Avelumab

What it is and how it works

Avelumab is a fully human IgG1 monoclonal antibody that binds programmed death-ligand 1 (PD-L1), blocking its interaction with PD-1 and B7.1 receptors. This releases suppression of T-cell antitumour responses; it may also mediate antibody-dependent cellular cytotoxicity.

Indications

Metastatic Merkel cell carcinoma; first-line maintenance of locally advanced or metastatic urothelial carcinoma without progression after platinum-based chemotherapy; first-line advanced renal cell carcinoma in combination with axitinib.

Dosage and administration (summary)

Adults: 800 mg by intravenous infusion over 60 minutes every 2 weeks until progression or unacceptable toxicity. Premedication with an antihistamine and paracetamol is required before at least the first 4 infusions.

Contraindications

Hypersensitivity to avelumab or any excipient.

Warnings and precautions

Infusion-related reactions and immune-related adverse reactions (pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, myocarditis, skin reactions) may occur and require monitoring, corticosteroids, and interruption or discontinuation. Hepatotoxicity is more frequent when combined with axitinib; monitor liver function. Thyroid function, glucose and renal function should be checked regularly.

Pregnancy

Not recommended in pregnancy unless clearly necessary; women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose.

Storage and supply

Store vials at 2–8 °C in the original carton to protect from light; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.