How Orenitram® (treprostinil) Extended-Release Tablets May Help Lower Your Risk Status
Pulmonary arterial hypertension (PAH) is a progressive disease that causes the blood vessels in your lungs to narrow. This can lead to fatigue and shortness of breath, symptoms that may limit your ability to do daily activities.
Orenitram works differently than other oral PAH medications you may already take because it mimics the effects of prostacyclin, a natural substance your body creates to open blood vessels. By doing so, Orenitram helps make it easier for your heart to pump blood through your lungs.
Orenitram may help improve your symptoms and lower your risk status. That’s why it’s important to talk with your doctor about adding Orenitram to your treatment plan.
See how Orenitram could help control your PAH. Learn more >
SELECTED IMPORTANT SAFETY INFORMATION FOR ORENITRAM
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?
Tell your healthcare provider:
- If you have liver problems or diverticulosis.
- If you are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.
- 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®.
Please see Important Safety Information for Orenitram at the end of this article.
Orenitram can help put you on the path to low-risk status
Risk status can help your doctor make treatment decisions by showing how you’re doing now and projecting how you’ll be doing in the future. To determine your risk status, they may use a calculation that combines a number of factors, including ones you might be familiar with, such as:
- 6-minute walk distance (6MWD)
- Heart strain, as measured by NT-proBNP
- Functional class (FC)
Orenitram is proven to delay PAH progression
A clinical study that tracked clinical worsening showed that patients on Orenitram were 61% less likely to have their PAH progress over time compared with people not on Orenitram. The study also looked at how people on Orenitram improved their symptoms by assessing changes in their 6-minute walk distance, heart strain, and functional class. Orenitram has been shown to help improve symptoms that are associated with achieving low-risk status, the overall treatment goal for people with PAH.
This trial was a randomized clinical study of 690 people who were all taking a single oral PAH medicine (PDE-5i, sGCS, or ERA). At the beginning of the study, these patients added either Orenitram (n=346) or placebo (n=344) to their treatment.
Long-term improvements with Orenitram
After the original clinical study ended, patients who were initially not taking Orenitram could start on it. Patients who were not on Orenitram and showed signs of clinical worsening, like going to the hospital,* entered a long-term phase of the study where they began taking Orenitram. After 48 weeks, results showed that Orenitram had helped these patients in multiple ways.†
*This is considered a clinical worsening event. Other clinical worsening events include starting an inhaled or infused PAH therapy, continued disease progression, or unsatisfactory response to treatment.
†Patients in the original phase who were not taking Orenitram and experienced a clinical worsening event moved on to the long-term portion of the study, where they began taking Orenitram. This phase of the study started with 108 patients who had been taking a placebo and had experienced a clinical worsening event, evaluating changes in 6-minute walk distance, NT-proBNP levels, and functional class. Sixty-seven patients completed treatment at week 48.
Since starting Orenitram, my PAH symptoms have improved. I can walk farther distances. I’m not as short of breath all the time.
— Jenny
Watch the Video: Learn More About Jenny’s Experience With Orenitram
Hear from other patients about their personal treatment journeys on Orenitram. Hear their stories >
United Therapeutics offers a number of useful resources available for download.
Helpful links from United Therapeutics to learn more about Orenitram:
ERA=endothelin receptor antagonist; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PDE-5i=phosphodiesterase type 5 inhibitor; sGCS=soluble guanylate cyclase stimulator.
IMPORTANT SAFETY INFORMATION FOR ORENITRAM
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?
Tell your healthcare provider:
- If you have liver problems or diverticulosis.
- If you are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.
- 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®.
How should I take Orenitram?
- Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
- 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. This can lead to side effects.
- 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.
- 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.
What are the possible side effects of Orenitram?
Orenitram can cause serious side effects, including worsening of PAH symptoms.
- Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
- The most common side effects of Orenitram include headache, diarrhea, nausea, vomiting, flushing, and pain in arms, legs, and jaw. These are not all of the possible side effects of Orenitram. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
- Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.
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 can help slow down the progression of your disease and improve your ability to exercise. It is not known if Orenitram is safe and effective in children.
The risk information provided here is not comprehensive. To learn more about Orenitram, talk with your healthcare provider.
Please see Full Prescribing Information and Patient Information at www.orenitram.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
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