HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LINZESS safely and effectively. See full prescribing information for LINZESS.
LINZESS (linaclotide) capsules, for oral use
Initial U.S. Approval: 2012
WARNING: PEDIATRIC RISK
See full prescribing information for complete boxed warning.
LINZESS is contraindicated in pediatric patients up to 6 years of age. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide caused deaths in young juvenile mice (4, 5.1, 8.4, 13.2).
INDICATIONS AND USAGE
LINZESS is a guanylate cyclase-C agonist indicated in adults for treatment of:
■Irritable bowel syndrome with constipation (IBS-C) (1.1)
■Chronic idiopathic constipation (CIC) (1.2)
DOSAGE AND ADMINISTRATION
■IBS-C: Take 290 mcg orally once daily (2.1)
■CIC: Take 145 mcg orally once daily (2.2)
■Take on empty stomach at least 30 minutes prior to first meal of the day (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 145 mcg and 290 mcg (3)
CONTRAINDICATIONS
■Pediatric patients up to 6 years of age (4)
■Patients with known or suspected mechanical gastrointestinal obstruction (4)
WARNINGS AND PRECAUTIONS
■Diarrhea: Patients may experience severe diarrhea. Hold or stop LINZESS (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence of at least 2%) reported in IBS-C or CIC patients are diarrhea, abdominal pain, flatulence and abdominal distension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Forest Pharmaceuticals, Inc., at 1- 800- 678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 08/2012
 FULL PRESCRIBING INFORMATION: CONTENTS *
WARNING: PEDIATRIC RISK
1 INDICATIONS AND USAGE
1.1 Irritable Bowel Syndrome with Constipation (IBS-C)
1.2 Chronic Idiopathic Constipation (CIC)
2 DOSAGE AND ADMINISTRATION
2.1 Irritable Bowel Syndrome with Constipation (IBS-C)
2.2 Chronic Idiopathic Constipation (CIC)
2.3 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pediatric Risk
5.2 Diarrhea
6 ADVERSE REACTIONS
6.1 Clinical Trials 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 Hepatic or Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Irritable Bowel Syndrome with Constipation (IBS-C)
14.2 Chronic Idiopathic Constipation (CIC)
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing information are not listed.
Linzess
Forest Laboratories, Inc.
FDA批准利那洛肽治疗便秘
2012年8月30日，美国食品与药物管理局（FDA）批准了利那洛肽（商品名：Linzess）用于治疗成人慢性特发性便秘和便秘型肠易激综合征（IBS—C）患者。
该药是一种每日空腹服用一次的胶囊剂，在一天当中的第一餐前至少30分钟口服。它通过增加肠蠕动次数来缓解便秘。在IBS-C患者中，它也有助于缓解患者的腹痛。
根据美国国立卫生研究院的数据，估计有6300万人群受慢性便秘的影响。慢性特发性便秘是一种患者遭受持久的便秘，并对标准治疗无效的一种疾病。另外，估计有1530万人群受IBS影响。IBS—C是以腹痛和大便硬结为特点