Vilobelimab (Monograph)

Drug class: Monoclonal Antibodies
Molecular formula: C₆₄₅₆H₉₉₇₆O₂₀₅₄S₄₄
CAS number: 2250440-41-4

Introduction

Antiviral; anti-C5a monoclonal antibody.

Uses for Vilobelimab

Coronavirus Disease 2019 (COVID-19)

Vilobelimab is available under an emergency use authorization (EUA) for treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Consult the vilobelimab EUA letter of authorization ([Web]), EUA fact sheet for health care providers ([Web]), and EUA fact sheet for patients and caregivers ([Web]) for additional information.

National Institutes of Health (NIH) COVID-19 treatment guideline recommends administration of dexamethasone to all patients with COVID-19 who require mechanical ventilation or ECMO. The guideline also recommends that a second immunomodulator in addition to dexamethasone, either oral baricitinib or IV tocilizumab, should be promptly added to therapy if such therapy is not currently administered.

Infectious Disease Society of America (IDSA) COVID-19 treatment guideline recommends dexamethasone administration in hospitalized patients with critical disease. Equivalent total daily doses of alternative glucocorticoids may be administered if dexamethasone is unavailable. IDSA guideline also suggests the use of tocilizumab or sarilumab in this setting.

Recommendations for use of vilobelimab in patients who require mechanical ventilation or ECMO not currently available in either guideline. Consult the most recent NIH ([Web]) and IDSA ([Web]) treatment guidelines for additional information as updates occur frequently.

Related/similar drugs

Paxlovid, Lagevrio, remdesivir, molnupiravir, Actemra, nirmatrelvir / ritonavir

Vilobelimab Dosage and Administration

General

Patient Monitoring

• Monitor for hypersensitivity reactions during administration.

• Monitor for signs and symptoms of new infections during and after treatment.

Dispensing and Administration Precautions

• Completion of FDA MedWatch forms to report all medications errors and all serious adverse events potentially related to vilobelimab is mandatory. The FDA fact sheet for health care providers should be consulted for requirements and instructions regarding reporting of adverse reactions and medication errors.

Administration

Parenteral

Administer via IV infusion. Do not administer with other medications in the same IV line.

Dilution

Dilute recommended dose of vilobelimab in 0.9% sodium chloride as follows:

• Withdraw 80 mL of 0.9% sodium chloride from a 250 mL 0.9% sodium chloride infusion bag and discard.

• Withdraw 80 mL of vilobelimab from vials and slowly add to the 0.9% sodium chloride infusion bag to a final concentration of 3.2 mg/mL.

• Gently invert the infusion bag to avoid foaming and mix the solution.

Dosage

Adults

Treatment of COVID-19

IV infusion

800 mg, for a maximum of 6 doses. Initiate within 48 hours of intubation (Day 1) and then administer on Days 2, 4, 8, 15, and 22 if the patient is hospitalized.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Vilobelimab

Contraindications

• None.

Warnings/Precautions

Serious Infections

Serious infections (bacterial, fungal, viral) have been reported. Monitor patients for signs and symptoms of new infections during and after treatment. Consider risks and benefits of therapy in patients with COVID-19 and other concurrent infections.

Hypersensitivity Reactions

Hypersensitivity reactions have been reported. Immediately discontinue therapy upon occurrence of signs and/or symptoms of a severe hypersensitivity reaction and initiate appropriate treatment.

Immunogenicity

Potential for immunogenicity development with therapy. In the Phase 3 clinical study, 2 patients developed anti-drug antibodies (1 in the vilobelimab group and 1 in the placebo group). Clinical significance of anti-drug antibody development is unclear.

EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

Safety and efficacy of vilobelimab not established. FDA EUA that permits use of vilobelimab for the treatment of COVID-19^{† [off-label]} in certain hospitalized adults requires use of dosages recommended in the EUA.

Only limited data are available to date regarding adverse effects with vilobelimab. Serious and unexpected adverse events may occur that have not been previously reported with use.

Completion of FDA MedWatch forms to report all medication errors and serious adverse events potentially related to vilobelimab is mandatory. Consult FDA fact sheet for health care providers for requirements and instructions regarding reporting of adverse reactions and medication errors.

Specific Populations

Pregnancy

Data insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Monoclonal antibodies cross the placenta to a greater degree during the third trimester of pregnancy; therefore, potential fetal effects are more likely to occur during this trimester.

NIH COVID-19 Treatment Guidelines Panel recommends against withholding COVID-19 treatments because of pregnancy status.

Lactation

Not known whether vilobelimab is distributed into human or animal milk or has effects on the breast-fed infant or on milk production. Maternal immunoglobulin G (IgG) is known to be present in human milk.

Developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

NIH COVID-19 Treatment Guidelines Panel recommends against withholding COVID-19 treatments because of lactation status.

Pediatric Use

FDA EUA does not permit use of vilobelimab for treatment of COVID-19 in hospitalized pediatric patients when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.

Geriatric Use

In clinical studies evaluating use for patients receiving invasive mechanical ventilation or ECMO, 53 (30%) were >65 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger adults.

Hepatic Impairment

Manufacturer does not make recommendations regarding use in patients with hepatic impairment.

Renal Impairment

Manufacturer does not make recommendations regarding use in patients with renal impairment.

Common Adverse Effects

Adverse effects (≥3%) include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, increased hepatic enzymes, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.

Drug Interactions

No formal drug interaction studies conducted to date.

Vilobelimab Pharmacokinetics

Absorption

Maximum serum concentration showed dose proportionality and AUC showed greater than dose proportionality following single 2 to 4 mg/kg IV infusion.

Distribution

Not known whether vilobelimab distributes into human milk.

Elimination

Half-Life

95 hours after a single 4 mg/kg IV dose (healthy subjects).

Stability

Storage

Parenteral

Store unopened vials under refrigeration (2–8°C) in the original carton. Protect from light and do not freeze or shake.

Use diluted vilobelimab within 4 hours if stored at room temperature (20–25°C) or 24 hours when stored under refrigeration (2–8°C). Once removed from refrigeration, allow the diluted solution to acclimatize to room temperature prior to administration.

Actions

• Binds to C5a, thereby blocking interaction of C5a with its receptor.

• Activation of C5a, as part of the innate immune response, results in initiation of an inflammatory cascade (e.g., increased vascular permeability, coagulation, proinflammatory cytokine release, recruitment and activation of neutrophils and other myeloid cells).

Advice to Patients

The Fact Sheet for Patients and Caregivers: Emergency Use Authorization (EUA) of Vilobelimab for Coronavirus Disease 2019 (COVID-19), available at [Web], must be provided to patients or caregivers prior to administration of vilobelimab.

• Inform patients that FDA authorized the emergency use of vilobelimab, which is an investigational drug that has not received FDA approval, for treatment of COVID-19 in certain hospitalized adult patients.

• Inform patients that they have the option to accept or refuse vilobelimab.

• Provide patients with information on available alternative treatments and the risks and benefits of those alternatives.

• Advise patients of the potential for severe hypersensitivity reactions with vilobelimab administration and to report any reactions that occur during or after administration (e.g., trouble breathing, rash, swelling of the face, eyes, lips, mouth, tongue, or throat).

• Advise patients to monitor for any signs and symptoms of serious infection during and after vilobelimab therapy since the drug can lower the ability of the immune system to fight infections other than COVID-19.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Advise patient to inform their clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise patients of other important precautionary information.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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