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The power of flexibility is yours with REVATIO Oral Suspension

Adjust your dosing to each patient ’ s needs .
With REVATIO you have 3 dosage forms to treat pulmonary arterial hypertension ( PAH ): oral suspension , tablet , and injection .
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 %).
Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity .
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 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
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 .
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 .
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 visual disturbances .
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 :
● Tablets : 20 mg
● Injection : 10 mg / 12 . 5 mL in a single use vial
● Oral Suspension : 10 mg / mL ( when reconstituted )
The
Family Available in OS , tablet , and injection forms .
Please see brief summary of Full Prescribing Information on following pages .
PP-REV-USA-0067-01 © 2016 Pfi zer Inc . All rights reserved . April 2016