vilobelimab (Investigational)

>10%

Pneumonia (other than COVID-19) (31.4%)

Sepsis (21.7%)

Delirium (12.6%)

Pulmonary embolism (10.9%)

1-10%

Hypertension (9.1%)

Pneumothorax (8%)

Deep vein thrombosis (6.3%)

Herpes simplex (6.3%)

Enterococcal infection (5.7%)

Bronchopulmonary aspergillosis (5.7%)

Hepatic enzyme increased (5.1%)

Urinary tract infection (5.1%)

Hypoxia (4.6%)

Thrombocytopenia (4.6%)

Pneumomediastinum (4.6%)

Respiratory tract infection (4%)

Supraventricular tachycardia (4%)

Constipation (3.4%)

Rash (3.4%)

Required Reporting

Serious and unexpected adverse events may occur not previously reported with this therapy

Prescribers and/or the provider’s designee are/is responsible for mandatory reporting of all serious adverse events and medication errors potentially drug-related within 7 calendar days from the onset of the event

Serious adverse events are defined as

• Death or life-threatening adverse event;
• Medical or surgical intervention to prevent death, life-threatening event, hospitalization, disability, or congenital anomaly;
• Inpatient hospitalization or prolongation of existing hospitalization;
• Persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; or
• Congenital anomaly/birth defect

How to report

• Complete and submit the report online
• Complete and submit a postage-paid FDA Form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
• Fax to 1-800-FDA-0178, or Call 1-800-FDA-1088 to request a reporting form

Contraindications

None

Cautions

Serious infections

• Serious infections due to bacterial, fungal, and viral pathogens reported
• Monitor for signs and symptoms of new infections during and after treatment
• Information is limited regarding use in patients with COVID-19 and concomitant active serious infections
• Consider risks and benefits of treatment with vilobelimab in patients with concurrent infections

Hypersensitivity reactions

• Hypersensitivity reactions observed
• If severe hypersensitivity reaction occurs, discontinue administration and initiate appropriate therapy

Drug interactions

• No drug interaction studies have been conducted

Pregnancy

There are no available data on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Placental transfer of monoclonal antibodies is greater during third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during that time

Animal studies

• In an enhanced pre- and post-natal (ePPND) study conducted in cynomolgus monkeys, placental transport of vilobelimab was observed, but there was no evidence of fetal harm following IV administration throughout pregnancy at doses 2.5 times the maximum recommended human dose (MRHD) of 800 mg on a mg/kg basis

Lactation

Data are unavailable regarding presence of vilobelimab in either human or animal milk, effects on breastfed infants, or effects on milk production

Maternal IgG is known to be present in human milk

Effects of local gastrointestinal exposure and limited systemic exposure in breastfed infants are unknown

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Chimeric human/mouse immunoglobulin G4 (IgG4) antibody consisting of mouse anti-human complement factor 5a (C5a) monoclonal binding sites

C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells

Absorption

Plasma concentration (Day 8): 137 mcg/mL

Elimination

Half-life: 95 hr

IV Incompatibilities

Avoid concomitant administration with other drugs in same IV line

IV Compatibilities

0.9%NaCl

IV Preparation

Dilute 80 mL (800 mg) in 170 mL of 0.9% NaCl at room temperature

Using a 250 mL infusion bag of 0.9% NaCl, follow steps below

• Withdraw 80 mL from 250 mL infusion bag of 0.9% NaCl and discard
• Withdraw 80 mL (800 mg) of vilobelimab from vials and add slowly to infusion bag
• Final concentration = 3.2 mg/mL
• Mix by gently inverting bag to avoid foaming
• If diluted solution refrigerated, allow it to acclimate to room temperature before administration

IV Administration

Visually inspect diluted solution for particulate matter and discoloration before administration; discard if discoloration or visible particles are present

Administer IV over 30-60 minutes

Storage

Unopened vials

• Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
• Do not freeze
• Do not shake

Diluted solution

• Use within 4 hr of preparation if stored at 20-25ºC (68-77ºF)
• Use within 24 hr of preparation if refrigerated at 2-8ºC (36-46ºF)