Avelumab

Approved Indications

Avelumab is indicated for the treatment of:

• Metastatic Merkel Cell Carcinoma (MCC) in adults and pediatric patients ≥12 years
• Locally advanced or metastatic urothelial carcinoma as maintenance treatment after platinum-based chemotherapy without disease progression
• Advanced renal cell carcinoma (RCC) in combination with axitinib as first-line therapy

Off-Label / Clinically Accepted Uses

• Investigational use in combination immunotherapy regimens for advanced solid tumors

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults

Metastatic Merkel Cell Carcinoma (MCC)

• 800 mg intravenously every 2 weeks over 60 minutes

Urothelial Carcinoma

• 800 mg intravenously every 2 weeks as maintenance therapy after platinum-based chemotherapy in patients without disease progression.

Advanced Renal Cell Carcinoma (RCC)

• 800 mg intravenously every 2 weeks in combination with:

o    Axitinib 5 mg orally twice daily

Pediatrics

·         Approved for metastatic Merkel cell carcinoma in patients 12 years and older.

·         Recommended dose:

o    800 mg IV every 2 weeks

Elderly

·         No specific dose adjustment generally required.

·         Clinical monitoring is recommended.

Special Populations

Renal Impairment

·         No clinically significant dosage adjustment usually required.

·         Limited data available in dialysis patients.

Hepatic Impairment

·         No dosage adjustment generally required in mild to moderate impairment.

·         Use cautiously in severe hepatic impairment.

Administration Instructions

·         Administer as an intravenous infusion over 60 minutes.

·         Do not administer as IV push or bolus.

·         Premedication with an antihistamine and acetaminophen is recommended before the first 4 infusions to reduce infusion-related reactions.

·         Continue premedication if infusion-related reactions occur.

Dose Modification

Treatment may need to be withheld or permanently discontinued in severe immune-mediated adverse reactions, including:

·         Pneumonitis

·         Colitis

·         Hepatitis

·         Nephritis

·         Endocrine disorders

·         Severe infusion-related reactions

Corticosteroids may be required for management of severe immune-related toxicity.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Avelumab is a human monoclonal antibody that binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interaction with PD-1 receptors on T-cells. This restores antitumor immune response and enhances immune-mediated destruction of cancer cells.

• Distribution: Steady-state volume of distribution approximately 4.7 L
• Metabolism: Degraded into peptides and amino acids through proteolytic pathways
• Excretion: Not excreted unchanged through kidneys or liver
• Half-life: Approximately 6 days
• Clearance: About 0.59 L/day

Antineoplastic Agent — PD-L1 Immune Checkpoint Inhibitor (Monoclonal Antibody)

Pregnancy

• May cause fetal harm based on its mechanism of action
• Use during pregnancy only if clearly necessary

Lactation

• Breastfeeding is not recommended during treatment and for at least 1 month after the last dose

• Known hypersensitivity to avelumab or any component of the formulation

• Immune-mediated adverse reactions may occur, including:
• Pneumonitis
• Colitis
• Hepatitis
• Endocrinopathies
• Nephritis
• Severe skin reactions
• Infusion-related reactions may occur
• Monitor liver, kidney, and thyroid function during therapy

Common

• Fatigue
• Musculoskeletal pain
• Nausea
• Diarrhea
• Rash
• Constipation
• Infusion-related reactions

Serious

• Immune-mediated pneumonitis
• Hepatitis
• Colitis
• Endocrine disorders
• Severe hypersensitivity reactions

• No major CYP-mediated drug interactions expected
• Additional precautions may be required when used with axitinib

Avelumab is internationally approved as a PD-L1 checkpoint inhibitor for selected advanced cancers and is widely used in modern cancer immunotherapy protocols.

Human IgG1 monoclonal antibody targeting PD-L1

Store refrigerated at 2°C–8°C. Do not freeze or shake. Protect from light.