Selexipag

Selexipag is used in adults to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) to slow down the worsening of symptoms and reduce the chance of being hospitalized for PAH. Selexipag is in a class of medications called selective nonprostanoid IP prostacyclin receptor agonists. It works by relaxing the blood vessels in the lungs to allow blood to flow easily.

Selexipag comes as a tablet to take by mouth. It is usually taken with food twice a day. Take selexipag at around the same times 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 selexipag 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, chew, or crush them.

Your doctor will probably start you on a low dose of selexipag and gradually increase your dose, not more than once every week.

Selexipag controls the symptoms of PAH but does not cure it. Continue to take selexipag even if you feel well. Do not stop taking selexipag without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before taking selexipag,

• tell your doctor and pharmacist if you are allergic to selexipag, any other medications, or any of the ingredients in selexipag tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking gemfibrozil. Your doctor may tell you not to take selexipag if you are taking this medication.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: clopidogrel (Plavix), deferasirox (Exjade, Ferriprox, Jadenu), rifampin (Rifadin, Rimactane), and teriflunomide (Aubagio). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with selexipag, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs), thyroid problems, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking selexipag, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is within 6 hours of 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. If you miss taking selexipag for 3 days or more, talk to your doctor before you start taking it again. You will probably have to restart taking selexipag at a lower dose.

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

• headache
• pain in jaw, joints, muscles, arms, or legs
• decreased appetite
• nausea
• diarrhea
• vomiting
• flushing
• rash

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

• shortness of breath
• rapid breathing
• dizziness
• weakness

Selexipag 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).

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.

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

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:

• nausea

Do not let anyone else take your medication.

Selexipag is not available at retail pharmacies. Your medication will be mailed to you or to your doctor from a specialty pharmacy. Ask your doctor if you have any questions about how you will receive your medication.

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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