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. INDICATIONS AND USAGE
1.1 Pulmonary Arterial Hypertension
Remodulin is 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%) [see Clinical Studies (14.1)].
It may be administered as a continuous subcutaneous infusion or continuous intravenous (IV) infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections (BSIs), reserve continuous intravenous infusion for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted [see Warnings and Precautions 5.1].
1.2 Pulmonary Arterial Hypertension in Patients Requiring Transition from Flolan®
In patients with pulmonary arterial hypertension requiring transition from Flolan (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.
2 DOSAGE AND ADMINISTRATION
2.1 General
Remodulin can be administered without further dilution for subcutaneous administration, or diluted for intravenous infusion with Sterile Diluent for Remodulin or similar approved high-pH glycine diluent (e.g. Sterile Diluent for Flolan or Sterile Diluent for Epoprostenol Sodium), 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.
Table 1. Selection of Diluent
| Route |
Diluent |
Storage limits |
Administration limits |
| SC |
None |
See section 16 |
72 hours at 37°C |
| IV |
Sterile Diluent for RemodulinSterile Diluent for FlolanSterile Diluent for Epoprostenol Sodium |
14 days at room temperature |
48 hours at 40 °C |
| Sterile water for injection0.9% Sodium Chloride for injection |
4 hours at room temperature or 24 hours refrigerated |
48 hours at 40°C |
2.2 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.
2.3 Dosage Adjustments
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 (5.4)]. 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.
2.4 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)].
2.5 Administration
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.
