Generic Medicine Info
Pregnancy and lactation.
Special Precautions
Patient with CV risk factors (e.g. hypertension, diabetes mellitus, dyslipidaemia). Patient Counselling This drug may cause fatigue, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs, serum creatinine, thyroid function tests, blood glucose, and LVEF (in combination with axitinib) at baseline, periodically during therapy, and as clinically indicated. Assess for signs and symptoms of infusion-related reactions, immune-related reactions including pneumonitis, hepatitis, colitis, endocrinopathies (e.g. adrenal insufficiency, hyperglycaemia, thyroid disorders), and CV events (in combination with axitinib).
Adverse Reactions
Significant: Immune-mediated reactions such as colitis, thyroid disorders (e.g. hypo- or hyperthyroidism, thyroiditis), adrenal insufficiency, type 1 diabetes mellitus (including diabetic ketoacidosis), nephritis. Rarely, immune-mediated reactions like myositis, hypopituitarism, uveitis, Guillain-Barré syndrome, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, systemic inflammatory response. Blood and lymphatic system disorders: Anaemia, lymphopenia, thrombocytopenia. Gastrointestinal disorders: Nausea, diarrhoea, constipation, vomiting, dry mouth. General disorders and administration site conditions: Fatigue, asthenia, influenza-like illness. Immune system disorders: Hypersensitivity. Investigations: Decreased weight; increased ALT/AST, amylase, lipase, serum creatinine. Metabolism and nutrition disorders: Decreased appetite, peripheral oedema, hyponatraemia. Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia. Nervous system disorders: Headache, dizziness, peripheral neuropathy. Renal and urinary disorders: Acute renal injury, UTI. Respiratory, thoracic and mediastinal disorders: Cough, dysphonia. Skin and subcutaneous tissue disorders: Rash, pruritus, maculo-papular rash, dry skin, cellulitis. Vascular disorders: Hypertension.
Potentially Fatal: Immune-mediated reactions including pneumonitis, hepatitis; severe infusion-related reactions (e.g. pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, abdominal pain, urticaria). Rarely, immune-mediated myocarditis, pancreatitis; severe CV events (e.g. MI, CHF) when used in combination with axitinib.
ATC Classification
L01XC31 - avelumab
Disclaimer: This information is independently developed by CIMS based on avelumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in