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Generic Name: treprostinil (oral) (tre PROS ti nil)
Brand Name: Orenitram

What is treprostinil?

Treprostinil dilates (widens) the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise.

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

What is the most important information I should know about treprostinil?

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

What should I discuss with my healthcare provider before taking treprostinil?

You should not use treprostinil if you are allergic to it, or if you have severe liver disease.

To make sure treprostinil is safe for you, tell your doctor if you have:

  • diverticulosis (an intestinal disorder); or

  • liver disease.

It is not known whether treprostinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take treprostinil?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not use a broken pill.

Take with food.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

You should not reduce your dose or stop using treprostinil suddenly. Stopping suddenly may make your condition worse.

Tell your doctor if you need to stop taking treprostinil for any reason. You may need an alternate treatment during that time.

Treprostinil is made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of treprostinil and will not make the medication less effective.

Call your doctor if you have new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin.

Use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

What happens if I overdose?

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

What should I avoid while taking treprostinil?

Do not drink alcohol. Alcohol can cause the tablet to release treprostinil too quickly.

Treprostinil side effects

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

Call your doctor at once if you have:

  • severe headache;

  • vomiting; or

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

Common side effects may include:

  • headache;

  • pain in your arms or legs;

  • diarrhea, nausea; or

  • flushing (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.

Side Effects (complete list)

Treprostinil dosing information

Usual Adult Dose for Pulmonary Hypertension:

Extended-release tablets:
-Initial dose: 0.25 mg orally every 12 hours or 0.125 mg every 8 hours
-Maintenance dose: Titrate to the highest tolerated dose in increments of 0.25 or 0.5 mg twice a day or 0.125 mg 3 times a day every 3 to 4 days

-If dose increments are not tolerated, consider titrating slower.
-Appropriate maintenance dose determined by tolerability.
-If intolerable effects occur, decrease the dose in increments of 0.25 mg to avoid abrupt discontinuation.
-When discontinuing use, reduce the dose in steps of 0.5 to 1 mg per day.

-Initial dose: 3 breaths (18 mcg) per treatment session 4 times a day; if 3 breaths are not tolerated, reduce to 1 or 2 breaths and subsequently increase to 3 breaths as tolerated
-Maintenance dose: Increase by an additional 3 breaths at about 1 to 2 week intervals as tolerated until the target dose of 9 breaths (54 mcg) is reached per treatment session 4 times a day
-Maximum dose: 9 breaths (54 mcg) per treatment session 4 times a day

-Administer in 4 separate, equally spaced (about 4 hours apart) treatment sessions each day during waking hours.
-This drug should be continued at the highest tolerated dose.
-Use only with the Tyvaso(R) Inhalation System.

Patients New to Prostacyclin Infusion Therapy:
-Initial dose: 1.25 ng/kg/min via continuous subcutaneous or IV infusion; if this dose cannot be tolerated, reduce to 0.625 ng/kg/min
-Maintenance dose: Increase infusion rate by 1.25 ng/kg/min per week for the first 4 weeks and thereafter, by 2.5 ng/kg/min per week for the remaining duration of infusion

-May be administered as a continuous subcutaneous infusion or continuous IV infusion; however, high risks associated with chronic indwelling central venous catheters (e.g., serious blood stream infections).
-Administration by continuous subcutaneous infusion is the preferred and continuous IV infusion should be reserved for patients in which the subcutaneous route is not tolerated due to severe site pain or reaction, or in whom the above risks are considered warranted.
-The goal of chronic dose adjustments is to establish a dose at which pulmonary arterial hypertension (PAH) symptoms are improved and excessive pharmacological effects are minimized.
-Dose adjustments may be undertaken more often if tolerated.

Patients Transitioning from Epoprostenol:
-Initial dose: Initiate treprostinil at a recommended dose of 10% of the current epoprostenol dose and then escalate as the epoprostenol dose is decreased; the manufacturer product information should be consulted for appropriate recommended titration doses

Comments: Transition from epoprostenol to treprostinil is accomplished by initiating the infusion of treprostinil and increasing it, while simultaneously reducing the dose of IV epoprostenol and should take place in a hospital setting.

Use: For the treatment of PAH (WHO Group 1) to improve exercise capacity

What other drugs will affect treprostinil?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gemfibrozil;

  • blood pressure medication;

  • a blood thinner--warfarin, Coumadin, Jantoven;

  • other medicine to prevent blood clots--dalteparin, tinzaparin, Fragmin, Lovenox, and others; or

  • other forms of treprostinil--Remodulin, Tyvaso.

This list is not complete. Other drugs may interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about treprostinil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02.

Date modified: December 03, 2017
Last reviewed: September 01, 2017