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Generic Name: treprostinil
Date of Approval: December 20, 2013
Company: United Therapeutics Corporation

FDA Approves Orenitram

The United States Food and Drug Administration (FDA) has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.

Orenitram is an oral, extended-release prostacyclin vasodilator for the treatment of PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. Orenitram contains the same active ingredient (treprostinil) as Remodulin (treprostinil) Injection and Tyvaso (treprostinil) Inhalation Solution.

Patient Information for Orenitram

Read the Medication Guide that comes with this medicine before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

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What is Orenitram?

Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram may improve your ability to exercise. It is not known if it is safe and effective in children under 18 years of age.

Who should not take Orenitram?

Do not take Orenitram if you have severe liver problems.

What should I tell my healthcare provider before taking Orenitram?

Before you take Orenitram, tell your healthcare provider if you:

  • have liver problems
  • have low blood pressure or high blood pressure
  • have had a stroke
  • have stomach ulcers
  • have diverticulosis
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breastmilk. You and your healthcare provider should decide if you will take Orenitram or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider.

Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin or Tyvaso. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Orenitram?

  • Take exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will slowly increase your dose to find the dose that is right for you.
  • Do not change your dose or suddenly stop taking this medicine without first talking to your healthcare provider. Stopping this medicine suddenly may cause worsening of your PAH symptoms.
  • Orenitram is usually taken every 12 hours, but may be taken three times daily (approximately every 8 hours). If you have side effects, your healthcare provider may tell you to change your dose or dosing schedule.
  • Take this medicine with food.
  • Swallow tablets whole. Do not split, chew, crush, or break the tablets. Do not take Orenitram tablets that are damaged or broken. If the tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
  • You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.
  • If you miss your dose, take the dose as soon as possible with food.
  • If you miss two or more doses, call your healthcare provider to see if you need to change your dose.
  • If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid?

  • Do not take this medicine with alcohol.

Orenitram side effects

Orenitram can cause serious side effects, including an increased risk of bleeding.

The most common side effects include:

  • headache
  • nausea
  • diarrhea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Orenitram?

  • Store at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep Orenitram and all medicines out of the reach of children.

General information about the safe and effective use of Orenitram

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Use this medicine only for the condition for which it was prescribed.

Do not give it to other people, even if they have the same symptoms you have.

It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals. For more information, go to www.Orenitram.com or call 1-877-864-8437.

What are the ingredients in Orenitram?

Active ingredient: treprostinil

Inactive ingredients: xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprinting ink contains shellac glaze, ethanol, isopropyl alcohol, iron oxide black, n-butyl alcohol, propylene glycol, and ammonium hydroxide.