Frequently asked questions (FAQs)

Here are some of the most commonly asked questions about Remodulin and pulmonary arterial hypertension (PAH).

PAH is high blood pressure in the arteries of the lungs (the pulmonary arteries). These are the vessels that carry blood from the heart into the lungs, where blood 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.1 This deprives the body of much needed oxygen and puts extra strain on the heart as it works harder to do its job.2

Remodulin (treprostinil) Injection is a prescription medicine for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Remodulin is a prostacyclin-class therapy that can increase the blood flow to the arteries.3

Remodulin may be taken 1 of 2 ways: as a continuous subcutaneous (SC) infusion or continuous intravenous (IV) infusion. Review each administration type with your patients and determine which administration type may be right for them.

For patients 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.3

Prostacyclin is a natural substance that keeps arteries in the lungs open and working properly.4,5 Patients with PAH may not produce enough prostacyclin.6 Remodulin is a prostacyclin analogue.5,7 It helps open pulmonary arteries, making it easier for a PAH patient’s heart to pump blood through the lungs.4,5

Continuous infusion means the drug is delivered steadily to the patient through a small pump outside of the body and a catheter. This may be done 1 of 2 ways3:

  • By SC infusion—through a small catheter under the skin, usually in the abdominal area
  • By IV infusion—through a catheter that is inserted directly into a vein, usually placed surgically in the chest

Remodulin does not cure PAH, rather it helps to treat some of 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.3

No. Remodulin does not require ice packs for administration or refrigeration for storage.3

  • Patients may administer Remodulin at temperatures up to 104°F regardless of concentration when prepared and used as directed8,9
    • Store unopened vials of Remodulin at room temperature: 77°F (25°C)3*
    • Additional testing has shown that Remodulin is stable up to 104°F8,9

*Stability demonstrated as low as 0.004 mg/mL.3

Remodulin may be administered as a continuous SC infusion or continuous IV infusion.3

Patients will receive the Remodulin Patient Starter Kit from their Specialty Pharmacy Services (SPS) provider. The Remodulin Patient Starter Kit includes resources to help patients as they begin treatment with Remodulin.

The Remodulin Support Program is a series of communications offering information and resources to support patients while they are taking Remodulin. Click here to access the patient registration form to receive these communications.

There is no mixing required with Remodulin SC. With Remodulin IV, there are 2 options. Patients can prepare their Remodulin every 2 days when they refill their pump. They can also premix reservoirs for Remodulin IV up to 14 days when mixing with a sterile, high-pH glycine diluent.3* Remodulin cannot be stored for 14 days when mixed with Sterile Water for Injection or 0.9% Sodium Chloride Injection.3 The CADD-MS® 3 should not be used for premixing.

*Stability demonstrated as low as 0.004 mg/mL.3

Patients can administer Remodulin for up to 3 days before changing an SC infusion cassette, and up to 2 days before refilling an IV infusion cassette.3

The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved while minimizing excessive pharmacologic effects of Remodulin (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction).3

  • Remodulin is initiated at 1.25 ng/kg/min (or 0.625 ng/kg/min if not tolerated)3
  • Increase dose based on clinical response3
    • First 4 weeks: increase by 1.25 ng/kg/min per week
    • After week 4: increase in increments of 2.5 ng/kg/min per week
  • Dose adjustments can be undertaken more frequently as tolerated3
  • In the pivotal, randomized, controlled studies of Remodulin SC, the mean dose at week 12 was 9.3 ng/kg/min3,10

Please refer to the dosing section of the Prescribing Information to learn more.

To get your patients started, download the Remodulin Patient Referral Form. For more information, contact your United Therapeutics Cardiopulmonary Sales Specialist or your SPS provider.

In clinical studies of SC Remodulin infusion, the most common adverse events reported were 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 bloodstream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache, diarrhea, nausea, jaw pain, vasodilatation, and edema. For a complete list of adverse events associated with Remodulin, refer to the Remodulin package insert.

  • Chronic intravenous (IV) infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of bloodstream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration3
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms3
  • Titrate slowly in patients with hepatic or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function3
  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Co-administration of Remodulin with a CYP2C8 inhibitor increases exposure to treprostinil, or with an inducer, decreases exposure to treprostinil3

Remodulin offers pump options for both SC and IV administrations.

Yes, the Remodulin Hospital Access Program (RHAP) allows hospitals to order Remodulin on a consignment basis. Pharmacies pay only for the amount of Remodulin used. Currently, all dose strengths of Remodulin are available through RHAP.

Specialty Pharmacy Services (SPS): SPS providers can help your patients and your practice. They provide support to help you initiate Remodulin therapy, dispense medication and manage refills, and offer long-term support to answer questions and help patients manage their PAH and Remodulin treatment.

Managing patient expectations can help patients get the most out of their Remodulin treatment. United Therapeutics offers the following resources to help your patients:

There are a number of financial assistance programs to help your patients. ASSIST can provide information to help patients determine if they qualify for financial assistance and which financial assistance programs are most appropriate for them. Call 1-877-UNITHER for more information.

Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) 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 (SC) infusion is the preferred mode of administration.
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Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) 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 (SC) infusion is the preferred mode of administration.
  • Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
  • Titrate slowly in patients with hepatic or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Co-administration of Remodulin with a CYP2C8 inhibitor increases exposure to treprostinil, or with an inducer, decreases exposure to treprostinil.

Drug Interactions/Specific Populations

  • Remodulin is a potent pulmonary and systemic vasodilator. Concomitant administration of Remodulin with blood pressure lowering agents, such as diuretics, antihypertensive agents, or other vasodilators, may increase the risk of symptomatic hypotension.
  • Since Remodulin inhibits platelet aggregation, there may be an increased risk of bleeding, particularly among patients receiving anticoagulants.
  • Safety and effectiveness of Remodulin in pediatric patients have not been established. It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
  • There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk.

Adverse Reactions

  • Adverse Reactions: In clinical studies of SC Remodulin infusion, the most common adverse events reported were 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 a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache, diarrhea, nausea, jaw pain, vasodilatation, and edema.

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.

References: 1. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association. J Am Coll Cardiol. 2009;53(17):1573-1619. 2. Badano LP, Ginghina C, Easaw J, et al. Right ventricle in pulmonary arterial hypertension: haemodynamics, structural changes, imaging, and proposal of a study protocol aimed to assess remodeling and treatment effects. Eur J Echocardiogr. 2010;11(1):27-37. 3. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2014. 4. O'Callaghan DS, Savale L, Montani D, et al. Treatment of pulmonary arterial hypertension with targeted therapies. Nat Rev Cardiol. 2011;8(9):526-538. 5. Mubarak KK. A review of prostaglandin analogs in the management of patients with pulmonary arterial hypertension. Respir Med. 2010;104(1):9-21. 6. Tuder RM, Cool CD, Geraci MW, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med. 1999;159(6):1952-1932. 7. Gomberg-Maitland M, Olschewski H. Prostacyclin therapies for the treatment of pulmonary arterial hypertension. Eur Respir J. 2008;31(4):891-901. 8. Phares KR, Weiser WE, Miller SP, Myers MA, Wade M. Stability and preservative effectiveness of treprostinil sodium after dilution in common intravenous diluents. Am J Health Syst Pharm. 2003;60(9):916-922. 9. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 10. Simonneau G, Barst RJ, Galiè N, et al; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(6):800-804.