Drug updated on 4/15/2024
| Dosage Form | Capsule (oral; 72 mcg, 145 mcg, 290 mcg) |
| Drug Class | Guanylate cyclase-C agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
- Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
- Indicated for the treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.
Summary
- Linaclotide (Linzess) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients aged 6 to 17 years. It demonstrates substantial efficacy across these conditions, particularly notable for its effectiveness at relieving abdominal bloating among FDA-licensed drugs for IBS-C.
- Information was derived from a total of eight systematic reviews and meta-analyses that compared linaclotide's safety and effectiveness against other treatments such as lubiprostone, elobixibat, and various laxatives.
- In terms of safety profiles when treating CC and IBS-C, linaclotide is primarily associated with diarrhea as the main adverse reaction. This differs from other treatments like lubiprostone or elobixibat which may have different side effects.
- A study focusing on Japanese patients revealed potential variability in response across different ethnicities; while linaclotide showed equal efficacy to new medications overall, elobixibat and lubiprostone might be more effective at increasing spontaneous bowel movements within this population group.
- Linaclotide has been found effective not only for specific symptoms but also forms part of broader assessments related to increasing spontaneous bowel movements - an important factor in managing chronic constipation conditions.
- While being versatile enough to treat a range of constipation-related disorders across age groups including adults with IBS-C or CIC or children aged between 6 to 17 years suffering from FC; considering individual variability in response, particularly based on ethnicity observed in studies, remains crucial.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Linzess (linaclotide) Prescribing Information. | 2023 | AbbVie, Inc. North Chicago, IL and Ironwood Pharmaceuticals, Inc. Boston, MA |