INDICATION

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

• Have disease progression during or following platinum-containing chemotherapy 
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing 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.

IMPORTANT SAFETY INFORMATION

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

Immune-Related Pneumonitis

• Immune-related pneumonitis, including 2 fatal cases, occurred with TECENTRIQ treatment
• Across clinical trials, 2.6% of patients developed pneumonitis
• Permanently discontinue TECENTRIQ for grade 3 or 4 pneumonitis
  

Immune-Related Hepatitis

• Immune-mediated hepatitis, including a fatal case, and liver test abnormalities have occurred with TECENTRIQ treatment
• Across clinical trials, grade 3 or 4 elevation occurred in ALT (2.5% of patients), AST (2.3%), and total bilirubin (1.6%). In urothelial carcinoma, immune-mediated hepatitis occurred in 1.3% of patients
• Permanently discontinue TECENTRIQ for grade 3 or 4 immune-mediated hepatitis
  

Immune-Related Colitis

• Immune-related colitis, including a fatal case of diarrhea-associated renal failure, have occurred with TECENTRIQ treatment
• Across clinical trials, colitis or diarrhea occurred in 19.7% of patients
• In urothelial carcinoma, immune-mediated colitis occurred in 0.8% of patients
• Permanently discontinue TECENTRIQ for grade 4 diarrhea or colitis
  

Immune-Related Endocrinopathies

• Immune-related thyroid disorders, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have occurred in patients receiving TECENTRIQ. For specific information on dosing, refer to the Prescribing Information
• Across clinical trials, hypothyroidism and hyperthyroidism occurred in 3.9% and 1.0%, respectively
• Across clinical trials, adrenal insufficiency occurred in 0.4% of patients
  
• In urothelial carcinoma, hypophysitis occurred in 0.2% of patients. Permanently discontinue for grade 4 hypophysitis
• Diabetes mellitus without an alternative etiology occurred in 0.2% of patients with urothelial carcinoma
  

Other Immune-Related Adverse Reactions

• Other immune-related adverse reactions, including meningoencephalitis, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, ocular inflammatory toxicity, and pancreatitis, including increases in serum amylase and lipase levels, have occurred in ≤1.0% of patients treated with TECENTRIQ
• Symptomatic pancreatitis without an alternative etiology occurred in 0.1% of patients across clinical trials
• Permanently discontinue TECENTRIQ for any grade of meningitis or encephalitis; or myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome
• Permanently discontinue TECENTRIQ for grade 4 or any grade of recurrent pancreatitis
  

Infection

• Severe infections, including sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage occurred in patients receiving TECENTRIQ
• Across clinical trials, infections occurred in 38.4% of patients
• In urothelial carcinoma, infection occurred in 37.7% of patients. Grade 3 or 4 infection occurred in 11.5% of patients, while 3 patients died due to infections
  

Infusion-Related Reactions

• Severe infusion reactions have occurred in patients in clinical trials of TECENTRIQ. Infusion-related reactions occurred in 1.7% in urothelial carcinoma
• Permanently discontinue TECENTRIQ in patients with grade 3 or 4 infusion reactions

Embryo-Fetal Toxicity

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

Nursing Mothers

• Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
  

Most Common Adverse Reactions

The most common adverse reactions (rate ≥20%) included fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation.

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.