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, including fatal cases. 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. Permanently discontinue TECENTRIQ for grade 3 or 4 immune-mediated hepatitis
• Immune-related colitis, including a fatal case of diarrhea-associated renal failure. 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. Permanently discontinue TECENTRIQ for grade 4 hypophysitis. For specific information on dose modifications, refer to Prescribing Information
• Other immune-related adverse reactions. Meningo-
  encephalitis, myasthenic syndrome/
  myasthenia gravis, Guillain-Barré syndrome, ocular inflammatory toxicity, and pancreatitis, including increases in serum amylase and lipase levels, have occurred. 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, including fatal cases. Severe infections, including sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage have occurred
• Infusion-related reactions have occurred. Permanently discontinue TECENTRIQ in patients with grade 3 or 4 infusion reactions
• Embryo-fetal toxicity. TECENTRIQ can cause fetal harm in pregnant women. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose
• 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.