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Tecentriq特善奇

Tecentriq Dosage/Direction for Use

atezolizumab

Manufacturer:

Roche

Distributor:

DKSH
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
840 mg/14 mL: PD-L1 testing for patients with UC or TNBC: Patients with previously untreated UC and TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics under Actions).
1,200 mg/20 mL: PD-L1 testing for patients with UC: Patients with previously untreated UC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics under Actions).
Posology: Dose modifications during treatment: Dose reductions of Tecentriq are not recommended.
Dose delay or discontinuation (see also Precautions and Adverse Reactions): 840 mg/14 mL: See Tables 16a and 16b.

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Click on icon to see table/diagram/image

1,200 mg/20 mL: See Tables 17a and 17b.

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Click on icon to see table/diagram/image

840 mg/14 mL: Tecentriq monotherapy: The recommended dose of Tecentriq is: 840 mg administered intravenously every two weeks; or 1,680 mg administered intravenously every four weeks.
Tecentriq in combination with nab-paclitaxel in 1L mTNBC: The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel. For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15. Refer to the full prescribing information for the combination product (see also Pharmacology: Pharmacodynamics under Actions).
Duration of treatment: It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see Pharmacology: Pharmacodynamics under Actions) or unmanageable toxicity.
For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see Pharmacology: Pharmacodynamics under Actions).
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.
1,200 mg/20 mL: Tecentriq monotherapy: The recommended dose of Tecentriq is 1,200 mg administered intravenously every three weeks.
Tecentriq in combination therapy: Please also refer to the full prescribing information for the combination products (see also Pharmacology: Pharmacodynamics under Actions).
1L non-squamous NSCLC: Tecentriq in combination with bevacizumab, paclitaxel, and carboplatin: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles.
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every three weeks.
Tecentriq in combination with nab-paclitaxel and carboplatin: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles. For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1. In addition, nab-paclitaxel is administered on days 8 and 15.
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
1L ES-SCLC: Tecentriq in combination with carboplatin and etoposide: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1. Etoposide is also administered by intravenous infusion on days 2 and 3. This regimen is administered every three weeks for four cycles.
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
HCC: Tecentriq in combination with bevacizumab: The recommended dose of Tecentriq is 1,200 mg followed by bevacizumab 15 mg/kg of body weight, administered by intravenous infusion every three weeks.
Duration of treatment: It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see Pharmacology: Pharmacodynamics under Actions) or unmanageable toxicity.
For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity. Treatment beyond disease progression may be considered at the discretion of the physician (see Pharmacology: Pharmacodynamics under Actions).
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 a 3-week interval between doses.
Special populations: Paediatric population: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
840 mg/14 mL: No data are available.
1,200 mg/20 mL: Currently available data are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions and Adverse Reactions 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 Pharmacology: Pharmacodynamics under Actions and Adverse Reactions).
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: 840 mg/14 mL: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment. Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
1,200 mg/20 mL: 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: 840 mg/14 mL: Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC and 2nd line UC (see Precautions and Pharmacology: Pharmacodynamics under Actions).
1,200 mg/20 mL: Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, ES-SCLC, 2nd line UC and HCC (see Pharmacology: Pharmacodynamics under Actions and Precautions).
Asian patients: 1,200 mg/20 mL: 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.
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.
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