Reference ID: 4111034
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`Patient Information
`Orenitram(R) (oh-REN-i-tram)
`(treprostinil) extended-release tablets
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`What is Orenitram?
`Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure
`in the arteries of your lungs. Orenitram may improve your ability to exercise.
`It is not known if Orenitram is safe and effective in children under 18 years of age.
`Who should not take Orenitram?
`Do not take Orenitram if you have severe liver problems.
`What should I tell my healthcare provider before taking Orenitram?
`
`Before you take Orenitram, tell your healthcare provider if you:
` have liver problems
` have diverticulosis
` have any other medical conditions
` are pregnant or plan to become pregnant. It is not known if Orenitram will harm your unborn baby.
` are breastfeeding or plan to breastfeed. It is not known if Orenitram passes into your breast milk. You and your
`healthcare provider should decide if you will take Orenitram or breastfeed. You should not do both.
`Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
`medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side
`effects. Do not start any new medicine until you check with your healthcare provider.
`Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin® or
`Tyvaso®.
`Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a
`new medicine.
`How should I take Orenitram?
` Take Orenitram exactly as your healthcare provider tells you to take it.
` Your healthcare provider will slowly increase your dose to find the dose of Orenitram that is right for you.
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`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.
` Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare
`provider. Stopping Orenitram suddenly may cause worsening of your PAH symptoms.
` Orenitram is usually taken 2 times a day (about every 12 hours) or three times a day (about every 8 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. This 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 dose as soon as possible with food.
`If you miss two 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.
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`Reference ID: 4111034
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`What are the possible side effects of Orenitram?
`Orenitram can cause serious side effects, including an increased risk of bleeding.
`The most common side effects of Orenitram include:
` headache
` nausea
` diarrhea
` flushing
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`The following side effects have also been observed in patients taking Orenitram after approval: dizziness, indigestion,
`vomiting, muscle pain, and joint pain.
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`Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
`These are not all the possible side effects of Orenitram. For more information, ask your healthcare provider or
`pharmacist.
`Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
`How should I store Orenitram?
` Store Orenitram at room temperature between 68°F to 77°F (20°C to 25°C).
`Keep Orenitram and all medicines out of the reach of children.
`General information about the safe and effective use of Orenitram.
`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
`Do not use Orenitram for a condition for which it was not prescribed. Do not give Orenitram to other people, even if they
`have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for
`information about Orenitram that is written for health professionals.
`What are the ingredients in Orenitram?
`Active ingredient: treprostinil
`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 imprinting ink contains shellac glaze, ethanol, isopropyl alcohol, iron oxide
`black, n-butyl alcohol, and propylene glycol.
`United Therapeutics Corp., Research Triangle Park, NC 27709 USA
`Copyright 2017, United Therapeutics Corp. All rights reserved.
`ORENITRAM is a registered trademark of United Therapeutics Corp.
`For more information, go to www.ORENITRAM.com or call 1-877-864-8437.
`This Patient Information has been approved by the U.S. Food and Drug Administration.
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` Revised: 06 2017
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