Treprostinil diolamine

What is Treprostinil diolamine?

• Treprostinil diolamine (Orenitram) is a prostacyclin mimetic used to treat certain kinds of pulmonary arterial hypertension.
• Treprostinil can help slow down the progression of your disease and improve your ability to exercise.

Treprostinil

Treprostinil

What are the uses of this medicine?

• Treprostinil diolamine (Orenitram) is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs.

How does this medicine work?

• The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe hepatic impairment

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• another medicine that contains treprostinil, such as Remodulin or Tyvaso
• gemfibrozil (Lopid), or rifampin (Rifadin, Rimactane)

Is this medicine FDA approved?

• Treprostinil was approved for use in the United States in May 2002.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose of Orenitram is 0.125 mg three times daily (TID) with food, taken approximately 8 hours apart or 0.25 mg twice daily (BID) with food, taken approximately 12 hours apart.
• Titrate by 0.125 mg TID or by 0.25 mg or 0.5 mg BID, not more frequently than every 3 to 4 days as tolerated.
• If transitioning from intravenous (IV) or subcutaneous (SC) Remodulin®, the Orenitram dose should be increased while simultaneously decreasing the IV/SC infusion rate.

Dose Adjustment in Patients with Hepatic Impairment:

• Initiate at 0.125 mg BID.
• Increment at 0.125 mg BID not more frequently than every 3 to 4 days.
• Avoid use in patients with moderate hepatic impairment.

Dose Adjustment for Use with CYP2C8 Inhibitors:

• When co-administered with strong CYP2C8 inhibitors (e.g., gemfibrozil) the initial dose is 0.125 mg BID with 0.125 mg BID dose increments not more frequently than every 3 to 4 days.

Administration:

• Treprostinil comes as extended-release (long acting) tablets to take by mouth.
• Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a day (about every 12 hours).
• Your healthcare provider will tell you how often you should take Orenitram.
• If you have side effects, your healthcare provider may tell you to change your dose or when you take Orenitram.
• Take Orenitram with food.
• Swallow Orenitram tablets whole.
• Do not split, chew, crush, or break your Orenitram tablets.
• Do not take Orenitram tablets that are damaged or broken.
• If Orenitram tablets are not taken whole, they may release too much medicine at one time. T
• his can lead to side effects.
• You may see the tablet shell in your stools (bowel movements).
• This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.
• If you miss your dose of Orenitram, take the missed dose as soon as possible with food.
• If you miss 2 or more doses of Orenitram, call your healthcare provider to see if you need to change your dose.
• If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.
• If you take the medicine Remodulin and your healthcare provider is switching you to Orenitram, your healthcare provider will decrease your dose of Remodulin over a period of time when you start taking Orenitram.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-Release Tablets: 0.125 mg, 0.25 mg, 1 mg, 2.5 mg and 5 mg.

This medicine is available in fallowing brand namesː

• Orenitram

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• diarrhea
• nausea
• vomiting
• flushing
• pain in arms and legs
• jaw pain

• Orenitram can cause serious side effects, including worsening of PAH symptoms.

What special precautions should I follow?

• Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.'
• The tablet shell does not dissolve. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.
• It is not known if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.
• Treprostinil therapy has not been associated with serum enzyme elevations above the rate in control subjects and has not been linked to instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe headache, nausea, vomiting, diarrhea, and hypotension.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Limited published data from case reports with Orenitram use in pregnant women are not sufficient to assess for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• It is not known if Orenitram will harm your unborn baby.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: treprostinil diolamine
• Inactive ingredients: xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol, iron oxide black, n-butyl alcohol, and propylene glycol.

Who manufactures and distributes this medicine?

• United Therapeutics Corp., Research Triangle Park, NC 27709 USA
• Copyright 2019, United Therapeutics Corp. All rights reserved.
• ORENITRAM is a registered trademark of United Therapeutics Corp.

What should I know about storage and disposal of this medication?

• Store at 68 to 77°F (20 to 25°C).

• Dailymed label info on Treprostinil diolamine
• FDA Treprostinil diolamine

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