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ABOUT LINZESS

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LINZESS FOR IBS-C

EFFICACY

SAFETY

IBS-C PATIENT IDENTIFICATION

LINZESS FOR CIC

EFFICACY

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IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions

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, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

Diarrhea

  • Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

Please see full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/linzess_pi.pdf.

US-LIN-210714

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Ironwood® and its three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc. LINZESS® and its design are registered trademarks of Ironwood Pharmaceuticals, Inc. © 2022 AbbVie and Ironwood Pharmaceuticals, Inc. All rights reserved. The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside the United States.

US-LIN-210927 09/22

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You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

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LINZESS is celebrating 10 years of helping patients with IBS-C and CIC1

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).1

Please see Important Safety Information below.

Please see link for full Prescribing Information above for additional information.

US-LIN-220238

LINZESS is celebrating 10 years of helping patients with IBS-C and CIC1

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).1

Please see Important Safety Information below.

Please see link for full Prescribing Information above for additional information.

US-LIN-220238

IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING: 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 nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.

Contraindications

  • LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions

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, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

Diarrhea

  • Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

Please see full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/linzess_pi.pdf.

US-LIN-210714