"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
LINZESS is contraindicated in pediatric patients up to 6 years of age; in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations and Nonclinical Toxicology].
LINZESS (linaclotide) is a guanylate cyclase-C agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide).
The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below:
Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 145 mcg and 290 mcg capsules for oral administration.
The inactive ingredients of LINZESS capsules include: calcium chloride dihydrate, L-leucine, hypromellose, microcrystalline cellulose, gelatin, and titanium dioxide. Page 9 of 20
What are the possible side effects of linaclotide (Linzess)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using linaclotide and call your doctor at once if you have a serious side effect such as:
- severe or ongoing diarrhea;
- severe stomach pain; or
- black, bloody, or tarry stools.
Other common side effects may include:
- mild diarrhea;
- mild stomach discomfort;
- heartburn, vomiting, gas, bloating;
- headache; or
- cold symptoms such as stuffy nose,...
Last reviewed on RxList: 6/1/2016
This monograph has been modified to include the generic and brand name in many instances.
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