TECENTRIQ Resources TECENTRIQ Resources

Find additional TECENTRIQ resources that can support your practice and your patients taking TECENTRIQ.

TECENTRIQ access resources

TECENTRIQ Hospital Formulary eToolkit

TECENTRIQ
Hospital Formulary eToolkit

TECENTRIQ Distribution Guide

TECENTRIQ
Distribution Quick Reference Guide

TECENTRIQ Billing and Coding Information

TECENTRIQ
Billing and Coding Guide

TECENTRIQ nurse education resources

TECENTRIQ Dosing and Administration Information

TECENTRIQ
Dosing and Administration

Managing TECENTRIQ Adverse Events

TECENTRIQ
Adverse Reactions Management

TECENTRIQ
Product Overview

TECENTRIQ
and the Cancer Immunity Cycle

TECENTRIQ
Patient Profiles

TECENTRIQ
Resource Guide

TECENTRIQ patient education resources

TECENTRIQ Patient Medication Guide

TECENTRIQ
Patient Medication Guide

TECENTRIQ
Patient Information Card

IMPORTANT SAFETY INFORMATION AND INDICATION

Indication

TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who:

  • Are not eligible for cisplatin-containing chemotherapy, or
  • Have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

Immune-Mediated Pneumonitis

  • Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, have occurred with TECENTRIQ treatment
  • Across clinical trials, 2.5% of patients developed pneumonitis, including Grade 3 (0.6%), Grade 4 (0.1%), and Grade 5 (<0.1%) events
  • Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. Administer corticosteroids followed by a taper. Withhold TECENTRIQ for Grade 2 and permanently discontinue for Grade 3 or 4 pneumonitis

Immune-Mediated Hepatitis

  • Liver test abnormalities and immune-mediated hepatitis, including fatal cases, have occurred with TECENTRIQ treatment
  • Across clinical trials, hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events
  • Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids followed by a taper for immune-mediated hepatitis. Withhold TECENTRIQ for AST or ALT elevations 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. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal

Immune-Mediated Colitis

  • Immune-mediated colitis or diarrhea have occurred with TECENTRIQ treatment
  • Across clinical trials, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events
  • Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or 3 and permanently discontinue for Grade 4 diarrhea or colitis

Immune-Mediated Endocrinopathies

  • TECENTRIQ can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, and type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism
  • Withhold TECENTRIQ for Grade 2 to 4 endocrinopathies
  • Thyroid Disorders
    • Across clinical studies, hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients
    • Monitor thyroid function prior to and during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated
  • Adrenal Insufficiency
    • Across clinical studies, adrenal insufficiency occurred in 0.4% of patients, including Grade 3 (<0.1%) events
    • Monitor patients for clinical signs and symptoms of adrenal insufficiency. For Grade 2 to 4 adrenal insufficiency, initiate corticosteroids and hormone replacement therapy as clinically indicated
  • Type 1 Diabetes Mellitus
    • Across clinical studies, type 1 diabetes mellitus occurred in <0.1% of patients
    • Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated
  • Hypophysitis
    • Across clinical studies, Grade 2 hypophysitis occurred in <0.1% of patients
    • For Grade 2 to 4 hypophysitis, initiate corticosteroids and hormone replacement therapy as clinically indicated

Other Immune-Mediated Adverse Reactions

  • TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system
  • Across clinical trials, cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular immune-mediated adverse reactions occurred at an incidence of <1% in patients who received TECENTRIQ or were reported for other products in this class of therapy
  • For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. For severe (Grade 3 or 4) adverse reactions, withhold TECENTRIQ and administer corticosteroids. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ

Infections

  • TECENTRIQ can cause severe infections including fatal cases
  • Across clinical trials, infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events
  • Monitor patients for signs and symptoms of infection. For Grade 3 or 4 infections, withhold TECENTRIQ and resume once clinically stable

Infusion-Related Reactions

  • TECENTRIQ can cause severe or life-threatening infusion-related reactions
  • Across clinical trials, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events
  • Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2 infusion-related reactions. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions

Embryo-Fetal Toxicity

  • Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose

Nursing Mothers/Fertility

  • Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
  • Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment

Most Common Adverse Reactions
The most common adverse reactions in cisplatin-ineligible UC (rate ≥20%) were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%).

The most common adverse reactions in previously treated UC (rate ≥20%) were fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.