The power of flexibility is yours
with REVATIO Oral Suspension
With REVATIO you have 3 dosage forms to treat pulmonary arterial
hypertension (PAH): oral suspension, tablet, and injection.
Choose your dosage form based on each patient’s needs.
To learn more, please visit REVATIOHCP.com
Indication
REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of
pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise
ability and delay clinical worsening. Studies establishing effectiveness were shortterm (12 to 16 weeks), and included predominately patients with NYHA Functional
Class II-III symptoms. Etiologies were idiopathic (71%) or associated with
connective tissue disease (25%).
treatment of erectile dysfunction, including sildenafil. Physicians should advise
patients to seek immediate medical attention in the event of sudden loss of vision
while taking PDE5 inhibitors, including REVATIO. Physicians should also discuss
the increased risk of NAION with patients who have already experienced NAION
in one eye, including whether such individuals could be adversely affected by use
of vasodilators, such as PDE-5 inhibitors.
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any
beneficial effect on exercise capacity.
Sudden decrease or loss of hearing has been reported in temporal association
with the intake of PDE5 inhibitors, including REVATIO. It is not possible to
determine whether these events are related directly to the use of PDE5 inhibitors
or to other factors. Physicians should advise patients to seek prompt medical
attention in the event of sudden decrease or loss of hearing while taking PDE5
inhibitors, including REVATIO.
Important Safety Information
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.
REVATIO is contraindicated in patients with concomitant use of riociguat, a
soluble guanylate cyclase (sGC) stimulator medication. PDE5 inhibitors, including
sildenafil, may potentiate the hypotensive effects of riociguat.
REVATIO is contraindicated in patients with a known hypersensitivity to sildenafil
or any other ingredient in REVATIO. Hypersensitivity, including anaphylactic
reaction, anaphylactic shock, and anaphylactoid reaction has been reported in
association with the use of sildenafil.
Use of REVATIO, particularly chronic use, is not recommended in children.
Before starting REVATIO, physicians should carefully consider whether their
patients with underlying conditions could be adversely affected by the mild
and transient vasodilatory effects of REVATIO on blood pressure. Pulmonary
vasodilators may significantly worsen the cardiovascular status of patients
with pulmonary veno-occlusive disease (PVOD) and administration of REVATIO
to these patients is not recommended. Should signs of pulmonary edema occur
when sildenafil is administered, the possibility of associated PVOD should
be considered.
Caution is advised when PDE5 inhibitors, such as REVATIO, are administered with
α–blockers as both are vasodilators with blood pressure lowering ef