Treprostinil (Oral)

Treprostinil is used to treat symptoms of pulmonary arterial hypertension, a condition where there 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 harder to pass blood through, the right ventricle has to work harder to pump enough blood to the lungs. Treprostinil helps by relaxing these blood vessels and increasing blood flow to the lungs, which makes it easier for the heart to work.

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

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look 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 of more serious side effects.

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

This medicine may increase the 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. However, if you have diverticulosis (a bowel problem), the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.

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.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, including those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of treprostinil in children. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of treprostinil. However, older patients may have more liver or heart issues, which could require careful monitoring and possible dose adjustments for those taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, but your doctor might need to adjust the dose or take other precautions. It's especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant, but not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or may change your other medicines.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended but may be necessary in certain situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Certoparin
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Pixantrone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selumetinib
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Turmeric
• Valdecoxib
• Vilazodone
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions are significant but not all-inclusive.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Be sure to tell your doctor about any other health conditions, especially:

• Hypotension (low blood pressure) or
• Stomach or bowel problems (e.g., diverticulosis, ulcers) or
• History of stroke—Use with caution. This may worsen these conditions.

• Mild liver disease—Use with caution. The medicine may stay in your body longer.

• Moderate to severe liver disease—This medicine should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical help.

Check with your doctor right away if any of the following side effects happen:

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 signs of overdose happen:

Symptoms of overdose

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

Some side effects may happen that usually do not need medical help. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 sometimes, 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.

In the U.S.

• Orenitram

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Vasodilator

Pharmacologic Class: Prostaglandin

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, or 0.125 mg three times a day, taken 8 hours apart. 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.