Linaclotide

DEA Class; Rx

Common Brand Names; Linzess

• IBS Agents; 
• Gastrointestinals, Guanylate Cyclase-C Agonists

Oral selective guanylate cyclase C agonist
Used for irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) in adults
Boxed warning regarding the risk of serious dehydration in pediatric patients less than 2 years of age

Indicated for the treatment of chronic idiopathic constipation (CIC).

Patients aged <2 years due to risk of serious dehydration

Known or suspected mechanical gastrointestinal obstruction

IBS-C

• Diarrhea (20%)

• Abdominal pain (7%)

• Flatulence (4%)

• Headache (4%)

• Viral gastroenteritis (3%)

• Abdominal distension (2%)

• Severe diarrhea (2%)

• Defecation urgency (<2%)

• Fecal incontinence (<2%)

• Vomiting (<2%)

• Gastroesophageal reflux disease (<2%)

CIC

• Diarrhea (16-22%)

• Abdominal pain (7%)

• Flatulence (6%)

• Upper respiratory tract infection (5%)

• Sinusitis (3%)

• Abdominal distension (1-3%)

• Defecation urgency (<2%)

• Fecal incontinence (<2%)

• Dyspepsia (<2%)

• Viral gastroenteritis (<2%)

Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure

Linaclotide and its active metabolite were not detected in the milk of lactating women; in adults, concentrations of linaclotide and its active metabolite were below the limit of quantitation in plasma following multiple doses of the drug

Linaclotide 

capsule

• 72mcg
• 145mcg
• 290mcg