TREPROSTINIL SODIUM
| TREPROSTINIL SODIUM (tre-pros'tin-il) Remodulin Classifications: prostaglandin; pulmonary antihypertensive; Therapeutic:pulmonary antihypertensive Prototype: Epoprostenol Pregnancy Category: B |
Availability
1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL injection
Action
Causes direct vasodilation of the pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation. The vasodilatory effects reduce right and left ventricular afterload, and increase cardiac output and stroke volume. Also improves dyspnea, fatigue, and signs and symptoms of pulmonary arterial hypertension (PAH).
Therapeutic Effect
Vasodilation of the arteries in the pulmonary system results in lowering of pulmonary arterial hypertension (PAH).
Uses
Treatment of pulmonary arterial hypertension (PAH) in patients with severe heart failure.
Unlabeled Uses
Severe intermittent claudication
Contraindications
Severe hepatic insufficiency; hypersensitivity to treprostinil.
Cautious Use
Mild or moderate hepatic insufficiency; bleeding disorders; concurrent use of anticoagulants, NSAIDs, hypotensive drugs (e.g., diuretics, antihypertensive agents, etc.); renal disease, renal impairment, renal failure; lactation, pregnancy (category B); elderly. Safety and efficacy in children <16 y are not established.
Route & Dosage
| Pulmonary Arterial Hypertension Adult (>16 y): SC 1.25 ng/kg/min. If dose is not tolerated, reduce to 0.625 ng/kg/min. Then increase rate by no more than 1.25 ng/kg/min/wk for first 4 wk, then by 2.5 ng/kg/min/wk until achieve desired response. There is little experience with doses >40 ng/kg/min. Transition from Epoprostenol to Treprostinil Adult (>16 y): SC While still receiving IV epoprostenol, initiate a dose of SC treprostinil no greater than one-half of the current epoprostenol dose (generally ≤5 ng/kg/min). Maintain treprostinil at this dose for at least 6 h. During this time, reduce the epoprostenol dose in no greater than 2 ng/kg/min decrements, based on appearance of prostacyclin-related signs and symptoms. Continue to increase treprostinil dose by no more than one-half of the current dose and maintain for 6 h while reducing epoprostenol dose by no greater than 2 ng/kg/min decrements until epoprostenol is discontinued. |
Administration
Subcutaneous- Initiate therapy only in a setting with adequate personnel and equipment for physiological monitoring and emergency.
- Administer Remodulin undiluted.
- Avoid abrupt withdrawal or sudden large reductions in dosage as these may lead to worsening of PAH symptom.
- Note that in patients with mild to moderate hepatic insufficiency, the initial dose of should be 0.625 ng/kg/min ideal body weight and should be increased cautiously.
- Store at 15°–25° C (59°–77° F).
Adverse Effects (≥1%)
Body as a Whole: Jaw pain, flushing, syncope. CNS: Headache, dizziness. CV: Vasodilation, edema, hypotension. GI: Diarrhea, nausea, vomiting. Skin: Rash, pruritus. Other: Infusion site reactions (erythema, hematoma, induration, pruritus, rash, injection site pain).Interactions
Drug: nsaids, anticoagulants may increase risk of bleeding; antihypertensive agents, diuretics, vasodilators may exacerbate hypotension; ephedrine, pseudoephedrine may antagonize antihypertensive effects. Herbal: Ephedra, ma huang may antagonize antihypertensive effects.Pharmacokinetics
Absorption: Completely absorbed from SC site. Onset: Steady state reached in 10 h. Metabolism: Extensively in liver by unknown enzyme system. Elimination: 79% in urine, 13% in feces. Half-Life: 2–4 h.Nursing Implications
Assessment & Drug Effects
- Monitor for therapeutic effectiveness indicated by less dyspnea and fatigue, increased activity tolerance, and improved hemodynamic parameters.
- Monitor for and report symptoms of excessive response to the drug including: headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction (e.g., erythema, induration or rash). If these occur, the rate of SC infusion should be slowed.
- Monitor BP closely, especially if taking concurrent antihypertensive drugs (e.g., diuretics, vasodilators).
- Lab tests: Baseline and periodic LFTs and renal function tests. Monitor periodically coagulation parameters (more often if on concurrent anticoagulation therapy).
Patient & Family Education
- Note: Therapy with this drug may be needed for prolonged periods, possibly years.
- Report any of the following: headache, nausea, vomiting, restlessness, anxiety, and infusion site pain.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug