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Treprostinil (Oral route)

Pronunciation:

tre-PROST-i-nil

Brand Names:

  • Orenitram

Dosage Forms:

  • Tablet, Extended Release

Classifications:

Therapeutic—

Vasodilator

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Treprostinil is used to treat symptoms of pulmonary arterial hypertension, which is high blood pressure in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the small blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Treprostinil works by relaxing these blood vessels and increasing the supply of blood to the lungs, which reduces the workload of the heart.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of treprostinil in the elderly. However, elderly patients are more likely to have liver or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Apixaban
  • Aspirin
  • Dipyridamole
  • Eptifibatide
  • Fluoxetine
  • Levomilnacipran
  • Pixantrone
  • Vortioxetine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hypotension (low blood pressure) or
  • Stomach or bowel problems (eg, diverticulosis, ulcers) or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole. Do not crush, break, or chew it. Take this medicine with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For pulmonary arterial hypertension:
      • Adults—At first, 0.25 milligrams (mg) two times a day with food, taken 12 hours apart. You may also take it three times a day (approximately every 8 hours). Your doctor may increase your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed two or more doses, call your doctor if you need to change your dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

You should not use other medicines that also contain treprostinil. This includes Remodulin® or Tyvaso®. Using these medicines together may increase your chance for more serious side effects.

Do not suddenly stop using this medicine. Stopping or changing the dose of this medicine suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping or changing your dose.

This medicine may increase risk of bleeding, especially in patients receiving blood thinners. Tell your doctor if you are taking a blood thinner (such as warfarin).

While taking the medicine, part of the tablet may pass into your stools. This is usually normal. But, if you have diverticulosis (bowel problem), the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.

Do not drink alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Decreased urine
dry mouth
increased thirst
irregular heartbeat
muscle pain or cramps
nausea or vomiting
pain in the jaw, arms, or legs
unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Blurred vision
confusion
diarrhea
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
headache, severe
sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Abdominal or stomach discomfort
diarrhea
feeling of warmth
headache
redness of the face, neck, arms, and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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