Dosing and Administration
Multiple Pump Options
REMODULIN® (treprostinil sodium) Injection offers several small, convenient pump options for your patients with pulmonary arterial hypertension (PAH). Examples of these options are shown below.
Subcutaneous (SC) REMODULIN
Example SC pump option:
Smiths Medical CADD-MS™ 3 Microinfusion pump
Intravenous (IV) REMODULIN
Example IV pump options:
Smiths Medical CADD-MS 3 Microinfusion pump
Canè Crono Five Expanded reservoir miniature pump
CADD-Legacy® 1 Portable electronic infusion pump
Pump Specifications
CADD-MS 3. This microinfusion pump is just 3.2" x 1.8" x 0.95" and weighs only 3.2 ounces, including the battery and cartridge. Also intended for SC or IV REMODULIN continuous infusion, the CADD-MS 3 has a 3-mL reservoir capacity.
Expanded Reservoir Miniature Pump for SC or IV Infusions
Canè Crono Five. Expanded reservoir miniature pump. Only 3.0" x 1.8" x 1.1", it has a large medication reservoir capacity. Also for SC or IV REMODULIN continuous infusion, the Canč Crono Five has a reservoir capacity of 10 mL to 20 mL. The Canè Crono Five weighs less than 4 ounces, including the battery, without medication.
Portable Electronic Infusion Pump for IV Continuous Infusion
CADD-Legacy 1. Although somewhat larger than the pumps intended for either SC or IV REMODULIN continuous infusion, the CADD-Legacy 1 is a fully portable electronic infusion pump. At 1.6" x 3.8" x 4.4", it is still quite small for an IV pump and weighs just 13.8 ounces. The CADD-Legacy 1 has a 50 mL to 100 mL reservoir capacity.
CADD-MS is a trademark and CADD-Legacy is a registered trademark of Smiths Medical System. Canè Crono Five is manufactured by Canč Medical Technology.
Information for Patients
Patients receiving REMODULIN should be given the following information: REMODULIN is infused continuously through a self placed SC or surgically placed indwelling central venous catheter, via an infusion pump. Therapy with REMODULIN will be needed for prolonged periods, possibly years, and the patient’s ability to accept and care for a catheter and to use an infusion pump should be carefully considered. In order to reduce the risk of infection, aseptic technique must be used in the preparation and administration of REMODULIN. Additionally, patients should be aware that subsequent disease management may require the initiation of an alternative IV prostacyclin therapy, Flolan® (epoprostenol sodium) for Injection.
REMODULIN Dosing Guide
- REMODULIN should be used only by doctors experienced in the treatment of PAH, and must be started in a setting with equipment and personnel for emergency care
- Abrupt withdrawal or sudden large reductions in dosage of REMODULIN may result in worsening of PAH symptoms and should be avoided
- Caution should be used in patients with hepatic or renal problems
- Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal
SC Infusion Rate Calculation Formula1
IV REMODULIN Concentration Calculation1
Transitioning Patients to REMODULIN From Flolan
- When transitioning patients to REMODULIN from Flolan, patients are individually titrated to a dose that allows transition from Flolan therapy to REMODULIN while balancing prostacyclin-limiting adverse events
- Increases in the patient’s symptoms of PAH should be first treated with increases in the dose of REMODULIN
- Side effects normally associated with prostacyclin and prostacyclin analogues are to be first treated by decreasing the dose of Flolan
- The transition to REMODULIN should take place in a hospital with constant observation of response.
Recommended Transition Dose Changes From Flolan to REMODULIN1
Transitioning Patients to REMODULIN From Flolan
- When transitioning patients to REMODULIN from Flolan, patients are individually titrated to a dose that allows transition from Flolan therapy to REMODULIN while balancing prostacyclin-limiting adverse events
- Increases in the patient’s symptoms of PAH should be first treated with increases in the dose of REMODULIN
- Side effects normally associated with prostacyclin and prostacyclin analogues are to be first treated by decreasing the dose of Flolan
- The transition to REMODULIN should take place in a hospital with constant observation of response.
Recommended Transition Dose Changes From Flolan to REMODULIN1
For complete dosing information, please refer to full prescribing information.
Administration
SC Administration
- For SC infusion, REMODULIN is delivered without further dilution at a calculated SC infusion rate (mL/h)
- During use, a single reservoir (syringe) of undiluted REMODULIN can be administered up to 72 hours at 37°C
IV Administration
- Remodulin may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted
- IV REMODULIN must be diluted with either sterile water for injection or 0.9% sodium chloride injection and is administered intravenously by continuous infusion via a surgically placed indwelling central venous catheter, using an infusion pump designed for IV drug delivery
- Diluted REMODULIN has been shown to be stable at ambient temperature for up to 48 hours at concentrations as low as 0.004 mg/mL (4000 ng/mL)
For complete prescribing information, please refer to the REMODULIN package insert.
Reference: 1. REMODULIN [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2006.
REMODULIN is a registered trademark of United Therapeutics Corporation. Flolan is a registered trademark of GlaxoSmithKline.
