Plecanatide

Plecanatide may cause life-threatening dehydration in young laboratory mice. Children younger than 6 years of age should never take plecanatide due to the risk of serious dehydration. Children 6 to 17 years of age should not take plecanatide.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with plecanatide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to plecanatide.

Talk to your doctor about the risk(s) of taking plecanatide.

Plecanatide is used in adults to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication) and irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and constipation.) Plecanatide 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.

Plecanatide comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take plecanatide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take plecanatide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split or chew them.

If you are unable to swallow the tablets, you can crush and mix them with water or applesauce. Do not mix the tablets with other liquids or other foods. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.

• To mix the tablet with applesauce, crush it into a powder and combine with 1 teaspoonful of room temperature applesauce. Swallow the entire mixture immediately; do not store the mixture for later use.
• To mix the tablet with water, place the tablet in a clean cup and add 30 mL of water at room temperature. Mix by gently swirling the mixture for at least 10 seconds. Swallow the entire mixture immediately. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup and swirl for at least 10 seconds; then swallow the mixture immediately. Do not store the mixture for later use.
• If you have a feeding tube, the tablets can be crushed and mixed in water and given through the feeding tube. Ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

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

Before taking plecanatide,

• tell your doctor and pharmacist if you are allergic to plecanatide, any other medications, or any of the ingredients in plecanatide tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you may have or have a blockage in your stomach or intestines. Your doctor will probably tell you not to take plecanatide.
• tell your doctor if you have or have ever had any other medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking plecanatide, call your doctor.

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

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• stomach bloating or tenderness
• gas
• mild diarrhea
• nausea
• dizziness

Some side effects can be serious. If you experience this symptom, stop taking the medication and call your doctor immediately:

• severe diarrhea

Plecanatide 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 (http://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). Remove and discard the polyester coil (used to protect the tablets during shipping) after opening the bottle. Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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:

• diarrhea
• dehydration

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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