Tafasitamab-cxix

Class: Antineoplastic Agents
Chemical Name: Anti-(human CD19 antigen) (human-Mus musculus monoclonal MOR00208 heavy chain), disulfide with human-Mus musculus monoclonal MOR00208 k-chain dimer, immunoglobulin G1-G2-kappa
Molecular Formula: C₆₅₅₀H₁₀₀₉₂N₁₇₂₄O₂₀₄₈S₅₂
CAS Number: 1422527-84-1
Brands: Monjuvi

Medically reviewed by Drugs.com on May 24, 2021. Written by ASHP.

Introduction

Antineoplastic agent; anti-CD19 monoclonal antibody.

Uses for Tafasitamab-cxix

Diffuse Large B-cell Lymphoma (DLBCL)

Used in combination with lenalidomide for the treatment of relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, in those who are not candidates for autologous stem cell transplant (designated an orphan drug by FDA for this use).

Accelerated approval based on overall response rate; continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Tafasitamab-cxix Dosage and Administration

General

• To minimize risk of infusion-related reactions, premedicate with an antihistamine, acetaminophen, histamine H₂-receptor antagonist, and/or corticosteroid 30 minutes to 2 hours prior to infusion of tafasitamab. Premedication is not necessary for subsequent infusions if infusion-related events do not occur during the first 3 infusions of the drug. If infusion-related reactions occur, premedicate prior to subsequent infusions of the drug.

• Administer only in settings where emergency equipment and appropriate medical support is available. (See Infusion-related Effects under Cautions.)

Restricted Distribution

Obtain through designated specialty distributors.

Administration

IV Administration

Administer by IV infusion. Do not infuse simultaneously through the same IV line with any other drug.

Reconstitution

Reconstitute appropriate number of vials containing 200 mg of tafasitamab-cxix to achieve desired dose.

Reconstitute each vial containing 200 mg of tafasitamab-cxix with 5 mL of sterile water for injection to provide a solution containing 40 mg/mL. Direct diluent toward the wall of the vial. Gently swirl vial; dissolution of the powder may take up to 5 minutes. Do not shake or vigorously swirl vial.

Reconstituted solution should be colorless to slightly yellow. Discard solution if it is cloudy, discolored, or contains a precipitate.

Dilute reconstituted solution immediately or store at 2–8ºC or 20–25ºC for use within 12 hours. Do not freeze; protect from light until use.

Dilution

Withdraw and discard volume equivalent to the volume of the appropriate dose of tafasitamab-cxix from an infusion bag containing 250 mL of 0.9% sodium chloride injection.

To prepare final diluted solution for infusion, slowly add appropriate dose of reconstituted tafasitamab-cxix solution to the infusion bag containing 0.9% sodium chloride injection to yield a final concentration of 2–8 mg/mL. Mix by gentle inversion; do not shake.

Discard any pa...