Tecentriq

Tecentriq Dosage/Direction for Use

atezolizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
General: Tecentriq must be administered as an intravenous (IV) infusion under the supervision of a qualified healthcare professional. Do not administer as an IV push or bolus.
Do not co-administer other medicinal products through the same infusion line.
Substitution by any other biological medicinal product requires the consent of the prescribing physician.
The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be administered over 30 minutes.
Tecentriq monotherapy: NSCLC: The recommended dose of Tecentriq in monotherapy is: 840 mg administered by IV infusion every 2 weeks, or 1200 mg administered by IV infusion every 3 weeks, or 1680 mg administered by IV infusion every 4 weeks.
1L NSCLC: Patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Tecentriq combination therapy: For the use of Tecentriq in combination therapy, please also refer to the full prescribing information for the combination product. Tecentriq should be administered prior to IV combination therapy if given on the same day.
1L Non-Squamous NSCLC: Tecentriq in combination with Avastin, paclitaxel, and carboplatin: During the induction phase, the recommended dose of Tecentriq is 1200 mg administered by intravenous (IV) infusion, followed by Avastin, paclitaxel, and then carboplatin every 3 weeks for four or six cycles.
The induction phase is followed by a maintenance phase without chemotherapy in which 1200 mg Tecentriq followed by Avastin, is administered by IV infusion every 3 weeks.
Tecentriq in combination with nab-paclitaxel and carboplatin: During the induction phase, the recommended dose of Tecentriq is 1200 mg administered by IV infusion, followed by nab-paclitaxel and carboplatin every 3 weeks for four or six cycles. For each 21-day cycle, Tecentriq, nab-paclitaxel and carboplatin is 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 1200 mg Tecentriq is administered by IV infusion every 3 weeks.
1L ES-SCLC: Tecentriq in combination with carboplatin and etoposide: During the induction phase, the recommended dose of Tecentriq is 1200 mg administered by IV infusion followed by carboplatin, and then etoposide administered by IV infusion on day 1. Etoposide is also administered by IV infusion on days 2 and 3. This regimen is administered every 3 weeks for four cycles.
The induction phase is followed by a maintenance phase without chemotherapy in which 1200 mg Tecentriq is administered by IV infusion every 3 weeks.
1L TNBC: Tecentriq in combination with nab-paclitaxel: The recommended dose of Tecentriq is 840 mg administered by IV 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.
Patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
HCC: Tecentriq in combination with Avastin: Administer TECENTRIQ 1,200 mg, followed by 15 mg/kg Avastin on the same day every 3 weeks. If Avastin is discontinued, administer TECENTRIQ as: 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks.
Duration of treatment: Patients are treated with Tecentriq until loss of clinical benefit (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions) or unacceptable toxicity.
1L TNBC: Patients are treated with Tecentriq until disease progression or unacceptable toxicity (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies 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 should be adjusted to maintain the appropriate interval between doses.
Dose Modifications: No dose reductions of Tecentriq are recommended.
Dose modifications for immune-mediated adverse reactions: Recommendations for specific adverse drug reactions (see General under Precautions and Clinical Trials under Adverse Reactions) are presented in Table 12. (See Table 12.)

Click on icon to see table/diagram/image

For other immune-mediated reactions, based on the type and severity of the reaction, treatment with Tecentriq should be withheld for Grades 2 or 3 immune-mediated adverse reactions and corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) should be initiated. If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated. Treatment with Tecentriq may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤10 mg oral prednisone or equivalent per day.
Treatment with Tecentriq should be permanently discontinued for Grade 4 immune-mediated adverse reactions, or when unable to reduce corticosteroid dose to the equivalent for ≤10 mg prednisone per day within 12 weeks after onset.
Special Dosage Instructions: Pediatric use: The safety and efficacy of Tecentriq in children and adolescents below 18 years of age have not been established (see Use in Children under Precautions and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Geriatric use: Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see Use in the Elderly under Precautions, and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
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 severe hepatic impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Route of Administration: Intravenous (IV) infusion.
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