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Important Safety Information & Indication
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.
TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.
Important Safety Information
Serious Adverse Reactions
- Immune-related pneumonitis. Immune-mediated pneumonitis or interstitial lung disease have occurred. Fatal cases have been observed in patients with urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC). Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis.
- Immune-related hepatitis. Immune-mediated hepatitis and liver test abnormalities, including a fatal case of hepatitis in a patient with UC, have 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 in a patient with UC, 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, have occurred. Permanently discontinue TECENTRIQ for Grade 4 hypophysitis.
- Other immune-related adverse reactions. Meningoencephalitis, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, ocular inflammatory toxicity, pancreatitis, including increases in serum amylase and lipase levels, and myocarditis 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. Permanently discontinue TECENTRIQ for Grade 3 or 4 myocarditis.
- Infection. Severe infections, such as sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage, have occurred. Fatal cases have been observed in patients with UC and NSCLC.
- Infusion-related reactions. Severe infusion reactions 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.
Most Common Adverse Reactions
The most common adverse reactions (rate ≥20%) in cisplatin-ineligible UC were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%).
The most common adverse reactions (rate ≥20%) in previously treated UC were fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%).
The most common adverse reactions in NSCLC (rate ≥20%) included fatigue (46%), decreased appetite (35%), dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain (22%), and constipation (20%).
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 and important dose management information specific to adverse reactions.