CardioSource WorldNews - Page 31
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
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
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
Caution is advised when PDE5 inhibitors, such as REVATIO, are administered with
α–blockers as both are vasodilators with blood pressure lowering effects.
In PAH patients, the concomitant use of vitamin K antagonists and REVATIO
resulted in a greater incidence of reports of bleeding (primarily epistaxis) versus
placebo. The incidence of epistaxis was higher in patients with PAH secondary to
CTD (sildenafil 13%, placebo 0%) than in PPH patients (sildenafil 3%, placebo 2%).
Co-administration of REVATIO with potent CYP3A4 inhibitors (eg, ketoconazole,
itraconazole, and ritonavir) is not recommended as serum concentrations of
sildenafil substantially increase. Co-administration of REVATIO with potent
CYP3A4 inducers such as barbiturates, carbamazepine, phenytoin, efavirenz,
nevirapine, rifampin, and rifabutin, is expected to cause substantial decreases in
plasma levels of sildenafil. Treatment with doses higher than 20 mg three times a
day is not recommended.
Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported postmarketing in temporal association with the use of PDE5 inhibitors for the
REVATIO should be used with caution in patients with anatomical deformation of
the penis or patients who have conditions which may predispose them to priapism.
The effectiveness of REVATIO in pulmonary hypertension (PH) secondary to sickle
cell anemia has not been established. In a small, prematurely terminated study of
patients with PH secondary to sickle cell disease, vaso-occlusive crises requiring
hospitalization were more commonly reported by patients who received REVATIO
than by those randomized to placebo.
Patients with retinitis pigmentosa and patients on bosentan did not participate in
the preapproval clinical trial. The safety of REVATIO is unknown in patients with
bleeding disorders and patients with active peptic ulceration. In these patients,
physicians should prescribe REVATIO with caution.
REVATIO contains sildenafil, the same active ingredient found in VIAGRA®.
Combinations of REVATIO with VIAGRA or other PDE5 inhibitors have not been
studied. Patients taking REVATIO should not take VIAGRA or other PDE5 inhibitors.
The most common side effects of REVATIO (placebo-subtracted) were epistaxis
(8%), headache (7%), dyspepsia (6%), flushing (6%), and insomnia (6%). Adverse
events were generally transient and mild to moderate. Adverse events of REVATIO
injection were similar to those seen with oral tablets.
The most common side effects of REVATIO (placebo-subtracted) as an adjunct to
intravenous epoprostenol were headache (23%), edema (14%), dyspepsia (14%),
pain in extremity (11%), diarrhea (7%), nausea (7%), and nasal congestion (7%).
At doses higher than the recommended 20 mg TID, there was a greater
incidence of some adverse events including flushing, diarrhea, myalgia, and
No dose adjustment required for renal impaired.
No dose adjustment required for mild to moderate hepatic impaired. Severe
impairment has not been studied.
REVATIO is available in the following dosage forms:
l Tablets: 20 mg
l Injection: 10 mg/12.5 mL in a single use vial
l Oral Suspension: 10 mg/mL (when reconstituted)
Available in OS, tablet, and injection forms.
Please see brief summary of Full Prescribi ng Information on
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