Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 16 April 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 [see Clinical Studies (14.2)].

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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-Related Pneumonitis [see Warnings and Precautions (5.1)] Immune-Related Hepatitis [see Warnings and Precautions (5.2)] Immune-Related Colitis [see Warnings and Precautions (5.3)] Immune-Related Endocrinopathies [see Warnings and Precautions (5.4)] Other Immune-Related Adverse Reactions [see Warnings and Precautions (5.5)] Infection [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, cough, nausea, musculoskeletal pain, and constipation. (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. Urothelial Carcinoma Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma The safety of TECENTRIQ was evaluated in Study 4, 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 1200 mg of TECENTRIQ intravenously every 3 weeks until either unacceptable toxicity or disease progression. The median duration of exposure was 15.0 weeks (range 0, 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% (5/119) 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 of TECENTRIQ 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. Immune-related adverse reactions requiring systemic corticosteroids or hormone replacement therapy occurred in 19.3% (23/119) patients, including 12.6% (15/119) patients who required systemic corticosteroid therapy and 6.7% (8/119) patients who required only hormone replacement therapy. Six patients (5.0%) received an oral prednisone dose equivalent to ≥40 mg daily for an immune-mediated adverse reaction [see Warnings and Precautions (5)]. Table 1 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 2 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in Study 4. Table 1: All Grade Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in Study 4 TECENTRIQ N = 119 Adverse Reaction All Grades (%) Grades 3–4 (%) General Disorders FatigueIncludes fatigue, asthenia, lethargy, and malaise 52 8 Peripheral edemaIncludes edema peripheral, scrotal edema, lymphedema, and edema 17 2 Pyrexia 14 0.8 Gastrointestinal Disorders 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 Disorders Decreased appetiteIncludes decreased appetite and early satiety 24 3 Musculoskeletal and Connective Tissue Disorders Back/Neck pain 18 3 Arthralgia 13 0 Skin and Subcutaneous Tissue Disorders 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 Disorders CoughIncludes cough and productive cough 14 0 DyspneaIncludes dyspnea and exertional dyspnea 12 0 Table 2: Grade 3–4 Laboratory Abnormalities in Patients with Urothelial Carcinoma in Study 4 in ≥ 1% of Patients Laboratory Test Grades 3–4 (%) Hyponatremia 15 Hyperglycemia 10 Lymphopenia 9 Anemia 7 Increased Alkaline phosphatase 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 Study 1, a multicenter, open-label, single-arm trial that included 310 patients in a single arm trial 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 1200 mg of TECENTRIQ intravenously every 3 weeks until unacceptable toxicity or either radiographic or clinical progression. The median duration of exposure was 12.3 weeks (range: 0.1, 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 (1.0%) 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 the 310 patients. Sepsis led to discontinuation in 0.6% (2/310) of patients. Adverse reactions leading to interruption of TECENTRIQ 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. Immune-related adverse reactions requiring systemic corticosteroids or hormone replacement therapy occurred in 11.0% (34/310) patients, including 8.4% (26/310) patients who required systemic corticosteroid therapy and 2.6% (8/310) patients who required only hormone replacement therapy. Eighteen patients (5.8%) received an oral prednisone dose equivalent to ≥40 mg daily for an immune-mediated adverse reaction [see Warnings and Precautions (5)]. Table 3 summarizes the adverse reactions that occurred in ≥ 10% of patients while Table 4 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in Study 1. Table 3: All Grade Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in Study 1 TECENTRIQ N=310 Adverse Reaction All Grades (%) Grades 3–4 (%) Gastrointestinal Disorders Nausea 25 2 Constipation 21 0.3 Diarrhea 18 1 Abdominal pain 17 4 Vomiting 17 1 General Disorders Fatigue 52 6 Pyrexia 21 1 Peripheral edema 18 1 Infections Urinary tract infection 22 9 Metabolism and Nutrition Disorders Decreased appetite 26 1 Musculoskeletal and Connective Tissue Disorders Back/Neck pain 15 2 Arthralgia 14 1 Renal and urinary disorders Hematuria 14 3 Respiratory, Thoracic, and Mediastinal Disorders Dyspnea 16 4 Cough 14 0.3 Skin and Subcutaneous Tissue Disorders Rash 15 0.3 Pruritus 13 0.3 Table 4: Grade 3–4 Laboratory Abnormalities in Patients with Urothelial Carcinoma in Study 1 in ≥ 1% of Patients Laboratory Test Grades 3–4 (%) Lymphopenia 10 Hyponatremia 10 Anemia 8 Hyperglycemia 5 Increased Alkaline phosphatase 4 Increased Creatinine 3 Increased ALT 2 Increased AST 2 Hypoalbuminemia 1 NSCLC The safety of TECENTRIQ was evaluated in Study 3, 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)]. Patients received 1200 mg of TECENTRIQ (n=142) administered intravenously every 3 weeks until unacceptable toxicity or either radiographic or clinical progression or docetaxel (n=135) administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The median duration of exposure was 3.7 months (range: 0–19 months) in TECENTRIQ-treated patients and 2.1 months (range: 0–17 months) in docetaxel-treated patients. The most common adverse reactions (≥ 20%) in patients receiving TECENTRIQ were fatigue (46%), decreased appetite (35%), dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain (22%), and constipation (20%). The most common Grade 3-4 adverse reactions (≥2%) were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Nine patients (6.3%) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (2), pneumothorax, ulcer hemorrhage, cachexia secondary to dysphagia, myocardial infarction, or large intestinal perforation which led to death. TECENTRIQ was discontinued due to adverse reactions in 4% (6/142) of patients. Adverse reactions leading to interruption of TECENTRIQ occurred in 24% of patients; the most common (>1%) were pneumonia, liver function test abnormality, upper respiratory tract infection, pneumonitis, acute kidney injury, hypoxia, hypothyroidism, dyspnea, anemia, and fatigue. Serious adverse reactions occurred in 37% of patients. The most frequent serious adverse reactions (> 2%) were pneumonia, dyspnea, pleural effusion, pyrexia, and venous thromboembolism. Table 5 summarizes adverse reactions that occurred in at least 10% of TECENTRIQ-treated patients and at a higher incidence than in the docetaxel arm. Table 6 summarizes selected laboratory abnormalities worsening from baseline that occurred in ≥10% of TECENTRIQ-treated patients and at a higher incidence than in the docetaxel arm. Table 5: Adverse Reactions Occurring in ≥10% of TECENTRIQ-Treated Patients with NSCLC and at a Higher Incidence than in the Docetaxel Arm (Between Arm Difference of ≥5% [All Grades] or ≥2% [Grades 3–4]) (Study 3) TECENTRIQ (n=142) Docetaxel (n=135) Adverse Reaction All grades Grade 3–4 All grades Grade 3–4 Percentage (%) of Patients General Disorders Pyrexia 18 0 13 0 Infections Pneumonia 18 6 4 2 Metabolism and nutrition disorders Decreased appetite 35 1 22 0 Musculoskeletal and connective tissue disorders Arthralgia 16 2 9 2 Back pain 14 1 9 1 Psychiatric Disorders Insomnia 14 0 8 2 Respiratory, thoracic and mediastinal disorders Dyspnea 32 7 24 2 Cough 30 1 25 0 Table 6: Selected Laboratory Abnormalities Worsening from Baseline Occurring in ≥10% of TECENTRIQ-Treated Patients with NSCLC and at a Higher Incidence than in the Docetaxel Arm (Between Arm Difference of ≥5% [All Grades] or ≥2% [Grades 3–4]) (Study 3) Percentage of Patients with Worsening Laboratory Test from Baseline TECENTRIQ Docetaxel Test All grades % Grade 3–4 % All grades % Grade 3–4 % Hyponatremia 48 13 28 8 Hypoalbuminemia 48 5 49 1 Alkaline Phosphatase increased 42 2 24 1 Aspartate aminotransferase increased 33 2 15 0 Alanine aminotransferase increased 31 2 9 1 Creatinine increased 19 1 14 2 Hypokalemia 18 2 11 4 Hypercalcemia 13 0 5 0 Total Bilirubin increased 11 0 5 1 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Among 275 patients in Study 1, 114 patients (41.5%) tested positive for treatment-emergent (treatment-induced or treatment-enhanced) anti-therapeutic antibodies (ATA) at one or more post-dose time points. Among 135 patients in Study 3, 73 patients (54.1%) tested positive for treatment-emergent ATAs at one or more post-dose time points. Among 111 patients in Study 4, 53 patients (47.7%) tested positive for treatment-emergent ATAs at one or more post-dose time points. In Study 1, Study 3, and Study 4, the presence of ATAs did not appear to have a clinically significant impact on pharmacokinetics, safety or efficacy. Immunogenicity assay results are highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of incidence of ATAs to TECENTRIQ with the incidence of antibodies 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. (2.1) Dilute prior to intravenous infusion. (2.3) 2.1 Recommended Dosing The recommended dose of TECENTRIQ is 1200 mg administered 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. Do not administer TECENTRIQ as an intravenous push or bolus. 2.2 Dose Modifications No dose reductions of TECENTRIQ are recommended. Withhold TECENTRIQ for any of the following: Grade 2 pneumonitis [see Warnings and Precautions (5.1)] Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN [see Warnings and Precautions (5.2)] Grade 2 or 3 diarrhea or colitis [see Warnings and Precautions (5.3)] Symptomatic hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, or Grade 3 or 4 hyperglycemia [see Warnings and Precautions (5.4)] Grade 2 ocular inflammatory toxicity [see Warnings and Precautions (5.5)] Grade 2 or 3 pancreatitis, or Grade 3 or 4 increases in amylase or lipase levels (greater than 2.0 times ULN) [see Warnings and Precautions (5.5)] Grade 2 myocarditis [see Warnings and Precautions (5.5)] Grade 3 or 4 infection [see Warnings and Precautions (5.6)] Grade 2 infusion-related reactions [see Warnings and Precautions (5.7)] Grade 3 rash TECENTRIQ may be resumed in patients whose adverse reactions recover to Grade 0–1. Permanently discontinue TECENTRIQ for any of the following: Grade 3 or 4 pneumonitis [see Warnings and Precautions (5.1)] AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN [see Warnings and Precautions (5.2)] Grade 4 diarrhea or colitis [see Warnings and Precautions (5.3)] Grade 4 hypophysitis [see Warnings and Precautions (5.4)] Myasthenic syndrome/myasthenia gravis, Guillain-Barré or meningoencephalitis (all grades) [see Warnings and Precautions (5.5)] Grade 3 or 4 ocular inflammatory toxicity [see Warnings and Precautions (5.5)] Grade 4 or any grade of recurrent pancreatitis [see Warnings and Precautions (5.5)] Grade 3 or 4 myocarditis [see Warnings and Precautions (5.5)] Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.7)] Grade 4 rash 2.3 Preparation and Administration Preparation Visually inspect drug product for particulate matter and discoloration prior to administration whenever solution and container permit. TECENTRIQ is a colorless to slightly yellow solution. 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, it can be stored 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 for infusion. Under refrigeration at 2°C–8°C (36°F–46°F) for no more than 24 hours. 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 co-administer other drugs through the same intravenous line.
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, TECENTRIQ can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. 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]. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient 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 a lactating woman not to breastfeed during treatment and for at least 5 months after the last dose. 8.3 Females and Males of Reproductive Potential 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 310 previously-treated patients with urothelial carcinoma treated with TECENTRIQ in Study 1, 59% were 65 years or older. Of the 142 patients with NSCLC treated with TECENTRIQ in Study 3, 39% 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 119 cisplatin-ineligible patients with urothelial carcinoma treated with TECENTRIQ in Study 4, 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% (23/99) and in patients 75 years or older was 29% (14/49). Grade 3 or 4 adverse reactions occurred in 53% (52/99) of patients 65 years or older and 51% (25/49) of patients 75 years or older. No overall differences in safety or efficacy were observed between patients ≥ 75 years of age and younger patients. 8.6 Renal Impairment Based on a population pharmacokinetic analysis, no dose adjustment of TECENTRIQ is recommended for patients with renal impairment [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment Based on a population pharmacokinetic analysis, no dose adjustment of TECENTRIQ is recommended for patients with mild hepatic impairment. TECENTRIQ has not been studied in patients with moderate or severe hepatic impairment [see Clinical Pharmacology (12.3)].

More information

Category Value
Authorisation number BLA761034
Agency product number 52CMI0WC3Y
Orphan designation No
Product NDC 50242-917
Date Last Revised 22-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1792785
Storage and handling Storage: 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.