.
• Before starting infusion, ensure correct needle placement. Attach a sterile syringe to the end of the infusion tubing, and pull the plunger back gently. If you see blood in the tubing, take the needle out of the injection site, and throw away the tubing and needle. Try a different site with new infusion tubing and a new needle.
• Secure needle(s) placement by placing a sterile, clear bandage over the needle.
• Initial and maintenance infusion rates:
• Patients weighing 40 kg and greater: Initial subcutaneous infusion rate is 20 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 30 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 30 mL/hour/site, then 30 mL multiplied by 4 sites would be 120 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 240 mL/hour.
• Patients weighing less than 40 kg: Initial subcutaneous infusion rate is 15 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 20 mL/hour/site, then 20 mL multiplied by 4 sites would be 80 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 160 mL/hour.
• To start the subcutaneous infusion, follow the pump manufacturer's instructions.
• After infusion completion, remove clear bandage and needle(s). If needed, gently press a small piece of gauze over the injection site and cover with a protective dressing.
• Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
• Storage: Protect vials from light by storing in their original boxes. Unopened Gammagard vials may be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 36 months or at a room temperature up to 25 degrees C (77 degrees F) for up to 24 months. Both the vial and carton labels contain the refrigerator and room temperature expiration dates. Once a vial has been stored at room temperature, do not refrigerate again. Do not freeze.[42655]

Gammaked:

• Gammaked may be administered subcutaneously for the treatment of primary immunodeficiency.
• Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
• If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
• Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
• Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
• Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
• Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing. Injection sites should be at least two inches apart.
• Select the number of infusion sites based on the volume of the total dose.
  • Adult patients: Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
  • Adolescents and children: Do not exceed a total of 6 simultaneous infusion sites.
• Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
• Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
• Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
• If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
• Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
• Initial and maintenance infusion rates:
• Adult patients: Initial, maintenance, and maximum subcutaneous infusion rate is 20 mL/hour/infusion site. Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
• Adolescents and children weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
• Adolescents and children weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
• To start the subcutaneous infusion, follow the pump manufacturer's instructions.
• After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
• Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
• Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.[54820]

Gamunex-C:

• Gamunex-C may be administered by subcutaneous infusion for the treatment of primary immunodeficiency.
• Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
• Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
• If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
• Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
• Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
• Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
• Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing.
• Injection sites should be at least two inches apart.
• Select the number of infusion sites based on the volume of the total dose.
  • Adult patients: Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
  • Adolescents and children: Do not exceed a total of 6 simultaneous infusion sites.
• Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
• Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
• Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
• If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
• Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
• Initial and maintenance infusion rates:
  • Adult patients: Initial, maintenance, and maximum subcutaneous infusion rate is 20 mL/hour/infusion site. Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
  • Adolescents and children weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
  • Adolescents and children weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
• To start the subcutaneous infusion, follow the pump manufacturer's instructions.
• After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
• Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
• Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.[51240]

Peak serum concentrations occur immediately after IV injection and are dose-related. Following infusion, IVIG products show a biphasic decay curve. The initial phase is characterized by an immediate post-infusion peak in serum IgG and is followed by rapid decay due to equilibration between the plasma and extravascular fluid compartments. The second phase is characterized by a slower and constant rate of decay.

After receipt of Octagam 300 to 450 mg/kg every 3 weeks or 400 to 600 mg/kg every 4 weeks, the mean total IgG serum concentration decreased approximately 47% to 55% over 28 days. The mean trough total IgG concentration after 6 or 7 infusions of Octagam was 766 to 871 mg/dL. The concentrations were similar to the patient's baseline trough total concentrations (883 to 986 mg/dL) on other IVIG products.

Some immune globulin products (e.g., Gammagard Liquid, Gamunex-C) have been administered as subcutaneous infusions. The subcutaneous dose required to provide an exposure non-inferior to the exposure from intravenous (IV) administration was 137% of the IV dose.[42655][54339][51240] Specifically, the mean adjusted SC dose was 137.3% (125.7 to 150.8%) of the IV dose for patients at least 12 years of age and 141% (100.5% to 160%) for patients younger than 12 years old. After subcutaneous administration, the peak IgG concentration occurred 2.9 (1.2 to 3.2) days later, and the mean peak concentration was 1,393 +/- 289 mg/dL. The mean trough concentration was 1,202 +/- 282 mg/dL. As compared with IV administration, the mean peak concentration was lower after subcutaneous administration, and the mean trough concentration was higher.[42655]

Neonates

Volume of distribution in neonates has been reported with variance, ranging from 0.04 to 0.25 L/kg. The IVIG half-life is comparable to normal adult parameters with a reported range of 18 to 29 days.[53227][53228][53229] In a study of 15 neonates (gestational age 32 to 41 weeks; birth weight more than 1,500 grams), IVIG infusions of 500 mg/kg resulted in a mean peak IgG concentration of 2,171 mg/dL, 15 minutes after infusion; this dosage resulted in a significant increase in IgG concentrations greater than 8 days after the infusion. IVIG infusions of 1,000 mg/kg resulted in mean peak IgG concentrations of 2,734 mg/dL and resulted in significant increases in IgG concentrations more than 11 days after the infusion. A biphasic decay curve resulted in an initial rapid decay within 24 hours after infusion followed by a slower decay over the next 6 weeks. Plasma clearance was 3 mL/kg/day. Gestational age, birth weight, dose, and pretreatment serum IgG concentrations had minimal effect on pharmacokinetic parameters.[53228]

Children and Adolescents

The pharmacokinetics of intravenous and subcutaneous immune globulin are similar in children, adolescents, and adults.[51240] Both intravenous and subcutaneous infusions of immune globulin appear to be effective in children and with similar trough IgG concentrations achieved as in adults.[54339] No pediatric specific dose requirements are necessary to achieve the desired serum IgG levels. Dosage, as in adults, must be individualized and adjusted over time to achieve the desired trough levels and clinical responses.

Immunodeficiency

Immunodeficiency appears to be associated with a longer half-life of IgG. For example, the apparent half-life of IgG after Octagam is approximately 40 days (range, 23 to 84 days) in immunosuppressed patients.[30276] As there are significant differences in the half-life of IgG among patients with primary immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient.