Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

1 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody 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. (1.1) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.1) Metastatic non-small cell lung cancer 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. (1.2) 1.1 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 [see Clinical Studies (14.1)]. 1.2 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.

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Immune-Mediated Pneumonitis [see Warnings and Precautions (5.1)] Immune-Mediated Hepatitis [see Warnings and Precautions (5.2)] Immune-Mediated Colitis [see Warnings and Precautions (5.3)] Immune-Mediated Endocrinopathies [see Warnings and Precautions (5.4)] Other Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.5)] Infections [see Warnings and Precautions (5.6)] Infusion-Related Reactions [see Warnings and Precautions (5.7)] Most common adverse reactions (≥ 20%) in patients with locally advanced or metastatic urothelial carcinoma were fatigue, decreased appetite, nausea, constipation, urinary tract infection, diarrhea, and pyrexia. (6.1) Most common adverse reactions (≥ 20%) in patients with metastatic non-small cell lung cancer were fatigue, decreased appetite, dyspnea, and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the Warnings and Precautions section reflect exposure to TECENTRIQ in 2616 patients in two randomized, active-controlled studies (POPLAR, OAK) and four open-label, single arm studies (PCD4989g, IMvigor210, BIRCH, FIR) which enrolled 524 patients with metastatic urothelial carcinoma, 1636 patients with metastatic NSCLC, and 456 patients with other tumor types. TECENTRIQ was administered at a dose of 1200 mg intravenously every 3 weeks in all studies except PCD4989g. Among the 2616 patients, 36% were exposed for longer than 6 months and 20% were exposed for longer than 12 months. The data described in this section were obtained from one open-label, single arm, multiple cohort study (IMvigor210) and one randomized open-label, active-controlled study (OAK) in which TECENTRIQ was administered to 429 patients with locally advanced and metastatic urothelial carcinoma and 609 patients with metastatic NSCLC. In these trials, TECENTRIQ was administered at a dose of 1200 mg intravenously every 3 weeks. Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma The safety of TECENTRIQ was evaluated in IMvigor 210 (Cohort 1), a multicenter, open-label, single-arm trial that included 119 patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy and were either previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy [see Clinical Studies (14.1)]. Patients received TECENTRIQ 1200 mg intravenously every 3 weeks until either unacceptable toxicity or disease progression. The median duration of exposure was 15 weeks (0 to 87 weeks). The most common adverse reactions (≥ 20%) were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%). The most common Grade 3–4 adverse reactions (≥ 2%) were fatigue, urinary tract infection, anemia, diarrhea, blood creatinine increase, intestinal obstruction, ALT increase, hyponatremia, decreased appetite, sepsis, back/neck pain, renal failure, and hypotension. Five patients (4.2%) who were treated with TECENTRIQ experienced one of the following events which led to death: sepsis, cardiac arrest, myocardial infarction, respiratory failure, or respiratory distress. One additional patient (0.8%) was experiencing herpetic meningoencephalitis and disease progression at the time of death. TECENTRIQ was discontinued for adverse reactions in 4.2% of patients. The adverse reactions leading to discontinuation were diarrhea/colitis (1.7%), fatigue (0.8%), hypersensitivity (0.8%), and dyspnea (0.8%). Adverse reactions leading to interruption occurred in 35% of patients;the most common (≥ 1%) were intestinal obstruction, fatigue, diarrhea, urinary tract infection, infusion related reaction, cough, abdominal pain, peripheral edema, pyrexia, respiratory tract infection, upper respiratory tract infection, creatinine increase, decreased appetite, hyponatremia, back pain, pruritus, and venous thromboembolism. Serious adverse reactions occurred in 37% of patients. The most frequent serious adverse reactions (≥ 2%) were diarrhea, intestinal obstruction, sepsis, acute kidney injury, and renal failure. Table 2 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 3 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in IMvigor210 (Cohort 1). Table 2: Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 1) Adverse Reaction TECENTRIQ N = 119 All Grades (%) Grades 3–4 (%) General FatigueIncludes fatigue, asthenia, lethargy, and malaise 52 8 Peripheral edemaIncludes edema peripheral, scrotal edema, lymphedema, and edema 17 2 Pyrexia 14 0.8 Gastrointestinal DiarrheaIncludes diarrhea, colitis, frequent bowel movements, autoimmune colitis 24 5 Nausea 22 2 Vomiting 16 0.8 Constipation 15 2 Abdominal painIncludes abdominal pain, upper abdominal pain, lower abdominal pain, and flank pain 15 0.8 Metabolism and Nutrition Decreased appetiteIncludes decreased appetite and early satiety 24 3 Musculoskeletal and Connective Tissue Back/Neck pain 18 3 Arthralgia 13 0 Skin and Subcutaneous Tissue Pruritus 18 0.8 RashIncludes rash, dermatitis, dermatitis acneiform, rash maculo-papular, rash erythematous, rash pruritic, rash macular, and rash papular 17 0.8 Infections Urinary tract infectionIncludes urinary tract infection, urinary tract infection bacterial, cystitis, and urosepsis 17 5 Respiratory, Thoracic, and Mediastinal CoughIncludes cough and productive cough 14 0 DyspneaIncludes dyspnea and exertional dyspnea 12 0 Table 3: Grade 3–4 Laboratory Abnormalities in ≥ 1% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 1) Laboratory Abnormality Grades 3–4 (%) Hyponatremia 15 Hyperglycemia 10 Lymphopenia 9 Anemia 7 Increased Alkaline Pphosphatase 7 Increased Creatinine 5 Hypophosphatemia 4 Increased ALT 4 Increased AST 4 Hyperkalemia 3 Hypermagnesemia 3 Hyperbilirubinemia 3 Previously Treated Patients with Locally Advanced or Metastatic Urothelial Carcinoma The safety of TECENTRIQ was evaluated in IMvigor210 (Cohort 2), a multicenter, open-label, single-arm trial that included 310 patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or following at least one platinum-containing chemotherapy regimen or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen [see Clinical Studies (14.1)]. Patients received TECENTRIQ 1200 mg intravenously every 3 weeks until unacceptable toxicity or either radiographic or clinical progression. The median duration of exposure was 12.3 weeks (0.1 to 46 weeks). The most common adverse reactions (≥ 20%) were fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%). The most common Grade 3–4 adverse reactions (≥ 2%) were urinary tract infection, anemia, fatigue, dehydration, intestinal obstruction, urinary obstruction, hematuria, dyspnea, acute kidney injury, abdominal pain, venous thromboembolism, sepsis, and pneumonia. Three patients (1%) who were treated with TECENTRIQ experienced one of the following events which led to death: sepsis, pneumonitis, or intestinal obstruction. TECENTRIQ was discontinued for adverse reactions in 3.2% (10/310) of patients. Sepsis led to discontinuation in 0.6% (2/310) of patients. Adverse reactions leading to interruption occurred in 27% of patients; the most common (> 1%) were liver enzyme increase, urinary tract infection, diarrhea, fatigue, confusional state, urinary obstruction, pyrexia, dyspnea, venous thromboembolism, and pneumonitis. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions (> 2%) were urinary tract infection, hematuria, acute kidney injury, intestinal obstruction, pyrexia, venous thromboembolism, urinary obstruction, pneumonia, dyspnea, abdominal pain, sepsis, and confusional state. Table 4 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 5 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in IMvigor210 (Cohort 2). Table 4: Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 2) TECENTRIQ N=310 Adverse Reaction All Grades (%) Grades 3–4 (%) Gastrointestinal Nausea 25 2 Constipation 21 0.3 Diarrhea 18 1 Abdominal pain 17 4 Vomiting 17 1 General Fatigue 52 6 Pyrexia 21 1 Peripheral edema 18 1 Infections Urinary tract infection 22 9 Metabolism and Nutrition Decreased appetite 26 1 Musculoskeletal and Connective Tissue Back/Neck pain 15 2 Arthralgia 14 1 Renal and Urinary Hematuria 14 3 Respiratory, Thoracic, and Mediastinal Dyspnea 16 4 Cough 14 0.3 Skin and Subcutaneous Tissue Rash 15 0.3 Pruritus 13 0.3 Table 5: Grade 3–4 Laboratory Abnormalities in ≥ 1% of Patients with Urothelial Carcinoma in IMvigor210 (Cohort 2) Laboratory Abnormality Grades 3–4 (%) Lymphopenia 10 Hyponatremia 10 Anemia 8 Hyperglycemia 5 Increased Alkaline Pphosphatase 4 Increased Creatinine 3 Increased ALT 2 Increased AST 2 Hypoalbuminemia 1 NSCLC The safety of TECENTRIQ was evaluated in OAK, a multicenter, international, randomized, open-label trial in patients with metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression [see Clinical Studies (14.2)]. A total of 609 patients received TECENTRIQ 1200 mg intravenously every 3 weeks weeks until unacceptable toxicity, radiographic progression, or clinical progression or docetaxel (n=578) 75 mg/m2 intravenously every 3 weeks until unacceptable toxicity or disease progression. The study excluded patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids . The study population characteristics were: median age of 63 years (25 to 85 years), 46% age 65 years or older, 62% male, 71% White, 20% Asian, 68% former smoker, 16% current smoker, and 63% had ECOG performance status of 1. The median duration of exposure was 3.4 months (0 to 26 months) in TECENTRIQ-treated patients and 2.1 months (0 to 23 months) in docetaxel-treated patients. The most common adverse reactions (≥ 20%) in patients receiving TECENTRIQ were fatigue (43.5%), decreased appetite (23.5%), dyspnea (22%), and cough (26.4%). The most common Grade 3–4 adverse reactions (≥ 2%) were dyspnea, pneumonia, fatigue, anemia, and pulmonary embolism. TECENTRIQ was discontinued due to adverse reactions in 8% of patients. The most common adverse reactions leading to TECENTRIQ discontinuation were fatigue, infections and dyspnea. Fatal adverse reactions occurred in 1.6% of patients; these included pneumonia, sepsis, septic shock, dyspnea, pulmonary hemorrhage, sudden death, myocardial ischemia or renal failure. Adverse reactions leading to interruption of TECENTRIQ occurred in 25% of patients; the most common (> 1%) were pneumonia, liver function test abnormality, dyspnea, fatigue, pyrexia, and back pain. Serious adverse reactions occurred in 33.5% of patients. The most frequent serious adverse reactions (> 1%) were pneumonia, sepsis, dyspnea, pleural effusion, pulmonary embolism, pyrexia and respiratory tract infection. Table 6 summarizes adverse reactions that occurred in at least 10% of patients treated with TECENTRIQ. Table 7 summarizes selected laboratory abnormalities worsening from baseline that occurred in ≥ 20% of patients treated with TECENTRIQ . Table 6: Adverse Reactions Occurring in ≥ 10% of Patients with NSCLC Receiving TECENTRIQ in OAK TECENTRIQ 1200 mg every 3 weeks n= 609 Docetaxel 75 mg/m2 every three weeks n= 578 Adverse ReactionGraded per NCI CTCAE v4.0 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) General Fatigue/AstheniaIncludes fatigue and asthenia 44 4 53 6 Pyrexia 18 <1 13 <1 Respiratory CoughIncludes cough and exertional cough 26 <1 21 <1 Dyspnea 22 2.8 21 2.6 Musculoskeletal Myalgia/painIncludes musculoskeletal pain, musculoskeletal stiffness, musculoskeletal chest pain, myalgia 20 1.3 20 <1 Arthralgia 12 0.5 10 0.2 Metabolism and Nutrition Decreased appetite 23 <1 24 1.6 Gastrointestinal Nausea 18 <1 23 <1 Constipation 18 <1 14 <1 Diarrhea 16 <1 24 2 Skin RashIncludes rash,erythematous rash,generalized rash, maculopapular rash, papular rash, pruritic rash, pustular rash,pemphigoid. 12 <1 10 0 Table 7: Laboratory Abnormalities Worsening From Baseline Occurring in ≥ 20% of NSCLC Patients Receiving TECENTRIQ in OAK Laboratory Abnormality TECENTRIQ 1200 mg every 3 weeks Docetaxel 75 mg /m2 every 3 weeks Grade All GradesGraded according to NCI CTCAE version 4.0 (%)Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ (range: 546–585) and docetaxel (range: 532–560) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Chemistry Hypoalbuminemia 48 4 50 3 Hyponatremia 42 7 31 6 Increased Alkaline Phosphatase 39 2 25 1 Increased AST 31 3 16 0.5 Increased ALT 27 3 14 0.5 Hypophosphatemia 27 5 23 4 Hypomagnesemia 26 1 21 1 Increased Creatinine 23 2 16 1 Hematology Anemia 67 3 82 7 Lymphocytopenia 49 14 60 21 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Among 565 patients with NSCLC in OAK, 30% tested positive for treatment-emergent anti-drug antibodies (ADA) at one or more post-dose time points. The median onset time to ADA formation was 3 weeks. The ability of these binding ADA to neutralize atezolizumab is unknown. Patients who tested positive for treatment-emergent ADA also had decreased systemic atezolizumab exposure [see Clinical Pharmacology (12.3)]. Exploratory analyses showed that the subset of patients who were ADA positive by week 4 (21%; 118/560) appeared to have less efficacy (effect on overall survival) as compared to patients who tested negative for treatment-emergent ADA by week 4 [see Clinical Studies (14.2)]. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. Among 275 patients with urothelial carcinoma in IMvigor210 (Cohort 2), 42% tested positive for treatment-emergent ADA at one or more post-dose time points. Among 111 patients in IMvigor210 (Cohort 1), 48% tested positive for treatment-emergent ADA at one or more post-dose time points. Patients who tested positive for treatment-emergent ADA also had decreased systemic atezolizumab exposures. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to atezolizumab in the studies described above with the incidence of antibodies in other studies or to other products may be misleading.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Administer 1200 mg as an intravenous infusion over 60 minutes every 3 weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. (2.1) 2.1 Recommended Dosage The recommended dosage of TECENTRIQ is 1200 mg as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. 2.2 Dosage Modifications for Adverse Reactions No dose reductions of TECENTRIQ are recommended. Recommendations for dosage modifications are provided in Table 1. Table 1: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity of Adverse ReactionNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 Dosage Modifications Pneumonitis [see Warnings and Precautions (5.1)] Grade 2 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) Grade 3 or 4 Permanently discontinue Hepatitis [see Warnings and Precautions (5.2)] AST or ALT 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 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) AST or ALT more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal Permanently discontinue Colitis or diarrhea [see Warnings and Precautions (5.3)] Grade 2 or 3 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) Grade 4 Permanently discontinue Endocrinopathies (including but not limited to hypophysitis, adrenal insufficiency, hyperthyroidism, and type 1 diabetes mellitus) [see Warnings and Precautions (5.4)] Grade 2, 3, or 4 Withhold dose until Grade 1 or resolved and clinically stable on hormone replacement therapy. Other immune-mediated adverse reactions involving a major organ [see Warnings and Precautions (5.5)] Grade 3 Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) Grade 4 Permanently discontinue Infections [see Warnings and Precautions (5.6)] Grade 3 or 4 Withhold dose until Grade 1 or resolved Infusion-Related Reactions [see Warnings and Precautions (5.7)] Grade 1 or 2 Interrupt or slow the rate of infusion Grade 3 or 4 Permanently discontinue Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathies) Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last TECENTRIQ dose Permanently discontinue Inability to taper corticosteroid Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after last TECENTRIQ dose Permanently discontinue Recurrent Grade 3 or 4 adverse reaction Recurrent Grade 3 or 4 (severe or life-threatening) adverse reaction Permanently discontinue 2.3 Preparation and Administration Preparation Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial. Prepare the solution for infusion as follows: Withdraw 20 mL of TECENTRIQ from the vial. Dilute into a 250 mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride Injection, USP. Dilute with 0.9% Sodium Chloride Injection only. Mix diluted solution by gentle inversion. Do not shake. Discard used or empty vials of TECENTRIQ. Storage of Infusion Solution This product does not contain a preservative. Administer immediately once prepared. If diluted TECENTRIQ infusion solution is not used immediately, store solution either: At room temperature for no more than 6 hours from the time of preparation. This includes room temperature storage of the infusion in the infusion bag and time for administration of the infusion, or Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from time of preparation. Do not freeze. Do not shake. Administration Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. Do not coadminister other drugs through the same intravenous line. Do not administer as an intravenous push or bolus.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. (8.2) 8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)], TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death (see Data). Advise females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with TECENTRIQ to evaluate its effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to a fetus and to result in an increase in fetal loss; therefore, potential risks of administering TECENTRIQ during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-L1/PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to atezolizumab may increase the risk of developing immune-mediated disorders or altering the normal immune response. 8.2 Lactation Risk Summary There is no information regarding the presence of atezolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise women not to breastfeed during treatment and for at least 5 months after the last dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating TECENTRIQ [see Use in Specific Populations (8.1)]. Contraception Females Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months following the last dose. Infertility Females Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment [see Nonclinical Toxicology (13.1)]. 8.4 Pediatric Use The safety and effectiveness of TECENTRIQ have not been established in pediatric patients. 8.5 Geriatric Use Of the 609 patients with NSCLC treated with TECENTRIQ in OAK, 45% were 65 years or older. No overall differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients. Of the 310 previously-treated patients with urothelial carcinoma treated with TECENTRIQ in IMvigor210 (Cohort 2), 59% were 65 years or older. Of the 119 cisplatin-ineligible patients with urothelial carcinoma treated with TECENTRIQ in IMvigor210 (Cohort 1), 83% were 65 years or older and 41% were 75 years or older. The overall response rate in patients 65 years or older was 23% and in patients 75 years or older was 29% . Grade 3 or 4 adverse reactions occurred in 53% of patients 65 years or older and 51% of patients 75 years or older. No overall differences in safety or efficacy were observed between patients ≥ 75 years of age and younger patients.

More information

Category Value
Authorisation number BLA761034
Agency product number 52CMI0WC3Y
Orphan designation No
Product NDC 50242-917
Date Last Revised 30-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1792785
Storage and handling Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
Marketing authorisation holder Genentech, Inc.