Can a primary care physician (PCP) prescribe Linzess (linaclotide)?

Can a Primary Care Physician Prescribe Linzess?

Yes, primary care physicians can prescribe Linzess (linaclotide) without restriction, as it requires no specialty authorization and is FDA-approved for use in adults with IBS-C and chronic constipation, though insurance prior authorization is typically required. 1

Prescribing Authority and Scope

• PCPs have full prescribing authority for linaclotide across all FDA-approved indications without requiring gastroenterology consultation or specialty referral. 1

• The medication is indicated for irritable bowel syndrome with constipation (IBS-C) in adults, chronic idiopathic constipation (CIC) in adults, and functional constipation in pediatric patients 6-17 years of age. 1

When PCPs Should Prescribe Linzess

For IBS-C patients, linaclotide should be considered as a second-line agent after failure of first-line therapies (dietary modifications, fiber supplementation, over-the-counter laxatives). 2

• The British Society of Gastroenterology identifies linaclotide as the most efficacious secretagogue available for IBS-C, though it is recommended for use in secondary care settings. 2

• The American Gastroenterological Association provides a strong recommendation for linaclotide in IBS-C with high certainty of evidence, supporting its use when first-line treatments fail. 2

For chronic constipation patients, PCPs should trial osmotic or stimulant laxatives first due to cost considerations before escalating to linaclotide. 3

• Linaclotide increases complete spontaneous bowel movements by approximately 1.37 per week compared to placebo and improves stool consistency significantly. 4

Practical Prescribing Details

Dosing by indication:

• IBS-C in adults: 290 mcg orally once daily 1
• CIC in adults: 145 mcg once daily (or 72 mcg once daily based on tolerability) 1
• Functional constipation in pediatric patients 6-17 years: 72 mcg once daily 1

Administration requirements:

• Take on an empty stomach at least 30 minutes before the first meal of the day 1
• Swallow capsule whole; do not crush or chew 1
• For patients unable to swallow capsules, can be opened and mixed with applesauce or water 1

Insurance and Documentation Requirements

Prior authorization is typically required due to the medication's cost (approximately $523 per month). 5

For IBS-C (ICD-10: K58.9), documentation should include:

• Symptoms consistent with Rome criteria 6
• Failure of first-line treatments 6
• Severity of symptoms affecting quality of life 6

For CIC (ICD-10: K59.00 or K59.04), documentation should include:

• Duration of constipation 6
• Failure of over-the-counter laxatives 6
• Specific symptoms 6

Safety Considerations for PCPs

Diarrhea is the most common adverse effect, occurring in 16.3% of patients receiving linaclotide compared to 2.3% receiving placebo. 2

• Approximately 3.4-4.7% of patients discontinue due to diarrhea. 2, 4
• If diarrhea occurs, consider dose reduction. 4

Contraindications:

• Patients less than 2 years of age (black box warning: risk of serious dehydration and death) 1
• Known or suspected mechanical gastrointestinal obstruction 1

Special populations:

• Efficacy in patients over 65 years is similar to the general population with no dose adjustment required. 4, 5
• Patients on diuretics may be at higher risk of hyponatremia. 4

Common Pitfalls to Avoid

• Do not prescribe to pediatric patients under 6 years of age due to the black box warning for children under 2 years and lack of approval for ages 2-5. 1

• Do not use as first-line therapy for chronic constipation due to cost; reserve for patients who have failed less expensive options. 3

• Ensure proper timing of administration (30 minutes before first meal) to maximize efficacy. 1

• Document failed first-line therapies thoroughly to facilitate insurance approval. 6