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Tecentriq Dosage

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

Medically reviewed by Drugs.com. Last updated on Nov 16, 2020.

Patient Selection for Treatment of Urothelial Carcinoma, Triple-Negative Breast Cancer, or Non-Small Cell Lung Cancer and Melanoma

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

Select patients with first-line metastatic non-small cell lung cancer for treatment with TECENTRIQ as a single agent based on the PD-L1 expression on tumor cells or on tumor infiltrating immune cells [see Clinical Studies (14.2)].

Select patients with locally advanced or metastatic triple-negative breast cancer for treatment with TECENTRIQ in combination with paclitaxel protein-bound based on the PD-L1 expression on tumor infiltrating immune cells [see Clinical Studies (14.3)].Information on FDA-approved tests for the determination of PD-L1 expression in locally advanced or metastatic urothelial carcinoma, triple-negative breast cancer, or non-small cell lung cancer are available at: http://www.fda.gov/CompanionDiagnostics

Select patients with unresectable or metastatic melanoma for treatment with TECENTRIQ in combination with cobimetinib and vemurafenib after confirming the presence of a BRAF V600 mutation [see Clinical Studies (14.5)]. Information on FDA-approved tests for the detection of BRAF V600E and V600K mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics. An FDA-approved test for the detection of other BRAF V600 mutations for this use is not currently available.

Recommended Dosage for Urothelial Carcinoma

The recommended dosage of TECENTRIQ is:

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

administered intravenously over 60 minutes until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Recommended Dosage for NSCLC

Single Agent

The recommended dosage of TECENTRIQ is:

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

administered intravenously over 60 minutes until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

TECENTRIQ with Platinum-based Chemotherapy

The recommended dosage of TECENTRIQ is 1200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity.

Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day. Refer to the Prescribing Information for the chemotherapy agents or bevacizumab administered in combination with TECENTRIQ for recommended dosing information.

Following completion of 4-6 cycles of chemotherapy, and if bevacizumab is discontinued, the recommended dosage of TECENTRIQ is:

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

administered intravenously until disease progression or unacceptable toxicity.

Administer the initial infusion of TECENTRIQ over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Recommended Dosage for Locally Advanced or Metastatic TNBC

The recommended dosage of TECENTRIQ is 840 mg administered intravenously over 60 minutes, followed by 100 mg/m2 paclitaxel protein-bound.

For each 28 day cycle, TECENTRIQ is administered on days 1 and 15, and paclitaxel protein-bound is administered on days 1, 8, and 15 until disease progression or unacceptable toxicity.

TECENTRIQ and paclitaxel protein-bound may be discontinued for toxicity independently of each other.

If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. Refer to the Prescribing Information for paclitaxel protein-bound for recommended dosing information.

Recommended Dosage for SCLC

The recommended dosage of TECENTRIQ is 1200 mg intravenously every 3 weeks, when administered in combination with carboplatin and etoposide, until disease progression or unacceptable toxicity.

Administer TECENTRIQ prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with TECENTRIQ for recommended dosing information.

Following completion of 4 cycles of carboplatin and etoposide, the recommended dosage of TECENTRIQ is:

  • 840 mg every 2 weeks or
  • 1200 mg every 3 weeks or
  • 1680 mg every 4 weeks

administered intravenously until disease progression or unacceptable toxicity.

Administer the initial infusion of TECENTRIQ over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Recommended Dosage for HCC

The recommended dosage of TECENTRIQ is 1,200 mg administered as an intravenous infusion over 60 minutes, followed by 15 mg/kg of bevacizumab on the same day, every 3 weeks until disease progression or unacceptable toxicity.

Refer to the Prescribing Information for bevacizumab prior to initiation.

If bevacizumab is discontinued for toxicity, the recommended dosage of TECENTRIQ is:

  • 840 mg every 2 weeks or
  • 1,200 mg every 3 weeks or
  • 1,680 mg every 4 weeks

administered intravenously until disease progression or unacceptable toxicity.

If the first infusion of TECENTRIQ is tolerated, all subsequent infusions may be delivered over 30 minutes

Recommended Dosage for Melanoma

Prior to initiating TECENTRIQ, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

The recommended dose of TECENTRIQ is 840 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity, when administered with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily.

If the first infusion of TECENTRIQ is tolerated, all subsequent infusions may be delivered over 30 minutes.

Refer to the Prescribing Information for cobimetinib and vemurafenib prior to initiation.

Dosage Modifications for Adverse Reactions

No dose reduction for TECENTRIQ is recommended. In general, withhold TECENTRIQ for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TECENTRIQ for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for TECENTRIQ for adverse reactions that require management different from these general guidelines are summarized in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson syndrome, TEN = toxic epidermal necrolysis
*
Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.
Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue TECENTRIQ based on recommendations for hepatitis with no liver involvement.
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis Grade 2 Withhold
Grades 3 or 4 Permanently discontinue
Colitis Grades 2 or 3 Withhold
Grade 4 Permanently discontinue
Hepatitis with no tumor involvement of the liver AST or ALT increases to more than 3 and up to 8 times ULN
or
Total bilirubin increases to more than 1.5 and up to 3 times ULN
Withhold
AST or ALT increases to more than 8 times ULN
or
Total bilirubin increases to more than 3 times ULN
Permanently discontinue
Hepatitis with tumor involvement of the liver Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN
or
Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN
Withhold
AST or ALT increases to more than 10 times ULN
or
Total bilirubin increases to more than 3 times ULN
Permanently discontinue
Endocrinopathies Grades 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction Grades 2 or 3 increased blood creatinine Withhold
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative Dermatologic Conditions Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grades 2, 3, or 4 Permanently discontinue
Neurological Toxicities Grade 2 Withhold
Grades 3 or 4 Permanently discontinue
Other Adverse Reactions
Infusion-Related Reactions [see Warnings and Precautions (5.2)] Grades 1 or 2 Interrupt or slow the rate of infusion
Grades 3 or 4 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:

  • Select the appropriate vial(s) based on the prescribed dose.
  • Withdraw the required volume of TECENTRIQ from the vial(s).
  • Dilute to a final concentration between 3.2 mg/mL and 16.8 mg/mL in a polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride Injection, USP.
  • Dilute with only 0.9% Sodium Chloride Injection, USP.
  • 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.

Frequently asked questions

Further information

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