Generic name: treprostinil 20mg in 20mL
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Jul 2, 2019.
Remodulin can be administered with or without further dilution with Sterile Diluent for Remodulin or similar approved high-pH glycine diluent (e.g., Sterile Diluent for Flolan or Sterile Diluent for Epoprostenol), Sterile Water for Injection, or 0.9% Sodium Chloride Injection prior to administration. See Table 1 below for storage and administration time limits for the different diluents.
Diluted Remodulin has been shown to be stable at ambient temperature when stored for up to 14 days using high-pH glycine diluent at concentrations as low as 0.004 mg/mL (4,000 ng/mL).
|Diluent||Storage Limits||Administration Limits|
|None||See Section 16||16 weeks at 40°C|
|Sterile Diluents for Remodulin, Flolan, or Epoprostenol||14 days at room temperature||48 hours at 40°C|
|Sterile Water for Injection
0.9% Sodium Chloride for Injection
|4 hours at room temperature or 24 hours refrigerated||48 hours at 40°C|
Initial Dose for Patients New to Prostacyclin Infusion Therapy
Remodulin is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion. Remodulin is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated because of severe site pain or reaction. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min.
Initial Dose for Patients Transitioning to an Implantable Intravenous Infusion Pump
The initial dose of Remodulin should be the same as the current dose the patient is receiving using the external infusion pump at the time of transition.
The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, while minimizing excessive pharmacologic effects of Remodulin (headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction).
The infusion rate should be increased in increments of 1.25 ng/kg/min per week for the first four weeks of treatment and then 2.5 ng/kg/min per week for the remaining duration of infusion, depending on clinical response. Dosage adjustments may be undertaken more often if tolerated. Avoid abrupt cessation of infusion [see Warnings and Precautions (5.2)]. Restarting a Remodulin infusion within a few hours after an interruption can be done using the same dose rate. Interruptions for longer periods may require the dose of Remodulin to be re-titrated.
Patients with Hepatic Insufficiency
In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min ideal body weight. Remodulin has not been studied in patients with severe hepatic insufficiency [see Warnings and Precautions (5.3), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either particulate matter or discoloration is noted, do not use.
Remodulin is administered by subcutaneous or intravenous infusion at a calculated rate based on a patient's dose (ng/kg/min), weight (kg) and the Remodulin concentration (mg/mL).
For administration of Undiluted Remodulin the rate is calculated using the following formula:
|Undiluted Infusion Rate (mL/hour)||=||Dose (ng/kg/min)||×||Weight (kg)||×||0.00006*|
|Remodulin Vial Strength (mg/mL)|
For administration of Diluted Remodulin the rate and concentration is calculated using the following formulas:
|Diluted Remodulin Concentration
|Dose (ng/kg/min)||×||Weight (kg)||×||0.00006|
The volume of Remodulin Injection needed to make the required diluted Remodulin concentration for the given reservoir size can then be calculated using the following formula:
|Volume of Remodulin Injection
|=||Diluted Remodulin Concentration
|×||Total Volume of Diluted Remodulin Solution in Reservoir
|Remodulin Vial Strength
The calculated volume of Remodulin Injection is then added to the reservoir along with the sufficient volume of diluent to achieve the desired total volume in the reservoir.
Remodulin is administered subcutaneously by continuous infusion, via a subcutaneous catheter, using an infusion pump designed for subcutaneous drug delivery. The infusion pump should: (1) be adjustable to approximately 0.002 mL/hour, (2) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (3) have delivery accuracy of ±6% or better, (4) be positive pressure-driven, and (5) have a reservoir made of polyvinyl chloride, polypropylene or glass. Alternatively, use an infusion pump cleared for use with Remodulin. To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and subcutaneous infusion sets.
External Intravenous Infusion Pump:
Remodulin is administered intravenously by continuous infusion via a surgically placed indwelling central venous catheter using an external infusion pump designed for intravenous drug delivery. If clinically necessary, a temporary peripheral intravenous cannula, preferably placed in a large vein, may be used for short term administration of Remodulin. Use of a peripheral intravenous infusion for more than a few hours increases the risk of thrombophlebitis. The infusion pump used to administer Remodulin should: (1) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (2) have delivery accuracy of ±6% or better of the hourly dose, (3) be positive pressure driven, and (4) have a reservoir made of polyvinyl chloride, polypropylene or glass. Alternatively, use an infusion pump cleared for use with Remodulin. To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and infusion sets.
Infusion sets with an in-line 0.22 or 0.2 micron pore size filter should be used.
Implantable Intravenous Infusion Pump:
Use an implantable intravenous infusion pump approved for use with Remodulin, such as the Implantable System for Remodulin® (ISR). Refer to the pump manufacturer's manual for specific instructions regarding preparation, programing, implantation, and refilling.
Patients Requiring Transition from Epoprostenol
Transition from epoprostenol to Remodulin is accomplished by initiating the infusion of Remodulin and increasing it, while simultaneously reducing the dose of intravenous epoprostenol. The transition to Remodulin should take place in a hospital with constant observation of response (e.g., walk distance and signs and symptoms of disease progression). Initiate Remodulin at a recommended dose of 10% of the current epoprostenol dose, and then escalate as the epoprostenol dose is decreased (see Table 2 for recommended dose titrations).
Patients are individually titrated to a dose that allows transition from epoprostenol therapy to Remodulin while balancing prostacyclin-limiting adverse events. Treat increases in the patient's symptoms of PAH first with increases in the dose of Remodulin. Treat side effects normally associated with prostacyclin and prostacyclin analogs first by decreasing the dose of epoprostenol.
|Step||Epoprostenol Dose||Remodulin Dose|
|1||Unchanged||10% Starting Epoprostenol Dose|
|2||80% Starting Epoprostenol Dose||30% Starting Epoprostenol Dose|
|3||60% Starting Epoprostenol Dose||50% Starting Epoprostenol Dose|
|4||40% Starting Epoprostenol Dose||70% Starting Epoprostenol Dose|
|5||20% Starting Epoprostenol Dose||90% Starting Epoprostenol Dose|
|6||5% Starting Epoprostenol Dose||110% Starting Epoprostenol Dose|
|7||0||110% Starting Epoprostenol Dose + additional 5-10% increments as needed|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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