Selexipag is used to treat pulmonary arterial hypertension (PAH). Selexipag helps keep your condition from getting worse and helps lower your risk of needing to be hospitalized for PAH.

Selexipag may also be used for purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with selexipag.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Selexipag oral is taken by mouth.

You may take selexipag with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Selexipag injection is given in a vein by a healthcare provider if you are unable to take medicine by mouth.

Your condition may get worse if you stop using selexipag suddenly. Ask your doctor before stopping the medicine.

Store tablets at room temperature away from moisture and heat.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 200 mcg orally twice a day
Maintenance dose: Increase in increments of 200 mcg orally twice a day at weekly intervals to the highest tolerated dose
Maximum dose: 1600 mcg orally twice a day

Comment:
-If the patient reaches a dose that is not well tolerated, reduce to a previously tolerated dose.

Use: For the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH

You should not use selexipag if you are allergic to it.

Some drugs should not be used with selexipag. Your treatment plan may change if you also use:

• clopidogrel; or

• gemfibrozil.

Tell your doctor if you have ever had:

• a condition called pulmonary veno-occlusive disease (narrowing of the veins that carry blood from the lungs to the heart); or

• liver disease.

It is not known if selexipag will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

If you miss doses for 3 or more days, call your doctor before taking another dose. You may need to restart the medicine at a lower dose than you took before.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Selexipag may cause serious side effects. Call your doctor at once if you have:

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or

• new lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects of selexipag may include:

• headache;

• jaw pain;

• muscle pain, pain in your arms or legs;

• joint pain;

• flushing (warmth, redness, or tingly feeling);

• rash;

• anemia;

• nausea, vomiting, loss of appetite, diarrhea; or

• pain, redness, or swelling where a selexipag injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect selexipag, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.