| Orenitram is a prostacyclin analogue |
|
Prostacyclin analogues mimic some of the effects of the natural prostacyclin your body lacks. For more than 2 decades,
doctors have recommended the use of prostacyclin class therapies to treat PAH. Until 2013, prostacyclin therapy was
available only in inhaled and pump options. Orenitram may improve your ability to exercise. It is not known if Orenitram is
safe and effective in children under 18 years of age.
|
| The most common side effects of Orenitram include headache, diarrhea, nausea, and flushing. These are not all of the possible side effects of Orenitram. Tell your doctor about any side effects that bother you, get worse over time, or do not go away. |
| Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. |
| Consider the possibilities |
|
PAH is a progressive disease that affects your ability to perform everyday tasks and enjoy activities with loved ones.
Maybe you’re wondering if your current PAH treatment is meeting your needs. Or perhaps your PAH medicine is in a pump,
and you’re curious about what else is out there. Have you considered Orenitram?
|
| Could Orenitram work for you? |
|
Because Orenitram is an oral therapy, there is no equipment to maintain or manage and no restrictions on taking part in water
activities or bathing. Orenitram is taken 2 or 3 times per day, always with food. Your doctor will work with you to find the
right dose of Orenitram based on your symptoms and how you tolerate the medicine.
|
| Why wait? |
|
Ask your doctor about the only prostacyclin analogue in a tablet with similar medicine as in a pump.
|
|
Do not take Orenitram if you have severe liver problems.
|
|
Before you take Orenitram, tell your healthcare provider if you:
|
- Have liver problems, diverticulosis, or any other medical conditions
- 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. 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 or stop any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains the same ingredient, treprostinil. Know the medicines you take. Keep a list of them and the dose you take to show to your healthcare provider and pharmacist when you get a new medicine.
|
|
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. If you miss two or more doses of Orenitram, call your healthcare provider. If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.
|
|
If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. Take Orenitram with food.
|
|
Orenitram can cause serious side effects, including an increased risk of bleeding. This risk could be increased if you are taking blood thinners such as warfarin.
|
|
The most common side effects of Orenitram include headache, diarrhea, nausea and flushing. These are not all of the possible side effects of Orenitram. Tell your doctor about any side effects that bother you, get worse over time, or do not go away.
|
|
OREISIdtcJAN16
|
|
|
Please see the Full Prescribing Information and Patient Information for Orenitram.
|
| For additional information, visit Orenitram.com or call 1-877-UNITHER (1-877-864-8437). |
|
Remodulin is a prescription medication used in adults with pulmonary arterial hypertension (PAH; WHO Group 1), to
diminish symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Remodulin was
studied mainly in patients with NYHA Functional Class II-IV symptoms. Remodulin is delivered (infused) continuously
using a pump connected to a small tube that is either placed under the skin (subcutaneously [SC]) or inserted into a
vein in the upper chest (intravenously [IV]). Because there are risks associated with continuous IV infusion, such as
serious blood stream infections, IV infusion should be reserved for people who cannot tolerate SC infusion or for
those in whom the risks are considered acceptable.
|
|
In people with PAH who need to switch from Flolan® (epoprostenol sodium), Remodulin is approved to slow the worsening of symptoms.
The risks and benefits of each drug should be carefully considered before switching.
|
- Continuous intravenous (IV) infusions of Remodulin are delivered using a tube placed in a central vein within the chest. This type of delivery is associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery.
- You should not stop or greatly reduce your Remodulin dose without consulting your doctor, as this may cause your PAH symptoms to worsen.
- Other medical conditions and medicines may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug’s effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.
- If you have liver or kidney problems, your ability to tolerate Remodulin may be affected.
- If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Remodulin dosage.
- Remodulin acts by lowering your blood pressure. In some cases your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
- Because Remodulin can reduce the blood’s ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
- If you are pregnant, breast-feeding, or planning to become pregnant, talk with your doctor about whether you should take Remodulin.
- Side Effects: In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain. Other common side effects seen with either SC or IV Remodulin were headache, diarrhea, jaw pain, nausea, vasodilatation (widening of the blood vessels), and edema (swelling).
|
|
Please see the Full Prescribing Information for Remodulin.
|
|
For additional information, visit Remodulin.com or call 1-877-UNITHER (1-877-864-8437).
|
|
|
This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a
healthcare professional for treatment advice.
|
| Sincerely, |
|
Your Orenitram Support Team
|
|
|
