VELETRI is a prostanoid vasodilator 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. (1)
DOSAGE AND ADMINISTRATION

• Dosage

  -

  Infusion of VELETRI should be initiated at 2 ng/kg/min and increased in increments of 2 ng/kg/min every 15 minutes or longer until dose-limiting pharmacologic effects are elicited or until a tolerance limit to the drug is established. ( 2.1)

  -

  If symptoms of pulmonary hypertension persist or recur after improving - the infusion should be increased by 1- to 2-ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 minutes. ( 2.2)

• Administration

  -

  VELETRI is administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. ( 2.3)

  -

  Do not mix with any other parenteral medications or solutions prior to or during administration. ( 2.4)

• Reconstitution

  -

  Reconstituted in vial with only 5 mL of either Sterile Water for Injection or Sodium Chloride 0.9% Injection.

  -

  VELETRI solution reconstituted and immediately diluted to the final concentration in the drug delivery reservoir can be administered per the conditions of use as outlined in Table 1. ( 2.4 )

  -

  Solution for chronic delivery should be prepared in a drug delivery reservoir appropriate for the infusion pump. ( 2.4)

10 mL vial with 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) VELETRI. (3)
CONTRAINDICATIONS

• VELETRI should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension. (5.1)
• Reconstitute only as directed, with Sterile Water for Injection or Sodium Chloride 0.9% Injection.(5.1)
• Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored. (5.3, 5.4)

• Most common adverse reactions during:

  -

  Dose Initiation and Escalation: Nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia ( 6.1)

  -

  Chronic Dosing: Headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, please contact: ACTELION at 1-866-228-3546 or FDA at 1-800-FDA-1088, or http://www.fda.gov/medwatch

• Diuretics, antihypertensive agents, or other vasodilators: reduction in blood pressure (7)
• Antiplatelet agents or anticoagulants: increase the risk of bleeding (7)
• Patients on digoxin: elevations of digoxin concentrations clinically significant in patients prone to digoxin toxicity (7)