的一种亚型IBS。
2项纳入1604例患者的随机双盲试验确定了利那洛肽在IBS-C患者中应用的安全性和有效性。这些患者被随机分为接受290 μg利那洛肽治疗组或安慰剂组，治疗至少12周。结果显示，与安慰剂相比，利那洛肽在缓解患者腹痛和增加完全自发排便次数方面更有效。
另外纳入1272例患者的2项研究确定了利那洛肽在慢性特发性便秘患者中的安全性和有效性。这些患者被随机分为接受利那洛肽145μg组或290μg组或安慰剂组，治疗12周。结果显示，与安慰剂组相比，利那洛肽组的患者完全自发排便次数更多。实验并未显示出患者服用利那洛肽290μg比服用145μg更有效。
利那洛肽有一项加框警告，提示患者和医务人员该药不应用于年龄≤17岁的患者，临床试验中报告的最常见不良反应为腹泻。
FULL PRESCRIBING INFORMATION
1WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years of age. Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].
11 INDICATIONS AND USAGE
1.11.1 Irritable Bowel Syndrome with Constipation (IBS-C)
LINZESS (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C).
1.21.2 Chronic Idiopathic Constipation (CIC)
LINZESS is indicated in adults for the treatment of chronic idiopathic constipation (CIC).
22 DOSAGE AND ADMINISTRATION
2.12.1 Irritable Bowel Syndrome with Constipation (IBS-C)
The recommended dose of LINZESS is 290 mcg taken orally once daily on an empty stomach, at least 30 minutes prior to the first meal of the day.
2.22.2 Chronic Idiopathic Constipation (CIC)
The recommended dose of LINZESS is 145 mcg taken orally once daily on an empty stomach, at least 30 minutes prior to the first meal of the day.
2.32.3 Important Administration Instructions
Swallow capsules whole; do not break apart or chew.
33 DOSAGE FORMS AND STRENGTHS
■145 mcg capsules are white to off-white opaque with gray imprint “FL 145”
■290 mcg capsules are white to off-white opaque with gray imprint “FL 290”
44 CONTRAINDICATIONS
LINZESS is contraindicated in:
■Pediatric patients up to 6 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)]
■Patients with known or suspected mechanical gastrointestinal obstruction
55 WARNINGS AND PRECAUTIONS
5.15.1 Pediatric Risk
LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide [see Contraindications (4), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].
Avoid the use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans ages 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of LINZESS in pediatric patients 6 through 17 years of age [see Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].
5.25.2 Diarrhea
Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in
