Patients can start Remodulin SC at home

No infusion-related bloodstream infections, as reported in Remodulin SC clinical trials1*

No mixing or reconstitution required1

Up to 3 days per reservoir1

Patients can start Remodulin SC at home

No infusion-related bloodstream infections, as reported in Remodulin SC clinical trials1*

No mixing or reconstitution required1

Up to 3 days per reservoir1

*To reduce the risk of infection, aseptic technique must be used in the preparation and administration of Remodulin.

Learn how SC Remodulin helps Errin in her fight against PAH

For more information and support on Remodulin IV, contact a United Therapeutics representative.

Incidence of adverse infusion site reactions1

Adverse Event Remodulin (n=236) Placebo (n=233)
Infusion site pain 85% 27%
Infusion site reaction 83% 27%

Site reaction (%) Site pain (%)
Remodulin Placebo Remodulin Placebo
Severe 38 1 39 2
Requiring narcotics NA§ NA§ 32 1
Leading to discontinuation 3 0 7 0

NA=not available; SC=subcutaneous.

Infusion site reaction was defined as any local adverse event other than pain or bleeding/bruising at the infusion site and included symptoms such as erythema, induration, or rash.

Based on prescriptions for narcotics, not actual use.

§Medications used to treat infusion site pain were not distinguished from those used to treat site reactions.

Managing infusion site pain and reactions

For SC administration, infusion site pain and reaction are common.1 Work with your Specialty Pharmacy Services (SPS) provider to set patient expectations and offer tips to manage site reactions. With appropriate site management, most patients are able to stay on Remodulin therapy as prescribed.

Tips for patient discussion and managing SC site reactions

Set expectations with regard to site pain

Explain that site pain is a common occurrence

  • During clinical trials, infusion site pain (85% vs placebo 27%) and infusion site reaction (83% vs placebo 27%) were the most common adverse events reported1

Several small, uncontrolled studies characterized the course of site pain

  • Site pain generally reaches an apex approximately 2 to 5 days after a site change and starts to lessen about a week after a site change2-4

Discuss starting a site and when to change sites

  • The best time to change the infusion site is when there is ongoing site pain, itching, erythema, drainage, or bleeding5

Considerations for choosing the best administration sites

  • Start therapy on the abdomen - it is a relatively accessible location to administer medication, monitor, and apply topical remedies as needed2
    • Start with a dry needle tip after priming the catheter line
    • Avoid sensitive areas, including:
      • Stretch marks
      • Scar tissue
      • Bruises
      • Under the waistbands of clothes
      • Folds of the belly
    • In case of continued discomfort, relocate to a new infusion site
  • Good relocation sites include2:
    • Upper buttocks
    • Lower flanks
    • Backs of upper arms
    • Thighs

Lightweight, easily concealed microinfusion pump

When discussing Remodulin with your patients, advise them that continuous SC infusion of Remodulin uses the CADD-MS® 3 microinfusion pump, which can be concealed under clothes. This compact pump allows patients to go about their daily activities without carrying the pump in a separate case or backpack.

To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump.1

Consult your United Therapeutics sales representative to request more information about pumps or contact your Specialty Pharmacy.

Show your patients how to wear the pump

Here are some creative ways patients have developed to wear their pumps. It is important that patients do this in a manner that does not compromise the delivery of Remodulin.

  • In a passport holder worn under clothes
  • In pockets or a fanny pack
  • By sewing a “pump pocket” under the arm of a sports bra
  • In biking shorts under a dress
  • For a form-fitting dress: using an Ace™ bandage on the inside leg to keep a pump in place

Let patients know they can access the PEER Network and connect with other patients who have experienced the challenges of incorporating the same medication into their daily routine.

This is an actual Remodulin patient.

The pump worn by the patient is the CADD-MS® 3. Other pumps may not be as easily hidden.

The CADD-MS® 3 is a trademark of its respective owner. The maker of this brand is not affiliated with and does not endorse United Therapeutics or its products.

Specialty Pharmacy

Specialty Pharmacy perform services that include

  • Dispensing medication and managing patients’ drug inventories and supplies
  • Coordinating medication refills
  • Educating healthcare providers and staff on dose optimization and adverse event management
  • Answering questions from both patients and healthcare practices

For more information and support on Remodulin SC, contact a United Therapeutics representative.

Remodulin® (treprostinil) Injection

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%).

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Remodulin® (treprostinil) Injection

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%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

Important Safety Information for Remodulin

Warnings and Precautions

  • Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are 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 is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding.

Adverse Reactions

  • In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin with an external infusion pump 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 (27% vs. 23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), rash (14% vs. 11%) jaw pain (13% vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and hypotension (4% vs. 2%).

Drug Interactions

  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

Specific Populations

  • In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
  • 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 or if it affects the breastfed infant or milk production.

REMISIhcpJUL18

References: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018. 2. Mathier MA, McDevitt S, Saggar R. Subcutaneous treprostinil in pulmonary arterial hypertension: practical considerations. J Heart Lung Transplant. 2010;29(11):1210-1217. 3. Lang I, Gomez-Sanchez M, Kneussl M, et al. Efficacy of long-term subcutaneous treprostinil sodium therapy in pulmonary hypertension. Chest. 2006;129(6):1636-1643. 4. Sadushi-Kolici R, Skoro-Sajer N, Zimmer D, et al. Long-term treatment, tolerability, and survival with sub-cutaneous treprostinil for severe pulmonary hypertension. J Heart Lung Transplant. 2012;31(7):735-743. 5. White JR, Levin Y, Wessman K, Heininger A, Frutiger K. Subcutaneous treprostinil is well tolerated with infrequent site changes and analgesics. Pulm Circ. 2013;3(3):611-621.