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2014年6月2日，FDA批准百时美施贵宝公司的硫酸阿扎那韦口服散剂（Atazanavir Sulfate 商品名Reyataz）上市，规格为50毫克/袋。该药与其他抗逆转录病毒药物联用，用于3个月以上、体重至少10千克的患者治疗1型人类免疫缺陷病毒（HIV-1）感染。口服散剂须与利托那韦合用，且不推荐用于体重低于10千克、大于或等于25千克的儿童。口服散剂应混于食物或饮料中给药，给药后应立即给予利托那韦。此前，硫酸阿扎那韦有胶囊剂上市。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for REYATAZ.
REYATAZ® (atazanavir) capsules, for oral use
REYATAZ®(atazanavir) oral powder
Initial U.S. Approval: 2003
RECENT MAJOR CHANGESIndications and Usage (1) 6/2014
Dosage and Administration,
Overview (2.1) 6/2014
Dosage and Administration of REYATAZ Oral Powder
in Pediatric Patients (2.4) 6/2014
Contraindications (4) 6/2014
Warnings and Precautions,
Patients with Phenylketonuria (5.4) 6/2014
INDICATIONS AND USAGEREYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 10 kg. (1)
DOSAGE AND ADMINISTRATION•
Treatment-naive adults: REYATAZ 300 mg with ritonavir 100 mg once daily with food or REYATAZ 400 mg once daily with food. (2.2)•
Treatment-experienced adults: REYATAZ 300 mg with ritonavir 100 mg once daily with food. (2.2)•
Pediatric patients: REYATAZ capsule dosage is based on body weight not to exceed the adult dose and must be taken with food. (2.3)•
REYATAZ oral powder: Must be taken with ritonavir and food and should not be used in children who weigh less than 10 kg or who weigh 25 kg or more. (2.4)•
Pregnancy: REYATAZ 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for some concomitant medications. (2.5)•
Concomitant therapy: Dosing modifications may be required. (2.2, 2.3, 2.4, 2.4, 7)•
Renal impairment: Dosing modifications may be required. (2.6)•
Hepatic impairment: Dosing modifications may be required. (2.7)
DOSAGE FORMS AND STRENGTHS•
Capsules: 150 mg, 200 mg, 300 mg. (3, 16)•
Oral powder: 50 mg packet. (3, 16)
CONTRAINDICATIONS•
REYATAZ is contraindicated in patients with previously demonstrated hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. (4)•
Coadministration with alfuzosin, triazolam, orally administered midazolam, ergot derivatives, rifampin, irinotecan, lovastatin, simvastatin, indinavir, cisapride, pimozide, St. John’s wort, nevirapine, and sildenafil when dosed as REVATIO®. (4)
WARNINGS AND PRECAUTIONS•
Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.1, 7.3, 12.2, 17)•
Rash: Discontinue if severe rash develops. (5.2, 17)•
Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a concomitant transaminase increase occurs, evaluate for alternative etiologies. (5.3)•
Hepatotoxicity: Patients with hepatitis B or C infection are at risk of increased transaminases or hepatic decompensation. Monitor hepatic laboratory tests prior to therapy and during treatment. (2.5, 5.5, 8.8)•
Nephrolithiasis and cholelithiasis have been reported. Consider temporary interruption or discontinuation. (5.6)•
Patients receiving REYATAZ may develop new onset or exacerbations of diabetes mellitus/hyperglycemia (5.7), immune reconstitution syndrome (5.8), and redistribution/accumulation of body fat (5.9).•
Hemophilia: Spontaneous bleeding may occur and additional factor VIII may be required. (5.10)•
Phenylketonuria: REYATAZ oral powder contains phenylalanine which can be harmful to patients with phenylketonuria. (5.4)
ADVERSE REACTIONSMost common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. (6.1, 6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSCoadministration of REYATAZ can alter the concentration of other drugs and other drugs may alter the concentration of atazanavir. The potential drug-drug interactions must be considered prior to and during therapy. (4, 7, 12.3)
USE IN SPECIFIC POPULATIONS•
Pregnancy: Use only if the potential benefit justifies the potential risk. (8.1)•
Nursing mothers should be instructed not to breastfeed due to the potential for postnatal HIV transmission. (8.3)•
Hepatitis B or C co-infection: Monitor liver enzymes. (5.5, 6.3)•
Renal impairment: REYATAZ is not recommended for use in treatment-experienced patients with end stage renal disease managed with hemodialysis. (2.6, 8.7)•
Hepatic impairment: REYATAZ is not recommended in patients with severe hepatic impairment. REYATAZ/ritonavir is not recommended in patients with any degree of hepatic impairment. (2.7, 8.8)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 06/2014
REYATAZ (atazanavir) Oral Powder & Capsule
Company: Pfizer Central Research
Application No.: 206352 & 21567s035
Approval Date: 6/02/2014
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