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IMPORTANT SAFETY INFORMATION AND INDICATION

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.

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

Immune-Mediated Pneumonitis

  • Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, have occurred with TECENTRIQ treatment
  • Across clinical trials, 2.5% of patients developed pneumonitis, including Grade 3 (0.6%), Grade 4 (0.1%), and Grade 5 (<0.1%) events 
  • Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. Administer corticosteroids followed by a taper. Withhold TECENTRIQ for Grade 2 and permanently discontinue for Grade 3 or 4 pneumonitis

Immune-Mediated Hepatitis

  • Liver test abnormalities and immune-mediated hepatitis, including fatal cases, have occurred with TECENTRIQ treatment 
  • Across clinical trials, hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events
  • Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids followed by a taper for immune-mediated hepatitis. Withhold TECENTRIQ for AST or ALT elevations more than 3 and up to 8 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal

Immune-Mediated Colitis

  • Immune-mediated colitis or diarrhea have occurred with TECENTRIQ treatment 
  • Across clinical trials, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events
  • Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or 3 and permanently discontinue for Grade 4 diarrhea or colitis

Immune-Mediated Endocrinopathies 

  • TECENTRIQ can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, and type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism
  • Withhold TECENTRIQ for Grade 2 to 4 endocrinopathies
  • Thyroid Disorders
    • Across clinical studies, hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients
    • Monitor thyroid function prior to and during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated
  • Adrenal Insufficiency
    • Across clinical studies, adrenal insufficiency occurred in 0.4% of patients, including Grade 3 (<0.1%) events
    • Monitor patients for clinical signs and symptoms of adrenal insufficiency. For Grade 2 to 4 adrenal insufficiency, initiate corticosteroids and hormone replacement therapy as clinically indicated
  • Type 1 Diabetes Mellitus
    • Across clinical studies, type 1 diabetes mellitus occurred in <0.1% of patients
    • Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated
  • Hypophysitis
    • Across clinical studies, Grade 2 hypophysitis occurred in <0.1% of patients
    • For Grade 2 to 4 hypophysitis, initiate corticosteroids and hormone replacement therapy as clinically indicated

Other Immune-Mediated Adverse Reactions

  • TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system 
  • Across clinical trials, cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular immune-mediated adverse reactions occurred at an incidence of <1% in patients who received TECENTRIQ or were reported for other products in this class of therapy
  • For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. For severe (Grade 3 or 4) adverse reactions, withhold TECENTRIQ and administer corticosteroids. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ

Infections

  • TECENTRIQ can cause severe infections including fatal cases 
  • Across clinical trials, infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events
  • Monitor patients for signs and symptoms of infection. For Grade 3 or 4 infections, withhold TECENTRIQ and resume once clinically stable

Infusion-Related Reactions

  • TECENTRIQ can cause severe or life-threatening infusion-related reactions
  • Across clinical trials, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events
  • Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2 infusion-related reactions. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions

Embryo-Fetal Toxicity

  • Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential 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 

Nursing Mothers/Fertility

  • Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
  • Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment

Most Common Adverse Reactions
The most common adverse reactions in NSCLC (rate ≥20%) were fatigue (43.5%), decreased appetite (23.5%), dyspnea (22%), and cough (26.4%).

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.