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Remodulin Pump Systems

At United Therapeutics, we are committed to transforming patient expectations for life with pump therapy. We strive to bring innovation to PAH treatment that goes beyond delivering therapeutic excellence, including an ongoing investment in state-of-the-art delivery systems.

Training on each pump is available through Specialty Pharmacies, SP nurses, and United Therapeutics Representatives.

Pump system options are available

Remodulin is available via subcutaneous (SC) and intravenous (IV) administration.

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Explore more information about the SC Remodulin pump options from United Therapeutics

Small, discreet pump helping to simplify delivery of Remodulin

New Remunity®

The small, simple, and safe SC prefilled pump that is water resistant and provides state-of-the-art dosing accuracy

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Traditional, all-in-one SC Remodulin pump

CADD-MS® 3 ambulatory infusion pump

The all-in-one pump

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Learn more about the IV Remodulin pump option

Proven pump for continuous IV delivery of Remodulin and other medicines

CADD-Legacy® 1 PCA ambulatory infusion pump

Reliably delivering Remodulin since 2004

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The Implantable System for Remodulin (ISR)

Implantable System for Remodulin (ISR)

Implantable System for Remodulin (ISR)*

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*FDA requires that certain conditions of Medtronic’s PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions for approval.

The Remodulin Patient Brochure can provide patients more information about the different administration options available.

PAH=pulmonary arterial hypertension; PMA=premarket approval; SP=Specialty Pharmacy.

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.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line 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.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).