Intravenous Formulation Treats Pulmonary Arterial Hypertension


November 23, 2009

An intravenous formulation of Revatio (sildenafil) Injection is now available for the treatment of adult patients with pulmonary arterial hypertension to improve exercise ability and delay clinical worsening.

Pfizer said the drug is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. The injectable version was cleared by the FDA in November 2009.

The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio tablets but who are temporarily unable to take oral medication.

Revatio Injection will be supplied in a single-use vial. The recommended dose of Revatio Injection is 10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. Revatio is also available as a 20 mg tablet taken three times a day.

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