Label Changes for:

Ventavis (iloprost) inhalation solution

April 2010

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010

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.

ADVERSE REACTIONS

Postmarketing Experience
  • Cases of dizziness, diarrhea, mouth and tongue irritation, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Ventavis has been shown to be teratogenic in rats as described below.
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