vilobelimab

Therapeutic Classification: antivirals

Pharmacologic Classification: complement.inhibitors, monoclonal antibodies

Indications ⬆ ⬇

REMS

Coronavirus disease 2019 (COVID-19) in hospitalized adults when initiated within 48 hr of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.
An emergency use authorization (EUA) has been issued for this use of vilobelimab; this drug is not FDA-approved for the above indication.

Action ⬆ ⬇

Monoclonal antibody that binds to C5a and prevents it from interacting with the C5a receptor. C5a is part of the complement system; when activated, it initiates an inflammatory cascade, including increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.

Therapeutic effects:

Improved survival.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 95 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: DEEP VEIN THROMBOSIS (DVT), hypertension, supraventricular tachycardia

Derm: rash

GI: constipation, ↑liver enzymes

Hemat: thrombocytopenia

Neuro: delirium

Resp: pulmonary embolism (PE), hypoxia, pneumothorax

Misc: hypersensitivity reactions, INFECTION

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults ): 800 mg on Days 1, 2, 4, 8, 15, and 22 for a maximum of 6 doses (as long as the patient remains hospitalized).

Availability ⬆ ⬇

Solution for injection: 10 mg/mL

Assessment ⬆ ⬇

Monitor for signs and symptoms (fever, chills) of new infections (bacterial, fungal, and viral pathogens) during and after treatment.
Monitor for signs and symptoms of DVT (swelling, warmth, change of color in leg or arm) and PE (chest pain or pressure, coughing up blood, shortness of breath).
Assess vital signs and respiratory status, including oxygen saturation levels and oxygen effort.
Assess for hypersensitivity reactions (rash, itching, flushing, anaphylaxis). If these occur, discontinue and initiate appropriate therapy.

Lab Test Considerations:

Obtain CBC, BUN, and serum creatinine at baseline and throughout therapy. Monitor for leukopenia, anemia, and thrombocytopenia.
Monitor C-reactive protein, procalcitonin, blood cultures, and lactate levels.
Monitor coagulation studies, D-dimer, and PT/aPTT.

Implementation ⬆ ⬇

IV Administration:

Intermittent Infusion: Diluent: Withdraw 80 mL of 0.9% NaCl from a 250 mL infusion bag and discard. Inject 80 mL of vilobelimab into infusion bag. Gently invert the bag to avoid foaming. Visually inspect for particulate matter and discoloration before administration. Do not use if discoloration or visible particles are present. Diluted solution must be used within 4 hr when stored at room temperature. Diluted solution can be stored under refrigeration and must be used within 24 hr. The bag must be left to acclimatize to room temperature before administration. Concentration: 3.2 mg/mL. Rate: Infuse over 30–60 min.
Y-Site Incompatibility:
- Do not administer other drugs through same IV line.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions, DVT, or PE occur.
Advise patient of risk of getting an infection. Some infections can be severe. Wash hands often. Stay away from people with infections, colds, or flu.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

71851- Wuxi Biologics Co., Ltd.
- 71851-003-
  - 71851-003-01- 20 mL in 1 VIAL, SINGLE-DOSE (71851-003-01)

83000- InflaRx GmbH
- 83000-110- GOHIBIC
  - 83000-110-04- 4 VIAL, SINGLE-DOSE in 1 CARTON (83000-110-04) / 20 mL in 1 VIAL, SINGLE-DOSE

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Pronunciation ⬇

Classifications ⬆ ⬇