OTEZLA (apremilast) tablets, for oral use - America[美国药品]

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OTEZLA (apremilast) tablets, for oral use

2015-03-05 09:31:30 来源: 作者: 【大中小】浏览:339次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA® (apremilast) tablets, for oral use Initial U.S. Approval: 2014 RECENT MAJOR CHANGES Indications and Usage (1.2) 09/2014 Dosage and Administration (2.1) 09/2014 Warnings and Precautions (5.1, 5.2) 09/2014 INDICATIONS AND USAGE OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with active psoriatic arthritis (1.1) Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2) DOSAGE AND ADMINISTRATION To reduce risk of gastrointestinal symptoms, titrate to recommended dose of 30 mg twice daily according to the following schedule (2.1) Day 1: 10 mg in morning Day 2: 10 mg in morning and 10 mg in evening Day 3: 10 mg in morning and 20 mg in evening Day 4: 20 mg in morning and 20 mg in evening Day 5: 20 mg in morning and 30 mg in evening Day 6 and thereafter: 30 mg twice daily Dosage in Severe Renal Impairment: Recommended dose is 30 mg once daily (2.2) For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, 20 mg, 30 mg (3) CONTRAINDICATIONS Known hypersensitivity to apremilast or any excipients in formulation (4) WARNINGS AND PRECAUTIONS Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior. (5.1) Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, eva luate weight loss and consider discontinuation of OTEZLA (5.2) Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur (5.3, 7.1) ADVERSE REACTIONS Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache (6.1) Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch USE IN SPECIFIC POPULATIONS Severe Renal Impairment: Increased systemic exposure of OTEZLA has been observed, reduction in dose to 30 mg once daily is recommended (2.2, 8.6) See 17 for PATIENT COUNSELING INFORMATION. Revised: 12/2014 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Psoriatic Arthritis 1.2 Psoriasis 2 DOSAGE AND ADMINISTRATION 2.1 Dosage in Psoriatic Arthritis and Psoriasis 2.2 Dosage Adjustment in Patients with Severe Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Depression 5.2 Weight Decrease 5.3 Drug Interactions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 7.1 Strong CYP450 Inducers 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 Psoriatic Arthritis 14.2 Psoriasis 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
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