Atezolizumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Locally advanced urothelial carcinoma; Metastatic urothelial carcinoma 1.2 g once every 3 weeks via infusion over 60 minutes, until disease progression or unacceptable toxicity. Locally advanced non-small cell lung carcinoma; Metastatic non-small cell lung carcinoma For previously treated: 1.2 g once every 3 weeks via infusion over 60 minutes, until disease progression or unacceptable toxicity. As first-line treatment: 1.2 g on day 1 every 3 weeks via infusion over 60 minutes followed by bevacizumab, paclitaxel, and carboplatin for 4-6 cycles of chemotherapy, until disease progression or unacceptable toxicity occurs. All doses may be modified, interrupted, or discontinued (based on severity) if immune- or infusion-related reactions occur.
Dosage Details
Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma
Adult: 1.2 g once every 3 weeks via infusion over 60 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: For previously treated: 1.2 g once every 3 weeks via infusion over 60 minutes, until disease progression or unacceptable toxicity. As first-line treatment: 1.2 g on day 1 every 3 weeks via infusion over 60 minutes followed by bevacizumab, paclitaxel, and carboplatin for 4-6 cycles of chemotherapy, until disease progression or unacceptable toxicity occurs. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).
Reconstitution
Withdraw 20 mL and dilute in 250 mL NaCl 0.9% solution to prepare a final concentration 4.4 mg/mL. Mix gently. Do not shake.
Special Precautions
Pregnancy and lactation.
Adverse Reactions
Significant: Endocrine disorders (e.g. hyper/hypothyroidism, type 1 diabetes mellitus, adrenal insufficiency), hypophysitis, uveitis, iritis, other immune-mediated effects (e.g. meningoencephalitis, myasthenia gravis, Guillain-Barre syndrome), pancreatitis, myocarditis.
Blood and lymphatic system disorders: Thrombocytopenia, autoimmune hemolytic anaemia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dysphagia.
General disorders and admin site conditions: Pyrexia, fatigue, asthenia, influenza-like illness.
Immune system disorders: Hypersensitivity.
Investigations: Increased AST and ALT.
Metabolism and nutrition disorders: Decreased appetite, hypokalaemia, hyponatremia.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, musculoskeletal pain, chills.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, hypoxia, nasal congestion, nasopharyngitis.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Vascular disorders: Hypotension.
Potentially Fatal: Immune-related hepatitis, pneumonitis and interstitial lung disease, colitis or diarrhoea, severe infection (e.g. sepsis, herpes encephalitis), infusion-related reactions.
Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor PD-L1 expression status, LFT, thyroid function, serum glucose; signs/symptoms of colitis, diarrhoea, endocrinopathies, hepatitis, hypophysitis, infection, infusion reactions, pneumonitis, and ocular toxicity.
Drug Interactions
May enhance the adverse effect of belimumab.
Action
Description: Atezolizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody which binds to programmed death ligand 1 (PD-L1) and selectively prevents the interaction between PD-1 and B7.1 (also known as CD80) receptors found on T-cells and antigen presenting cells, releasing PD-L1/PD-1 mediated inhibition of immune response thereby enhancing the immune response to tumour cells.
Pharmacokinetics:
Distribution: Volume of distribution at steady state: 6.9 L.
Excretion: Elimination half-life: 27 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01XC32 - atezolizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Atezolizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/03/2019.

Anon. Atezolizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/03/2019.

Buckingham R (ed). Atezolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/03/2019.

Tecentriq (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/03/2019.

Disclaimer: This information is independently developed by MIMS based on Atezolizumab 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
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in