Avanafil
Avanafil Prescribing Information
Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.
• The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis (
The recommended starting dose is 100 mg. Avanafil tablet should be taken orally as needed as early as approximately 15 minutes before sexual activity.
Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity. The lowest dose that provides benefit should be used.
The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.
• Take avanafil tablet no more than once a day (
The recommended starting dose is 100 mg. Avanafil tablet should be taken orally as needed as early as approximately 15 minutes before sexual activity.
Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity. The lowest dose that provides benefit should be used.
The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.
• Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit (
The recommended starting dose is 100 mg. Avanafil tablet should be taken orally as needed as early as approximately 15 minutes before sexual activity.
Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity. The lowest dose that provides benefit should be used.
The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.
• Avanafil tablet may be taken with or without food (
Avanafil tablet may be taken with or without food.
• Do not use avanafil tablet with strong CYP3A4 inhibitors (
Concomitant use of nitrates in any form is contraindicated
If avanafil tablet is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with avanafil tablet, and avanafil tablet should be initiated at the 50 mg dose
• For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil tablet
• For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil tablet is 50 mg, not to exceed once every 24 hours
• If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period (
Concomitant use of nitrates in any form is contraindicated
If avanafil tablet is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with avanafil tablet, and avanafil tablet should be initiated at the 50 mg dose
• For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil tablet
• For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil tablet is 50 mg, not to exceed once every 24 hours
• In patients on stable alpha-blocker therapy, the recommended starting dose of avanafil tablet is 50 mg (
Concomitant use of nitrates in any form is contraindicated
If avanafil tablet is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with avanafil tablet, and avanafil tablet should be initiated at the 50 mg dose
• For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil tablet
• For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil tablet is 50 mg, not to exceed once every 24 hours
Avanafil tablets, 50 mg are white to off white, oval shape, biconvex tablets debossed with ‘A41’ on one side and ‘H’ on the other side.
Avanafil tablets, 100 mg are white to off white, oval shape, biconvex tablets debossed with ‘A42’ on one side and ‘H’ on the other side.
Avanafil tablets, 200 mg are white to off white, oval shape, biconvex tablets debossed with ‘A43’ on one side and ‘H’ on the other side.
• Do not use in patients with severe renal impairment (
In a clinical pharmacology trial using single 200 mg doses of avanafil, avanafil exposure (AUC or Cmax)in normal subjects was comparable to patients with mild (creatinine clearance greater than or equal to 60 to less than 90 mL/min) or moderate (creatinine clearance greater than or equal to 30 to less than 60 mL/min) renal impairment. No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance greater than or equal to 30 to less than 90 mL/min). The pharmacokinetics of avanafil in patients with severe renal disease or on renal dialysis has not been studied; do not use avanafil in such patients
• Do not use in patients with severe hepatic impairment (
In a clinical pharmacology trial, avanafil AUC and Cmaxin patients with mild hepatic impairment (Child-Pugh Class A) was comparable to that in healthy subjects when a dose of 200 mg was administered. Avanafil Cmaxwas approximately 51% lower and AUC was 11% higher in patients with moderate hepatic impairment (Child Pugh Class B) compared to subjects with normal hepatic function. No dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child Pugh Class A or B). The pharmacokinetics of avanafil in patients with severe hepatic disease has not been studied; do not use avanafil in such patients
• Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated (
Administration of avanafil tablets with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, avanafil has been shown to potentiate the hypotensive effects of nitrates.
In a patient who has taken avanafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 12 hours should elapse after the last dose of avanafil tablets before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring
• Hypersensitivity to any component of the avanafil tablet (
Avanafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. Hypersensitivity reactions have been reported, including pruritis and eyelid swelling.
• Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat (
Do not use avanafil tablets in patients who are using a GC stimulator, such as riociguat or vericiguat. PDE5 inhibitors, including avanafil tablets may potentiate the hypotensive effects of GC stimulators.
Evaluation of erectile dysfunction (ED) should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.
Before prescribing avanafil, it is important to note the following: