ARRANON (nelarabine) Injection - America[美国药品]

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ARRANON (nelarabine) Injection

2016-12-12 00:35:26 来源: 作者: 【大中小】浏览:442次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARRANON safely and effectively. See full prescribing information for ARRANON. ARRANON (nelarabine) Injection Initial U.S. Approval: 2005 WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. (5.1) Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic adverse reactions is strongly recommended, and ARRANON should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria Grade 2 or greater. (5.1) INDICATIONS AND USAGE ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. (1) DOSAGE AND ADMINISTRATION •Adult dose: 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. ( 2.1) •Pediatric dose: 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. ( 2.1) •Discontinue treatment for ≥Grade 2 neurologic reactions. ( 2.2) •Dosage may be delayed for hematologic reactions ( 2.2) •Take measures to prevent hyperuricemia. ( 2.4) DOSAGE FORMS AND STRENGTHS 250 mg/50 mL (5 mg/mL) vial (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS •Severe neurologic reactions have been reported. Monitor for signs and symptoms of neurologic toxicity. ( 5.1) •Hematologic Reactions: Complete blood counts including platelets should be monitored regularly. ( 5.2) •Fetal harm can occur if administered to a pregnant woman. Women should be advised not to become pregnant when taking ARRANON. ( 5.3) ADVERSE REACTIONS The most common (≥ 20%) adverse reactions were: •Adult: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea ( 6.1) •Pediatric: anemia, neutropenia, thrombocytopenia, and leukopenia ( 6.1) The most common (>10%) neurological adverse reactions were: •Adult: somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia ( 6.1) •Pediatric: headache and peripheral neurologic disorders ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Administration in combination with adenosine deaminase inhibitors, such as pentostatin, is not recommended. (7, 12.3)USE IN SPECIFIC POPULATIONS •Renal Impairment: Closely monitor patients with moderate or severe renal impairment for toxicities. ( 8.6) •Hepatic Impairment: Closely monitor patients with severe hepatic impairment for toxicities. ( 8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2014 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: NEUROLOGIC ADVERSE REACTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Dosage Modification 2.3 Adjustment of Dose in Special Populations 2.4 Prevention of Hyperuricemia 2.5 Instructions for Handling, Preparation, and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Neurologic Adverse Reactions 5.2 Hematologic Adverse Reactions 5.3 Pregnancy 5.4 Hyperuricemia 5.5 Vaccinations 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Adult Clinical Trial 14.2 Pediatric Clinical Trial 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage This product is for intravenous use only. The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment. Adult Dosage: The recommended adult dose of ARRANON is 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. ARRANON is administered undiluted. Pediatric Dosage: The recommended pediatric dose of ARRANON is 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. ARRANON is administered undiluted. 2.2 Dosage Modification Administration of ARRANON should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria Grade 2 or greater. Dosage may be delayed for other toxicity including hematologic toxicity. [See Boxed Warning, Warnings and Precautions (5.1, 5.2).] 2.3 Adjustment of Dose in Special Populations ARRANON has not been studied in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6, 8.7)]. No dose adjustment is recommended for patients with a creatinine clearance (CLcr) ≥50 mL/min [see Clinical Pharmacology (12.3)]. There are insufficient data to support a dose recommendation for patients with a CLcr <50 mL/min. 2.4 Prevention of Hyperuricemia Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia [see Warnings and Precautions (5.4)]
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