Frequently Asked Questions
What is pulmonary arterial hypertension (PAH)?
PAH is high blood pressure in the blood vessels in the lungs. In people who have PAH, the blood vessels in the lungs become too narrow. This makes it harder for blood that is being pumped to the lungs from the heart to pick up the important oxygen it needs and carry it to the rest of the body. It also puts extra stress on the heart.
What are the symptoms of PAH?
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)
What is REMODULIN® (treprostinil sodium) Injection?
REMODULIN is a medication used to treat PAH. REMODULIN is a type of medication called a prostacyclin analog.
Remodulin is indicated for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. 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.
Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan®; the risks and benefits of each drug should be carefully considered prior to transition.
What is prostacyclin therapy?
Prostacyclin is a substance that is naturally present in the body. It helps keep blood vessels open and working properly. Prostacyclin medications work by opening the blood vessels, and may reduce buildup of cells around the blood vessel walls. Prostacyclins were the first type of drugs introduced specifically to treat PAH and continue to be an important therapy. Some prostacyclins are delivered by a method called continuous infusion.
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 in 2 ways:
- Subcutaneously (through a small catheter under the skin, usually in the abdominal area)
- Intravenously (through a catheter that goes directly into a vein, usually placed surgically in the chest)
How long does a patient stay on REMODULIN?
Therapy with infused prostacyclin 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.
Does REMODULIN require ice packs?
No. Because it is stable at room temperature, patients who use REMODULIN do not have to use ice packs to keep the drug cold.
How often do you 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.
How do I get REMODULIN?
REMODULIN requires a prescription from your doctor. You will then obtain REMODULIN and the pump directly from a distribution company. In the United States REMODULIN is distributed by the following companies*:
Accredo Therapeutics
(866) 344-4874
http://www.accredotx.com
Curascript
(866) 474-8326
http://www.curascript.com
CVSCaremark
(877) 242-2738
http://www.caremark.com
*Disclaimer: Accredo Therapeutics, CuraScript Inc., and Caremark Inc. 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.
What about side effects?
Chronic intravenous 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.
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).
For a list of all side effects, please refer to the REMODULIN package insert.
Can I take REMODULIN if I take other medications?
Patients being treated for PAH are likely to be taking a number of medications, so it is possible for some of these medicines to interact with each other. Reduction in blood pressure caused by REMODULIN may become more severe when taken with other drugs that also lower blood pressure. These include diuretics and other high blood pressure medications and vasodilators. Patients who take REMODULIN might be at risk for bleeding, especially if they are also taking an anticoagulant.
It is important to tell your doctor about all the drugs you take — even those you can buy without a prescription.
What is the PEER Network?
PEER stand for "Patients Exchanging Experiences with REMODULIN." The PEER Network is a unique program that connects people who are considering taking REMODULIN or who have recently started therapy with experienced REMODULIN patients — called PEER Mentors. The PEER Network allows for the exchange of private phone calls and one-to-one e-mails through a secure Web-based system and also offers a supportive group speaker program. http://www.peernetwork.net
What is the REMODULIN Patient Assistance Program (PAP)?
United Therapeutics created this program to provide access to REMODULIN medication and supplies for patients who cannot afford therapy because of their financial situations, those who do not have enough insurance or are between insurance plans, and those who have insurance restrictions.
For more information, please contact United Therapeutics at 1-888-485-8350.
What is REMODULIN Therapy Assistance (RTA)?
Through RTA, every REMODULIN patient has the opportunity to build a relationship with a dedicated REMODULIN Therapy Assistant whose role is to offer nonmedical assistance in support of REMODULIN therapy. Assistance may include providing additional information about REMODULIN and answering general insurance questions.
For more information, please contact United Therapeutics at or call 1-877-UNITHER.
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. Also, if you would like to contact United Therapeutics about REMODULIN, please e-mail or call 866-458-6479.
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 the Web site of the Pulmonary Hypertension Association (PHA) at http://www.phassociation.org.
Is there a way to connect with other PAH patients?
Speaking with other people who have PAH and are currently taking REMODULIN is a valuable outlet and information resource for individuals such as yourself. The PEER Network (Patients Exchanging Experiences with REMODULIN) is a unique program that connects people who are considering taking REMODULIN, or who have recently started therapy, with experienced REMODULIN patients--called PEER Mentors. The PEER Network allows for the exchange of private phone calls and one-to-one e-mails through a secure Web-based system and also offers a supportive group speaker program. Simply visit http://www.peernetwork.net to learn more.
For complete prescribing information, please refer to the REMODULIN package insert.
REMODULIN is a registered trademark of United Therapeutics Corporation. Flolan is a registered trademark of GlaxoSmithKline.
