Important Safety Information

Indications

Locally advanced or metastatic urothelial carcinoma
TECENTRIQ is indicated for the treatment of adult 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 a confirmatory trial(s).

Metastatic non-small cell lung cancer
TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, as a single agent, is indicated for the treatment of adult 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 NSCLC harboring these aberrations prior to receiving TECENTRIQ.

Metastatic triple-negative breast cancer
TECENTRIQ, in combination with paclitaxel protein-bound, is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Extensive-stage small cell lung cancer
TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

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
  • In clinical studies of TECENTRIQ as a single agent, 2.5% of patients developed pneumonitis, including Grade 3 (0.6%), Grade 4 (0.1%), and Grade 5 (<0.1%) events
  • In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy for NSCLC and SCLC, pneumonitis occurred in 5.5% of patients, including Grades 3 to 4 (1.4%) 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
  • In clinical studies of TECENTRIQ as a single agent, hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events
  • In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy for NSCLC and SCLC, hepatitis occurred in 14% of patients, including Grades 3 to 4 (4.1%) 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 diarrhea or colitis have occurred with TECENTRIQ treatment
  • In clinical studies of TECENTRIQ as a single agent, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events
  • In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy for NSCLC and SCLC, diarrhea or colitis occurred in 29% of patients, including Grades 3 to 4 (4.3%) 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 Grades 2 to 4 endocrinopathies
  • Thyroid Disorders
    • In clinical studies of TECENTRIQ as a single agent, hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients
    • In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy for NSCLC and SCLC, hypothyroidism occurred in 11% of patients, including Grades 3 to 4 (0.3%) events
    • Monitor thyroid function prior to and during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated
  • Adrenal Insufficiency
    • In clinical studies of TECENTRIQ as a single agent, 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 or higher adrenal insufficiency, initiate corticosteroids and hormone replacement therapy as clinically indicated
  • Type 1 Diabetes Mellitus
    • In clinical studies of TECENTRIQ as a single agent, 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
    • In clinical studies of TECENTRIQ as a single agent, Grade 2 hypophysitis occurred in <0.1% of patients
    • For Grades 2 to 4 hypophysitis, initiate corticosteroids and hormone replacement therapy as clinically indicated
  • The frequency and severity of hyperthyroidism, thyroiditis, adrenal insufficiency, diabetes mellitus, and hypophysitis were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC

Other Immune-Mediated Adverse Reactions

  • TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system
  • In clinical studies of TECENTRIQ as a single agent, and in combination with platinum-based chemotherapy or were reported in other products in this class, cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular immune-mediated adverse reactions occurred at an incidence of <1%
  • 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
  • Evaluate for Vogt-Koyanagi-Harada syndrome if uveitis occurs in combination with other immune-mediated adverse reactions

Infections

  • TECENTRIQ can cause severe infections including fatal cases
  • In clinical studies of TECENTRIQ as a single agent, infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events
  • The frequency and severity of infections were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC
  • Monitor patients for signs and symptoms of infection. For Grade 3 or higher infections, withhold TECENTRIQ and resume once clinically stable

Infusion-Related Reactions

  • TECENTRIQ can cause severe or life-threatening infusion-related reactions
  • In clinical studies of TECENTRIQ as a single agent, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events
  • The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC
  • Monitor patients 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 (rate ≥20%) in patients who received TECENTRIQ alone were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with other antineoplastic drugs for NSCLC and SCLC were fatigue/asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%), and decreased appetite (27%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ with paclitaxel protein-bound for mTNBC were alopecia (56%), peripheral neuropathies (47%), fatigue (47%), nausea (46%), diarrhea (33%), anemia (28%), constipation (25%), cough (25%), headache (23%), neutropenia (21%), vomiting (20%), and decreased appetite (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 full Prescribing Information for additional Important Safety Information.