Serious Adverse Reactions
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 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-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, 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, 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 UC included 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 Brief Summary of Prescribing Information on adjacent pages.
© 2016 Genentech USA, Inc. All rights reserved. PDL/072716/0182
TECENTRIQ 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
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.
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
FOR PREVIOUSLY TREATED LOCALLY ADVANCED
OR METASTATIC UROTHELIAL CARCINOMA
FOR PREVIOUSLY TREATED METASTATIC
NON-SMALL CELL LUNG CANCER
NOW APPROVED FOR 2 TUMOR TYPES
THE FIRST AND ONLY FDA-APPROVED
ANTI-PDL1 CANCER IMMUNOTHERAPY
Learn more at TECENTRIQ.com/learn
ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; PD-L1=programmed death-ligand 1.