Orenitram

What is Orenitram?

Orenitram (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.

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

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

Important information

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

Before taking this medicine

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:

• diverticulosis (an intestinal disorder); or

• liver disease.

It is not known whether Orenitram 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 Orenitram?

Take Orenitram exactly as prescribed by your doctor. Follow Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. 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 the tablet whole. Do not use a broken tablet.

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 Orenitram suddenly. Stopping suddenly may make your condition worse.

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

Orenitram 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 Orenitram 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 Orenitram 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.

Orenitram dosing information

Usual Adult Dose of Orenitram for Pulmonary Hypertension:

Oral formulation:
Initial dose: 0.25 mg orally every 12 hours with food
Recommended titration: 0.25 or 0.5 mg 2 times daily every 3 to 4 days (if 0.25 mg 2 times daily increments are not tolerated consider titrating slower)
-The total daily dose can be divided and given every 8 hours with food, titrating by increments of 0.125 mg 3 times daily.
Mean dose: 3.5 mg orally every 12 hours with food.
Maximum dose: Determined by tolerability. The maximum dose studied was 21 mg orally every 12 hours with food.

Infusion:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). Although doses of up to 100 nanograms/kg/minute have been reported, there is little experience with doses greater than 40 nanograms/kg/minute.

Inhalation:
Use only with the Tyvaso (R) Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso (R) delivers approximately 6 mcg of Orenitram
Initial dosage: 3 breaths [18 mcg] per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.
Maintenance dose: Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated. Titrate to target maintenance dosage of 9 breaths or 54 mcg per treatment session as tolerated.

Usual Pediatric Dose of Orenitram for Pulmonary Hypertension:

Oral formulation: Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Inhalation:
Less than 16 years: Safety and efficacy have not been established.
16 to 18 years:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). There is little experience with doses greater than 40 nanograms/kg/minute.

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 Orenitram.

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 Orenitram?

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

Orenitram side effects

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

What other drugs will affect Orenitram?

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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.