INDICATION

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.

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; 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 in urothelial carcinoma (UC), 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 in 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. 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 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, 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 (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/med-watch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

PDL/092016/0267