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Concise Prescribing Info
Monotherapy for metastatic Merkel cell carcinoma. 1st-line maintenance treatment of patient w/ locally advanced or metastatic urothelial carcinoma whose disease has not progressed w/ 1st-line platinum-based induction chemotherapy. 1st-line treatment of adult w/ advanced renal cell carcinoma in combination w/ axitinib.
Dosage/Direction for Use
IV infusion Premed: Antihistamine & paracetamol prior to the 1st 4 infusion. Monotherapy: 800 mg over 60 min every 2 wk. Combination therapy: 800 mg over 60 min every 2 wk & axitinib 5 mg PO bd (12 hr apart) until disease progression or unacceptable toxicity.
Special Precautions
Not to be administered as IV push or bolus inj. Monitor for signs & symptoms of infusion-related reactions. Permanently discontinue if Grade 3 or 4 infusion-related reactions occur. For Grade 1 infusion-related reactions, decrease infusion rate by 50%. For Grade 2 infusion-related reactions, temporarily discontinue infusion until Grade 1 or resolved, then restart infusion w/ 50% slower infusion rate. Perform adequate evaluation to confirm aetiology or exclude other causes for suspected immune-related AR. Consider other systemic immunosuppressants in patients whose immune-related AR could not be controlled w/ corticosteroid use. Monitor for signs & symptoms of immune-related pneumonitis, hepatitis & colitis; rule out other causes. Confirm suspected pneumonitis w/ radiographic imaging. Administer corticosteroids for Grade ≥2 events in immune-related pneumonitis, hepatitis & colitis. W/hold treatment for Grade 2 immune-related pneumonitis until resolution, & permanently discontinue for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis. W/hold treatment for Grade 2 immune-related hepatitis until resolution, & permanently discontinue for Grade 3 or 4 immune-related hepatitis. W/hold treatment for Grade 2 or 3 immune-related colitis until resolution & permanently discontinue for Grade 4 or recurrent Grade 3 immune-related colitis. Monitor for signs & symptoms of immune-related pancreatitis & myocarditis; w/hold if suspected or permanently discontinue if confirmed. Possible immune-related thyroid disorders, immune-related adrenal insufficiency, & type 1 DM. Monitor for clinical signs & symptoms of endocrinopathies. W/hold treatment for Grade 3 or 4 endocrinopathies until resolution. Possible immune-related nephritis; monitor for elevated serum creatinine prior to & periodically during treatment. Administer corticosteroids for Grade ≥2 nephritis. W/hold treatment for Grade 2 or 3 nephritis until resolution to Grade ≤1 & permanently discontinue for Grade 4 nephritis. Possible myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome & Guillain-Barré syndrome; w/hold treatment & administer corticosteroids based on severity of AR; resume treatment when immune-related AR returns to Grade ≤1 following corticosteroid taper; permanently discontinue for any recurrent Grade 3 & for Grade 4 immune-related AR. Possible hepatotoxicity in combination w/ axitinib; frequently monitor changes in liver function & symptoms; w/hold for Grade 2 hepatotoxicity until resolution & permanently discontinue for Grade 3 or 4 hepatotoxicity; consider corticosteroids for Grade ≥2 events. Patients w/ active CNS metastasis; active or history of autoimmune disease; history of other malignancies w/in the last 5 yr; organ transplant; therapeutic immune suppression requiring conditions or active HIV, hepatitis B or C infection. Possible fatigue following administration; advise caution when driving or operating machinery. Severe renal impairment. Moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 1 mth after the last dose. Not recommended to be used during pregnancy unless clinical condition requires treatment. Advise not to breast-feed during treatment & for at least 1 mth after the last dose due to potential serious AR in breast-fed infants. Childn & adolescent <18 yr.
Adverse Reactions
Monotherapy: UTI; anaemia; decreased appetite; cough, dyspnoea; nausea, diarrhoea, constipation, vomiting, abdominal pain; back pain, arthralgia; fatigue, pyrexia, peripheral oedema; decreased wt; infusion-related reaction. Lymphopenia; hypothyroidism; headache, dizziness, peripheral neuropathy; HTN, hypotension; pneumonitis; dry mouth; rash, pruritus, maculo-papular rash, dry skin; myalgia; asthenia, chills, flu-like illness; increased γ-glutamyltransferase, blood alkaline phosphatase, amylase, lipase & blood creatinine. Combination therapy: Hypothyroidism; decreased appetite; headache, dizziness; HTN; dysphonia, cough, dyspnoea; diarrhoea, nausea, constipation, vomiting, abdominal pain; rash, pruritus; arthralgia, back pain, myalgia; fatigue, chills, asthenia, pyrexia; decreased wt, increased ALT & AST; infusion-related reaction. Anaemia, thrombocytopenia; hypersensitivity; hyperthyroidism, adrenal insufficiency, thyroiditis; hyperglycaemia; peripheral neuropathy; hypotension, flushing; pneumonitis; dry mouth, colitis; abnormal hepatic function; pruritic, maculo-papular, macular, papular, erythematous, & generalized rash, generalized pruritus, dermatitis acneiform, erythema, dermatitis, eczema; acute kidney injury; peripheral oedema, flu-like illness; increased blood creatinine, amylase, lipase, γ-glutamyltransferase, transaminases, blood alkaline phosphatase & creatine phosphokinase, decreased blood TSH.
MIMS Class
Cancer Immunotherapy
ATC Classification
L01XC31 - avelumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Bavencio conc for soln for infusion 200 mg/10 mL
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