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DEMONSTRATED RESULTS FOR PATIENTS1
Since 2002, Remodulin has helped people with PAH do more of the things they love.1 As the #1 prescribed parenteral therapy for PAH, Remodulin continues to impact patients every day.2
Why Remodulin? Because of our longevity, reliability, and clinical credentials. Click the jump links to get the specifics.
Two Decades. One Community.
In May 2002, Remodulin was approved and soon became available to patients.1 Over the last 2 decades, we’ve worked together to improve clinical outcomes for people with PAH.
This anniversary is a celebration of our partnership, and we wouldn’t have reached this point without your commitment to patient well-being. Here’s to 20 more years of helping patients do more.
Voices of Remodulin
Your experiences shape our shared journey. Listen to members of the PAH community as they discuss the impact Remodulin has made on their lives.
20 Years of Making a Difference
- Remodulin has been studied in more than 4500 patients since 20022
- Remodulin has been recommended in treatment guidelines since 20033
- Remodulin is currently the #1 prescribed branded parenteral therapy2
- Remodulin is available via subcutaneous (SC) and intravenous (IV) administration and features multiple pump options designed to help make living with a pump easier on patients1
- Remodulin has gone 2 decades without a single supply interruption by always maintaining 2 years of both raw materials and ready-to-ship medicine
- United Therapeutics offers a growing network of resources as well as educational tools to help simplify the referral and prescribing process of Remodulin for HCPs
- Various support resources are also available for patients, including information on financial assistance and 24/7 access to Specialty Pharmacy nurses
- United Therapeutics recently became the first publicly traded pharmaceutical company to take the form of a public benefit corporation (PBC), reaffirming our patient-first philosophy
The power of Remodulin
With an established clinical profile, Remodulin has been demonstrated to diminish symptoms associated with exercise and, for patients requiring transition from Flolan® (epoprostenol sodium), slow the rate of clinical deterioration.1
Remodulin was launched in 2002 and has been recommended in guidelines for treatment of PAH since 2003.1,3
Remodulin has been included in the ACCF/AHA Consensus, 6th World Symposium, CHEST Treatment Recommendations, and ESC/ERS Treatment Guidelines.3-6
Learn more about treatment guidelines for patients in FC III and FC IVMedian change of +10 meters in 6MWD at week 121,7
In two 12-week, multicenter, randomized, double-blind, placebo-controlled trials, SC Remodulin infusion was compared to placebo in a total of 470 patients. The primary endpoint of these trials was the median change in 6MWD at week 12.1,7
- Median change in the Remodulin group: +10 meters
- Median change in the placebo group: 0 meters
- Mean Remodulin dose: 9.3 ng/kg/min at 12 weeks
- The most common adverse reactions: infusion site pain and reaction, headache, diarrhea, rash, nausea, jaw pain, vasodilatation, dizziness, edema, and hypotension
The difference was not statistically significant.1
Average dose in real-world use of Remodulin2
Based on Specialty Pharmacy shipment data during January 2022. Dose data reported in Specialty Pharmacy shipments only. Limited to unique quarterly patients with dosing data.
Remodulin At The Heart
At 3 months in a pivotal study of Remodulin, patients on an average dose of 9.3 ng/kg/min showed significant hemodynamic improvements in7:
Mean pulmonary arterial pressure
Cardiac index
Pulmonary vascular resistance
Mean right atrial pressure
Mixed venous oxygen saturation
Hemodynamic Results From An Open-Label Uncontrolled Study
Results reported are from a 48-week extension trial based on an initial trial of 12 weeks. At baseline, 88% of patients were WHO FC III and 13% were WHO FC IV. Baseline 6MWD for the de novo* group was 307 ± 115 m. The results below are from the de novo patients (N=11).8
As the study was uncontrolled, results should be interpreted with caution.
| Baseline | Week 12 | Week 48 | |
|---|---|---|---|
| mPAP | 58 mm Hg | 54 mm Hg | 48 mm Hg |
| CI | 1.6 L/min/m2 | 2.2 L/min/m2 | 2.5 L/min/m2 |
| PVRI | 32 units • m2 | 20 units • m2 | 16 units • m2 |
| mRAP | 12 mm Hg | 12 mm Hg | 8 mm Hg |
| Baseline | |
|---|---|
| mPAP | 58 mm Hg |
| CI | 1.6 L/min/m2 |
| PVRI | 32 units • m2 |
| mRAP | 12 mm Hg |
| Week 12 | |
|---|---|
| mPAP | 54 mm Hg |
| CI | 2.2 L/min/m2 |
| PVRI | 20 units • m2 |
| mRAP | 12 mm Hg |
| Week 48 | |
|---|---|
| mPAP | 48 mm Hg |
| CI | 2.5 L/min/m2 |
| PVRI | 16 units • m2 |
| mRAP | 8 mm Hg |
The dose of IV treprostinil increased from baseline through week 48 to a mean of 98 ng/kg/min in the de novo group.8
The initial analysis was a 12-week, prospective, open-label, uncontrolled, multicenter study of continuous IV treprostinil in 16 patients aged 12 to 65 with PAH that was idiopathic (n=8), related to connective tissue disease (n=6), or related to congenital heart disease (n=2). The primary endpoint was change in exercise capacity assessed by the 6MWD test.8
*De novo patients are defined as newly diagnosed WHO FC II, III, or IV patients not previously treated with specific targeted PAH therapies.8
Remodulin has bioequivalent SC and IV administration options
SC Remodulin:
Patients can start SC Remodulin at home
No infusion-related bloodstream infections† reported in SC Remodulin clinical trials1
No mixing or reconstitution required9
Up to 3 days between refills9
†To reduce the risk of infection, aseptic technique must be used in the preparation and administration of Remodulin.
IV Remodulin:
Patients usually start treatment in the hospital9
No infusion site pain or infusion site reactions as commonly reported with SC administration10
Up to 2 days between pump refills8
Options available for mixing, including at-home premixing and the SPmix Program
SC and IV Remodulin: Bioavailable within minutes, bioequivalent in less than 6 hours1,11
Remodulin pharmacokinetics were analyzed in 51 healthy volunteers receiving IV or SC Remodulin at a dose of 10 ng/kg/min for 72 hours. Following a 4-day washout, volunteers were given the opposite route of their initial administration. Pharmacokinetics were then compared between IV and SC administration.11
Figure adapted from Laliberte K, et al. J Cardiovasc Pharmacol. 2004;44(2):209-214.
Remodulin has a 4-hour half-life and can be delivered via SC or IV routes over 24 hours for patients who need continuous prostacyclin therapy.1
Identifying appropriate Remodulin patients
NYHA FC II-IV patients: Remodulin is indicated for FC II-IV patients1
High-risk and progressing patients: Remodulin is appropriate for high-risk and progressing patients who need quick intervention4,9
Learn more about managing risk
Patients transitioning from Flolan: Flolan patients may benefit from transitioning to Remodulin because of the longer 4-hour half-life, reducing the risk of rebound pulmonary hypertension following hemodynamic compromise1,9
Learn more about transitioning patients from FlolanInformative video to share with your patients
Carey’s Story
Carey shares how she persevered and didn’t let her disease define her.
6MWD=6-minute walk distance; ACCF=American College of Cardiology Foundation; AHA=American Heart Association; CI=cardiac index; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=functional class; mPAP=mean pulmonary arterial pressure; mRAP=mean right atrial pressure; NYHA=New York Heart Association; PAH=pulmonary arterial hypertension; PVRI=pulmonary vascular resistance index; WHO=World Health Organization.
Important Safety Information
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 (BSIs) 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.
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.
REMISIhcpMAY2021
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
Important Safety Information
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 (BSIs) 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.
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.
REMISIhcpMAY2021
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
References: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2021. 2. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 3. Galiè N, Channick RN, Frantz RP, et al. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019;53(1):1801889. doi: 0.1183/13993003.01889-2018. 4. Galiè N, Humbert M, Vachiery JL, et al; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2016;37(1):67-119. 5. McLaughlin VV, Archer SL, Badesch DB, et al; ACCF/AHA. 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: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009;119(16):2250-2294. 6. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-475. 7. 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. 8. Benza RL, Tapson VF, Gomberg-Maitland M, et al. One-year experience with intravenous treprostinil for pulmonary arterial hypertension. J Heart Lung Transplant. 2013;32(9):889-896. 9. Farber HW, Gin-Sing W. Practical considerations for therapies targeting the prostacyclin pathway. Eur Respir Rev. 2016;25(142):418-430. 10. Kingman M, Archer-Chicko C, Bartlett M, et al. Management of prostacyclin side effects in adult patients with pulmonary arterial hypertension. Pulm Circ. 2017;7(3):598-608. 11. 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.
