For eligible patients with PAH (WHO Group 1), Functional Class II-III

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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 short-term (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%).

Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.

IMPORTANT SAFETY INFORMATION

Do not use REVATIO in patients taking organic nitrates in any form, either regularly or intermittently. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates.

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 post-marketing 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.

Use of REVATIO, particularly chronic use, is not recommended in children.

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.

Please see full Prescribing Information.

REVATIO $4 CO-PAY VALUE CARD TERMS AND CONDITIONS

By using the REVATIO $4 Co-pay Value Card, you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions. Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state health care programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico formerly known as “La Reforma de Salud”). Offer is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs. By using the Card, patients will receive savings of up to $500 per fill and pay a minimum of $4 per fill. The Card is good for a maximum of $6,000 per year. After a maximum of $6,000, patient will pay monthly out-of-pocket costs. The Card may be used once per month for the life of the program. You must deduct the value of the Card from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law. Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Card will be accepted only at participating pharmacies. Card is not health insurance. Offer good only in the US and Puerto Rico. Card is limited to 1 per person during this offering period and is not transferable. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. No membership fee. Offer expires 12/31/2015.

For further information call 1-800-382-7060 or visit www.REVATIO.com.
Pfizer Inc, 235 E. 42nd Street, New York, NY 10017

 

Scroll for important Safety Information and Indication below.

IMPORTANT SAFETY INFORMATION

Do not use REVATIO in patients taking organic nitrates in any form, either regularly or intermittently. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates.

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 post-marketing 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.

Use of REVATIO, particularly chronic use, is not recommended in children.

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.

Please see full Prescribing Information.

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 short-term (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%).

Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.