Cemiplimab-rwlc

Class: Antineoplastic Agents
- Programmed death receptor-1 antagonist
- PD-1 Inhibitor
Chemical Name: Anti-(human programmed cell death protein 1) (human monoclonal REGN2810 heavy chain), disulfide with human monoclonal REGN2810 k-chain immunoglobulin G4 dimer
Molecular Formula: C₆₃₈₀H₉₈₀₈N₁₆₈₈O₂₀₀₀S₄₄
CAS Number: 1801342-60-8
Brands: Libtayo

Medically reviewed by Drugs.com on Aug 16, 2021. Written by ASHP.

Introduction

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

Uses for Cemiplimab-rwlc

Cutaneous Squamous Cell Carcinoma

Treatment of metastatic or locally advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or radiation therapy.

Cemiplimab-rwlc Dosage and Administration

General

• Monitor blood chemistries and liver and thyroid function tests prior to initiation of and periodically during therapy.

Restricted Distribution

• Available through a limited network of speciality distributors or pharmacies. Consult the Libtayo website ([Web]) for specific ordering and availability information.

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Cemiplimab-rwlc injection concentrate must be diluted prior to administration.

Administer using a sterile, 0.2- to 5-μm inline or add-on filter.

Dilution

Undiluted solution should be clear to slightly opalescent and colorless to pale yellow. Do not use if cloudy or discolored or if particulate matter other than trace amounts of the translucent to white particles are present.

Withdraw 7 mL of cemiplimab-rwlc injection concentrate (containing 50 mg/mL) and dilute in a sufficient volume of 0.9% sodium chloride injection or 5% dextrose injection to a final concentration of 1–20 mg/mL. Mix diluted solution by gentle inversion; do not shake.

Discard any partially used vial.

If the diluted solution was previously refrigerated, bring to room temperature prior to administration.

Rate of Administration

Administer by IV infusion over 30 minutes.

Dosage

Adults

Cutaneous Squamous Cell Carcinoma

IV

350 mg every 3 weeks. Continue therapy until disease progression or unacceptable toxicity occurs.

Therapy Interruption for Toxicity

Permanently discontinue therapy in patients experiencing persistent grade 2 or 3 immune-mediated adverse effects lasting ≥12 weeks and those requiring a corticosteroid dosage of ≥10 mg of prednisone daily (or equivalent) for ≥12 weeks. (See Warnings/Precautions under Cautions.)

Permanently discontinue therapy if grade 3 or 4 immune-mediated adverse effects recur.

Immune-mediated Pneumonitis

If grade 2 immune-mediated pneumonitis occurs, interrupt therapy until recovery to grade 0 or 1. May resume following comple.