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Tecentriq Dosage

Generic name: atezolizumab 1200mg in 20mL
Dosage form: injection, solution

Medically reviewed on July 12, 2018.

Selection of Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Select cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma for treatment with TECENTRIQ as a single agent based on the PD-L1 expression on tumor-infiltrating immune cells [see Clinical Studies (14.1)].

Information on FDA-approved tests for the determination of PD-L1 expression in locally advanced or metastatic urothelial carcinoma is available at: http://www.fda.gov/CompanionDiagnostics

Recommended Dosage

The recommended dosage of TECENTRIQ is 1200 mg as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Dosage Modifications for Adverse Reactions

No dose reductions of TECENTRIQ are recommended. Recommendations for dosage modifications are provided in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity of Adverse Reaction* Dosage Modifications
*
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Pneumonitis [see Warnings and Precautions (5.1)] Grade 2 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
Grade 3 or 4 Permanently discontinue
Hepatitis [see Warnings and Precautions (5.2)] AST or ALT more than 3 and up to 8 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
AST or ALT more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal Permanently discontinue
Colitis or diarrhea [see Warnings and Precautions (5.3)] Grade 2 or 3 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
Grade 4 Permanently discontinue
Endocrinopathies (including but not limited to hypophysitis, adrenal insufficiency, hyperthyroidism, and type 1 diabetes mellitus) [see Warnings and Precautions (5.4)] Grade 2, 3, or 4 Withhold dose until Grade 1 or resolved and clinically stable on hormone replacement therapy.
Other immune-mediated adverse reactions involving a major organ [see Warnings and Precautions (5.5)] Grade 3 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent)
Grade 4 Permanently discontinue
Infections [see Warnings and Precautions (5.6)] Grade 3 or 4 Withhold dose until Grade 1 or resolved
Infusion-Related Reactions [see Warnings and Precautions (5.7)] Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue
Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathies) Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last TECENTRIQ dose Permanently discontinue
Inability to taper corticosteroid Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after last TECENTRIQ dose Permanently discontinue
Recurrent Grade 3 or 4 adverse reaction Recurrent Grade 3 or 4 (severe or life-threatening) adverse reaction Permanently discontinue

Preparation and Administration

Preparation

Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial.

Prepare the solution for infusion as follows:

  • Withdraw 20 mL of TECENTRIQ from the vial.
  • Dilute into a 250 mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride Injection, USP.
  • Dilute with 0.9% Sodium Chloride Injection only.
  • Mix diluted solution by gentle inversion. Do not shake.
  • Discard used or empty vials of TECENTRIQ.

Storage of Infusion Solution

This product does not contain a preservative.

Administer immediately once prepared. If diluted TECENTRIQ infusion solution is not used immediately, store solution either:

  • At room temperature for no more than 6 hours from the time of preparation. This includes room temperature storage of the infusion in the infusion bag and time for administration of the infusion, or
  • Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from time of preparation.

Do not freeze.

Do not shake.

Administration

Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Do not coadminister other drugs through the same intravenous line.

Do not administer as an intravenous push or bolus.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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