INDICATION

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

PD-L1=programmed death-ligand 1.

IMPORTANT SAFETY INFORMATION

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

• Immune-related pneumonitis. Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, occurred. Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
• Immune-related hepatitis. Immune-mediated hepatitis, including a fatal case, and liver test abnormalities occurred. Permanently discontinue TECENTRIQ for Grade 3 or 4 immune-mediated hepatitis
• Immune-related colitis. Immune-mediated colitis or diarrhea, including a fatal case of diarrhea-associated renal failure, occurred. 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, occurred. Permanently discontinue TECENTRIQ for Grade 4 hypophysitis
• Other immune-related adverse reactions. Meningoencephalitis, 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 any grade of myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome. Permanently discontinue TECENTRIQ for Grade 4 or any grade of recurrent pancreatitis
• Infection. Severe infections, including fatal cases, have occurred. Sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage have been observed
• Infusion-related reactions. Severe infusion 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 patients 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
• Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose

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.

PDL/122215/0178(2)