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Linzess Now Available in New Dosage Strengths

Allergan news release; 2017 Jan 26

FDA has approved a new lower dose of Linzess (linaclotide), available from Allergan, giving clinicians more flexibility in managing adult patients with chronic idiopathic constipation (CIC).

Indications: Linzess is a once daily capsule designed to relieve the abdominal pain and constipation associated with irritable bowel syndrome accompanied by constipation (IBS-C). It can also relieve the infrequent stools, hard stools, and incomplete evaluation that accompanies chronic idiopathic constipation. While the 145 mcg dose is intended for CIC patients, the 72 mcg dose has been approved for use in CIC depending on individual patient presentation or tolerability.

Dosage and administration: The new 72 mcg formulation means the drug can be prescribed in 3 doses: 72, 145, and 290 mcg. Both the 72 and 145 mcg doses are intended for patients with CIC while the 290 mcg formulation is designed to treat IBS-C.

Adverse reactions: The most common adverse reactions (≥2%) reported in IBS-C or CIC patients are: diarrhea, abdominal pain, flatulence and abdominal distension.

Citation:

Linzess now FDA-approved in three dosage strengths: 72 mcg and 145 mcg for CIC; 290 mcg for IBS-C—New dosage strength expected to be available in first quarter of 2017 [news release]. Cambridge, Mass. http://www.allergan.com/NEWS/News/Thomson-Reuters/U-S-Food-and-Drug-Administration-Approves-72-mcg-D. Accessed February 8, 2017.