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Evaluating patient risk status
Prognostic implications of NYHA functional class
REVEAL Registry observational analysis: FC III patients who improved to FC I-II within 1 year of enrollment had a significantly better prognosis than patients who remained in FC III or worsened to FC IV.1*
| Reveal FC III Patients1 12 months post-enrollment (N=982) | ||
|---|---|---|
| Improved FC | FC Unchanged | Worsened FC |
| 27% | 66% | 8% |
Lack of improvement in key clinical indicators correlated with poorer prognosis compared with patients whose indicators improved.2
REVEAL: Nearly 7 in 10 patients may be at risk of a poor prognosis, compared to patients with improving indicators2
*Only patients who obtained a follow-up FC assessment within 1 year of enrollment were included. The first follow-up FC assessment was performed at a mean ± SD of 4 ± 3 months.1
Download the Risk Assessment Sheets to learn more about the ESC/ERS or REVEAL risk criteria.
Consistent Guideline Inclusion of Remodulin for Intermediate-high and High Risk Patients
Recommended in guidelines for FC III/INTERMEDIATE-HIGH and FC IV/HIGH RISK patients since 20043
2009
ACCF/AHA4
2013
World
Symposium5
2014
CHEST Treatment
Recommendations6
2015
ESC/ERS
Guidelines7
2022
ESC/ERS
Guidelines8
2024
World
Symposium9
7th World Symposium on PH-Therapy for Group 1 PAH recommends SC/IV PPA9:
At Baseline:
- High risk or
- Non-high risk with severe hemodynamics/poor RV function
At Follow-up*:
- Intermediate-high and
- High risk patients, consistent with previous guidelines
*Follow-up risk assessments should occur at 3-4 months and repeated frequently.9
ACCF=American College of Cardiology Foundation; AHA=American Heart Association; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=functional class; NYHA=New York Heart Association; PAH=pulmonary arterial hypertension; REVEAL=Registry to Evaluate Early and Long-Term PAH Disease Management; SD=standard deviation; WSPH=World Symposium on PH-Therapy SC=subcutaneous; IV=intravenous; PPA=prostacyclin pathway agent.
Remodulin® (treprostinil) Injection
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 (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 insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic 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.
REMISIhcpFEB2025
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-844-UNITHER (1-844-864-8437).
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-844-UNITHER (1-844-864-8437).
Remodulin® (treprostinil) Injection
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 (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 insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic 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.
REMISIhcpFEB2025
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-844-UNITHER (1-844-864-8437).
References: 1. Barst RJ, Chung L, Zamanian RT, et al. Functional class improvement and 3-year survival outcomes in patients with pulmonary arterial hypertension in the REVEAL Registry. Chest. 2013;144(1):160-168. doi:10.1378/chest.12-2417. 2. Benza RL, Miller DP, Foreman AJ, et al. Prognostic implications of serial risk score assessments in patients with pulmonary arterial hypertension: a Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL) analysis. J Heart Lung Transplant. 2015;34(3):356-361. doi:10.1016/j.healun.2014.09.016. 3. Galiè N, Torbicki A, Barst R, et al. Guidelines on diagnosis and treatment of pulmonary arterial hypertension. Eur Heart J. 2004 Dec;25(24):2243-78. doi: 10.1016/j.ehj.2004.09.014. 4. 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: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association [published correction appears in Circulation. 2009 Jul 14;120(2):e13]. Circulation. 2009;119(16):2250-2294. doi:10.1161/CIRCULATIONAHA.109.192230. 5. Galiè N, Simonneau G. The Fifth World Symposium on Pulmonary Hypertension. J Am Coll Cardiol. 2013;62(25 Suppl):D1-D3. doi:10.1016/j.jacc.2013.10.030. 6. Klinger JR, Elliott CG, Levine DJ, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report [published correction appears in Chest. 2021 Jan;159(1):457. doi:10.1016/j.chest.2020.11.021.]. Chest. 2019;155(3):565-586. doi:10.1016/j.chest.2018.11.030. 7. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension. Rev Esp Cardiol (Engl Ed). 2016;69(2):177. doi:10.1016/j.rec.2016.01.002. 8. Humbert M, Kovacs G, Hoeper MM, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023;61(1):2200879. Published 2023 Jan 6. doi:10.1183/13993003.00879-2022. 9. Chin KM, Gaine SP, Gerges C, et al. Treatment algorithm for pulmonary arterial hypertension. Eur Respir J. 2024;64(4):2401325. Published 2024 Oct 31. doi:10.1183/13993003.01325-2024.
