Bavencio

Monotherapy in adults w/ metastatic Merkel cell carcinoma (MCC); for 1st-line maintenance treatment of adults w/ locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy w/ gemcitabine+cisplatin or gemcitabine+carboplatin. In combination w/ axitinib for 1st-line treatment of adults w/ advanced renal cell carcinoma (RCC).

IV infusion Administer over 60 min. Premed: Antihistamine w/ paracetamol prior to first 4 infusions. May administer subsequent doses of premed if 4th infusion is completed w/o infusion-related reaction. Monotherapy: 800 mg every 2 wk. Combination w/ axitinib: 800 mg every 2 wk & axitinib 5 mg orally twice daily (12 hr apart).

Hypersensitivity.

Permanently discontinue treatment for Grade 3 or 4 infusion related reactions, immune-related hepatitis or hepatotoxicity; Grade 3, 4 or recurrent Grade 2 immune-related pneumonitis; Grade 4 or recurrent Grade 3 immune-related colitis or any immune-related adverse reaction; Grade 4 nephritis; if immune-related pancreatitis or myocarditis is confirmed. Temporary discontinue treatment for patients w/ Grade 2 infusion related reactions. Withhold treatment based on severity of adverse reaction; Grade 2 immune-related pneumonitis, hepatitis & hepatotoxicity; Grade 2 or 3 immune-related colitis or nephritis; suspected immune-related pancreatitis or myocarditis; Grade 3 or 4 endocrinopathies, thyroid disorders, symptomatic adrenal insufficiency; Grade ≥3 hyperglycaemia. Infusion related reactions. Immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, nephritis, myositis, hypopituitarism, uveitis, myasthenia gravis, myasthenic syndrome, cystitis noninfective, & Guillain-Barré syndrome. Increased risk of immune-related adverse reactions following immune-checkpoint inhibitor therapy in patients w/ pre-existing autoimmune disease. Type 1 DM including diabetic ketoacidosis. 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 infection w/ HIV, or hepatitis B or C. Monitor for signs & symptoms of infusion related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back & abdominal pain, & urticaria; immune-related pneumonitis, colitis, pancreatitis, myocarditis; adrenal insufficiency during & after treatment; for liver & thyroid (at start of, periodically during treatment, & as indicated based on clinical evaluation) function changes & symptoms of immune-related hepatitis & thyroid disorders; hyperglycaemia or other signs & symptoms of diabetes; elevated serum creatinine prior to & periodically during treatment. Closely monitor patients in case of recurrent Grade 1 or 2 infusion-related reaction. Consider administration of other systemic immunosuppressants in patients whose immune-related adverse reactions could not be controlled w/ corticosteroid use. Hepatotoxicity in combination w/ axitinib. Severe renal & moderate or severe hepatic impairment. Women of childbearing potential should avoid becoming pregnant while receiving treatment & use effective contraception during treatment & for at least 1 mth after last dose. Not recommended during pregnancy. Not to breastfeed during treatment & for at least 1 mth after last dose. Childn & adolescents <18 yr.

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

Cancer Immunotherapy

L01FF04 - avelumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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