Avelumab

Cytostatic · Monoclonal antibody

Indications

For the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). First-Line Maintenance Treatment of Urothelial Carcinoma of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Dosage

Adults & Children: Age 12 years and older: Administer as IV infusion over a period of 60 minute. Premedicate for the first 4 infusions and subsequently as needed. Merkel Cell Carcinoma: 800 mg every 2 weeks. Urothelial Carcinoma: 800 mg every 2 weeks. Renal Cell Carcinoma: 800 mg every 2 weeks in combination with axitinib 5 mg orally twice daily Children: Below 12 year age not recommended.

Administration

Withdraw the required volume of Avelumab from the vial(s) and inject it into a 250 mL infusion bag containing either 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection. Gently invert the bag to mix the diluted solution and avoid foaming or excessive shearing.

Adverse Effects

Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema, urinary tract infection, rash, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated effect not determined.

Interactions

Axitinib, systemic corticosteroids.

Advice to Patient

Advise patients to report immediately for new or worsening cough, chest pain, or shortness of breath, jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding, diarrhea or severe abdominal pain. Advise patients to report immediately for signs or symptoms of adrenal insufficiency, hypothyroidism, hyperthyroidism, and diabetes mellitus, decreased urine output, blood in urine, swelling in ankles, loss of appetite, and any other symptoms of renal dysfunction, chest discomfort, dyspnea, or peripheral edema. Advise patients to use contraceptive. Advise nursing mothers not to breastfeed for at least one month after the final dose.

Pharmacokinetics

Half-life, elimination: 6.1 days. Excretion: Total systemic clearance was 0.59 L/day in patients receiving a 10mg/kg dose.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.