Registered South Africa · SAHPRA

BAVENCIO 20 mg/ml

AVELUMAB

61/30.5/0848 antineoplastic and immunomodulating agents INN generic

What it does

Avelumab is a medication used to help the immune system fight certain types of cancer.

Commonly used for: Merkel cell carcinoma, urothelial carcinoma, non-small cell lung cancer

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Registration & product details

Registration no.
61/30.5/0848
Registration date
2026/03/31
Expiry date
-
Status
Registered
Active ingredient
AVELUMAB
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
L01FF - PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
RxNorm RxCUI
1875534
Manufacturer / MAH
-
Applicant / LTR
Merck (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-26 04:24:03 · updated 2026-09-20 04:02:14

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Avelumab is a medication used to help the immune system fight certain types of cancer.

What it treats

  • Merkel cell carcinoma
  • urothelial carcinoma
  • non-small cell lung cancer

How it works

Avelumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the body to better fight the cancer.

Who it's for

Avelumab is for adults and children with specific types of cancer that are difficult to treat.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Avelumab

BNF-referenced

Avelumab is a human monoclonal antibody targeting programmed death-ligand 1 (PD-L1). By binding to PD-L1, it reactivates the immune response against tumor cells, thereby aiding the body's ability to fight cancer. It is primarily used in the treatment of certain types of malignancies, including Merkel cell carcinoma, renal cell carcinoma, and urothelial carcinoma. As an immunotherapy, it enhances the immune system's recognition and destruction of cancer cells.

Indications

  • Merkel cell carcinoma (specialist use only)
  • Renal cell carcinoma (specialist use only)
  • Urothelial carcinoma (specialist use only)

Dosage

Children: Paediatric dosing information is not provided in the BNF; refer to the BNF for Children for guidance.

Adults: The recommended dosage of avelumab for adults is 800 mg administered every 2 weeks by intravenous infusion.

Mechanism of action

Avelumab binds to the programmed death-ligand 1 (PD-L1), preventing its interaction with programmed death-1 (PD-1) receptors on T-cells. This blockade enhances T-cell activation and proliferation, leading to a robust anti-tumor immune response.

Pharmacodynamics

The binding of avelumab to PD-L1 results in the inhibition of PD-L1-mediated immune suppression, allowing T-cells to exert their cytotoxic effects on tumor cells. This mechanism is crucial in enhancing the immune response against various malignancies, leading to potential tumor regression.

Pharmacokinetics

Avelumab is administered via intravenous infusion. The pharmacokinetics profile of avelumab includes a half-life of approximately 12 to 20 days. The drug is primarily eliminated through the reticuloendothelial system, and its plasma concentration increases proportionally with dose. It is not extensively metabolized by cytochrome P450 enzymes, making it less susceptible to drug-drug interactions.

Adverse effects

  • Infusion-related reactions
  • Immune-related reactions
  • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • Fatigue

Precautions

  • Monitor for signs and symptoms of infusion-related and immune-related reactions
  • Patients with a history of severe SCAR associated with other immunostimulant antineoplastic drugs should be treated with caution
  • Pre-medication may be required to mitigate infusion-related reactions

Pregnancy

Manufacturer advises avoid unless essential-no information available.

Breast-feeding

Manufacturer advises avoid during treatment and for at least 1 month after stopping treatment-no information available.

Storage

Store in a refrigerator (2–8 °C). Consult product literature for storage conditions after preparation of the infusion.

Formulations

  • Solution for infusion: 800 mg/14 ml
BNF 85 (British National Formulary) p.966 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.