Flolan


Also found in: Dictionary.

epoprostenol

(e-poe-pross-te-nole) ,

Flolan

(trade name),

Prostacyclin

(trade name),

Prostaglandin I2 (PGI2)

(trade name),

Prostaglandin X (PGX)

(trade name),

Veletri

(trade name)

Classification

Therapeutic: vasodilators
Pharmacologic: prostaglandins
Pregnancy Category: B

Indications

Pulmonary arterial hypertension (WHO Group 1).

Action

A prostaglandin that directly dilates pulmonary and systemic arterial vasculature.
Also inhibits platelet aggregation.

Therapeutic effects

Improved exercise capacity.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Rapidly and extensively degraded in plasma; some metabolites are pharmacologically active.
Half-life: ≤6 min.

Time/action profile (hemodynamic effects)

ROUTEONSETPEAKDURATION
IVrapid (within min)unknown2–3 min†
†Following discontinuation

Contraindications/Precautions

Contraindicated in: Hypersensitivity to epoprostenol or similar compounds; HF due to severe left ventricular systolic dysfunction; Patients who develop pulmonary edema during dose initiation.
Use Cautiously in: Geriatric: Dose adjustments may be necessary; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety (most frequent)
  • headache (most frequent)
  • dizziness (most frequent)

Respiratory

  • dyspnea
  • pulmonary edema

Cardiovascular

  • tachycardia (most frequent)
  • chest pain (most frequent)
  • hypotension (most frequent)
  • bradycardia

Gastrointestinal

  • nausea (most frequent)
  • vomiting (most frequent)
  • abdominal pain (most frequent)
  • diarrhea (most frequent)

Dermatologic

  • flushing (most frequent)
  • rash

Musculoskeletal

  • myalgia (most frequent)
  • jaw pain (most frequent)

Hematologic

  • bleeding
  • thrombocytopenia

Neurologic

  • hypesthesia/hyperesthesia/paresthesia (most frequent)

Miscellaneous

  • flu-like symptoms (most frequent)
  • injection site reactions
  • sweating

Interactions

Drug-Drug interaction

Additive hypotension may occur with antihypertensives, diuretics, or other vasodilators.Although concurrent use is common and accepted, risk of bleeding may be ↑ by anticoagulants or other agents affecting platelet function.May ↑ levels of digoxin.

Route/Dosage

Intravenous (Adults) Initiate at 2 ng/kg/min; may ↑ by 2 ng/kg/min every 15 min or longer until dose-limiting adverse effects (e.g. nausea, vomiting, headache, abdominal pain, flushing, or dyspnea) or a tolerance to the effects of the drug are noted. If dose-limiting adverse effects occur, infusion rate may be ↓ in decrements of 2 ng/kg/min at intervals of at least 15 min. Changes in infusion rate should be based upon persistance, recurrence, or worsening of symptoms and/or emergence of adverse reactions. Abrupt withdrawal or large reductions in infusion rate should be avoided.

Availability (generic available)

Powder for injection: 0.5 mg/vial, 1.5 mg/vial

Nursing implications

Nursing assessment

  • Monitor hemodynamic parameters (cardiac index, mean pulmonary arterial pressure, pulmonary vascular resistance, total pulmonary resistance, mean systemic arterial pressure) frequently during acute dose ranging and periodically during chronic infusion.
  • Acute Dose Ranging: Monitor for dose-limiting side effects (nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, tachycardia) frequently.
  • Chronic Infusion: Monitor BP (supine and standing) and heart rate closely for several hours after dose adjustments.
    • Make dose adjustments during chronic therapy at the first sign of recurrence or worsening of symptoms of pulmonary hypertension or adverse effects of epoprostenol. Most common adverse effects occurring during chronic therapy include headache, jaw pain, flushing, diarrhea, nausea, vomiting, flu-like symptoms, and anxiety.
  • Lab Test Considerations: May cause thrombocytopenia.

Potential Nursing Diagnoses

Decreased cardiac output (Indications)
Ineffective tissue perfusion (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Intravenous Administration
  • Anticoagulant therapy is usually administered concurrently, unless contraindicated, to decrease the risk of pulmonary or systemic embolism.
    • Administer via peripheral infusion during acute dose ranging and by chronic continuous infusion via Broviac or Hickman central venous catheter using a programmable ambulatory infusion pump for chronic administration.
  • Continuous Infusion: Diluent: For either the 3000- or 5000-ng/mL concentration, dissolve contents of one 0.5-mg vial with 5 mL of sterile diluent for epoprostenol. Withdraw 3 mL for the 3000-ng/mL concentration and the entire vial contents for the 5000-ng/mL concentration and add to a sufficient quantity of sterile diluent for epoprostenol to make a total of 100 mL. Concentration: 3000 ng/mL or 5000 ng/mL. Diluent: For the 10,000-ng/mL concentration, dissolve the contents of two 0.5-mg vials with 5 mL each of sterile diluent for epoprostenol. Withdraw the entire vial contents, and add to a sufficient quantity of sterile diluent for epoprostenol to make a total of 100 mL. Concentration: 10,000 ng/mL. Diluent: For the 15,000-ng/mL concentration, dissolve the contents of the 1.5-mg vial with 5 mL of sterile diluent for epoprostenol or with 5 mL of 0.9% NaCl or Sterile Water for Injection if using Veletri. Withdraw the entire contents of the vial, and add to a sufficient quantity of sterile diluent for epoprostenol to make a total of 100 mL; use same diluent as for reconstitution with Veletri. Use only sterile diluent provided by manufacturer for dilution (except with Veletri). Do not reconstitute or mix with any other parenteral medications or solutions. Concentration: 15,000 ng/mL.
    • May require more than one solution strength during acute dose ranging. Usually 3000 and 10,000 ng/mL are used to deliver an infusion rate between 2–16 ng/kg/min.
    • Unopened vials and reconstituted solutions must be protected from light. Reconstituted solutions are Stable for 8 hr at room temperature or 48 hr if refrigerated. Do not freeze. Discard any reconstituted solution that has been frozen, has been refrigerated more than 48 hr, or has been at room temperature for more than 8 hr.
    • Solutions have been administered while in cold pouches. May be administered while in cold pouches with frozen gel packs over 24 hr, with gel packs changed every 12 hr.
  • Rate: Infusion rate usually ranges from 2–16 ng/kg/min in adults.

Patient/Family Teaching

  • Home Care Issues: Instruct patient on reconstitution, administration, and care of the permanent central venous catheter.
  • Advise patient of the importance of continuous therapy. Inform patient that even brief interruptions of the infusion may cause symptoms of rebound pulmonary hypertension (dyspnea, dizziness, asthenia). Provide patient with access to a backup infusion pump and intravenous infusion sets to prevent potential interruptions in drug delivery. Also inform patients that therapy may be prolonged, possibly lasting years.

Evaluation/Desired Outcomes

  • Increase in cardiac index and stroke volume and decrease in pulmonary vascular resistance, total pulmonary resistance, and mean systemic arterial pressure in patients with PPH.

Flolan

A brand name for EPOPROSTENOL.
References in periodicals archive ?
Flolan is delivered in a powdered form that must be protected from light and reconstituted with a sterile diluent.
A randomized controlled trial of epoprostenol therapyforsevere congestive heartfailure: The Flolan International Randomized Survival Trial (FIRST).
Epoprostenol/Veletri, Flolan, Remodulin, Selexipag, Tyvaso &
Myogen is a big player in PAH already with Flolan, but could really capture big market share in the category once phase III product ambrisentan comes to market.
Actelion will also provide further information on VELETRI at the American Heart Association Scientific Sessions 2010 in Chicago with a poster entitled "Biocomparability of Two Formulations of Epoprostenol, Epoprostenol for Injection (ACT-385781A) And Flolan, Via Pharmacokinetic Assessment of Two Primary Metabolites.
In patients with PAH requiring transition from Flolan (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration.
The new report entitled Pulmonary Arterial Hypertension: Of Five Emerging Agents, Only One Promises the Efficacy that Pulmonologists Demand also finds that Novartis's Gleevec will earn Decision Resources' proprietary clinical gold standard status for the treatment of pulmonary arterial hypertension disease by 2011 as interviewed pulmonologists indicate that Gleevec has competitive advantages in measures of safety and delivery over the current clinical gold standard, GlaxoSmithKline/Gilead's Flolan.
Flolan was approved in 1995 and is indicated for the long-term intravenous treatment of primary pulmonary hypertension.
The Phase 4 study, which was successfully completed last year, involved the transition of patients from Flolan to either Remodulin or placebo.
With the launch of Flolan commercial operations and with our PAH-focused sales force now fully engaged, we have taken an important step forward in our growth as a commercial company.
Specifically, 13 of 14 patients (93%) in the Remodulin arm were able to successfully transition from Flolan and complete the study without the need to institute rescue therapy, compared to only 1 of 7 patients (14%) in the placebo arm.