Orenitram® (treprostinil) Extended-Release Tablets

  • Is the only oral prostacyclin analogue
  • Available in 4 strengths: 0.125, 0.25, 1, and 2.5 mg. The strength and number of tablets prescribed may vary
  • Tablets must be taken with food

INDICATION

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.

IMPORTANT SAFETY INFORMATION for Orenitram

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, 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.

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Please see the Full Prescribing Information and Patient Information for Orenitram.

For additional information about Orenitram, visit www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).

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.


Tyvaso® (treprostinil) Inhalation Solution

  • The only inhaled treatment approved as an add on to oral PAH medicines (pills) bosentan or sildenafil
  • Treatments are taken 4x daily, using a lightweight, portable, hand-held inhalation system
  • Must be used with the Tyvaso Inhalation System

INDICATION
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist, (ERA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking Tyvaso.

The effects of Tyvaso are unknown in patients under 18 years of age.

IMPORTANT SAFETY INFORMATION FOR TYVASO

  • Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System.
  • Before you take Tyvaso, tell your healthcare provider about all of your medical conditions, including if you:
  • Have a lung disease (such as asthma or chronic obstructive pulmonary disease (COPD)).
  • Have a lung infection.
  • Have liver or kidney problems, as your ability to tolerate Tyvaso may be affected.
  • Have low blood pressure, as Tyvaso may cause symptomatic hypotension (low blood pressure).
  • Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso.
  • Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk.

It is important to tell your healthcare provider about all the medicines you may be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements, as they may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. Especially tell your healthcare provider if you take any of these medicines:

  • Medicines that decrease blood clotting such as warfarin or heparin, as Tyvaso reduces the ability of your blood to clot (coagulate), and increases your risk for bleeding if you are taking blood thinners (anticoagulants).
  • Diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure), as Tyvaso may increase your risk for hypotension (low blood pressure).
  • Gemfibrozil such as Lopid (for high cholesterol) or rifampin such as Rimactane, Rifadin, Rifamate or Rifater (for infection), as your Tyvaso dosage may need adjustment.

The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your healthcare provider about any side effects that bother you or do not go away. Your healthcare provider may be able to help you manage the side effects.

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Please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual.

For additional information about Tyvaso, visit www.tyvaso.com or call 1-877-UNITHER (1-877-864-8437).

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.


Remodulin® (treprostinil) Injection

  • Has been approved to treat PAH patients for more than 10 years
  • Can be used with 2 types of pumps, including the lightweight CADD-MS 3® micro infusion pump
  • No ice packs needed for administration, nor refrigeration for storage
  • You should not stop or greatly reduce your Remodulin dose without consulting your doctor, as this may cause your PAH symptoms to worsen

INDICATION

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.

IMPORTANT SAFETY INFORMATION

  • 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 about Remodulin, visit www.remodulin.com or call 1-877-UNITHER (1-877-864-8437).

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.