Remodulin SPmix Program

The Remodulin SPmix Program delivers up to 7 days of premixed Remodulin IV and all necessary supplies to your patients homes each week.

Who is eligible?

The Remodulin SPmix Program is for patients who lack dexterity or mixing support, or who would prefer to receive their medication premixed.

Patients must be:

  • On a stable dose of Remodulin IV for at least a month with no immediate plans for titration
  • Self-mixing for at least 3 months prior to submitting an enrollment form for the program

Get your patients started

STEP 1
Determine if your patient is eligible and if the program is right for them.

STEP 2
Submit a Remodulin SPmix Program enrollment form.

If your patient is eligible and has no immediate needs for titration, download a Remodulin SPmix Program enrollment form to enroll them in the program.

Program details

Pharmacy technicians mix medication in accordance with USP 797 standards, ensuring sterile preparation.

Your patient will receive more overall shipments per month; each shipment contains the exact amount of medication necessary for the treatment period in convenient premixed cassettes.

A Specialty Pharmacy nurse will visit patients at home to educate them on the premixed cassettes. They will also schedule 2 to 4 visits a year to ensure maintenance of patients’ self-mixing skills.

Patients will need to store the premixed Remodulin IV cassettes in a refrigerator.

If a patient is traveling or moving, advise them to speak to their Specialty Pharmacy for assistance. Their Specialty Pharmacy will not deliver outside the United States.

Each patient will always have a backup supply of Remodulin and a high-pH glycine sterile diluent for Remodulin available to self-mix.

Some payer restrictions may apply. Your Specialty Pharmacy will be able to help you identify areas/plans where restrictions may apply.

The Remodulin SPmix Program is only available to Remodulin IV patients using the CADD Legacy Pump with high-pH glycine Sterile Diluent for Remodulin. Remodulin may be administered as a continuous SC infusion or continuous IV infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious bloodstream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

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%).

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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 (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.

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