Fulyzaq(crofelemer)缓释片-2012年美国FDA批准用于治疗HIV腹泻
FULYZAQ (crofelemer) tablet, coated
[Salix Pharmaceuticals, Inc.]
 美国FDA于2012年12月31日批准了Fulyzaq (crofelemer)，用于缓解HIV/AIDS患者因服用抗逆转录病毒药物引起的腹泻症状，为治疗HIV感染的辅助用药。在Napo制药公司的许可下，Fulyzaq由alix Pharmaceuticals公司负责销售。
很多HIV/AIDS患者都存在腹泻症状，这也是患者停止或切换抗反转录病毒疗法的普遍原因。Fulyzaq旨在用于治疗HIV/AIDS患者非病毒、细菌和寄生物感染造成的腹泻。患者每天服用两次Fulyzaq控制水性腹泻，舒缓胃肠道中电解质和水分泌。
Fulyzaq从龙血巴豆红色汁液中提取，是FDA批准的第二个植物处方药。植物药通常是一种或多种植物物质经多级纯化得到的复合物。2006年，FDA批准了第一个植物处方药Veregen (sinecatechins)，治疗外生殖器和肛周尖锐湿疣。
Julie Beitz博士介绍到“迄今为止FDA未批准过治疗HIV相关腹泻的药物，Fulyzaq对有此复杂情况的HIV/AIDS患者有帮助。”
向其它类型的药物一样，植物药的安全性和有效性也需通过临床试验来评估。此外，植物药的生产厂家必须确保对原材料严格控制，执行种植和采摘规范，以及复杂混合物的分析检测。
Fulyzaq的安全性和有效性由374个HIV-阳性患者入组的临床实验来评估，这些患者都接受抗反转录病毒治疗，且曾有1个月或更长时间的腹泻病史。每次水泻次数的中位数未2.5次/天。由感染或胃肠道疾病引起的腹泻患者排除在本试验之外。患者被随机指定服用Fulyzaq或安慰剂，一天2次。
临床试验旨在测定临床应答，确定每周有2次或更少水泻症状的患者人数。结果显示，服用Fulyzaq的患者中有17.6％有临床应答，而安慰剂组为8％。在一些患者中，能观察到长达20个周的持续抗腹泻效果。
在开始Fulyzaq治疗前，医师应该进行适当的测试，已确保腹泻不是因感染或胃肠道疾病引起的。临床试验中服用Fulyzaq的患者报告的副作用通常包括上呼吸道感染，支气管炎，咳嗽，肠胃气胀和肝酶胆红素水平增高。

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FULYZAQ safely and effectively. See full prescribing information for FULYZAQ.
FULYZAQ (crofelemer) delayed-release tablets for oral use
Initial U.S. Approval: 2012
INDICATIONS AND USAGE
FULYZAQ is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.(1)
DOSAGE AND ADMINISTRATION
One 125 mg delayed-release tablet taken orally twice a day, with or without food.(2)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 125 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Rule out infectious etiologies of diarrhea before starting crofelemer. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 3%) are upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-508-0024 or www.Salix.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
• Pregnancy: Based on animal data, may cause fetal harm. (8.1)
• Pediatric Use: Safety and effectiveness of FULYZAQ has not been established in patients less than 18 years of age. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 02/2013
Back to Highlights and Tabs
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FULYZAQ is indicated for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.
2 DOSAGE AND ADMINISTRATION
The recommended dose of FULYZAQ is one 125 mg delayed-release tablet taken orally two times a day, with or without food. FULYZAQ tablets should not be crushed or chewed. Tablets should be swallowed whole.
3 DOSAGE FORMS AND STRENGTHS
FULYZAQ is a white, oval, enteric-coated 125 mg delayed-release tablet printed on one side with 125SLXP.
4 CO