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U.S. Department of Health and Human Services

Safety

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Ventavis (iloprost) inhalation solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010 and April 2012

 

April 2012

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
 
FROM:
  • Cases of epistaxis and gingival bleeding have been reported within one month of starting Ventavis treatment. Cases of dizziness, diarrhea, mouth and tongue irritation, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.
TO:
  • Bleeding events most commonly reported as epistaxis and hemoptysis were observed on Ventavis treatment [see Drug Interactions (7.3)]. Cases of thrombocytopenia, dizziness, diarrhea, mouth and tongue irritation, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.
 

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • In rats a passage of low levels of iloprost or metabolites in to the milk was observed (less than 1% of iloprost dose given intravenously). No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.
 

PATIENT INFORMATION

What are the ingredients in Ventavis?
  • Ventavis is a clear, colorless solution

 

April 2010 

Summary View

 

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.