Atezolizumab

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

• After prior chemotherapy, or
• Who are considered cisplatin ineligibleand whose tumours have a PD-L1 expression ≥ 5%, or
• Who are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression.

Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer NSCLC after prior chemotherapy.

Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells suppresses cytotoxic T-cell activity through the inhibition of T-cell proliferation and cytokine production. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells, and can contribute to the inhibition of the antitumor immune response in the microenvironment.

Atezolizumab is an Fc-engineered humanized immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors, releasing PD-L1 / PD-1 pathway-mediated inhibition of the immune response, including reactivating the antitumor immune response. Atezolizumab leaves the PD-L2/PD-1 interaction intact. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased 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 a known hypersensitivity to atezolizumab or any of the excipients.

There are no clinical studies of Atezolizumab in pregnant women. Atezolizumab is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus

It is not known whether Atezolizumab is excreted in human breast milk. No studies have been conducted to assess the impact of Atezolizumab on milk production or its presence in breast milk.Asthe potential for harm to the nursing infant is unknown,a decision must be madeto either discontinue breast-feeding ordiscontinue Atezolizumabtherapy.

Immune-related pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of pneumonitis.

Immune-related hepatitis: Cases of hepatitis, some leading to fatal outcomes, have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of hepatitis. Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin prior to and periodically during treatment with Atezolizumab. Consider appropriate management of patients with abnormal liver function tests (LFTs) at baseline.

Immune-related colitis: Cases of diarrhea or colitis have been observed in clinical trials with Atezolizumab. Patients should be monitored for signs and symptoms of colitis.

Immune-related endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have been observed in clinical trials with Atezolizumab. Patients should be monitored for clinical signs and symptoms of endocrinopathies. Monitor thyroid function prior to and periodically during treatment with Atezolizumab. Consider appropriate management of patients with abnormal thyroid function tests at baseline. Patients with abnormal thyroid function tests who are asymptomatic may receive Atezolizumab.

There is no information on overdose with Atezolizumab

Anti neoplastic preparations, Vaccines, Anti-sera & Immunoglobulin

Pediatric use: The safety and efficacy of Atezolizumab in children and adolescents below 18 years of age have not been established.

Geriatric use: Based on a population pharmacokinetic analysis, no dose adjustment of Atezolizumab is required in patients ≥ 65 years of age

Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairment

Hepatic impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment. There are no data in patients with moderate or severe hepatic impairment

Store at 2°C-8°C. Atezolizumab should be protected from light. Do not freeze. Do not shake.