treprostinil

(redirected from Remodulin)

treprostinil (parenteral)

(tre-pross-ti-nil) ,

Remodulin

(trade name)

treprostinil (inhalation)

,

Tyvaso

(trade name)

Classification

Therapeutic: vasodilators
Pharmacologic: prostacyclins
Pregnancy Category: B

Indications

Intravenous: Pulmonary arterial hypertension (WHO Group I).Pulmonary arterial hypertension in patients requiring transition from epoprostenol. Inhalation: Pulmonary arterial hypertension (WHO Group I).

Action

Treprostinil is a prostacyclin that produces direct vasodilation of pulmonary and systemic arterial vascular beds.
Also inhibits platelet aggregation.

Therapeutic effects

Decreased exercise-associated symptoms in patients with pulmonary arterial hypertension.

Pharmacokinetics

Absorption: Rapidly and completely (near 100%) absorbed following subcut administration; bioavailability after inhalation is 64–72%.
Distribution: Unknown.
Protein Binding: 91%.
Metabolism and Excretion: Extensively metabolized by the liver (by CYP2C8), metabolites are renally excreted; minimal excretion of unchanged drug in urine.
Half-life: 4 hr.

Time/action profile (clinical improvement)

ROUTEONSETPEAKDURATION
Subcut/IVunknown1 wkunknown
Inhalnunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Known hypersensitivity.
Use Cautiously in: Renal impairment; Hepatic impairment (dose ↓ recommended in mild to moderate hepatic insufficiency; data not available for severe hepatic insufficiency); Pulmonary disease (inhalation only); Avoid abrupt discontinuation or rapid dose reduction; Obstetric: Use only if clearly needed; Lactation / Pediatric: Lactation, children ≤16 yr (parenteral), or children <18 yr (inhalation).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache (most frequent)

Cardiovascular

  • vasodilation (most frequent)
  • hypotension
  • edema

Gastrointestinal

  • diarrhea (most frequent)
  • nausea (most frequent)

Dermatologic

  • rash (most frequent)
  • pruritus
  • flushing

Hematologic

  • bleeding

Local

  • infusion site pain/reaction (most frequent)

Musculoskeletal

  • jaw pain (most frequent)

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

↑ risk of hypotension with antihypertensives, diuretics, or vasodilators.Effects may be ↑ by gemfibrozil.Effects may be ↓ by rifampin.Risk of bleeding may be ↑ by concurrent use of anticoagulants.

Route/Dosage

Subcutaneous Intravenous (Adults) Naive to prostacyclin therapy–1.25 ng/kg/min, may be ↓ 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. Avoid abrupt discontinuation or rapid ↓ in dosing; Patients requiring transition from epoprostenol—Initiate at 10% of current epoprostenol dose; ↑ dose as epoprostenol dose is ↓. Subcutaneous infusion rate may be calculated with the following formula: Subcutaneous infusion rate (mL/hr) = [Dose (ng/kg/min) × weight (kg) × 0.00006]/treprostinil vial strength (mg/mL).

Hepatic Impairment

Subcutaneous Intravenous (Adults) Mild or moderate hepatic impairment-↓ initial dose to 0.625 ng/kg/min (using ideal body weight).
Inhalation (Adults) 3 breaths (18 mcg) 4 times daily; may ↑ by 3 breaths/treatment every 1–2 wk until target dose of 9 breaths (54 mcg) 4 times daily is achieved.

Availability

Solution for injection: 1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL
Solution for oral inhalation: 0.6 mg/mL

Nursing implications

Nursing assessment

  • Monitor patient for signs of improvement in pulmonary arterial hypertension (decrease in dyspnea, increased exercise tolerance) periodically during therapy.
  • Intravenous: Assess patient for infusion site reactions (pain, erythema, induration, rash) during therapy.
  • Inhalation: Monitor BP during therapy. May cause hypotension.

Potential Nursing Diagnoses

Activity intolerance (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Treprostinil should be used only by clinicians 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.
    • Subcut route is preferred. IV route may be used if subcut route is not tolerated due to severe site pain or reaction.
    • Avoid abrupt withdrawal or large dose reductions; may result in worsening of symptoms of pulmonary arterial hypertension.
  • Subcutaneous: 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.
  • Intravenous Administration
  • Continuous Infusion: Administer via a surgically placed indwelling central venous catheter, using an 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. Use of a peripheral IV infusion for more than a few hours increases risk of thrombophlebitis.Diluent: 50–100 mL of sterile water for injection, 0.9% NaCl, Sterile Diluent for Flolan or Sterile Diluent for Eproprostenol Sodium. Do not administer solutions that are discolored or contain particulate matter.Concentration: Amount of diluent and concentration is calculated based on dose needed, patient, weight, and volume of reservoir. Diluted solutions are stable for up to 48 hr in concentrations as low as 0.004 mg/mL at room temperature. Refer to manufacturer's instructions.
  • Rate: Administer via infusion set with in-line 0.22 or 0.2 micron pore size filter. See Route and Dosage section.
  • Inhalation: Use only with the Tyvaso Inhalation System. Administer undiluted, as supplied. Solution is clear and colorless to slightly yellow. Do not administer solutions that are discolored or contain particulate matter. Do not mix with other medications. Single breath delivers approximately 6 mcg of treprostinil. Administer in 4 separate treatments each day approximately four hours apart, during waking hours. If initial 3 breaths are not tolerated, may decrease to 1 or 2 breaths. One ampule of Tyvaso contains a sufficient volume of medication for all 4 treatment sessions in a single day. Prior to first treatment session, twist top off a single ampule and squeeze entire contents into medicine cup. Cap device and store upright with remaining medication inside between each of the 4 daily treatment sessions. Discard medicine cup and any remaining medication at end of each day and clean device according to instructions.

Patient/Family Teaching

  • 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.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected.
  • Intravenous: 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.
  • Subcutaneous: Inform patient that subsequent disease management may require an alternative form of IV therapy.
  • Inhalation: Train patient in dosing, Tyvaso device set up, operation, cleaning, and maintenance, according to the instructions for use. Obtain access to a back-up Tyvaso device to avoid potential interruptions in drug delivery due to equipment malfunction. If a scheduled treatment session is missed or interrupted, resume therapy as soon as possible. Avoid skin and eye contact with solution.

Evaluation/Desired Outcomes

  • Improved exercise tolerance in patients with pulmonary arterial hypertension.

treprostinil

an antiplatelet agent used to treat pulmonary arterial hypertension.
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The FDA also approved three more drugs, Remodulin, Ventavis, and Revatio in 2002, 2004 and 2005 respectively for the treatment of PAH.
We begin this year impressively, with continued strong growth in revenues and operating results, which are primarily due to increased use of Remodulin and Tyvaso," said Martine Rothblatt, Ph.
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United Therapeutics Corporation (NASDAQ:UTHR) has been informed that the General Commission of the French Regulatory Agency has recommended that Remodulin not be approved in France based on insufficient demonstration of clinical efficacy for the claimed indication.
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Our increased stock price also highlights our mature pipeline, which has the potential for further growth through continued market penetration by Remodulin, our recent launch of Adcirca, the only once-daily PDE-5 inhibitor for PAH, and the expected launch of Tyvaso, our now FDA-approved inhaled prostacyclin analogue.
SILVER SPRING, Maryland and RESEARCH TRIANGLE PARK, North Carolina, March 8 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that AFSSAPS, the French drug regulatory agency, has issued an approval letter for Remodulin (treprostinil sodium) Injection for subcutaneous treatment of NYHA Class III Primary Pulmonary Hypertension patients.
Food and Drug Administration has issued new timelines for completion of a required Phase IV postmarketing study to further assess the clinical benefits of Remodulin, United Therapeutics' approved therapy for pulmonary arterial hypertension.