Avelumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic Merkel cell carcinoma 10 mg/kg, or 800 mg once every 2 weeks. Locally advanced or metastatic urothelial carcinoma In patients who have disease progression during or after platinum-based chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy: 800 mg once every 2 weeks. Advanced renal cell carcinoma In combination with axitinib: 800 mg once every 2 weeks. Continue treatment until disease progression or unacceptable toxicity occurs. All doses are given via infusion over 60 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Dosage Details
Intravenous
Metastatic Merkel cell carcinoma
Adult: 10 mg/kg, or 800 mg via infusion over 60 minutes once every 2 weeks. Continue treatment until disease progression or unacceptable toxicity occurs. Premedicate with antihistamine and paracetamol prior to the 1st 4 infusions. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Advanced renal cell carcinoma
Adult: In combination with axitinib: 800 mg via infusion over 60 minutes once every 2 weeks. Continue treatment until disease progression or unacceptable toxicity occurs. Premedicate with antihistamine and paracetamol prior to the 1st 4 infusions. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma
Adult: In patients who have disease progression during or after platinum-based chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy: 800 mg via infusion over 60 minutes once every 2 weeks. Continue treatment until disease progression or unacceptable toxicity occurs. Premedicate with antihistamine and paracetamol prior to the 1st 4 infusions. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Reconstitution
Withdraw appropriate volume from the vial then transfer to an IV infusion bag containing 250 mL 0.9% NaCl or 0.45% NaCl solution for inj. Mix the bag by gentle inversion. Do not shake.
Contraindications
Pregnancy and lactation.
Special Precautions
Patient with CV risk factors (e.g. hypertension, diabetes mellitus, dyslipidaemia).
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.
Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
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).
Drug Interactions
Potentially Fatal: May cause severe CV events and hepatotoxicity in combination therapy with axitinib.
Action
Description: Avelumab is a human immunoglobulin G1 monoclonal antibody that selectively binds to programmed death-ligand 1 (PD-L1) and blocks the interaction between PD-L1 and the programmed cell death-1 (PD-1) and B7.1 receptors. This activity removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell function.
Pharmacokinetics:
Distribution: Crosses placenta.
Metabolism: Metabolised via catabolic pathways.
Excretion: Elimination half-life: 6.1 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light. Diluted solution: Store between 20-25°C for up to 4 hours or between 2-8°C for up to 24 hours.
ATC Classification
L01XC31 - avelumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Avelumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/03/2020.

Anon. Avelumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/08/2019.

Bavencio 20 mg/mL Concentrate for Solution for Infusion (Merck Europe B.V.). European Medicines Agency [online]. Accessed 05/03/2020.

Bavencio Solution for Injection (EMD Serono, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 30/08/2019.

Buckingham R (ed). Avelumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/08/2019.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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