Selexipag, Oral

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KEY POINTS

• This medicine is taken by mouth to treat pulmonary hypertension. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Do not start or stop taking any other medicine without your healthcare provider’s advice.

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What are other names for this medicine?

Type of medicine: prostacyclin receptor agonist

Generic and brand names: selexipag, oral; Uptravi

What is this medicine used for?

This medicine is taken by mouth to treat pulmonary arterial hypertension (high blood pressure in the lungs).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver problems
• Narrowing of the pulmonary veins (pulmonary veno-occlusive disease)

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take your dosage of this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Do not break, crush, or chew the tablets. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 6 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider. If you miss 3 or more days of this medicine, call your healthcare provider. Your dose may need to be changed.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: nausea.

What should I watch out for?

Your healthcare provider will check you regularly while you are taking this medicine. Keep all appointments.

Contact your healthcare provider if your condition does not improve or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. If you need emergency medical care for a heart problem, it is very important you inform the healthcare provider when you last took this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening trouble breathing; coughing or wheezing; unusual tiredness or weakness.

Other: Headache, jaw pain, nausea, flushing, muscle or joint pain, decreased appetite, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as abiraterone (Zytiga), lapatinib (Tykerb), nilotinib (Tasigna), and tamoxifen
• Celecoxib (Celebrex)
• Clopidogrel (Plavix)
• Deferasirox (Exjade, Jadenu)
• Diabetes medicines such as pioglitazone (Actos) and rosiglitazone (Avandia)
• Gemfibrozil (Lopid)
• Heart medicines such as felodipine, irbesartan (Avapro), and losartan (Cozaar)
• HIV medicines such as efavirenz (Sustiva), lopinavir/ritonavir (Kaletra) and ritonavir (Norvir)
• Quinine
• Rabeprazole (AcipHex)
• Sulfamethoxazole/trimethoprim (Bactrim, Septra) or trimethoprim (Primsol)
• Teriflunomide (Aubagio)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.