Bavencio

Avelumab

Monotherapy for metastatic Merkel cell carcinoma (MCC). 1st-line maintenance treatment of patient w/ locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed w/ 1st-line platinum-based induction chemotherapy. 1st-line treatment of adult w/ advanced renal cell carcinoma (RCC) in combination w/ axitinib.

IV Monotherapy: 800 mg infusion over 60 min every 2 wk. Combination therapy: 800 mg infusion over 60 min every 2 wk & axitinib 5 mg PO bd (12 hr apart) w/ or w/o food until disease progression or unacceptable toxicity. Premed: Antihistamine & paracetamol prior to the 1st 4 infusions.

Not to be administered as IV push or bolus inj. Not recommended to escalate or reduce dose. May require dosing delay or discontinuation based on individual safety & tolerability. Monitor for signs & symptoms of infusion-related reactions. Permanently discontinue use 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. Administer corticosteroids for immune-related pancreatitis & myocarditis. 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. Administer corticosteroids for Grade ≥3 adrenal insufficiency followed by dose tapering until ≤10 mg/day has been reached. 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 aplastic anaemia. Possible hepatotoxicity in combination w/ axitinib; frequently monitor changes in liver function & symptoms; w/hold treatment 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; conditions requiring therapeutic immune suppression or active HIV, hepatitis B or C. 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. Pregnancy. 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.

Decreased appetite; cough, dyspnoea; nausea, diarrhoea, constipation, vomiting, abdominal pain; back pain, arthralgia; fatigue, pyrexia; decreased wt; infusion-related reaction. Anaemia; peripheral oedema, asthenia, chills, flu-like illness; myalgia; hypothyroidism; headache, dizziness, peripheral neuropathy; HTN, hypotension; rash, pruritus, maculo-papular rash; pneumonitis; dry mouth; increased γ-glutamyltransferase, blood alkaline phosphatase, amylase, lipase & blood creatinine. Monotherapy: UTI. Lymphopenia; dry skin. Combination therapy: Dysphonia; increased ALT & AST. Thrombocytopenia; hypersensitivity; hyperthyroidism, adrenal insufficiency, thyroiditis; hyperglycaemia; flushing; colitis; abnormal hepatic function; pruritic, macular, papular, erythematous & generalized rash, generalized pruritus, dermatitis acneiform, erythema, dermatitis, eczema; acute kidney injury; increased transaminases & blood creatine phosphokinase, decreased blood TSH.

Cancer Immunotherapy

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.