Important Safety Information For

• VENTAVIS^®

  VENTAVIS^® is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%).

  WARNINGS AND PRECAUTIONS

  RISK OF SYNCOPE

  • Monitor vital signs while initiating VENTAVIS^®. Do not initiate VENTAVIS^® in patients with systolic blood pressure below 85 mmHg.
  • Syncope can also occur in association with pulmonary arterial hypertension, particularly in association with physical exertion. The occurrence of exertional syncope may reflect a therapeutic gap or insufficient efficacy, and the need to adjust dose or change therapy should be considered.

  PULMONARY VENOUS HYPERTENSION

  • Stop VENTAVIS^® immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.

  BRONCHOSPASM

  • VENTAVIS^® inhalation can induce bronchospasm. Bronchospasm may be more severe or frequent in patients with a history of hyperreactive airways.
  • VENTAVIS^® has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.

  ADVERSE REACTIONS

  SERIOUS ADVERSE EVENTS

  • Serious adverse events reported include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

  Adverse Events

  • Adverse events reported in a Phase 3 clinical trial occurring with a ≥3% difference between VENTAVIS^® patients and placebo patients were vasodilation (flushing) (27% vs 9%), increased cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), insomnia (8% vs 2%), nausea (13% vs 8%), hypotension (11% vs 6%), vomiting (7% vs 2%), alkaline phosphatase increased (6% vs 1%), flu syndrome (14% vs 10%), back pain (7% vs 3%), tongue pain (4% vs 0%), palpitations (7% vs 4%), syncope (8% vs 5%), GGT increased (6% vs 3%), muscle cramps (6% vs 3%), hemoptysis (5% vs 2%), and pneumonia (4% vs 1%).

  DRUG INTERACTIONS

  ANTIHYPERTENSIVES AND VASODILATORS

  • VENTAVIS^® has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.

  ANTICOAGULANTS AND PLATELET INHIBITORS

  • VENTAVIS^® has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.

  USE IN SPECIFIC POPULATIONS

  LACTATION

  • Advise not to breastfeed during treatment with VENTAVIS^®.

  Please read full Prescribing Information.

  cp-134777v2

  INDICATION