Linaclotide

Linaclotide has caused life-threatening dehydration in young laboratory mice. Children younger than 2 years of age should never take linaclotide.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking linaclotide.

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools). It is also used to treat certain types of constipation in adults and children 6 years of age and older. Linaclotide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines.

Linaclotide comes as a capsule to take by mouth. Take once a day on an empty stomach, at least thirty minutes before a meal. Take linaclotide at around the same time every day. 

Take linaclotide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

If you cannot swallow the capsules whole, you can open the capsules and sprinkle the contents on a small amount of room temperature applesauce (about one teaspoonful). Swallow right away without chewing.  You can also sprinkle the contents into a cup containing 1 ounce (30 mL) of room temperature bottled water. Gently swirl the beads and water for at least 20 seconds and swallow the entire mixture right away without chewing. If you see beads in the cup, rinse the cup with 1 ounce (30 mL) of water, swirl the contents for at least 20 seconds, and drink the water right away to be sure you swallow any leftover beads. Do not mix with other foods or liquids.

The contents of linaclotide capsules can be given through a feeding tube. If you have a feeding tube, ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

Linaclotide controls the symptoms of IBS-C, CIC, and FC but does not cure these conditions. It may take 1 week or longer before you feel the full benefit of linaclotide. Continue to take linaclotide even if you feel well. Do not stop taking linaclotide without talking to your doctor. If you stop taking linaclotide, your symptoms may return in about 1 week.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking linaclotide,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. 
• tell your doctor if you have a blockage in your stomach or intestines. Your doctor will probably tell you not to take linaclotide.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking linaclotide, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you remember the missed dose before eating, take the missed dose as soon as you remember it. If you have already eaten, check with your doctor before taking the missed dose. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Linaclotide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• swelling or feeling of fullness or pressure in the stomach area
• gas
• headache

Some side effects can be serious. If you experience any of these symptoms, stop taking linaclotide and call your doctor immediately or get emergency medical treatment:

• unusual or severe stomach pain
• bright red or black, tarry stools
• hives; rash; itching; swelling of the lips, tongue, or throat; shortness of breath or difficulty breathing
• dizziness or fainting
• extreme thirst, dry mouth and/or skin, sunken eyes, or fast heartbeat

Linaclotide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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