LINZESS (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C).
1.2 Chronic Idiopathic Constipation (CIC)

LINZESS is indicated in adults for the treatment of chronic idiopathic constipation (CIC).
2 DOSAGE AND ADMINISTRATION
2.1 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.
2.2 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.
2.3 Important Administration Instructions

Swallow capsules whole; do not break apart or chew.
3 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”

4 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
5 WARNINGS AND PRECAUTIONS
5.1 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)].
5.2 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 2% of the LINZESS-treated patients. The incidence of diarrhea was similar between the IBS-C and CIC populations [see Adverse Reactions (6.1)].
 
Instruct patients to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension [see Patient Counseling Informati