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Important Safety Information & Indication
Indication
mUC
TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- Are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), as determined by an FDA-approved test, or
- Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status, 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.
NSCLC
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
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. Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
- Immune-mediated hepatitis. Immune-mediated hepatitis and liver test abnormalities, including fatal cases, have occurred. 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. Permanently discontinue TECENTRIQ for Grade 4 diarrhea or colitis
- Immune-mediated endocrinopathies. Thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism have occurred
- Other immune-mediated adverse reactions. TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ
- Infections. Severe infections, including fatal cases, have occurred
- Infusion-related reactions. Severe or life-threatening infusion-related reactions have occurred. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions
- Embryo-fetal toxicity. TECENTRIQ can cause fetal harm in pregnant women. Verify pregnancy status prior to initiating TECENTRIQ. 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 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%).
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 the full Prescribing Information for additional Important Safety Information.