Finished product reference
Atezolizumab
Injection, Solution, Concentrate · Intravenous · 60 mg/1mL · 20 mL
- List code
- 52835
- Pharmacologic class
- Antineoplastic; anti-PD-L1 monoclonal antibody (immune checkpoint inhibitor)
What it is and how it works
Atezolizumab is a humanised IgG1 monoclonal antibody that binds programmed death-ligand 1 (PD-L1), blocking its interaction with PD-1 and B7.1 receptors. This releases PD-L1/PD-1 mediated inhibition of the anti-tumour T-cell response.
Indications
Selected patients with urothelial carcinoma, non-small cell lung cancer (adjuvant, first-line and later lines), extensive-stage small cell lung cancer, hepatocellular carcinoma and triple-negative breast cancer, according to approved criteria (including PD-L1 expression where required).
Dosage and administration (summary)
Intravenous infusion of 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks, alone or in combination per indication, until disease progression or unacceptable toxicity.
Contraindications
Hypersensitivity to atezolizumab or excipients.
Warnings and precautions
Immune-related adverse reactions may affect any organ, including pneumonitis, hepatitis, colitis, endocrinopathies (thyroid, adrenal, pituitary, type 1 diabetes), nephritis, myocarditis and skin reactions; manage by withholding treatment and giving corticosteroids. Infusion-related reactions may occur. Monitor liver, renal and thyroid function and blood glucose.
Pregnancy
Avoid in pregnancy because PD-L1 blockade may cause fetal harm; effective contraception is required during and for 5 months after treatment.
Storage and supply
Store at 2–8 °C refrigerated; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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