Tecentriq Dosage/Direction for Use

Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
PD-L1 testing for patients with UC or TNBC or NSCLC: Tecentriq monotherapy: Patients with first-line (1L) UC, early-stage NSCLC, and 1L metastatic NSCLC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics under Actions).
Tecentriq in combination therapy: Patients with previously untreated TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics under Actions).
Posology: The recommended dose of Tecentriq is either 840 mg administered intravenously every two weeks, or 1 200 mg administered intravenously every three weeks, or 1 680 mg administered intravenously every four weeks, as presented in Table 17.
When Tecentriq is administered in combination therapy please also refer to the full prescribing information for the combination products (see also Pharmacology: Pharmacodynamics under Actions). (See Table 17.)

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Delayed or missed doses: If a planned dose of Tecentriq is missed, it should be administered as soon as possible. The schedule of administration must be adjusted to maintain the appropriate interval between doses.
Dose modifications during treatment: Dose reductions of Tecentriq are not recommended.
Dose delay or discontinuation (see also Precautions and Adverse Reactions): See Tables 18a and 18b.

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Special populations: Paediatric population: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Elderly: Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Asian patients: Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m² every three weeks.
Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Hepatic impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild or moderate hepatic impairment. Tecentriq has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2: Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC, ES-SCLC, 2^nd line UC and HCC (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Method of administration: Tecentriq is for intravenous use. The infusions must not be administered as an intravenous push or bolus.
The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
For instructions on dilution and handling of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.