Bavencio Injection

Product Description

1. Technical Specifications

2. Product Description

Bavencio 200 mg Injection contains Avelumab, a fully human IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1).

It works by binding to PD-L1 and blocking its interaction with PD-1 and B7.1 receptors. This prevents cancer cells from evading immune system detection, thereby restoring T-cell mediated antitumor activity.

3. Product Highlights

4. Therapeutic Uses

Bavencio is indicated for:

• Metastatic Merkel Cell Carcinoma (MCC) adults and pediatric patients 12 years

• Locally advanced or metastatic Urothelial Carcinoma (UC) previously treated with platinum chemotherapy

• Renal Cell Carcinoma (RCC) in combination with Axitinib as first-line treatment for advanced RCC

5. Side Effects

Common:

• Fatigue, weakness

• Nausea, vomiting, diarrhea

• Rash, itching, infusion-related reactions

• Loss of appetite

• Cough, dyspnea

• Muscle and joint pain

Serious / Severe (immune-mediated):

• Pneumonitis

• Hepatitis, elevated liver enzymes

• Colitis (diarrhea, abdominal pain)

• Endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes)

• Nephritis / renal dysfunction

• Severe infusion-related reactions (fever, chills, low BP, breathing difficulty)

6. Precautions

• Immune-Related Monitoring: Watch for pneumonitis, colitis, hepatitis, nephritis, and endocrinopathies; treat promptly with corticosteroids if severe.

• Infusion Reactions: Monitor closely during and after infusion; premedication may be required.

• Pregnancy & Breastfeeding: Contraindicated may cause fetal harm; avoid breastfeeding during and at least 1 month after last dose.

• Autoimmune Disorders: Use caution; may worsen underlying conditions.

• Organ Transplant Recipients: Risk of transplant rejection due to immune activation.

• Dose Adjustments: Interrupt or discontinue in severe/life-threatening immune-mediated toxicities.