Allergan, Inc.

Linzess

Brand

Generic: Linaclotide

ID: 00456120104

NaN

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📜 Prescription Required

FORM

Capsule

STRENGTH

145 mcg

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES SECTION BOXED WARNING SECTION INDICATIONS & USAGE SECTION DOSAGE & ADMINISTRATION SECTION SPL UNCLASSIFIED SECTION

🩺What it's for

LINZESS is indicated for the treatment of: irritable bowel syndrome with constipation (IBS-C) in adults chronic idiopathic constipation (CIC) in adults functional constipation (FC) in pediatric patients 6 to 17 years of age LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults. (1) Chronic idiopathic constipation (CIC) in adults. (1) Functional constipation (FC) in pediatric patients 6 to 17 years of age.

💊How to take it

The recommended dosage in adults is: IBS-C: 290 mcg orally once daily. (2.1) CIC: 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability. (2.1) The recommended dosage in pediatric patients 6 to 17 years is: FC: 72 mcg orally once daily. (2.1) Administration Instructions (2.2): Take on empty stomach at least 30 minutes prior to a meal at approximately the same time each day. Do not crush or chew LINZESS capsule or capsule contents.

ℹ️Common side effects

Most common adverse reactions ( 2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension. (6.1) Most common adverse reaction ( 2%) reported in pediatric patients 6 to 17 years of age with FC is diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

⚠️Serious risks

LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing information for complete boxed warning.

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Linaclotide (Linzess) Prices

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The efficacy of LINZESS for the treatment of FC in pediatric patients 6 to 17 years of age was established in a 12-week double-blind, placebo-controlled, randomized, multicenter, clinical trial (Trial 7; NCT04026113). A total of 328 patients received treatment with LINZESS 72 mcg or placebo once daily and were evaluated for efficacy. Patients in the trial had a mean age of 11 years (range 6 to 17 years); 55% were female; 45% identified as Hispanic or Latino; 70% identified as White, 26% as Black or African American, 2% as Asian, and 2% identified as another racial group. For trial enrollment, Rome III criteria for child/adolescent FC were modified to require that patients have less than 3 Spontaneous Bowel Movements (SBMs) per week (defined as a BM that occurred in the absence of laxative, enema, or suppository use on the calendar day of or before the BM) and 1 or more of the following criteria at least once per week for at least 2 months before the screening visit: History of stool withholding or excessive voluntary stool retention History of painful or hard bowel movements (BMs) History of large diameter stools that may obstruct the toilet Presence of a large fecal mass in the rectum At least 1 episode of fecal incontinence per week Patients were also required to have an average of less than 3 SBMs per week during the 2-week baseline period. Patients were excluded if they met criteria for pediatric IBS-C or had fecal impaction. Patients were allowed to continue previously stable doses of bulk laxatives, fiber, stool softeners, or probiotics. During the trial, patients could use bisacodyl or senna as needed, but were not allowed to take other laxatives, bismuth, prokinetic agents, or other drugs to treat functional constipation. The efficacy of LINZESS in the treatment of FC in pediatric patients 6 to 17 years of age was assessed using change-from-baseline endpoints. The primary efficacy endpoint was the 12-week change from baseline in SBM frequency rate. The results demonstrated that patients who received LINZESS had statistically significant improvements compared with placebo as shown in Table 7. Table 7: Efficacy Endpoint in Placebo-Controlled Trial of Pediatric Patients 6 to 17 Years of Age with FC (Trial 7): 12-week Change from Baseline in SBM Frequency Rate (SBMs/week) Trial 7 LINZESS 72 mcg Once Daily (N=164) Placebo (N=164) Treatment Difference [95% CI] Baseline SBM Frequency Rate 1.2 1.3 Least Squares 12-week Mean Change from Baseline in SBM Frequency Rate* 2.6 1.3 1.3 [0.7, 1.8] * Primary EndpointCI = Confidence Interval SBM frequency improved during week 1 and was maintained throughout the remainder of the 12-week treatment period.

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. Exposure in clinical development included approximately 2570, 2040, and 1220 adult patients with either IBS-C or CIC, treated with LINZESS for 6 months or longer, 1 year or longer, and 18 months or longer, respectively (not mutually exclusive). Demographic characteristics were comparable between treatment groups in all studies [see Clinical Studies ( 14.1 , 14.2 )]. Irritable Bowel Syndrome with Constipation (IBS-C) in Adults 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) [see Clinical Studies ( 14.1 )]. Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. 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: Most Common Adverse Reactionsa in Two Placebo-Controlled Trials (1 and 2) in Adult Patients with IBS-C Adverse Reactions LINZESS 290 mcg [N=807] % Placebo [N=798] % Gastrointestinal Diarrhea Abdominal painb Flatulence Abdominal distension 20742 3521 Infections and Infestations Viral Gastroenteritis 3 1 Nervous System Disorders Headache 4 3 a: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placebo b: Abdominal pain term includes abdominal pain, upper abdominal pain, and lower abdominal pain. Adverse reactions in an additional placebo-controlled trial in 614 IBS-C patients randomized to placebo or LINZESS 290 mcg once daily on an empty stomach for 12 weeks (Trial 6) were similar to those in Table 1. 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 [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. Less Common Adverse Reactions Defecation urgency, fecal incontinence, vomiting, and gastroesophageal reflux disease were reported in <2% of patients in the LINZESS-treatment group and at an incidence greater than in the placebo treatment group. Chronic Idiopathic Constipation (CIC) in Adults 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) [see Clinical Studies ( 14.2 )]. 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. 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: Most Common Adverse Reactionsa in the Two Placebo-controlled Trials (3 and 4) in Adult Patients with CIC Adverse Reactions LINZESS 145 mcg [N=430] % Placebo [N=423] % Gastrointestinal Diarrhea Abdominal painb Flatulence Abdominal distension 16763 5652 Infections and Infestations Upper respiratory tract infection Sinusitis 53 42 a: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placebo b: Abdominal pain term includes abdominal pain, upper abdominal pain, and lower abdominal pain. The safety of a 72 mcg dose was evaluated in an additional placebo-controlled trial in which 1223 patients were randomized to LINZESS 72 mcg, 145 mcg, or placebo once daily for 12 weeks (Trial 5). In Trial 5, adverse reactions that occurred at a frequency of 2% in LINZESS-treated patients (N=411 in each LINZESS 72 mcg and 145 mcg group) and at a higher rate than placebo (N=401) were: Diarrhea (LINZESS 72 mcg 19%; LINZESS 145 mcg 22%; placebo 7%) Abdominal distension (LINZESS 72 mcg 2%; LINZESS 145 mcg 1%; placebo < 1%) Diarrhea In Trials 3 and 4 (pooled) and Trial 5, diarrhea was the most commonly reported adverse reaction in LINZESS-treated patients in the CIC placebo-controlled studies. In all trials, the majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment. Severe diarrhea was reported in less than 1% of the 72 mcg LINZESS-treated patients (Trial 5), in 2% of the 145 mcg LINZESS-treated patients (Trials 3, 4, and 5), and less than 1% of the placebo-treated patients (Trials 3, 4, and 5) [see Warnings and Precautions ( 5.2 )]. Adverse Reactions Leading to Discontinuation In placebo-controlled trials in patients with CIC, 3% of patients treated with 72 mcg (Trial 5) and between 5% and 8% (Trials 3, 4, and 5) of patients treated with 145 mcg of LINZESS discontinued prematurely due to adverse reactions compared to between less than 1% and 4% (Trials 3, 4, and 5) of patients treated with placebo. In patients treated with 72 mcg LINZESS, the most common reason for discontinuation due to adverse reactions was diarrhea (2% in Trial 5) and, in patients treated with 145 mcg LINZESS, the most common reasons for discontinuation due to adverse reactions were diarrhea (between 3% and 5% in Trials 3, 4, and 5) and abdominal pain (1% in Trials 3 and 4). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain (Trials 3, 4, and 5). 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. Less Common Adverse Reactions Defecation urgency, fecal incontinence, dyspepsia, and viral gastroenteritis were reported in less than 2% of patients in the LINZESS treatment group and at an incidence greater than in the placebo treatment group. Functional Constipation (FC) in Pediatric Patients 6 to 17 Years of Age The safety of LINZESS 72 mcg once daily was evaluated in pediatric patients 6 to 17 years of age with FC in a 12-week double-blind, placebo-controlled clinical trial (Trial 7) [see Clinical Studies ( 14.3 )]. There were 164 patients per treatment group. Diarrhea was the most common adverse reaction and was reported in 4% of LINZESS-treated patients compared to 2% of placebo-treated patients. One patient in the LINZESS-treated group reported severe diarrhea and discontinued treatment. No patient in the placebo-treated group discontinued treatment due to severe diarrhea. Most reported cases of diarrhea started within the first 2 weeks of LINZESS treatment [see Warnings and Precautions ( 5.2 )]. Other adverse reactions reported at a higher incidence in the LINZESS group than the placebo group included nausea (2 patients) and abdominal discomfort and dehydration (1 patient each).

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 in fetal exposure to the drug. The available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage. Severe maternal toxicity associated with effects on fetal morphology were observed in mice ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data The potential for linaclotide to cause harm to embryo-fetal development was studied in rats, rabbits and mice. In pregnant mice, oral dose levels of at least 40,000 mcg/kg/day given during organogenesis produced severe maternal toxicity including death, reduction of gravid uterine and fetal weights, and effects on fetal morphology. Oral doses of 5,000 mcg/kg/day did not produce maternal toxicity or any adverse effects on embryo-fetal development in mice. Oral administration of up to 100,000 mcg/kg/day in rats and 40,000 mcg/kg/day in rabbits during organogenesis produced no maternal toxicity and no effects on embryo-fetal development. Additionally, oral administration of up to 100,000 mcg/kg/day in rats during organogenesis through lactation produced no developmental abnormalities or effects on growth, learning and memory, or fertility in the offspring through maturation. 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 in animals during organogenesis (AUC = 40, 640, and 25 ng hr/mL in rats, rabbits, and mice, respectively, at the highest dose levels). Linaclotide and its active metabolite are not measurable in human plasma following administration of the recommended clinical dosages. Therefore, animal and human doses should not be compared directly for evaluating relative exposure.

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 oral administration of linaclotide which increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in rapid and severe dehydration (see Juvenile Animal Toxicity Data ). A clinical GC-C ontogeny study in children 6 months to less than 18 years of age (N=99) was conducted to measure GC-C mRNA expression levels in duodenal and colonic samples to evaluate the risk of diarrhea and severe dehydration due to GC-C agonism. The results showed no age dependent trend in GC-C intestinal expression in children 2 to less than 18 years of age. There was insufficient data on GC-C intestinal expression to assess the risk of developing diarrhea and its potentially serious consequences in children less than 2 years of age [see Warnings and Precautions ( 5.1 )]. The safety and effectiveness of LINZESS for the treatment of FC in pediatric patients 6 to 17 years of age have been established. Use of LINZESS for this indication is supported by evidence from adequate and well-controlled studies in adults and pediatric patients 6 years of age and older. The safety of LINZESS in adult and pediatric patients 6 to 17 years of age in clinical studies was similar [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 )]. The safety and effectiveness of LINZESS in patients with FC less than 6 years of age or in patients with IBS-C less than 18 years of age have not been established. Juvenile Animal Toxicity Data In toxicology studies in neonatal mice, oral administration of linaclotide at 10 mcg/kg/day caused deaths on post-natal day 7 (human age equivalent of approximately 0 to 28 days). These deaths were due to rapid and severe dehydration produced by significant fluid shifts into the intestinal lumen resulting from GC-C agonism in neonatal mice [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. Tolerability to linaclotide increases with age in juvenile mice. In 2-week-old mice, linaclotide was well tolerated at a dose of 50 mcg/kg/day, but deaths occurred after a single oral dose of 100 mcg/kg. In 3-week-old mice, linaclotide was well tolerated at 100 mcg/kg/day, but deaths occurred after a single oral dose of 600 mcg/kg.

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 after oral doses of 72 mcg, 145 mcg, or 290 mcg were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t ) cannot be calculated. Food Effect Neither linaclotide nor its active metabolite were detected in the plasma following administration of LINZESS 290 mcg once daily for 7 days both in the non-fed and fed state in healthy subjects. Distribution Given that linaclotide plasma concentrations following recommended oral doses are not measurable, linaclotide is not expected to be distributed to tissues to any clinically relevant extent. Elimination Metabolism Linaclotide is metabolized within the gastrointestinal tract to its principal, active metabolite by loss of the terminal tyrosine moiety. Both linaclotide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids. Excretion Active peptide recovery in the stool samples of fed and fasted healthy subjects following administration of LINZESS 290 mcg once daily for seven days averaged about 5% (fasted) and about 3% (fed) and all of it as the active metabolite. Specific Populations Renal and Hepatic Impairment Renal or hepatic impairment is not expected to affect the clearance of linaclotide or the active metabolite because linaclotide metabolism occurs within the gastrointestinal tract and plasma concentrations are not measurable in plasma following administration of the recommended dosage. Drug Interaction Studies No drug-drug interaction studies have been conducted with LINZESS. Systemic exposures of drug and active metabolite are negligible following oral administration. Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide does not interact with common efflux and uptake transporters (including the efflux transporter P-glycoprotein (P-gp)). Based on these in vitro data no drug-drug interactions through modulation of CYP enzymes or common transporters are anticipated.

MEDICATION GUIDE LINZESS (lin-ZESS) (linaclotide) c apsules , for oral use What is the most important information I should know about LINZESS? Do not give LINZESS to children who are less than 2 years of age. It may harm them. See the section What are the possible side effects of LINZESS? for more information about side effects. What is LINZESS? LINZESS is a prescription medicine used to treat: irritable bowel syndrome with constipation (IBS-C) in adults. a type of constipation called chronic idiopathic constipation (CIC) in adults. Idiopathic means the cause of the constipation is unknown. functional constipation in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children with functional consti p ation less than 6 years of age or in children with I BS-C less than 18 years of age . Who should not take LINZESS? Do not give LINZESS to children who are less than 2 years of age. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt). Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction). Before you take LINZESS, tell your doctor about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby. are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LINZESS and breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. How should I take LINZESS? Take LINZESS exactly as your doctor tells you to take it. Take LINZESS 1 time each day on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day. You should also wait 30 minutes before eating a meal if you take LINZESS with applesauce or mixed with water. If you miss a dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time. LINZESS capsules should be swallowed whole. Do not crush or chew LINZESS. Patients who cannot swallow LINZESS capsules whole may open the LINZESS capsule and sprinkle the LINZESS beads over applesauce or mix LINZESS with bottled water before swallowing. It is not known if LINZESS is safe and effective when sprinkled on other foods or mixed with other liquids. Taking LINZESS in applesauce: Place 1 teaspoon of room temperature applesauce into a clean container. Open the LINZESS capsule and sprinkle all of the LINZESS beads onto the applesauce. Swallow all of the LINZESS beads and applesauce right away. Do not keep the applesauce for later use. Do not chew the LINZESS beads. Taking LINZESS in water: Pour 1 ounce (30 mL) of room temperature bottled water into a clean cup. Open the LINZESS capsule and sprinkle all of the LINZESS beads into the cup of water. Gently swirl the beads and water for at least 20 seconds. Swallow all of the LINZESS beads and water mixture right away. Do not keep the mixture for later use. If you see any LINZESS beads left in the cup, add another 1 ounce (30 mL) of water to the beads in the cup, swirl for at least 20 seconds, and swallow right away. Taking LINZESS in a nasogastric or gastrostomy feeding tube: Gather the supplies you will need to take your LINZESS dose. Your doctor should tell you what size catheter tipped syringe you will need for your dose. Ask your doctor if you have any questions about how to give LINZESS the right way. Open the LINZESS capsule and pour all of the LINZESS beads into a clean container with 1 ounce (30 mL) of room temperature bottled water. Gently swirl the beads and water for at least 20 seconds. Remove the plunger from the catheter tipped syringe, and then pour the LINZESS bead and water mixture into the syringe and replace the plunger. Remove the cap from the syringe, insert the tip of the syringe into the nasogastric or gastrostomy feeding tube and push the plunger all the way in to give the dose. If you see any LINZESS beads left in the container, add another 1 ounce (30 mL) of water to the beads in the container and repeat the process. After giving the LINZESS dose, flush the nasogastric or gastrostomy feeding tube with at least 10 mL of water. What are the possible side effects of LINZESS? LINZESS can cause serious side effects, including: See What is the most important information I should know about LINZESS? Diarrhea is the most common side effect of LINZESS, and it can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS. Other common side effects of LINZESS in people with IBS-C and CIC include: gas stomach-area (abdomen) pain swelling, or a feeling of fullness or pressure in your abdomen (distention) C all your doctor or go to the nearest hospital emergency room right away, if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar. These are not all the possible side effects of LINZESS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store LINZESS? Store LINZESS at room temperature between 68 F to 77 F (20 C to 25 C). Keep LINZESS in the bottle that it comes in. The LINZESS bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle. Keep the bottle of LINZESS tightly closed and in a dry place. Keep LINZESS and all medicines out of the reach of children. General information about the safe and effective use of LINZESS . Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LINZESS for a condition for which it was not prescribed. Do not give LINZESS to other people, even if they have the same symptoms that you have. It may harm them.You can ask your doctor or pharmacist for information about LINZESS that is written for health professionals. What are the ingredients in LINZESS? Active ingredient: linaclotide Inactive ingredients for the 145 mcg and 290 mcg capsules: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. Capsule shell: gelatin and titanium dioxide. Inactive ingredients for the 72 mcg capsules: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. Capsule shell: gelatin and titanium dioxide.LINZESS is a registered trademark of Ironwood Pharmaceuticals, Inc.Marketed by: AbbVie, Inc. North Chicago, IL 60064 and Ironwood Pharmaceuticals, Inc. Boston, MA 02110 2023 AbbVie and Ironwood Pharmaceuticals, Inc. All rights reserved.For more information, go to www.LINZESS.com or call 1-800-678-1605. This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 6/2023 V4.0MG1201