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IMPORTANT SAFETY INFORMATION AND INDICATIONS
Locally advanced or metastatic urothelial carcinoma
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.
Metastatic non-small cell lung cancer
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.
Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.
- Immune-related pneumonitis or interstitial lung disease, including 2 fatal cases, occurred with TECENTRIQ treatment
- Pneumonitis occurred in 3.7% of patients with non-small cell lung cancer (NSCLC) and 1.1% of patients with urothelial cancer (UC)
- Monitor patients for signs with radiographic imaging and symptoms of pneumonitis. Administer steroids for Grade 2 or greater pneumonitis. Withhold TECENTRIQ until resolution for Grade 2 pneumonitis. Permanently discontinue for Grade 3 or 4 pneumonitis
- Immune-mediated hepatitis, including a fatal case in urothelial carcinoma (UC), and liver test abnormalities have occurred with TECENTRIQ treatment
- Across clinical trials, Grade 3 or 4 elevation occurred in ALT (2.5%), AST (2.3%), and total bilirubin (1.6%). Immune-mediated hepatitis occurred in 1.3% of patients with UC and 0.9% of patients with NSCLC
- Monitor patients for signs and symptoms of hepatitis. Monitor AST, ALT, and bilirubin prior to and periodically during treatment
- Administer corticosteroids for Grade 2 or greater transaminase elevations, with or without concomitant elevation in total bilirubin. Withhold TECENTRIQ for Grade 2, and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis
- Immune-mediated colitis, including a fatal case of diarrhea-associated renal failure, have occurred with TECENTRIQ treatment
- Across clinical trials, colitis or diarrhea occurred in 19.7% of patients
- Immune-mediated colitis or diarrhea occurred in 0.8% of patients with UC and 0.5% of patients with NSCLC
- Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or Grade 3 diarrhea or colitis. Permanently discontinue for Grade 4 diarrhea or colitis
- Immune-related thyroid disorders, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have occurred in patients receiving TECENTRIQ. Monitor patients for clinical signs and symptoms of endocrinopathies
- Across clinical trials, hypo- and hyperthyroidism occurred in 3.9% and 1.0% of patients, respectively. In patients with NSCLC, hypo- and hyperthyroidism occurred in 4.2% and 1.1%, respectively. Monitor thyroid function prior to and periodically during treatment with TECENTRIQ. For symptomatic hypothyroidism, withhold TECENTRIQ and initiate hormone replacement as needed. Manage isolated hypothyroidism with replacement therapy and without corticosteroids. For symptomatic hyperthyroidism, withhold TECENTRIQ and initiate an anti-thyroid drug as needed
- Across clinical trials, adrenal insufficiency occurred in 0.4% of patients. For symptomatic adrenal insufficiency, withhold TECENTRIQ and administer steroids
- In UC, hypophysitis occurred in 0.2% of patients. Administer corticosteroids and hormone replacement as clinically indicated. Withhold for Grade 2 or Grade 3, and permanently discontinue for Grade 4 hypophysitis
- New onset diabetes with ketoacidosis occurred in patients. Diabetes mellitus without an alternative etiology occurred in 0.3% of patients with NSCLC. Initiate treatment with insulin for type 1 diabetes mellitus. For ≥Grade 3 hyperglycemia (fasting glucose >250-500 mg/dL), withhold TECENTRIQ
Other Immune-Related Adverse Reactions
- Other immune-related adverse reactions, including meningoencephalitis, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, ocular inflammatory toxicity, and pancreatitis, including increases in serum amylase and lipase levels, have occurred in ≤1.0% of patients treated with TECENTRIQ
- Symptomatic pancreatitis without an alternative etiology occurred in 0.1% of patients across clinical trials
- Monitor patients for clinical signs and symptoms of meningitis or encephalitis, as well as symptoms of motor and sensory neuropathy. Permanently discontinue TECENTRIQ for any grade of meningitis or encephalitis, or any grade of myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome
- Monitor patients for signs and symptoms of acute pancreatitis. Withhold TECENTRIQ for ≥Grade 3 serum amylase or lipase levels (>2.0 ULN), or Grade 2 or 3 pancreatitis. Permanently discontinue for Grade 4 or any grade of recurrent pancreatitis
- Severe infections, including sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage, occurred in patients receiving TECENTRIQ
- In UC, infection occurred in 37.7% of patients. Grade 3 or 4 infection occurred in 11.5% of patients, while 3 patients died due to infections. Urinary tract infections were the most common cause of Grade 3 or higher infection, occurring in 7.1% of patients
- In a NSCLC study, infection occurred in 43% (Grade 3 or 4 was 9.2%) of patients treated with TECENTRIQ compared with 34% (Grade 3 or 4 was 2.2%) with docetaxel. Two patients died due to infections. Pneumonia was the most common cause of Grade 3 or higher infection, occurring in 7.7% of patients
- Monitor patients for signs and symptoms of infection and treat with antibiotics for suspected or confirmed bacterial infections. Withhold TECENTRIQ for ≥Grade 3 infection
- Severe infusion reactions have occurred in patients in clinical trials of TECENTRIQ. Infusion-related reactions occurred in 1.7% of patients in UC, and 1.6% in NSCLC
- Interrupt or slow the rate of infusion in patients with Grade 2 infusion-related reactions. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion reactions
- Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Advise pregnant women or women planning to become pregnant of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose of TECENTRIQ
- 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
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 (rate ≥20%) in previously treated 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%).