Orenitram

Generic name: Treprostinil (oral)
Drug class: Agents for pulmonary hypertension

Usage of Orenitram

Orenitram is used in adults to treat certain kinds of pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness).

Orenitram may improve the ability to exercise and slow the worsening of symptoms in patients with PAH.

Orenitram belongs to a class of medications called vasodilators. Treprostinil works by relaxing the blood vessels, including those in the lungs, and improving blood flow.

Orenitram side effects

Get emergency medical help if you have signs of an allergic reaction to Orenitram: 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 Orenitram side effects 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.

    Before taking Orenitram

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

    To make sure Orenitram is safe for you, tell your doctor if you 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 Orenitram.

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    How to use Orenitram

    Usual Adult Dose for Pulmonary Hypertension:

    ORAL: 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 Comments: -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.

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

    Warnings

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

    You should not stop taking Orenitram suddenly. Your condition may get worse if you stop taking this medicine.

    What other drugs will affect Orenitram

    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 interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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