What is the proper usage of Linzess (linaclotide)?

From the Guidelines

Linzess (linaclotide) should be taken once daily on an empty stomach, at least 30 minutes before your first meal of the day, at a dosage of 290 mg once daily for the treatment of IBS-C, as recommended by the AGA clinical practice guideline on the pharmacological management of irritable bowel syndrome with constipation 1.

Dosage and Administration

• Swallow the capsule whole with water; do not crush, chew, or open it.
• The typical dosage ranges from 72 to 290 micrograms depending on your condition and doctor's recommendation.
• Stay well-hydrated while taking Linzess, as it works by increasing fluid secretion in your intestines to relieve constipation and related symptoms.

Mechanism of Action and Effects

• Linzess works by activating guanylate cyclase-C receptors on intestinal cells, increasing intestinal fluid and accelerating transit time, which helps relieve constipation and abdominal pain associated with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation.
• You may experience bowel movements within the first few hours after taking it.

Common Side Effects and Missed Doses

• Common side effects include diarrhea, abdominal pain, and gas.
• If you miss a dose, skip it and take your next dose at the regular time the following day; do not double up.

Clinical Evidence and Recommendations

• The AGA recommends using linaclotide in patients with IBS-C, with a strong recommendation and high certainty in the evidence of effects 1.
• Linaclotide is FDA-approved for the treatment of IBS-C at a dosage of 290 mg once daily and for CIC at dosages of 72 mg and 145 mg once daily 1.

From the FDA Drug Label

2. 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. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability Functional Constipation (FC) in pediatric patients 6 to 17 years of age The recommended dosage of LINZESS is 72 mcg orally once daily.

2. 2 Preparation and Administration Instructions • Take LINZESS 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. Do not take 2 doses at the same time. • Do not crush or chew LINZESS capsule or capsule contents. • Swallow LINZESS capsule whole • For patients who are unable to swallow the capsule whole, LINZESS capsules can be opened and administered orally in either applesauce or with water or administered with water via a nasogastric or gastrostomy tube.

To use Linzess, follow these key steps:

• Take the recommended dosage orally once daily: + 290 mcg for irritable bowel syndrome with constipation (IBS-C) in adults + 145 mcg for chronic idiopathic constipation (CIC) in adults, or 72 mcg based on individual presentation or tolerability + 72 mcg for functional constipation (FC) in pediatric patients 6 to 17 years of age
• Take Linzess 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
• Do not crush or chew the Linzess capsule or capsule contents
• Swallow the Linzess capsule whole, or administer orally in applesauce or water if unable to swallow whole 2

From the Research

Dosage Information

• The approved dosage for linaclotide is 290 µg once daily (QD) for irritable bowel syndrome with constipation (IBS-C) and 145 µg or 72 µg QD for chronic idiopathic constipation (CIC) 3.
• Linaclotide can be taken daily for 12-26 weeks, and long-term safety studies have shown that it can be taken for up to 78 additional weeks 3.

Administration and Usage

• Linaclotide should be taken orally, once daily, without regard to food 3.
• Patients should be advised to swallow the capsule whole and not to crush or chew it 3.

Common Adverse Events

• The most common adverse event associated with linaclotide is diarrhea, which is usually mild or moderate 3, 4.
• Other common adverse events include abdominal pain, nausea, and vomiting 5.
• The risk of diarrhea is higher with linaclotide than with placebo, but it is generally well-tolerated 3, 4.

Comparison with Other Medications

• Linaclotide has been compared to other medications, such as lubiprostone and elobixibat, in terms of efficacy and safety 6, 5.
• Studies have shown that linaclotide is similar in efficacy to these medications, but may have a different safety profile 5.
• The choice of medication will depend on individual patient needs and medical history 5.