Linaclotide: Side Effects, Uses, Dosage, Interactions, Warnings

What Is Linaclotide and How Does It Work?

Linaclotide is a prescription medicine used to treat:

• Irritable bowel syndrome with constipation (IBS-C) in adults and children 7 years of age and older
• Chronic idiopathic constipation (CIC) in adults
• Functional constipation in children 2 years of age and older

Linaclotide works locally in your intestines by increasing the amount of fluid in your bowels and helping food move through your digestive tract more quickly. It may also help reduce stomach pain associated with irritable bowel syndrome with constipation.

• Linaclotide is available under the following different brand names: Linzess.

What Are Side Effects Associated with Using Linaclotide?

Common side effects of Linaclotide include:

• Diarrhea
• Abdominal pain
• Gas
• Swelling or bloating of the abdomen

Serious side effects of Linaclotide include:

• Severe Dehydration in Children Younger Than 2 Years: Linaclotide can cause severe diarrhea and life-threatening dehydration in children younger than 2 years of age. Because of this risk, linaclotide must not be used in children younger than 2 years.
• Severe Diarrhea: Diarrhea is the most common side effect of linaclotide and can sometimes be severe. Stop taking linaclotide and call your healthcare provider right away if you develop severe diarrhea.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What Are the Doses of Linaclotide?

Dosage Forms & Strengths Capsules:

• 72 mcg
• 145 mcg
• 290 mcg

Irritable Bowel Syndrome with Constipation (IBS-C)

Adult Dose

• 290 mcg by mouth once daily on an empty stomach, at least 30 minutes before the first meal of the day.

Pediatric Dose

• Children 7 years of age and older: 145 mcg by mouth once daily on an empty stomach, at least 30 minutes before the first meal of the day.
• Children younger than 7 years: Safety and effectiveness have not been established.

Chronic Idiopathic Constipation

Adult Dose

• 145 mcg by mouth once daily on an empty stomach, at least 30 minutes before the first meal of the day.
• A lower dose of 72 mcg once daily may be used based on individual symptoms or tolerability.

Pediatric Dose

• Safety and effectiveness have not been established.

Functional Constipation

Adult Dose

• Not approved for this condition.

Pediatric Dose

• Children 2 years of age and older: 72 mcg by mouth once daily on an empty stomach, at least 30 minutes before the first meal of the day.
• Children younger than 2 years: Do not use. Linaclotide is contraindicated in children under 2 years of age.

What Other Drugs Interact with Linaclotide?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Linaclotide is right for you.

• No specific drug interactions are described in the prescribing information.

This may not be a complete list of medicines that can interact with Linaclotide. Always check with your healthcare provider.

What Are Warnings and Precautions for Linaclotide?

Contraindications

• Do not use linaclotide in children younger than 2 years of age because it may cause severe dehydration.
• Do not take linaclotide if you have a known or suspected blockage of your stomach or intestines (gastrointestinal obstruction).

Cautions

• Risk of Severe Dehydration in Children: Linaclotide must not be used in children younger than 2 years because it can cause severe diarrhea and life-threatening dehydration.
• Severe Diarrhea: Diarrhea is common and may be severe. If severe diarrhea occurs, stop taking linaclotide and contact your healthcare provider right away.
• Administration: Take linaclotide exactly as prescribed. Take it once daily on an empty stomach, at least 30 minutes before the first meal of the day. If taking the capsule contents mixed with applesauce or water, wait at least 30 minutes before eating.

Pregnancy:

• Linaclotide is minimally absorbed after it is taken by mouth and is not expected to expose an unborn baby to the drug. However, available data in pregnant women are not sufficient to determine whether there is a drug-related risk of major birth defects or miscarriage. Talk with your healthcare provider if you are pregnant or planning to become pregnant.

Lactation:

• Linaclotide was not detected in human breast milk and is not expected to expose a breastfed infant to the drug. It is not known whether linaclotide affects milk production. Talk with your healthcare provider about the best way to feed your baby during treatment.

From

https://reference.medscape.com/drug/linzess-linaclotide-999768#6