Selexipag (oral/injection)

Selexipag is used to treat pulmonary arterial hypertension (PAH). Selexipag helps prevent your condition from worsening and reduces your risk of being hospitalized for PAH.

Selexipag may also be used for reasons not mentioned in this medication guide.

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.

Tell your doctor about all the other medicines you are taking. Some drugs must not be used with selexipag.

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.

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

Selexipag may cause serious side effects. Call your doctor immediately 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.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 200 mcg orally twice a dayMaintenance dose: Increase in increments of 200 mcg orally twice a day at weekly intervals to the highest tolerated doseMaximum dose: 1600 mcg orally twice a dayComment:-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

Use the medicine as soon as possible, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at the same time.

If you miss doses for 3 or more days, contact your doctor before taking another dose. You may need to start the medicine again at a lower dose than what 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.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medicines work.

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