Treprostinil (tre-PROS-ti-nil)

Treats pulmonary arterial hypertension (PAH) and may improve exercise ability in patients with PAH.

Brand Name(s):

Orenitram, Orenitram Titration Kit Month 1, Orenitram Titration Kit Month 2, Orenitram Titration Kit Month 3

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Take each dose about 12 hours apart, unless your doctor tells you otherwise.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you miss 2 or more doses, call your doctor. Your dose may need to be changed.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine with other medicines that also contain treprostinil. This includes Remodulin® or Tyvaso®.
• Some medicines can affect how treprostinil works. Tell your doctor if you are using any of the following:
  • Gemfibrozil
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, low blood pressure, diverticulosis, or ulcers.
• This medicine may increase your risk of bleeding.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dry mouth, increased thirst, muscle cramps, vomiting, uneven heartbeat

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, stomach discomfort
• Headache
• Pain in the jaw, arms, or legs
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088