Zuellig Pharma
Concise Prescribing Info
Monotherapy for adult patients w/ metastatic Merkel cell carcinoma (MCC) & 1st-line maintenance treatment of adult patients w/ locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed w/ 1st-line platinum-based induction chemotherapy. In combination w/ axitinib for 1st-line treatment of adult patients w/ advanced renal cell carcinoma (RCC).
Dosage/Direction for Use
Monotherapy 800 mg IV infusion over 60 min every 2 wk. Combination therapy 800 mg IV infusion over 60 min every 2 wk & axitinib 5 mg PO bd until disease progression or unacceptable toxicity. Premed Antihistamine & paracetamol prior to 1st 4 infusions.
Special Precautions
Permanently discontinue use if Grade 3 or 4 infusion-related reactions, immune-related hepatitis & endocrinopathies, hepatotoxicity, Grade 3 or 4 or recurrent Grade 2 immune-related pneumonitis, Grade 4 or recurrent Grade 3 immune-related colitis, Grade 4 nephritis, Grade 4 or recurrent Grade 3 immune-related ARs occur; immune-related pancreatitis & myocarditis is confirmed. Withhold use if Grade 2 immune-related pneumonitis & hepatitis, Grade 2 or 3 immune-related colitis & nephritis, Grade 3 or 4 thyroid disorders & adrenal insufficiency, Grade ≥3 hyperglycaemia, Grade 2 hepatotoxicity occurs; immune-related pancreatitis & myocarditis is suspected. Myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome, noninfective cystitis, Guillain-Barré syndrome. Patients w/ active CNS metastasis; active or history of autoimmune disease; history of other malignancies w/in last 5 yr; organ transplant; conditions requiring therapeutic immune suppression or active HIV, hepatitis B or C infection. Monitor for signs & symptoms of infusion-related reactions, immune-related pneumonitis, colitis, pancreatitis & myocarditis, adrenal insufficiency, hyperglycaemia or other signs & symptoms of diabetes; clinical signs & symptoms of endocrinopathies & thyroid disorders. Monitor for hepatic & thyroid function changes. Periodically monitor elevated serum creatinine prior to & during treatment. May affect ability to drive & use machines. Severe renal & moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 1 mth after last dose. Not recommended during pregnancy. Not to be used during lactation. Childn & adolescents <18 yr.
Adverse Reactions
Anaemia; decreased appetite; cough, dyspnoea; nausea, diarrhoea, constipation, vomiting, abdominal pain; back pain, arthralgia, myalgia; fatigue, pyrexia, chills, asthenia, peripheral oedema; decreased wt; infusion-related reactions; hypothyroidism; headache, dizziness; HTN. Thrombocytopenia; hyperthyroidism; peripheral neuropathy; pneumonitis; dry mouth; pruritus, rash, maculopapular rash; flu-like illness; increased blood creatinine, alkaline phosphatase, amylase, lipase & γ-glutamyltransferase. Monotherapy: Lymphopenia; hyponatraemia; dry skin. Combination therapy: Dysphonia; increased ALT & AST. Hypersensitivity; adrenal insufficiency, thyroiditis; hyperglycaemia; hypotension, flushing; colitis; abnormal hepatic function; acneiform dermatitis, erythema, macular, papular & erythematous rash, dermatitis, eczema; acute kidney injury; increased blood creatine phosphokinase & transaminases, decreased blood TSH.
MIMS Class
Cancer Immunotherapy
ATC Classification
L01FF04 - avelumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.
Bavencio infusion conc 200 mg/10 mL
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