Dosing with Remodulin® (treprostinil) Injection

Please see Important Safety Information below.

Robert Schilz, DO, explains the importance of optimized dosing with Remodulin while balancing the art and science of titrating to therapeutic effect. 

 

 

 

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Optimizing Dosing With Remodulin

 

Lungs

Titrate as needed to achieve clinical response and tolerability with no maximum dose1

Clock

Dose can be adjusted as frequently as tolerated1

Target

Higher doses may correlate with better outcomes2,3

Chart

Published long-term studies show dosing requirements continue to increase over time4

 

66 ng/kg/min
Average dose in real-world use of Remodulin5
Remodulin dosing has evolved based on 20 years of clinical and real-world experience.

 

Based on Specialty Pharmacy shipment data during January 2020. Dose data reported in Specialty Pharmacy shipments only. Limited to unique quarterly patients with dosing data.

 

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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 (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.

 

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Please see accompanying Full Prescribing Information for Remodulin. 

 

For additional information, visit www.remodulin.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. Benza RL, Gomberg-Maitland M, Naeije R, et al. Prognostic factors associated with increased survival in patients with pulmonary arterial hypertension treated with subcutaneous treprostinil in randomized, placebo-controlled trials. J Heart Lung Transplant. 2011;30(9):982-989.
  3. Ramani G, Cassady S, Shen E, et al.  Novel dose -response analyses of treprostinil in pulmonary arterial hypertension and its effects on six-minute walk distance and hospitalizations.  Pulmonary Circulation. 2020;10(3):1-12 
  4. Balasubramanian V, Melendres-Groves L, Safdar Z, et al.  Real-World Dosing Characteristics of Parenteral Treprostinil. Am J of Respir Crit Care Med. 2019;199:A5066
  5. Data on file. United Therapeutics Corporation. Research Triangle Park, NC.

 

Remodulin is a registered trademark of United Therapeutics Corporation.
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