VYBRIQUE

Sildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25-63%). The pharmacokinetics of sildenafil are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil. Both sildenafil and the metabolite have terminal half-lives of about 4 hours. Figure 6 : Mean Sildenafil Plasma Concentrations in H...

Efficacy Results in VYBRIQUE Clinical Study The efficacy of VYBRIQUE in the treatment of erectile dysfunction was established in part on the basis of efficacy data from trials with the tablet formulation of sildenafil. VYBRIQUE was evaluated in one randomized, double-blind, placebo-controlled, flexible-dose study (25 mg, 50 mg, 75 mg, 100 mg) over 12 weeks study to evaluate the erectile function of men with erectile dysfunction (ED). The co-primary efficacy endpoints included both a 4-week assessment of sexual function based on the International Index of Erectile Function (IIEF) questionnaire ...

The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions ( 5.1 )] Prolonged Erection and Priapism [see Warnings and Precautions ( 5.2 )] Effects on the Eye [see Warnings and Precautions ( 5.3 )] Hearing Loss [see Warnings and Precautions ( 5.4 )] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions ( 5.5 ) ] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings an...

Administration of VYBRIQUE to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VYBRIQUE was shown to potentiate the hypotensive effect of nitrates. ( 4.1 , 7.1 , 12.2 ) Known hypersensitivity to sildenafil or any component of oral film. ( 4.2 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat. ( 4.3 ) 4.1 Nitrates Consistent wit...

Patients should not use VYBRIQUE if sexual activity is inadvisable due to cardiovascular status. ( 5.1 ) Patients should seek emergency treatment if an erection lasts >4 hours. Use VYBRIQUE with caution in patients predisposed to priapism. ( 5.2 ) Patients should stop VYBRIQUE and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). VYBRIQUE should be used with caution, and only when the antici...

7. DRUG INTERACTIONS VYBRIQUE can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate VYBRIQUE at 25 mg dose. ( 2.2 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin) increase VYBRIQUE exposure. ( 2.2 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maxim...