Linaclotide

Linaclotide is a prescription medicine used in adults to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Linaclotide belongs to a group of drugs called guanylate cyclase-C (GC-C) agonists, which stimulate the intestines to move food through the body faster.

This medication comes in the form of a capsule and is usually taken once daily, before breakfast.

Common side effects include diarrhea, gas, and stomach-area pain.

Linaclotide is a prescription medication used in adults to treat:

• irritable bowel syndrome with constipation (IBS-C)  
• a type of constipation called chronic idiopathic constipation (CIC).  “Idiopathic” means the cause of the constipation is unknown.  

Linaclotide may be found in some form under the following brand names:

• Linzess

Linaclotide can cause serious side effects. See “Drug Precautions”.

• Diarrhea is the most common side effect of linaclotide, and it can sometimes be severe. 
• Diarrhea often begins within the first 2 weeks of linaclotide treatment.  
• Stop taking linaclotide and call your doctor right away if you get severe diarrhea during treatment with linaclotide. 

• gas 
• stomach-area (abdomen) pain 
• swelling, or a feeling of fullness or pressure in your abdomen (distention)  

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

This medication can cause severe diarrhea. If severe diarrhea happens, notify your health care provider. Rehydration is recommended. 

• Do not give linaclotide to children who are under 6 years of age. It may harm them. Avoid use in children 6 to 17 years old. 
• Do not take linaclotide if a doctor has told you that you have a bowel blockage (intestinal obstruction). 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of linaclotide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take linaclotide, tell your doctor if you: 

• have any other medical conditions 
• are pregnant or plan to become pregnant. It is not known if linaclotide will harm your unborn baby. 
• are breastfeeding or plan to breastfeed. It is not known if linaclotide passes into your breast milk. Talk with your doctor about the best way to feed your baby, if you take linaclotide. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Linaclotide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if linaclotide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using linaclotide.

• Take linaclotide exactly as your doctor tells you to take it. 
• Take linaclotide one time each day on an empty stomach, at least 30 minutes before your first meal of the day. 
• Swallow linaclotide capsules whole. Do not break or chew the capsules.
• 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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of linaclotide for the treatment of irritable bowel syndrome with constipation is 290 mcg taken orally once daily.

The recommended dose of linaclotide for the treatment of chronic idiopathic constipation is 145 mcg taken orally once daily or 72 mcg orally once daily. The dose will be based on symptoms and how well the medication is tolerated. 

If you take too much linaclotide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store linaclotide at room temperature between 68°F to 77°F (20°C to 25°C). 

• Keep linaclotide in the bottle that it comes in. The linaclotide 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 container of linaclotide tightly closed and in a dry place. 
• Keep linaclotide and all medicines out of the reach of children. 

WARNING: PEDIATRIC RISK 

Linaclotide 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.