2000年通過美國FDA批準用於治療APL。批準上市了麽？

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021248s018lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRISENOX safely and effectively. See full prescribing information for TRISENOX. TRISENOX® (arsenic trioxide) injection, for intravenous use Initial U.S. Approval: 2000 WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES, and ENCEPHALOPATHY INCLUDING WERNICKE’S See full prescribing information for complete boxed warning. • Patients treated with TRISENOX may develop differentiation syndrome, which can be fatal. If symptoms occur, initiate high-dose steroids immediately and monitor hemodynamics. (5.1) • TRISENOX can cause QT interval prolongation and ventricular arrhythmia, which can be fatal. Before administering TRISENOX, assess the QT interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Do not administer TRISENOX to patients with ventricular arrhythmia or prolonged QTcF. (2.3, 5.2) • Encephalopathy including Wernicke’s encephalopathy (WE) occurred in patients receiving TRISENOX. If Wernicke’s encephalopathy is suspected, immediately interrupt TRISENOX treatment and initiate parenteral thiamine. (5.3) RECENT MAJOR CHANGES Warnings and Precautions (5.3) 06/2019 __________________INDICATIONS AND USAGE TRISENOX is an arsenical indicated: • In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.1) • For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2) _______________DOSAGE AND ADMINISTRATION ______________ Newly-diagnosed low-risk APL: • Induction: 0.15 mg/kg intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days of induction. (2.1) • Consolidation: 0.15 mg/kg intravenously daily 5 days per week during weeks 1-4 of an 8-week cycle for a total of 4 cycles in combination with tretinoin. (2.1) Relapsed or refractory APL: • Induction: 0.15 mg/kg intravenously daily until bone marrow remission. Do not exceed 60 days for total induction. (2.2) • Consolidation: 0.15 mg/kg intravenously daily for 25 doses over a period up to 5 weeks. (2.2) DOSAGE FORMS AND STRENGTHS______________ Injection: 12 mg arsenic trioxide in 6 mL in single-dose vial. (3) ___________________ CONTRAINDICATIONS ___________________ Hypersensitivity to arsenic. (4) _______________WARNINGS AND PRECAUTIONS _______________ • Hepatotoxicity: Grade ≥3 elevations in hepatic transaminase elevation have occurred in patients with newly diagnosed low or intermediate risk APL treated with TRISENOX in combination with tretinoin. Monitor hepatic function tests at least twice weekly during TRISENOX therapy. (5.4) • Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies. (5.5) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.6, 8.1, 8.3) ___________________ ADVERSE REACTIONS ___________________ The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia, and dizziness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS _______________ • Lactation: Advise women not to breastfeed. (8.2) • Renal Impairment: Monitor patients with severe renal impairment (creatinine clearance less than 30 mL/min) for toxicity when treated with TRISENOX; dose reduction may be warranted. (8.6) • Hepatic Impairment: Monitor patients with severe hepatic impairment (Child-Pugh Class C) for toxicity when treated with TRISENOX. (8.7) See 17 for PATIENT COUNSELING INFORMATION. Revised:06/2019 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DIFFERENTIATION SYNDROME AND CARDIAC CONDUCTION ABNORMALITIES 1 INDICATIONS AND USAGE 1.1 Newly-Diagnosed Low-Risk APL 1.2 Relapsed or Refractory APL 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Dose Modifications for Toxicities 2.3 Instructions for Preparation and Intravenous Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Differentiation Syndrome 5.2 Cardiac Conduction Abnormalities 5.3 Encephalopathy 5.4 Hepatotoxicity 5.5 Carcinogenesis 5.6 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Renal Impairment 8.7 Patients with Hepatic Impairment 10 OVERDOSAGE 10.1 Manifestations 10.2 Management 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Newly-Diagnosed Low-Risk APL 14.2 Relapsed or Refractory APL 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Reference ID: 4451624 FULL PRESCRIBING INFORMATION WARNING: DIFFERENTIATION SYND