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Suzanne E. Wang

This sounds like a great program!

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Linzess Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Linzess safely and effectively. Before taking Linzess please consult with your doctor. See full prescribing information for Linzess.

Warning

WARNING: PEDIATRIC RISK LINZESS is contraindicated in pediatric patients up to 6 years of age. Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)]. WARNING: PEDIATRIC RISK See full prescribing information for complete boxed warning. LINZESS is contraindicated in pediatric patients up to 6 years of age. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide caused deaths in young juvenile mice (4, 5.1, 8.4, 13.2).

Indications And Usage

LINZESS is a guanylate cyclase-C agonist indicated in adults for treatment of: Irritable bowel syndrome with constipation (IBS-C) (1.1) Chronic idiopathic constipation (CIC) (1.2) 1.1 Irritable Bowel Syndrome with Constipation (IBS-C) LINZESS (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C). 1.2 Chronic Idiopathic Constipation (CIC) LINZESS is indicated in adults for the treatment of chronic idiopathic constipation (CIC).

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Dosage Forms And Strengths

145 mcg capsules are white to off-white opaque with gray imprint “FL 145” 290 mcg capsules are white to off-white opaque with gray imprint “FL 290” Capsules: 145 mcg and 290 mcg (3)

Contraindications

LINZESS is contraindicated in: Pediatric patients up to 6 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)] Patients with known or suspected mechanical gastrointestinal obstruction Pediatric patients up to 6 years of age (4) Patients with known or suspected mechanical gastrointestinal obstruction (4)

Warning and Cautions

Diarrhea: Patients may experience severe diarrhea. Hold or stop LINZESS (5.2) 5.1 Pediatric Risk LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide [see Contraindications (4), Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)]. Avoid the use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans ages 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of LINZESS in pediatric patients 6 through 17 years of age [see Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)]. 5.2 Diarrhea Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in 2% of the LINZESS-treated patients. The incidence of diarrhea was similar between the IBS-C and CIC populations [see Adverse Reactions (6.1)]. Instruct patients to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension [see Patient Counseling Information (17)].

Adverse Reactions

Most common adverse reactions (incidence of at least 2%) reported in IBS-C or CIC patients are diarrhea, abdominal pain, flatulence and abdominal distension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Forest Pharmaceuticals, Inc., at 1- 800- 678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 another drug and may not reflect the rates observed in practice. During clinical development, approximately 2570, 2040, and 1220 patients with either IBS-C or CIC were treated with LINZESS for 6 months or longer, 1 year or longer, and 18 months or longer, respectively (not mutually exclusive). Irritable Bowel Syndrome with Constipation (IBS-C) Most Common Adverse Reactions The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2). Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. Demographic characteristics were comparable between treatment groups [see Clinical Studies (14.1)]. Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients in the LINZESS treatment group and at an incidence that was greater than in the placebo group. Table 1: Adverse Reactions Reported in at least 2% of LINZESS-treated Patients and at an Incidence Greater than in Placebo Group Patients in the Two Phase 3 Placebo-controlled Trials (1 and 2) in IBS-C a: “Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain. Adverse Reactions LINZESS 290 mcg [N=807] % Placebo [N=798] % Gastrointestinal Diarrhea Abdominal paina Flatulence Abdominal distension 20 7 4 2 3 5 2 1 Infections and Infestations Viral Gastroenteritis 3 1 Nervous System Disorders Headache 4 3 Diarrhea Diarrhea was the most commonly reported adverse reaction of the LINZESS-treated patients in the pooled IBS-C pivotal placebo-controlled trials. In these trials, 20% of LINZESS-treated patients reported diarrhea compared to 3% of placebo-treated patients. Severe diarrhea was reported in 2% of the LINZESS-treated patients versus less than 1% of the placebo-treated patients, and 5% of LINZESS-treated patients discontinued due to diarrhea vs less than 1% of placebo-treated patients. The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment. Fecal incontinence and dehydration were each reported in less than or equal to 1% of patients in the LINZESS treatment group [see Warnings and Precautions (5.2)]. Adverse Reactions Leading to Discontinuation In placebo-controlled trials in patients with IBS-C, 9% of patients treated with LINZESS and 3% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LINZESS treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5%) and abdominal pain (1%). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain. Adverse Reactions Leading to Dose Reductions In the open-label, long-term trials, 2147 patients with IBS-C received 290 mcg of LINZESS daily for up to 18 months. In these trials, 29% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions. Other Adverse Reactions Adverse reactions that were reported in at least 1% and less than 2% of IBS-C patients in the LINZESS treatment group and at an incidence greater than in the placebo treatment group are listed below by body system: Gastrointestinal Disorders: gastroesophageal reflux disease, vomiting General Disorders and Administration Site Conditions: fatigue Other Adverse Events In placebo-controlled trials in patients with IBS-C, less than 1% LINZESS-treated patients and no placebo-treated patients reported hematochezia; no patient in either treatment group reported melena. Less than 1% of LINZESS-treated and placebo-treated patients reported allergic reactions, urticaria, or hives as adverse events. Chronic Idiopathic Constipation (CIC) Most Common Adverse Reactions The data described below reflect exposure to LINZESS in the two double-blind placebo-controlled clinical trials of 1275 adult patients with CIC (Trials 3 and 4). Patients were randomized to receive placebo or 145 mcg LINZESS or 290 mcg LINZESS once daily on an empty stomach, for at least 12 weeks. Demographic characteristics were comparable between both LINZESS treatment groups and placebo [see Clinical Studies (14.2)]. Only data for the recommended LINZESS 145 mcg dose and placebo are presented. Table 2 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the 145 mcg LINZESS treatment group and at an incidence that was greater than in the placebo treatment group. Table 2: Adverse Reactions Reported in at least 2% of 145 mcg LINZESS-treated Patients and at an Incidence Greater than in Placebo Group Patients in the Two Phase 3 Placebo-controlled Trials (3 and 4) in CIC a: “Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain. Adverse Reactions LINZESS 145 mcg [N=430] % Placebo [N=423] % Gastrointestinal Diarrhea Abdominal paina Flatulence Abdominal distension 16 7 6 3 5 6 5 2 Infections and Infestations Upper respiratory tract infection Sinusitis 5 3 4 2 Diarrhea Diarrhea was the most commonly reported adverse reaction of the LINZESS-treated patients in the pooled CIC placebo-controlled trials. In these trials, 16% of LINZESS-treated patients reported diarrhea compared to 5% of placebo-treated patients. Severe diarrhea was reported in 2% of the 145 mcg LINZESS-treated patients versus less than 1% of the placebo-treated patients, and 5% of LINZESS-treated patients discontinued due to diarrhea vs less than 1% of placebo-treated patients. The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment. Fecal incontinence was reported in 1% of patients in the LINZESS treatment group, compared with less than 1% in the placebo group. Dehydration was reported in less than 1% of patients in the LINZESS treatment group [see Warnings and Precautions (5.2)]. Adverse Reactions Leading to Discontinuation In placebo-controlled trials in patients with CIC, 8% of patients treated with LINZESS and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the 145 mcg LINZESS treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5%) and abdominal pain (1%). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain. Adverse Reactions Leading to Dose Reductions In the open-label, long-term trials, 1129 patients with CIC received 290 mcg of LINZESS daily for up to 18 months. In these trials, 27% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions. Other Adverse Reactions Adverse reactions that were reported in at least 1% and less than 2% of CIC patients in the 145 mcg LINZESS treatment group and at an incidence greater than in the placebo treatment group are listed below by body system: Gastrointestinal Disorders: dyspepsia, fecal incontinence Infections and Infestations: viral gastroenteritis Other Adverse Events In placebo-controlled trials in patients with CIC, less than 1% of both LINZESS-treated and placebo-treated patients reported rectal hemorrhage, hematochezia or melena. Less than 1% of LINZESS-treated and placebo-treated patients reported allergic reactions, urticaria, or hives as adverse events.

Drug Interactions

No drug-drug interaction studies have been conducted with LINZESS. Linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses; hence, no systemic drug-drug interactions or drug interactions mediated by plasma protein binding of linaclotide or its metabolite are anticipated [see Clinical Pharmacology (12.3)]. Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide is neither a substrate nor an inhibitor of the efflux transporter P-glycoprotein (P-gp).

Use In Specific Populations

8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled studies with LINZESS in pregnant women. In animal developmental studies, adverse fetal effects were observed only with maternal toxicity and at doses of linaclotide much higher than the maximum recommended human dose. LINZESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data The potential for linaclotide to cause teratogenic effects was studied in rats, rabbits and mice. Oral administration of up to 100,000 mcg/kg/day in rats and 40,000 mcg/kg/day in rabbits produced no maternal toxicity and no effects on embryo-fetal development. In mice, oral dose levels of at least 40,000 mcg/kg/day produced severe maternal toxicity including death, reduction of gravid uterine and fetal weights, and effects on fetal morphology. Oral doses of 5000 mcg/kg/day did not produce maternal toxicity or any adverse effects on embryo-fetal development in mice. The maximum recommended human dose is approximately 5 mcg/kg/day, based on a 60-kg body weight. Limited systemic exposure to linaclotide was achieved at the tested dose levels in animals (AUC = 40, 640, and 25 ng•hr/mL in rats, rabbits, and mice, respectively, at the highest dose levels), whereas no detectable exposure occurred in humans. Therefore, animal and human doses should not be compared directly for evaluating relative exposure. 8.3 Nursing Mothers It is not known whether linaclotide is excreted in human milk; however, linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses [see Clinical Pharmacology (12.3)]. Caution should be exercised when LINZESS is administered to nursing women [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old-mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide [see Contraindications (4), Warnings and Precautions (5.1) and Nonclinical Toxicology (13.2)]. Avoid the use of LINZESS in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of LINZESS in pediatric patients 6 through 17 years of age [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.2)]. 8.5 Geriatric Use Irritable Bowel Syndrome with Constipation (IBS-C) Of 1605 IBS-C patients in the placebo-controlled clinical studies of LINZESS, 85 (5%) were at least 65 years of age, while 20 (1%) were at least 75 years old. Clinical studies of LINZESS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Chronic Idiopathic Constipation (CIC) Of 1275 CIC patients in the placebo-controlled clinical studies of LINZESS, 155 (12%) were at least 65 years of age, while 30 (2%) were at least 75 years old. Clinical trials of LINZESS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 8.6 Hepatic or Renal Impairment No dose adjustment is necessary based on hepatic or renal function [see Clinical Pharmacology (12.3)].

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