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VELETRI Enrollment Forms

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How VELETRI® (epoprostenol) is distributed

VELETRI is not available through local pharmacies; rather, it is carried by specialty pharmacies. Actelion has partnered with Accredo Health Group, Inc.* and CVS Specialty,* who are specialty pharmacies that ship VELETRI, along with needed supplies, directly and conveniently to your patient's home or your office each month.

Once you've prescribed VELETRI and faxed a completed patient enrollment form to the appropriate certified specialty pharmacy, Accredo Health Group, Inc. or CVS Specialty will verify the prescription and begin to ship VELETRI to your patient’s home or your office.

Specialty pharmacy services

Many specialty pharmacies have developed tools to help patients and healthcare providers keep track of treatment. These include call centers, websites, and apps that allow patients to:

  • Manage prescriptions and deliveries
  • Review insurance coverage
  • Track their spending
  • Connect with support services

Specialty pharmacies that offer VELETRI

The following are specialty pharmacies for VELETRI:

Name Phone
Accredo 1-866-344-4874
CVS Specialty 1-877-242-2738 

(Last updated October 2017)

For information on any changes to the list of VELETRI certified pharmacies, speak with an Actelion Pathways® Case Manager today by calling 1-866-ACTELION (1-866-228-3546) Mon-Fri, 8 am-8 pm ET.

*Accredo Health Group, Inc. and CVS Specialty are independent specialty pharmaceutical service providers that provide medications and related services in the home setting. Accredo and CVS Specialty have been contracted by Actelion Pharmaceuticals to distribute VELETRI.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VELETRI® (epoprostenol) for Injection is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

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Indication

VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases (CTD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VELETRI® (epoprostenol) for Injection is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

VELETRI should not be used chronically in patients who during dose initiation develop pulmonary edema, which may be associated with pulmonary veno-occlusive disease.

VELETRI is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.

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Indication

VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases (CTD).

WARNINGS AND PRECAUTIONS

General

Reconstitute VELETRI only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI with any other parenteral medications or solutions prior to or during administration. Each vial is for single use only; discard any unused solution. Use after reconstitution and immediate dilution to final concentration. Use at room temperature (77°F/25°C). Do not expose VELETRI to direct sunlight.

VELETRI should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.

Dose Initiation

VELETRI is a potent pulmonary and systemic vasodilator. Initiate VELETRI in a setting with adequate personnel and equipment for physiologic monitoring and emergency care. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.

Chronic Use and Dose Adjustment

During chronic use, deliver VELETRI continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, administer anticoagulant therapy to patients receiving VELETRI to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. To reduce the risk of infection, use aseptic technique in the reconstitution and administration of VELETRI and in routine catheter care.

Because epoprostenol is metabolized rapidly, even brief interruptions in the delivery of VELETRI may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Intravenous therapy with VELETRI will likely be needed for prolonged periods, possibly years, so consider the patient’s capacity to accept and care for a permanent intravenous catheter and infusion pump.

Dosage of VELETRI during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with epoprostenol. Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours.

Withdrawal Effects

Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of VELETRI may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia. Abrupt withdrawal should be avoided.

ADVERSE EVENTS

The most common and dose-limiting adverse events during dose initiation and escalation (≥1%) were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), anxiety/nervousness/agitation (11%), chest pain (11%), dizziness (8%), bradycardia (5%), abdominal pain (5%), musculoskeletal pain (3%), dyspnea (2%), back pain (2%), sweating (1%), dyspepsia (1%), hypesthesia/paresthesia (1%), and tachycardia (1%).

Adverse events occurring in patients with idiopathic or heritable PAH with ≥10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).

Adverse events occurring in patients with PAH/CTD with ≥10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).

Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol.

Potential adverse events from postmarketing evaluations include anemia, hypersplenism, pancytopenia, splenomegaly, and hyperthyroidism.

Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.

DRUG INTERACTIONS

Additional reductions in blood pressure may occur when VELETRI is administered with diuretics, antihypertensive agents, or other vasodilators. When other antiplatelet agents or anticoagulants are used concomitantly, there is the potential for VELETRI to increase the risk of bleeding. However, patients receiving infusions of epoprostenol in clinical trials were maintained on anticoagulants without evidence of increased bleeding. In clinical trials, epoprostenol was used with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen.

Please see full Prescribing Information.