Warnhinweise und Vorsichtsmaßnahmen
- Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1 )
- Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. ( 5.2 )
- Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.4 , 5.5 )
- Pulmonary hypertension (PH) secondary to sickle cell disease: REVATIO may cause serious vaso-occlusive crises. ( 5.8 )
5.1Hypotension
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 [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).
Monitor blood pressure when co‑administering blood pressure lowering drugs with REVATIO.
5.2Worsening 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.
5.3Epistaxis
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.
5.4Visual Loss
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking REVATIO.
There are no controlled clinical data on the safety or efficacy of REVATIO in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of REVATIO in patients with retinitis pigmentosa is not recommended.
5.5Hearing Loss Cases
of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including REVATIO. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of REVATIO, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including REVATIO.
5.6Combination with Other PDE-5 Inhibitors
Sildenafil is also marketed as VIAGRA ® . The safety and efficacy of combinations of REVATIO with VIAGRA or other PDE‑5 inhibitors have not been studied. Inform patients taking REVATIO not to take VIAGRA or other PDE‑5 inhibitors.
5.7Priapism Use
REVATIO with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease In a small, prematurely terminated study of patients with pulmonary hypertension (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. The effectiveness and safety of REVATIO in the treatment of PH secondary to sickle cell disease has not been established.
