TECENTRIQ Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION ¾¾¾¾¾¾¾DOSAGE AND ADMINISTRATION¾¾¾¾¾¾¾¾ These highlights do not include all the information needed to use Administer TECENTRIQ intravenously over 60 minutes. If the first infusion TECENTRIQ safely and effectively. See full prescribing information for is tolerated, all subsequent infusions may be delivered over 30 minutes. TECENTRIQ. Urothelial Carcinoma • Administer TECENTRIQ as a single agent as 840 mg every 2 weeks, 1200 TECENTRIQ® (atezolizumab) injection, for intravenous use mg every 3 weeks, or 1680 mg every 4 weeks. (2.2) Initial U.S. Approval: 2016 NSCLC • Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 ¾¾¾¾¾¾¾¾¾RECENT MAJOR CHANGES¾¾¾¾¾¾¾¾¾ weeks, or 1680 mg every 4 weeks. (2.2) Indications and Usage, Urothelial Carcinoma – Accelerated • When administering with chemotherapy with or without bevacizumab, Approval Indication Removed (1.1) 4/2021 administer TECENTRIQ prior to chemotherapy and bevacizumab when Indications and Usage, Non-Small Cell Lung Cancer (1.2) 5/2020 given on the same day. Indications and Usage, Triple-Negative Breast Cancer (1.3) 12/2020 Metastatic Treatment of TNBC Indications and Usage, Hepatocellular Carcinoma (1.5) 5/2020 • Administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, Indications and Usage, Melanoma (1.6) 7/2020 or 1680 mg every 4 weeks. Administer TECENTRIQ prior to paclitaxel Dosage and Administration (2.2) 2/2021 protein-bound when given on the same day. For each 28 day cycle, Dosage and Administration (2.3) 11/2020 paclitaxel protein-bound is administered at 100 mg/m2 on days 1, 8, and 15. Warnings and Precautions (5.1, 5.2, 5.3, 5.5) 11/2020 (2.2) Warnings and Precautions (5.4) 12/2020 Small Cell Lung Cancer • Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 ¾¾¾¾¾¾¾¾¾INDICATIONS AND USAGE¾¾¾¾¾¾¾¾¾ weeks, or 1680 mg every 4 weeks. When administering with carboplatin TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody and etoposide, administer TECENTRIQ prior to chemotherapy when given indicated: on the same day. (2.2) Urothelial Carcinoma Hepatocellular Carcinoma • for the treatment of adult patients with locally advanced or metastatic • Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 urothelial carcinoma who: weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to o are not eligible for cisplatin-containing chemotherapy and whose tumors bevacizumab when given on the same day. Bevacizumab is administered at express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] 15 mg/kg every 3 weeks. (2.2) covering ≥ 5% of the tumor area), as determined by an FDA-approved Melanoma test, or • Following completion of a 28 day cycle of cobimetinib and vemurafenib, o are not eligible for any platinum-containing chemotherapy regardless of administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, PD-L1 status or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 This indication is approved under accelerated approval based on tumor days on /7 days off) and vemurafenib 720 mg orally twice daily. (2.2) response rate and duration of response. Continued approval for this ¾¾¾¾¾¾¾DOSAGE FORMS AND STRENGTHS¾¾¾¾¾¾¾ indication may be contingent upon verification and description of clinical Injection: 840 mg/14 mL (60 mg/mL) and 1200 mg/20 mL (60 mg/mL) benefit in a confirmatory trial(s). (1.1) solution in a single-dose vial. (3) Non-Small Cell Lung Cancer (NSCLC) • for the first-line treatment of adult patients with metastatic NSCLC whose ¾¾¾¾¾¾¾¾¾¾CONTRAINDICATIONS¾¾¾¾¾¾¾¾¾¾ tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells None. (4) [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA- ¾¾¾¾¾¾¾WARNINGS AND PRECAUTIONS¾¾¾¾¾¾¾¾ approved test, with no EGFR or ALK genomic tumor aberrations. (1.2) • Immune-Mediated Adverse Reactions (5.1) • in combination with bevacizumab, paclitaxel, and carboplatin, for the first- o Immune-mediated adverse reactions, which may be severe or fatal, can line treatment of adult patients with metastatic non-squamous NSCLC with occur in any organ system or tissue, including the following: immune- no EGFR or ALK genomic tumor aberrations. (1.2) mediated pneumonitis, immune-mediated colitis, immune-mediated • in combination with paclitaxel protein-bound and carboplatin for the first- hepatitis, immune-mediated endocrinopathies, immune-mediated line treatment of adult patients with metastatic non-squamous NSCLC with dermatologic adverse reactions, immune-mediated nephritis and renal no EGFR or ALK genomic tumor aberrations (1.2) dysfunction, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver • for the treatment of adult patients with metastatic NSCLC who have o enzymes, creatinine, and thyroid function at baseline and periodically disease progression during or following platinum-containing during treatment. chemotherapy. Patients with EGFR or ALK genomic tumor aberrations Withhold or permanently discontinue based on severity and type of should have disease progression on FDA-approved therapy for NSCLC o reaction. harboring these aberrations prior to receiving TECENTRIQ. (1.2) Triple-Negative Breast Cancer (TNBC) • Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions. (5.2) • in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose • Complications of Allogeneic HSCT: Fatal and other serious complications tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] can occur in patients who receive allogeneic HSCT before or after being of any intensity covering ≥ 1% of the tumor area), as determined by an treated with a PD-1/PD-L1 blocking antibody. (5.3) FDA approved test. This indication is approved under accelerated approval • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of based on progression free survival. Continued approval for this indication reproductive potential of the potential risk to a fetus and use of effective contraception. (5.5, 8.1, 8.3) may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.3) ¾¾¾¾¾¾¾¾¾¾ADVERSE REACTIONS¾¾¾¾¾¾¾¾¾¾ Limitations of Use: TECENTRIQ is not indicated for use in combination • Most common adverse reactions (≥ 20%) with TECENTRIQ as a single- with paclitaxel for the treatment of adult patients with unresectable locally agent were fatigue/asthenia, nausea, cough, dyspnea, and decreased advanced or metastatic TNBC (1.3, 5.4, 14.4). appetite. (6.1) Small Cell Lung Cancer (SCLC) • Most common adverse reactions (≥ 20%) with TECENTRIQ in • in combination with carboplatin and etoposide, for the first-line treatment combination with other antineoplastic drugs in patients with NSCLC and of adult patients with extensive-stage small cell lung cancer (ES-SCLC). SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and (1.4) decreased appetite. (6.1) Hepatocellular Carcinoma (HCC) • The most common adverse reactions (≥ 20%) and laboratory abnormalities • in combination with bevacizumab for the treatment of patients with (≥ 50%) with TECENTRIQ in combination with paclitaxel protein-bound unresectable or metastatic HCC who have not received prior systemic in patients with TNBC were decreased hemoglobin, decreased leukocytes, therapy. (1.5) decreased neutrophils, alopecia, decreased lymphocytes, peripheral Melanoma neuropathies, fatigue, nausea, diarrhea, constipation, cough, headache, • in combination with cobimetinib and vemurafenib for the treatment of vomiting, and decreased appetite. (6.1) patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. (1.6) • The most common adverse reactions (≥ 20%) with TECENTRIQ in To report SUSPECTED ADVERSE REACTIONS, contact Genentech at combination with bevacizumab in patients with HCC were hypertension, 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. fatigue and proteinuria. (6.1) • The most common adverse reactions (≥ 20%) with TECENTRIQ in ¾¾¾¾¾¾¾USE IN SPECIFIC POPULATIONS¾¾¾¾¾¾¾¾ combination with cobimetinib and vemurafenib in patients with melanoma Lactation: Advise not to breastfeed. (8.2) were rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, See 17 for PATIENT COUNSELING INFORMATION and Medication pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction. Guide. (6.1) Revised: 4/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Urothelial Carcinoma 8.2 Lactation 1.2 Non-Small Cell Lung Cancer 8.3 Females and Males of Reproductive Potential 1.3 Locally Advanced or Metastatic Triple-Negative Breast Cancer 8.4 Pediatric Use 1.4 Small Cell Lung Cancer 8.5 Geriatric Use 1.5 Hepatocellular Carcinoma 11 DESCRIPTION 1.6 Melanoma 12 CLINICAL PHARMACOLOGY 2 DOSAGE AND ADMINISTRATION 12.1 Mechanism of Action 2.1 Patient Selection for Treatment of Urothelial Carcinoma, Triple- 12.3 Pharmacokinetics Negative Breast Cancer, Non-Small Cell Lung Cancer and 13 NONCLINICAL TOXICOLOGY Melanoma 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 2.2 Recommended Dosage 13.2 Animal Toxicology and/or Pharmacology 2.3 Dosage Modifications for Adverse Reactions 14 CLINICAL STUDIES 2.4 Preparation and Administration 14.1 Urothelial Carcinoma 3