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TRANSFORMAR COMO VOCÊ USA INFORMAÇÕES SOBRE DROGAS
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Due to a lack of sufficient evidence, the National Institutes of Health (NIH) COVID-19 treatment guidelines recommend neither for or against the use of vilobelimab to treat COVID-19.[65314]
800 mg IV for up to 6 doses while hospitalized, even if discharged from the intensive care unit (ICU). The first dose must be given within 48 hours of intubation (Day 1), followed by doses on Days 2, 4, 8, 15, and 22.[68815]
800 mg IV.
800 mg IV.
Use not authorized.
Use not authorized.
Use not authorized.
Use not authorized.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† Off-label indication
Vilobelimab is an investigational monoclonal immunoglobulin G4 (IgG4-kappa) antibody that works as an immunomodulator by binding to complement factor 5a (C5a). The drug is not an FDA-approved medication; however, it has been authorized for emergency use to treat coronavirus disease 2019 (COVID-19) in hospitalized adults who are within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Vilobelimab is administered via intravenous infusion for up to 6 doses if the patients remains hospitalized, even if discharged from the intensive care unit (ICU). Healthcare providers are advised to monitor for signs and symptoms of new infections during and after treatment, as serious bacterial, fungal, and viral infections have been reported.[68815] Due to a lack of sufficient evidence, the National Institutes of Health (NIH) COVID-19 treatment guidelines recommend neither for or against the use of vilobelimab to treat COVID-19.[65314]
For storage information, see the specific product information within the How Supplied section.
NOTE: Vilobelimab is not an FDA-approved medication; however, it has been authorized for emergency use to treat hospitalized adults with coronavirus disease (COVID-19) who are within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Under the Emergency Use Authorization (EUA), healthcare providers are required to communicate to the patient or caregiver information consistent with the "Fact Sheet for Patients and Caregivers" prior to the patient receiving treatment. However, if providing this information will delay administration of the drug to a degree that would endanger the life of the patient, then information must be provided to the caregiver as soon as feasible after administration.
NOTE: Under the EUA, healthcare providers are required to report all medication errors and serious adverse events potentially related to vilobelimab therapy within 7 calendar days from the healthcare provider's awareness of the event.[68815]
Preparation
Intermittent IV infusion
During the clinical trial, nonfatal serious infections occurred in 33.1% of patients who received vilobelimab and 29.1% of patients in the placebo group. The most commonly reported nonfatal serious infections included non-COVID-19 pneumonia (18.9% for vilobelimab vs. 13.8% for placebo), sepsis (14.9% vs. 7.4%), and septic shock (9.1% vs 7.4%). The overall rate of non-COVID-19 pneumonia and sepsis (i.e., serious and non-serious) in vilobelimab recipients was 31.4% and 21.7%, respectively. Other infectious adverse events reported in patients treated with vilobelimab included herpes simplex (6.3%), enterococcal infection (5.7%), bronchopulmonary aspergillosis (5.7%), urinary tract infection (5.1%), and respiratory tract infection (4%).[68815]
Cardiovascular adverse events reported by recipients of vilobelimab during the clinical trial include pulmonary embolism (10.9%), hypertension (9.1%), deep vein thrombosis (6.3%), and supraventricular tachycardia (SVT) (4%).[68815]
Respiratory adverse events reported by recipients of vilobelimab during the clinical trial include pneumothorax (8%), hypoxia (4.6%), and pneumomediastinum (4.6%).[68815]
During the clinical trial, 5.1% of patients treated with vilobelimab developed elevated hepatic enzymes and 4.6% developed thrombocytopenia.[68815]
Delirium, including intensive care unit delirium, was observed in 12.6% of patients who received vilobelimab during the clinical trial.[68815]
Constipation was reported in 3.4% of patients who received treatment with vilobelimab during the clinical trail.[68815]
Rash was reported in 3.4% of patients who received treatment with vilobelimab during the clinical trail.[68815]
During the clinical trial, 2 patients experienced treatment induced anti-drug antibody formation; one in the vilobelimab treatment group and 1 in the placebo group. The clinical relevance of these anti-drug antibodies is unclear.[68815]
Monitor patients receiving treatment with vilobelimab for signs of a hypersensitivity reaction. If a serious hypersensitivity reaction occurs, discontinue use of vilobelimab and initiate appropriate therapy.[68815]
Serious bacterial, fungal, and viral infections have been reported in patients receiving vilobelimab; therefore, it is recommended to monitor for signs and symptoms of new infections during and after treatment. There are limited data on the use of vilobelimab in COVID-19 patients who have a concomitant active serious infection. If a concurrent infection is identified, consider the risk and benefits of using vilobelimab to treat COVID-19.[68815]
No data are available regarding the use of vilobelimab during human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. In a study conducted in cynomolgus monkeys, placental transfer of vilobelimab was observed, but there was no evidence of fetal harm following administration of doses throughout pregnancy that were 2.5-times the maximum recommended human dose (MRHD) on a mg/kg basis. Of note, placental transfer of monoclonal antibodies such as vilobelimab is higher during the third trimester; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.[68815]
There are no data available regarding the presence of vilobelimab in human milk, the effects on the breast-fed infant, or the effects on milk production. Maternal immunoglobulin G (IgG) is known to be present in human milk. However, if vilobelimab is transferred into human milk, the effects of local gastrointestinal (GI) exposure and potential limited systemic exposure in the infant to the drug are unknown. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, the potential for viral transmission to SARS-CoV-2-negative infants, and the risk of an untreated or inadequately treated condition.[68815]
Vilobelimab is an investigational chimeric (human/mouse) monoclonal immunoglobulin G4 (IgG4-kappa) antibody authorized for the treatment of certain patients with COVID-19. The drug acts as an immunomodulator by binding to complement factor 5a (C5a) and blocking its interaction with the C5a receptor. By preventing the binding of C5a to the C5a receptor, vilobelimab prevents initiation of an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.[68815]
Revision Date: 09/27/2024, 01:34:38 PMVilobelimab is administered via intravenous infusion. Pharmacokinetic data are limited; however, the elimination half-life of a single 4 mg/kg intravenous dose in healthy subjects is 95 hours.[68815]
Affected cytochrome P450 isoenzymes and drug transporters:none
Following single intravenous infusions ranging from 2 mg/kg to 4 mg/kg in healthy subjects, maximum plasma concentration (Cmax) of vilobelimab showed dose proportionality while drug exposure (AUC) showed greater than dose proportionality. In patients with severe COVID-19 pneumonia requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received intravenous infusions on Days 1, 2, and 4, the pre-dose geometric mean plasma concentration (geometric CV%) of vilobelimab on Day 8 was 137.9 mcg/mL (51%).[68815]
No data are available regarding the use of vilobelimab during human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. In a study conducted in cynomolgus monkeys, placental transfer of vilobelimab was observed, but there was no evidence of fetal harm following administration of doses throughout pregnancy that were 2.5-times the maximum recommended human dose (MRHD) on a mg/kg basis. Of note, placental transfer of monoclonal antibodies such as vilobelimab is higher during the third trimester; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.[68815]
There are no data available regarding the presence of vilobelimab in human milk, the effects on the breast-fed infant, or the effects on milk production. Maternal immunoglobulin G (IgG) is known to be present in human milk. However, if vilobelimab is transferred into human milk, the effects of local gastrointestinal (GI) exposure and potential limited systemic exposure in the infant to the drug are unknown. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, the potential for viral transmission to SARS-CoV-2-negative infants, and the risk of an untreated or inadequately treated condition.[68815]
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