Davis's Drug Guide

treprostinil

General

Pronunciation
tre-PROSS-ti-nil

Trade Name(s)

• Remodulin



Pregnancy Category
Category B

Ther. class.
vasodilators

Pharm. class.
prostacyclins

Indications

Treatment of pulmonary arterial hypertension in patients with New York Heart Association (NYHA) class II—IV symptoms

Action

• Treprostinil is a prostacyclin that produces direct vasodilation of pulmonary and systemic arterial vascular beds

• Also inhibits platelet aggregation



Therapeutic Effect(s):
Decreased exercise-associated symptoms in patients with pulmonary arterial hypertension

Pharmacokinetics

Absorption: Rapidly and completely (near 100%) absorbed following subcut administration

Distribution: Unknown

Protein Binding: 91%

Metabolism and Excretion: Extensively metabolized by the liver, metabolites are renally excreted; minimal excretion of unchanged drug in urine

Half-life: 4 hr

TIME/ACTION PROFILE (clinical improvement)

ROUTEONSETPEAKDURATION
Subcutunknown1 wkunknown

Contraindication/Precautions

Contraindicated in:
Known hypersensitivity

Use Cautiously in:

• Renal impairment

• Hepatic impairment (dose reduction recommended in mild to moderate hepatic insufficiency; data not available for severe hepatic insufficiency)

• Avoid abrupt discontinuation or rapid dosage reduction

• Pregnancy (use only if clearly needed)

• Lactation or children <=16 yr

Adverse Reactions/Side Effects

CNS: dizziness, headache.

CV: vasodilation, hypotension, edema.

GI: diarrhea, nausea.

Derm: rash, pruritus, flushing.

Local: infusion site pain/reaction.

MS: jaw pain.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Increased risk of hypotension with antihypertensives, diuretics, or vasodilators

• Risk of bleeding may be increased by concurrent use of anticoagulants

Route/Dosage

SC (Adults): 1.25 ng/kg/min, may be reduced to 0.625 ng/kg/min if intolerance occurs. Increments of no more than 1.25 ng/kg/min may be made weekly for the first 4 wk and then no more than 2.5 ng/kg/min weekly for the remainder of therapy up to 40 ng/kg/min. Avoid abrupt discontinuation or rapid decrease in dosing. Infusion rate may be calculated with the following formula: Infusion rate (ml/hr) = Dose (ng/kg/min) × weight (kg) × [0.00006/treprostinil dose strength concentration (mg/ml) ].

Availability

Solution for continuous subcut administration (no dilution required): 1 mg/ml in 20–ml vials, 2.5 mg/ml in 20–ml vials, 5 mg/ml in 20–ml vials, 10 mg/ml in 20–ml vials

Assessment

• Monitor patient for signs of improvement in pulmonary arterial hypertension (decrease in dyspnea, increased exercise tolerance) periodically throughout therapy

• Assess patient for infusion site reactions (pain, erythema, induration, rash) throughout therapy

Potential Nursing Diagnoses

• Activity intolerance (Indications)

• Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

• Treprostinil should be used only by physicians experienced in the treatment of pulmonary arterial hypertension. Initiation of therapy should be in a setting equipment and personnel for monitoring and emergency treatment

» Assess patient's ability to accept and administer treprostinil, and insert and care for infusion system prior to initiating therapy

» Dose should be increased for lack of improvement or worsening in symptoms, or decreased for excessive side effects or infusion site reactions

» Avoid abrupt withdrawal or large dose reductions; may result in worsening of symptoms of pulmonary arterial hypertension

SC: Administer without diluting solution via a self-inserted subcut catheter and an infusion pump designed for subcut drug delivery. During use, a single syringe can be administered up to 72 hr. A single vial should be used for up to 14 days after initial introduction into vial. Do not administer solutions that are discolored or contain particulate matter. Refer to manufacturer's instructions

Rate: See Route and Dosage section

Patient/Family Teaching

• Instruct patient on insertion of catheter and use of pump. Patient must have immediate access to a backup infusion pump and subcut infusion sets to prevent potential interruptions in drug delivery

• Inform patient that subsequent disease management may require IV therapy

• Instruct patient to inform health care professional if headache, nausea, vomiting, restlessness, anxiety, or infusion site reactions occur

• Inform patient and family that therapy may be required for years to control disease

Evaluation/Desired Outcomes

Improved exercise tolerance in patients with pulmonary arterial hypertension



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