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Frequently Asked Questions

This section provides answers to some frequently asked questions, such as:

• What is pulmonary arterial hypertension (PAH)?
• What are some of the symptoms of PAH?
• What is Remodulin (treprostinil) Injection?
• What is prostacyclin analog therapy?
• What is continuous infusion?
• How long does a patient stay on Remodulin?
• Does Remodulin require ice packs to keep it cool?
• How often do I have to change the drug reservoir?
• How do I get Remodulin?
• What are the side effects of Remodulin?
• Can I take Remodulin if I take other medications?
• What is Living PAH?
• What is the PEER Network?
• What is the ASSIST program?
• How can I learn more about Remodulin?
• How can I learn more about PAH?

What is pulmonary arterial hypertension (PAH)?

Pulmonary arterial hypertension (PAH) is high blood pressure in the arteries of the lungs. These are the vessels that carry blood from the heart into the lungs, where it picks up oxygen to deliver to the rest of the body. In a person with PAH, the pulmonary arteries constrict and become narrow, making it difficult for the heart to pump blood through them. This deprives the body of much needed oxygen and puts extra strain on the heart as it works harder to do its job. Over time, this can cause the right side of the heart to become larger and the walls of the heart thicker. These effects can lead to symptoms of PAH.^3,4

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What are some of the symptoms of PAH?⁸

Symptoms of PAH include:

• Feeling tired or worn out (fatigue)
• Dizziness and/or fainting (syncope)
• Shortness of breath (dyspnea)
• Chest pain (angina)
• Swollen ankles and legs (edema)

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What is Remodulin (treprostinil) Injection?

Remodulin is a prescription medication called a prostacyclin analog. It is for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

In patients with pulmonary arterial hypertension requiring transition from Flolan^® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

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What is prostacyclin analog therapy?

Prostacyclin analog therapy works similarly to the prostacyclin that occurs naturally in the body. It helps to keep blood vessels open and working properly. Prostacyclin therapies were the first to be introduced specifically to treat PAH and continue to be an important therapeutic option. Some prostacyclin analogs are delivered by a method called continuous infusion, while others may be administered through inhalation.

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What is continuous infusion?

Continuous infusion means the drug is delivered steadily to the patient through a small pump outside of the body and a catheter (tube). This may be done one of two ways:

• By subcutaneous (SC) infusion—through a small catheter under the skin, usually in the abdominal area
• By intravenous (IV) infusion—through a catheter that goes directly into a vein, usually placed surgically in the chest

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How long does a patient stay on Remodulin?

Remodulin does not cure PAH, but rather helps to treat the symptoms of the disease. Therefore, therapy with infused Remodulin will be needed for a prolonged period of time, possibly years. It is important for patients to understand the commitment involved with infused drug delivery, including using and caring for the pump.

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Does Remodulin require ice packs to keep it cool?

No. Because it is stable at temperatures up to 104° F; patients who use Remodulin do not have to use ice packs to keep the drug cold.

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How often do I have to change the drug reservoir?

Patients can go up to 72 hours before changing a subcutaneous (SC) reservoir and up to 48 hours before changing an intravenous (IV) reservoir.

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How do I get Remodulin?

Remodulin requires a prescription from your doctor. You will then obtain Remodulin and the pump directly from a specialty pharmacy. In the United States, Remodulin is distributed by the following specialty pharmacies:*

Accredo Health Group, Inc.
(866) 344-4874
http://www.accredo.com

CuraScript Inc.
(866) 474-8326
http://www.curascript.com

CVS/Caremark
(877) 242-2738
http://www.cvscaremarkspecialtyrx.com/

*Disclaimer: Accredo Health Group, Inc., CuraScript Inc. and CVS/Caremark are separate, independent specialty pharmaceutical services providers that provide medications and related services to patients in the home setting and have been contracted by United Therapeutics Corporation to distribute Remodulin.

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What are the side effects of Remodulin?

The most common side effects of Remodulin included those related to the method of infusion. For SC infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For IV infusion, line infections, sepsis, arm swelling, tingling sensations, bruising and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilation (widening blood vessels) and edema (swelling).¹

Continuous intravenous (IV) infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal.¹

Click here to download the Full Prescribing Information for a list of all side effects.

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Can I take Remodulin if I take other medications?

Patients being treated for PAH are likely to be taking a number of medications, and it is possible for some of these medications to interact with each other.

It is important to tell your doctor about all the drugs you take—even those you can buy without a prescription.

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What is Living PAH?

Living PAH is a program for patients on United Therapeutics treatments. A number of support services that complement the efforts of your healthcare providers and pharmacists are provided to you at no cost. Living PAH can help you connect with others who have PAH, find educational seminars on PAH and more. These programs are designed to help you at every point in your treatment to manage the challenges of living with PAH. To learn more, visit www.LivingPAH.com or call the Living PAH call center at 1-877-948-9137.

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What is the PEER Network?

The PEER Network is a unique program that allows people who are considering taking or have recently started Remodulin therapy to connect with experienced patients called PEER Mentors. The PEER Network allows for the exchange of private phone calls and one-to-one emails through a secure Web-based system, and also offers a supportive group speaker program. Click here to learn more about PEER Network.

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What is the ASSIST Program?

There are a number of assistance programs available to help you obtain your medication, if you qualify. To find the program that best meets your needs, we have created ASSIST, your Access Solutions and Support Team. When you call 1-877-UNITHER (1-877-864-8437), your ASSIST Advisor will work to figure out which program is right for you. They can help you resolve issues and manage your case until completion.

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How can I learn more about Remodulin?

Whether you are a newly diagnosed PAH patient, a patient currently on PAH therapy or a relative of someone with PAH, your best source of information about Remodulin is your doctor. If you would like to contact United Therapeutics about Remodulin, please email info@remodulin.com, or call 1-866-458-6479.

Note: This line is for general Remodulin information only. To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or via email at drugsafety@unither.com, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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How can I learn more about PAH?

Again, your doctor is always your best source for information on PAH, especially regarding your own health and personal situation. However, for more online information about PAH, visit www.LivingPAH.com.

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Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

In patients with PAH requiring transition from Flolan^® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Important Safety Information for Remodulin

• Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration.
• Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Remodulin is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
• Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Therapy with Remodulin may be used for prolonged periods, and the patient’s ability to administer Remodulin and care for an infusion system should be carefully considered.
• Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms.
• Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal insufficiency.
• The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilatation, and edema.

For more information about REMODULIN, please see the Full Prescribing Information.
Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).