Inebilizumab-cdon

Class: Immunomodulatory Agents
CAS Number: 1299440-37-1
Brands: Uplizna

Medically reviewed by Drugs.com on Jul 27, 2020. Written by ASHP.

Introduction

Inebilizumab-cdon, a recombinant humanized monoclonal antibody, is an immunomodulatory agent.

Uses for Inebilizumab-cdon

Inebilizumab-cdon has the following uses:

Inebilizumab-cdon is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Inebilizumab-cdon Dosage and Administration

General

Inebilizumab-cdon is available in the following dosage form(s) and strength(s):

• Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• Screen for hepatitis B virus (HBV), quantitative serum immunoglobulins, and tuberculosis before the first dose.

• Prior to every infusion, determine if there is an active infection; delay the infusion until the active infection resolves.

• Prior to every infusion, premedicate with a corticosteroid, an antihistamine, and an antipyretic to reduce frequency and severity of infusion reactions.

• Monitor patients closely during each infusion and for at least 1 hour after completion of each infusion.

• Inebilizumab-cdon must be diluted in 250 mL of 0.9% sodium chloride injection, USP, prior to administration.

• Inebilizumab-cdon is administered by intravenous infusion using increasing infusion rates titrated per the manufacturer's instructions to complete the infusion within approximately 90 minutes.

• Initial doses: 300 mg by intravenous infusion, followed 2 weeks later by a second 300-mg dose by intravenous infusion.

• Subsequent doses (starting 6 months after the first infusion): Single 300-mg dose by intravenous infusion once every 6 months.

Cautions for Inebilizumab-cdon

Contraindications

• Previous life-threatening reaction to infusion of inebilizumab-cdon.

• Active HBV infection.

• Active or untreated latent tuberculosis.

Warnings/Precautions

Infusion Reactions

Inebilizumab-cdon can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other signs or symptoms. During the randomized ...