Avelumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

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).

Drug Interactions

Potentially Fatal: May cause severe CV events and hepatotoxicity in combination therapy with axitinib.

Action

Description:
Mechanism of Action: 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.

MIMS Class

Cancer Immunotherapy

ATC Classification

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.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com