Indications of Tecentriq 1200 mg/vial

Tecentriq 1200 mg/vial 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. ... Read moreTecentriq 1200 mg/vial 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. Tecentriq 1200 mg/vial is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer NSCLC after prior chemotherapy.

Theropeutic Class

Anti neoplastic preparations, Vaccines, Anti-sera & Immunoglobulin

Pharmacology

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. Tecentriq 1200 mg/vial 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. Tecentriq 1200 mg/vial leaves the PD-L2/PD-1 interaction intact. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth

Dosage & Administration of Tecentriq 1200 mg/vial

General: Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial 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

Dosage of Tecentriq 1200 mg/vial

General: Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial 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

Contraindications

Tecentriq 1200 mg/vial is contraindicated in patients with a known hypersensitivity to Tecentriq 1200 mg/vial or any of the excipients.

Pregnancy & Lactation

There are no clinical studies of Tecentriq 1200 mg/vial in pregnant women. Tecentriq 1200 mg/vial is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetusIt is not known whether Tecentriq 1200 mg/vial is excreted in human breast milk. No studies have been conducted to assess the impact of Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vialtherapy.

Precautions & Warnings

Immune-related pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with Tecentriq 1200 mg/vial. 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 Tecentriq 1200 mg/vial. 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 Tecentriq 1200 mg/vial. 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 Tecentriq 1200 mg/vial. 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 Tecentriq 1200 mg/vial. Patients should be monitored for clinical signs and symptoms of endocrinopathies. Monitor thyroid function prior to and periodically during treatment with Tecentriq 1200 mg/vial. Consider appropriate management of patients with abnormal thyroid function tests at baseline. Patients with abnormal thyroid function tests who are asymptomatic may receive Tecentriq 1200 mg/vial.

Overdose Effects of Tecentriq 1200 mg/vial

There is no information on overdose with Tecentriq 1200 mg/vial

Storage Conditions

Store at 2°C-8°C. Tecentriq 1200 mg/vial should be protected from light. Do not freeze. Do not shake.

Use In Special Populations

Pediatric use: The safety and efficacy of Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial is required in patients ≥ 65 years of ageRenal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairmentHepatic 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

Drug Classes

Anti neoplastic preparations, Vaccines, Anti-sera & Immunoglobulin

Mode Of Action

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. Tecentriq 1200 mg/vial 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. Tecentriq 1200 mg/vial leaves the PD-L2/PD-1 interaction intact. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth

Pregnancy

There are no clinical studies of Tecentriq 1200 mg/vial in pregnant women. Tecentriq 1200 mg/vial is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetusIt is not known whether Tecentriq 1200 mg/vial is excreted in human breast milk. No studies have been conducted to assess the impact of Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vialtherapy.

Pediatric Uses

Pediatric use: The safety and efficacy of Tecentriq 1200 mg/vial 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 Tecentriq 1200 mg/vial is required in patients ≥ 65 years of ageRenal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairmentHepatic 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