Dostarlimab-gxly

Class: Antineoplastic Agents
- Programmed death receptor-1 antagonist
- PD-1 Inhibitor
Chemical Name: Anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 γ4-chain), disulfide with humanized clone ABT1κ-chain immunoglobulin G4 dimer
Molecular Formula: C₆₄₂₀H₉₈₃₂N₁₆₈₀O₂₀₁₄S₄₄
CAS Number: 2022215-59-2
Brands: Jemperli

Medically reviewed by Drugs.com on Feb 18, 2022. Written by ASHP.

Introduction

Antineoplastic agent; humanized anti-programmed-death receptor-1 (anti-PD-1) monoclonal antibody.

Uses for Dostarlimab-gxly

Endometrial Cancer with Mismatch Repair Deficiency

Treatment of mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

Accelerated approval based on objective response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Solid Tumors with Mismatch Repair Deficiency

Treatment of dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment and for which there are no satisfactory alternative treatment options.

Accelerated approval based on objective response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Dostarlimab-gxly Dosage and Administration

General

Pretreatment Screening

• Prior to initiating therapy, confirm deficient mismatch repair (dMMR) tumor status with an FDA-approved diagnostic test.

• Confirm pregnancy status of females of reproductive potential prior to initiation of therapy.

• Evaluate liver function tests, serum creatinine concentrations, and thyroid function tests at baseline.

Patient Monitoring

• Monitor patients closely for manifestations of underlying immune-mediated adverse effects.

• Evaluate and monitor liver enzymes, serum creatinine concentrations, and thyroid function tests at baseline and periodically during treatment.

• Monitor patients for signs and symptoms of infusion-related reactions.

• Monitor patients for hyperglycemia or other manifestations of diabetes mellitus.

Administration

IV Administration

Administer by IV infusion after dilution. Do not administer as an IV push or bolus injection.

Do not co-administer with other drugs through the same infusion line.

Dilution

Must dilute injection concentrate prior to administration. Visually inspect vials of dostarlimab-gxly solution for discoloration or particulates prior to dilution. Undiluted solutions should be clear to slightly opalescent, and colorless to yellow; do not use if visible particles are observed.

To prepare a 500-mg dose: Withdraw 10 mL of dostarlimab-gxly solution from a vial using a polypropylene sterile syringe; dilute in an IV infusion bag containing 0.9% sodium chloride injection or 5% dextrose injection.