What is the recommended treatment and dosage for Linzess (linaclotide) in adults with Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)?

From the Guidelines

For adults with Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC), the recommended treatment is Linzess (linaclotide) at a dosage of 290 mcg once daily for IBS-C and 145 mcg once daily for CIC, taken on an empty stomach at least 30 minutes before the first meal of the day. This recommendation is based on the strongest and most recent evidence from the American Gastroenterological Association (AGA) clinical practice guideline on the pharmacological management of irritable bowel syndrome with constipation 1 and the American Gastroenterological Association-American College of Gastroenterology clinical practice guideline on the pharmacological management of chronic idiopathic constipation 1.

Key Considerations

• The dosage of Linzess for IBS-C is 290 mcg once daily, while for CIC, the recommended dosage is 145 mcg once daily 1.
• Taking Linzess with food significantly reduces its effectiveness, so it should be taken on an empty stomach at least 30 minutes before the first meal of the day 1.
• The capsule should be swallowed whole and should not be crushed or chewed, but for patients who have difficulty swallowing capsules, Linzess can be opened and the contents sprinkled on applesauce or mixed with water.
• Linzess works by increasing intestinal fluid secretion and accelerating transit time through the gut by activating guanylate cyclase-C receptors on the intestinal epithelium, leading to increased chloride and bicarbonate secretion into the intestinal lumen, resulting in increased intestinal fluid and accelerated transit 1.
• Patients should be aware that diarrhea is the most common side effect, particularly during the first two weeks of treatment, and should contact their healthcare provider if severe diarrhea occurs 1.

Important Safety Information

• Linzess is contraindicated in individuals with known or suspected mechanical GI obstruction 1.
• The use of linaclotide might be associated with diarrhea leading to discontinuation or dose reduction, but this is not very common, with approximately 4.7% of patients discontinuing the medication because of diarrhea in one study 1.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

1. 1 Recommended Dosage Irritable Bowel Syndrome with Constipation (IBS-C) in adults The recommended dosage of LINZESS is 290 mcg orally once daily. Chronic Idiopathic Constipation (CIC) in adults The recommended dosage of LINZESS is 145 mcg orally once daily.

The recommended treatment and dosage for Linzess (linaclotide) in adults with Irritable Bowel Syndrome with Constipation (IBS-C) is 290 mcg orally once daily, and for adults with Chronic Idiopathic Constipation (CIC) is 145 mcg orally once daily 2.

• The dosage should be taken on an empty stomach, at least 30 minutes prior to a meal, at approximately the same time each day.
• If a dose is missed, skip the missed dose and take the next dose at the regular time.
• Key administration instructions include swallowing the capsule whole and not crushing or chewing it.

From the Research

Linzess (Linaclotide) Overview

• Linzess (linaclotide) is a 14-amino acid peptide indicated for the treatment of adults with Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C) 3.
• It acts on guanylate cyclase-C receptors to increase chloride and bicarbonate secretions into the intestine, inhibiting the absorption of sodium ions and increasing water secretion into the lumen, thus improving defecation 3.

Recommended Treatment and Dosage

• Linaclotide is approved by the Food and Drug Administration (FDA) for oral once-daily administration at doses of 145 μg for CIC and 290 μg for IBS-C 3, 4.
• The treatment is recommended to be taken continuously, not sporadically, and patients should be warned about the risk of diarrhea and given choices concerning how to deal with this possible side effect 5.

Efficacy and Safety

• Linaclotide has been demonstrated to be effective in increasing weekly spontaneous bowel movements and complete spontaneous bowel movements (CSBMs) while reducing abdominal pain in patients with CIC and IBS-C 3, 6.
• The most common adverse effect of linaclotide is diarrhea, which was reported in 16-20% of clinical trial participants, with the majority being mild or moderate 3, 4, 6.
• Linaclotide's adverse effects are generally mild and confined to the gastrointestinal tract, and the treatment can be maintained for long periods of time due to the absence of tachyphylaxis or potential risks 3, 5.

Clinical Management

• A group of experts in functional digestive disorders recommends that linaclotide is indicated for the treatment of moderate to severe IBS-C in adults, and patients should be monitored and managed accordingly 5.
• The expert panel also recommends that patients take linaclotide continuously and not sporadically, and that they should be warned about the risk of diarrhea and given choices concerning how to deal with this possible side effect 5.