LINZESS Capsule, gelatin coated (2021)

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1. Indications and Usage

LINZESS is indicated in adults for the treatment of: irritable bowel syndrome with constipation (IBS-C) chronic idiopathic constipation (CIC)

2. Dosage and Administration

2.1 Recommended Dosage Irritable Bowel Syndrome with Constipation (IBS-C) The recommended dosage of LINZESS is 290 mcg orally once daily. Chronic Idiopathic Constipation (CIC) The recommended dosage of ...

3. Dosage Forms and Strengths

LINZESS capsules are white to off-white opaque: 72 mcg; gray imprint "FL 72" 145 mcg; gray imprint "FL 145" 290 mcg; gray imprint "FL 290"

4. Contraindications

LINZESS is contraindicated in: Patients less than 2 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. Patients with known ...

5. Warnings and Precautions

5.1 Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice (human age equivalent of approximately 0 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of LINZESS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

8.1. Pregnancy

Risk Summary Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology (12.3)], and maternal use is not expected to result ...

8.2. Lactation

Risk Summary Linaclotide and its active metabolite were not detected in the milk of lactating women (see Data). In adults, concentrations of linaclotide and its active metabolite were below the ...

8.4. Pediatric Use

LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies, deaths occurred within 24 hours in neonatal mice (human age equivalent of approximately 0 to 28 days) following ...

8.5. Geriatric Use

Irritable Bowel Syndrome with Constipation (IBS-C) Of 2219 IBS-C patients in the placebo-controlled clinical studies of LINZESS (Trials 1, 2, and 6), 154 (7%) were 65 years of age and over, while 34 (2%) ...

10. Overdosage

Single LINZESS doses of 2897 mcg were administered to 22 healthy subjects; the safety profile in these subjects was consistent with that in the overall LINZESS-treated population, with diarrhea being the ...

11. Description

LINZESS (linaclotide) is a guanylate cyclase-C (G-CC) 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, ...

12.1. Mechanism of Action

Linaclotide is structurally related to human guanylin and uroguanylin and functions as a guanylate cyclase-C (GC-C) agonist. Both linaclotide and its active metabolite bind to GC-C and act locally on the ...

12.2. Pharmacodynamics

Food Effect Taking LINZESS immediately after the high fat breakfast resulted in looser stools and a higher stool frequency compared with taking it in the fasted state [see Dosage and Administration ...

12.3. Pharmacokinetics

Absorption LINZESS is minimally absorbed with negligible systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In 2-year carcinogenicity studies, linaclotide was not tumorigenic in rats at doses up to 3500 mcg/kg/day or in mice at doses up to 6000 mcg/kg/day. The maximum recommended human dose is ...

14. Clinical Studies

14.1 Irritable Bowel Syndrome with Constipation (IBS-C) The efficacy of LINZESS for the management of symptoms of IBS-C was established in two double-blind, placebo-controlled, randomized, multicenter ...

16.1. How Supplied

LINZESS Capsule Strength Description Packaging NDC number 72 mcg White to off-white opaque hard gelatin capsules with gray imprint FL 72 Bottle of 30 0456-1203-30 145 mcg White to off-white ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep LINZESS in the original container. Do not subdivide or repackage. Protect from ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients Diarrhea To stop LINZESS and contact their healthcare provider if they experience unusual or severe abdominal ...