Treprostinil is used in adults to treat high blood pressure in the arteries of the lungs also known as pulmonary arterial hypertension (PAH). treprostinil improves your ability to exercise and can help prevent your condition from getting worse.

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

You should not use treprostinil if you have severe liver disease.

You should not stop taking treprostinil suddenly. Your condition may get worse if you stop taking treprostinil.

Treprostinil comes as extended-release (long acting) tablets to take by mouth. It is usually taken with food 2 times a day (every 12 hours) or 3 times a day (every 8 hours). Take treprostinil 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 treprostinil 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 treprostinil and gradually increase your dose, not more than once every 3 or 4 days. Your doctor may decrease your dose if you experience side effects.

Treprostinil may control the symptoms of PAH but does not cure it. Continue to take treprostinil even if you feel well. Do not stop taking treprostinil without talking to your doctor. If you suddenly stop taking treprostinil, your symptoms may get worse. Your doctor will probably decrease your dose gradually.

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

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.

Take with food.

Swallow the tablet whole and do not crush, chew, or break it. Do not use a cracked or broken tablet.

Treprostinil is usually taken 2 to 3 times per day. Follow your doctor's instructions. Your dose may change if you have side effects.

Use treprostinil regularly for the best results.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

You should not stop taking treprostinil suddenly. Your condition may get worse if you stop taking treprostinil. Follow your doctor's instructions about tapering your dose.

Part of a tablet shell may appear in your stool but this will not make the medicine less effective.

Store at room temperature away from moisture and heat.

You should not use treprostinil if you have severe liver disease.

Tell your doctor if you have or have ever had:

• diverticulosis (an intestinal disorder); or

• liver disease.

It is not known if treprostinil will harm an unborn baby. However, having high lung blood pressure during pregnancy may cause complications or medical problems in both mother and baby. The benefit of treating pulmonary hypertension may outweigh any risks to the baby.

Ask a doctor if it is safe to breastfeed while using treprostinil.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss 2 or more doses of treprostinil.

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

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).

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.

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

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.

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

• chest pain, trouble breathing, tiredness, pale skin, swelling in arms or legs; or

• a light-headed feeling, like you might pass out.

Common side effects of treprostinil may include:

• headache;

• stomach pain;

• jaw pain, pain in your arms or legs;

• diarrhea, nausea, vomiting; or

• flushing (sudden warmth, redness, or tingly feeling).

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.

Tell your doctor about all your other medicines, especially:

• gemfibrozil; or

• medicine that contains treprostinil--Remodulin, Tyvaso, or Tyvaso DPI.

This list is not complete. Other drugs may affect treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet shell in your stool. This is normal and does not mean that you did not receive the full dose of medication.

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.