Brief Summary of Prescribing Information.
Consult Full Prescribing Information at REVATIOHCP.com
INDICATION AND USAGE
REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in
adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening
was demonstrated when REVATIO was added to background epoprostenol therapy.
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately
patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic
etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect
on exercise capacity.
DOSAGE AND ADMINISTRATION
REVATIO Tablets and Oral Suspension The recommended dose of REVATIO is 5 mg or 20 mg
three times a day. Administer REVATIO doses 4–6 hours apart. In the clinical trial no greater
efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg
three times a day is not recommended.
Reconstitution of the Powder for Oral Suspension 1. Tap the bottle to release the powder.
2. Remove the cap. 3. Accurately measure out 60 mL of water and pour the water into the bottle.
4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. 5. Remove the
cap. 6. Accurately measure out another 30 mL of water and add this to the bottle. You should always
add a total of 90 mL of water irrespective of the dose prescribed. 7. Replace the cap and shake the
bottle vigorously for a minimum of 30 seconds. 8. Remove the cap. 9. Press the bottle adaptor into
the neck of the bottle. The adaptor is provided so that you can fill the oral syringe with medicine
from the bottle. Replace the cap on the bottle. 10. Write the expiration date of the constituted
oral suspension on the bottle label (the expiration date of the constituted oral suspension is 60
days from the date of constitution).
Incompatibilities Do not mix with any other medication or additional flavoring agent.
CONTRAINDICATIONS
REVATIO is contraindicated in patients with concomitant use of organic nitrates in any form,
either regularly or intermittently, because of the greater risk of hypotension [see Warnings and
Precautions], Concomitant use of riociguat, a guanylate cyclase stimulator. PDE5 inhibitors,
including sildenafil, may potentiate the hypotensive effects of riociguat. REVATIO is also
contraindicated in patients with known hypersensitivity to sildenafil or any component of
the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction,
anaphylactic shock and anaphylactoid reaction, has been reported in association with the use
of sildenafil.
WARNINGS AND PRECAUTIONS
Mortality with Pediatric Use In a long-term trial in pediatric patients with PAH, an increase in
mortality with increasing REVATIO dose was observed. Deaths were first observed after about
1 year and causes of death were typical of patients with PAH. Use of REVATIO, particularly
chronic use, is not recommended in children [see Use in Specific Populations].
Hypotension REVATIO has vasodilatory properties, resulting in mild and transient decreases in
blood pressure. Before prescribing REVATIO, carefully consider whether patients with certain
underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on
antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe
left ventricular outflow obstruction, or automatic dysfunction). Monitor blood pressure when coadministering blood pressure lowering drugs with REVATIO.
Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly
worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since
there are no clinical data on administration of REVATIO to patients with veno-occlusive disease,
administration of REVATIO to such patients is not recommended. Should signs of pulmonary
edema occur when REVATIO is administered, consider the possibility of associated PVOD.
Epistaxis The incidence of epistaxis was 13% in patients taking REVATIO with PAH secondary
to CTD. This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients. The
incidence of epistaxis was also higher in REVATIO-treated patients with a concomitant oral
vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).
The safety of REVATIO is unknown in patients with bleeding disorders or active peptic ulceration.
Visual Loss When used to treat erectile dysfunction, non-arteritic anterior ischemic optic
neuropathy (NAION), a cause of decreased vision including permanent loss