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Managing Side effects

Frequently asked questions (FAQs)

Full Prescribing Information/Package Insert

The power of a continuous prostacyclin therapy

Approved for the treatment of PAH (WHO Group 1) to diminish symptoms associated with exercise¹

Median change in 6MWD at week 12²

Two 12-week, multicenter, randomized, double-blind, placebo-controlled trials compared Remodulin SC infusion to placebo in a total of 470 patients.

• Median change of +10 meters in the Remodulin group²
• Median change of 0 meters in the placebo group²
• Mean Remodulin dose: 9.3 ng/kg/min at 12 weeks²
• The most common adverse reactions were infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, dizziness, edema, and hypotension²

6MWD=6-minute walk distance; FC=functional class; PAH=pulmonary arterial hypertension; SC=subcutaneous.

Remodulin SC and IV: Bioequivalent at a steady state^3,4

Remodulin pharmacokinetics were analyzed in 51 healthy volunteers receiving Remodulin IV or SC at a dose of 10 ng/kg/min

IV=intravenous; SC=subcutaneous.

Figure adapted from Laliberte K, et al. Cardiovasc Pharmacol. 2004, with permission.³

References: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018. 2. Simonneau G, Barst RJ, Galie 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. 3. Laliberte K, Arneson C, Jeffs R, et al. Pharmacokinetics and steady-state bioequivalence of treprostinil sodium (Remodulin) administered by the intravenous and subcutaneous route to normal volunteers. J Cardiovasc Pharmacol. 2004:44(2):209-214. 4. McSwain CS, Benza R, Shapiro S, et al. Dose proportionality of treprostinil sodium administered by continuous subcutaneous and intravenous infusion. J Clin Pharmacol. 2008;48(1):19-25.

Transitioning your patients from Flolan® (epoprostenol sodium)

Remodulin is approved to diminish the rate of clinical deterioration in patients requiring transition from Flolan.

• Remodulin SC prevented clinical deterioration* in patients who were transitioned from Flolan
• An 8-week, multicenter, randomized, placebo-controlled withdrawal trial of 22 patients stable on epoprostenol therapy who were transitioned to Remodulin SC or placebo (2:1)
• Safety findings were consistent with previous clinical trials of Remodulin SC

*Clinical deterioration was defined as an increase in Flolan dose, hospitalization due to PAH, or death (no patient died during this study).

6MWD=6-minute walk distance; FC=functional class; PAH=pulmonary arterial hypertension; SC=subcutaneous.

Figure adapted from Rubenfire M, et al. Chest. 2007, with permission.

Transitioning from Flolan to Remodulin IV

• In a 12-week, multicenter, open-label, investigator-initiated trial, 31 patients receiving optimal doses of conventional therapies for PAH as well as a stable dose of IV epoprostenol for ≥1 month were transitioned from IV epoprostenol to Remodulin IV
• 6MWD was maintained in patients transitioning from Flolan to Remodulin IV (438 m vs 439 m, respectively)
• Borg dyspnea scores: no significant change from baseline to week 12

Remodulin® adverse reactions

In controlled trials in PAH, patients receiving Remodulin SC experienced the following adverse reactions at least 3% more frequently than patients receiving placebo.*

Most common adverse reactions

*Reported adverse reactions (at least 3% more frequent on drug than on placebo) are included except those too general to be informative and those not plausibly attributable to the use of the drug because they were associated with the condition being treated or are very common in the treated population.

PAH=pulmonary arterial hypertension; SC=subcutaneous.

Incidence of infusion site reactions and site pain

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.

Reference: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018.

Remodulin offers 2 delivery options¹

Subcutaneous

Pump/Catheter location: External
Indication: FC II-IV
Pump: CADD-MS® 3
Time between refills: Up to 3 days
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Intravenous

Pump/Catheter location: External
Indication: FC II-IV
Pump: CADD-Legacy®
Time between refills: Up to 2 days
LEARN MORE

Initiation and titration

To help ensure a successful start on Remodulin:

• Set expectations for the patient.
• Complete the Patient Referral Form and submit documentation.
• Take advantage of UT support resources for your practice and patients.
• Develop a follow-up protocol for the patient.

Titrate up and down as needed to achieve clinical response

Dose adjustment can be used to establish a dose that improves PAH symptoms while minimizing excessive pharmacologic effects of Remodulin (ie, headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction).¹

• In the pivotal, randomized, controlled studies of subcutaneous Remodulin, the mean dose at week 12 was 9.3 ng/kg/min
• Dose adjustments can be made more frequently as tolerated

Based on Specialty Pharmacy shipment data through March 2017

Titrate slowly in patients with hepatic or renal insufficiency. Such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.¹

Dose 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 and with an inducer decreases exposure to treprostinil.¹

Talk to your patients about the potential benefits and risks of Remodulin before initiating therapy.

Remodulin open-label extension study¹

Reference: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018.

Parenteral conversation

Approaching the parenteral therapy conversation and increasing patient understanding

Research shows that differences in perspective between healthcare providers and their patients sometimes create barriers to communication. To understand and improve upon the healthcare provider-patient conversation regarding parenteral therapy, United Therapeutics partnered with leading PAH and behavioral science experts to develop the Remodulin Dialogue Initiative, a 4-step method:

1. Set a positive tone: Parenteral treatment can be a daunting proposition for patients—a little encouragement goes a long way.
2. Ask and listen: Patients may be hesitant to ask questions, or may not know what questions to ask. Ask if they know the options available to them, listen to their concerns, and probe further to understand what treatment option might work for them.
3. Make a confident recommendation and explain: Once you have chosen either Remodulin IV or SC, be sure to explain to your patient why this is your recommendation and what the treatment process for this option entails.
4. Discuss patient commitment: Parenteral treatment is an important decision; make sure patients are ready to move forward with the treatment process.

By following these simple steps, you may increase patient understanding of your recommendation to start parenteral therapy, thus helping to ensure that PAH patients initiate the right medication at the right time.

Barriers to communication

Additionally, consider all of the following aspects of communication that may lead to misunderstanding between you and your patient during the treatment conversation:

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.