Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC):

• Following prior chemotherapy, or
• In patients who are not eligible for cisplatin-based therapy and whose tumors express PD-L1 ≥ 5%, or
• In patients who are ineligible for any platinum-based chemotherapy, regardless of PD-L1 expression level

It is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received chemotherapy.

Binding of PD-L1 to PD-1 and B7.1 receptors on T-cells suppresses immune response by inhibiting T-cell proliferation and cytokine production. PD-L1 expression on tumor cells and tumor-infiltrating immune cells contributes to immune evasion within the tumor microenvironment.

Atezolizumab is an Fc-engineered humanized IgG1 monoclonal antibody that selectively binds to PD-L1 and blocks its interaction with PD-1 and B7.1 receptors. This action removes inhibitory signals on the immune system and restores T-cell-mediated antitumor activity. Importantly, atezolizumab does not interfere with the PD-L2/PD-1 interaction. In preclinical models, inhibition of PD-L1 activity has been shown to reduce tumor growth.

General: Atezolizumab must be administered as an intravenousinfusion under the supervision of a qualified healthcare professional. Do not administer as an IV push or bolus. Substitution by any other biological medicinal product requires the consent of the prescribing physician. The initial dose of Atezolizumab must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes. The recommended dose of Atezolizumab is either:

• 1200 mg administered by IV infusion every 3 weeks or
• 1680 mg administered by IV infusion every 4 weeks.

1L cisplatin-ineligible mUC: Patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test

Atezolizumab is contraindicated in patients with known hypersensitivity to atezolizumab or any of its formulation components.

There are no adequate clinical studies of atezolizumab in pregnant women. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

It is unknown whether atezolizumab is excreted in human breast milk. Due to the potential risk to the nursing infant, a decision should be made to either discontinue breastfeeding or discontinue the drug, considering the importance of treatment to the mother.

• Immune-related pneumonitis: Cases, including fatal outcomes, have been reported. Monitor patients for respiratory symptoms.
• Immune-related hepatitis: Monitor liver function tests (AST, ALT, bilirubin) before and during treatment. Severe cases may occur.
• Immune-related colitis: Diarrhea or colitis may develop; monitor for gastrointestinal symptoms.
• Immune-related endocrinopathies: Conditions such as hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and type 1 diabetes (including ketoacidosis) may occur. Monitor thyroid function and clinical signs regularly.

Pediatric use: Safety and efficacy in patients under 18 years have not been established.

Geriatric use: No dose adjustment is required in patients aged 65 years or older.

Renal impairment: No dose adjustment is required.

Hepatic impairment: No adjustment is needed in mild hepatic impairment; insufficient data are available for moderate to severe impairment.

There is no available information regarding overdose of atezolizumab.

Store at 2°C–8°C, protected from light. Do not freeze or shake.