avanafil (Rx)

Brand and Other Names:Stendra
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 50mg
  • 100mg
  • 200mg

Erectile Dysfunction

100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day

Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity

Use lowest effective dose

Dosage Modifications

Coadministration with strong CYP3A4 inhibitors or nitrates: Contraindicated

Coadministration with moderate CYP3A4 inhibitors: Not to exceed dose of 50 mg/24 hr

Coadministration with stable alpha-blocker therapy: Initiate therapy at 50 mg/24 hr

Renal Impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): Dose adjustment not necessary
  • Severe impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use

Hepatic impairment

  • Mild to moderate impairment: Dose adjustment not necessary
  • Severe impairment: Safety and efficacy not established; do not use

Safety and efficacy not established

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Interactions

Interaction Checker

and avanafil

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            Contraindicated (13)

            • chloramphenicol

              chloramphenicol will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • isosorbide dinitrate

              isosorbide dinitrate, avanafil. Either increases effects of the other by Mechanism: additive vasodilation. Contraindicated. Contraindicated; potentially fatal hypotension.

            • isosorbide mononitrate

              isosorbide mononitrate, avanafil. Either increases effects of the other by Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • itraconazole

              itraconazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration with strong CYP3A4 is contraindicated during and 2 weeks after itraconazole.

            • nitroglycerin IV

              nitroglycerin IV, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin PO

              nitroglycerin PO, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin rectal

              avanafil increases effects of nitroglycerin rectal by additive vasodilation. Contraindicated. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.

            • nitroglycerin sublingual

              nitroglycerin sublingual, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin topical

              nitroglycerin topical, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin transdermal

              nitroglycerin transdermal, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin translingual

              nitroglycerin translingual, avanafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • riociguat

              avanafil, riociguat. Either increases effects of the other by additive vasodilation. Contraindicated. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension.

            • vericiguat

              avanafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            Serious - Use Alternative (35)

            • abametapir

              abametapir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • amyl nitrite

              amyl nitrite, avanafil. Either increases effects of the other by Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Potentially fatal hypotension.

            • apalutamide

              apalutamide will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • atazanavir

              atazanavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • clarithromycin

              clarithromycin will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • cobicistat

              cobicistat will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Not recommended; safe/effective dose for avanafil has not been established; coadministration may increase PDE-5 inhibitor adverse effects including hypotension, syncope, visual changes, and prolonged erection

            • conivaptan

              conivaptan will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • darunavir

              darunavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • enzalutamide

              enzalutamide will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Potential effect of CYP3A4 inducers with avanafil was not evaluated. Concomitant use of avanafil and CY3A4 inducers is not recommended.

            • fexinidazole

              fexinidazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fosamprenavir

              fosamprenavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • idelalisib

              idelalisib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • imatinib

              imatinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • indinavir

              indinavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • isoniazid

              isoniazid will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • ivosidenib

              ivosidenib will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • lonafarnib

              lonafarnib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • lopinavir

              lopinavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • lorlatinib

              lorlatinib will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mifepristone

              mifepristone will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mitotane

              mitotane will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • nelfinavir

              nelfinavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • nicardipine

              nicardipine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • nitroprusside sodium

              nitroprusside sodium, avanafil. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Contraindicated. Additive hypotensive effects.

            • posaconazole

              posaconazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • ritonavir

              ritonavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • saquinavir

              saquinavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • tipranavir

              tipranavir will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • tucatinib

              tucatinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • vardenafil

              vardenafil, avanafil. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid combination; duplicate therapy is not recommended.

            • voriconazole

              voriconazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism. Coadministration with strong CYP3A4 is contraindicated.

            • voxelotor

              voxelotor will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (136)

            • acebutolol

              avanafil increases effects of acebutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • acetazolamide

              avanafil increases effects of acetazolamide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • alfuzosin

              avanafil increases effects of alfuzosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • aliskiren

              avanafil increases effects of aliskiren by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • amifostine

              amifostine, avanafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Monitor blood pressure response to phosphodiesterase type 5 (PDE5) inhibitors in patients receiving concurrent blood pressure lowering therapy.

            • amiloride

              avanafil increases effects of amiloride by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • amiodarone

              amiodarone will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • amlodipine

              avanafil increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • aprepitant

              aprepitant will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • armodafinil

              armodafinil will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • asenapine

              avanafil increases effects of asenapine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • atenolol

              avanafil increases effects of atenolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • azilsartan

              avanafil increases effects of azilsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • belzutifan

              belzutifan will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • benazepril

              avanafil increases effects of benazepril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • betaxolol

              avanafil increases effects of betaxolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • bicalutamide

              bicalutamide will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • bisoprolol

              avanafil increases effects of bisoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • bosentan

              bosentan will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bumetanide

              avanafil increases effects of bumetanide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • butabarbital

              butabarbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness

            • butalbital

              butalbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness

            • candesartan

              avanafil increases effects of candesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • captopril

              avanafil increases effects of captopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • carbamazepine

              carbamazepine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness

            • carvedilol

              avanafil increases effects of carvedilol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • cenobamate

              cenobamate will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • chlorthalidone

              avanafil increases effects of chlorthalidone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • cimetidine

              cimetidine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • clevidipine

              avanafil increases effects of clevidipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • clonidine

              avanafil increases effects of clonidine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • clotrimazole

              clotrimazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • crizotinib

              crizotinib increases levels of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

            • cyclosporine

              cyclosporine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • dabrafenib

              dabrafenib will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • dasatinib

              dasatinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • deferasirox

              deferasirox will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • desipramine

              desipramine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • dexamethasone

              dexamethasone will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • diltiazem

              diltiazem will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Moderate CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; maximum recommended dose of avanafil is 50 mg over 24 hours for patients taking concomitant moderate CYP3A4 inhibitors.

            • doxazosin

              avanafil increases effects of doxazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • dronedarone

              dronedarone will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • duvelisib

              duvelisib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. will increase the level or effect of

            • efavirenz

              efavirenz will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • elagolix

              elagolix will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • enalapril

              avanafil increases effects of enalapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • encorafenib

              encorafenib, avanafil. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • eplerenone

              avanafil increases effects of eplerenone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • eprosartan

              avanafil increases effects of eprosartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • erythromycin base

              erythromycin base will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • esmolol

              avanafil increases effects of esmolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • ethacrynic acid

              avanafil increases effects of ethacrynic acid by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • ethanol

              ethanol, avanafil. additive vasodilation. Use Caution/Monitor. Combination may increase risk of orthostatic hypotension, tachycardia, dizziness and headache.

            • etravirine

              etravirine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • fedratinib

              fedratinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • felodipine

              avanafil increases effects of felodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • fluconazole

              fluconazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • fluvoxamine

              fluvoxamine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Maximum recommended dose of STENDRA is 50mg, not to exceed once every 24hr for patients taking concomitant moderate CYP3A4 inhibitors

            • fosinopril

              avanafil increases effects of fosinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • furosemide

              avanafil increases effects of furosemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • grapefruit

              grapefruit will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • griseofulvin

              griseofulvin will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • guanfacine

              avanafil increases effects of guanfacine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • haloperidol

              haloperidol will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • hydralazine

              avanafil increases effects of hydralazine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • hydrochlorothiazide

              avanafil increases effects of hydrochlorothiazide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • indapamide

              avanafil increases effects of indapamide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • irbesartan

              avanafil increases effects of irbesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • isradipine

              avanafil increases effects of isradipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • istradefylline

              istradefylline will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • labetalol

              avanafil increases effects of labetalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • lapatinib

              lapatinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • lisinopril

              avanafil increases effects of lisinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • losartan

              avanafil increases effects of losartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • lumefantrine

              lumefantrine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • maraviroc

              maraviroc, avanafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.

            • metolazone

              avanafil increases effects of metolazone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • metoprolol

              avanafil increases effects of metoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • metronidazole

              metronidazole will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • minoxidil

              avanafil increases effects of minoxidil by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • nadolol

              avanafil increases effects of nadolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • nebivolol

              avanafil increases effects of nebivolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • nevirapine

              nevirapine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • nifedipine

              avanafil increases effects of nifedipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              nifedipine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • nilotinib

              nilotinib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • nimodipine

              avanafil increases effects of nimodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • nisoldipine

              avanafil increases effects of nisoldipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • olmesartan

              avanafil increases effects of olmesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • pazopanib

              pazopanib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • penbutolol

              avanafil increases effects of penbutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • pentobarbital

              pentobarbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • phenobarbital

              phenobarbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • phenoxybenzamine

              avanafil increases effects of phenoxybenzamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • phentolamine

              avanafil increases effects of phentolamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • phenytoin

              phenytoin will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • prazosin

              avanafil increases effects of prazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • primidone

              primidone will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • propranolol

              avanafil increases effects of propranolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • quinapril

              avanafil increases effects of quinapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • ramipril

              avanafil increases effects of ramipril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • ribociclib

              ribociclib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • rifabutin

              rifabutin will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • rifampin

              rifampin will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • rifapentine

              rifapentine will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • rucaparib

              rucaparib will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • rufinamide

              rufinamide will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • sacubitril/valsartan

              avanafil increases effects of sacubitril/valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • sapropterin

              sapropterin, avanafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Possible additive vasorelaxation, leading to low blood pressure.

            • secobarbital

              secobarbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • sertraline

              sertraline will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • silodosin

              avanafil increases effects of silodosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • sotalol

              avanafil increases effects of sotalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • spironolactone

              avanafil increases effects of spironolactone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • St John's Wort

              St John's Wort will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • stiripentol

              stiripentol, avanafil. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tamsulosin

              avanafil, tamsulosin. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. Risk of hypotension.

            • tazemetostat

              tazemetostat will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • telmisartan

              avanafil increases effects of telmisartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • terazosin

              avanafil increases effects of terazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • tetracycline

              tetracycline will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • timolol

              avanafil increases effects of timolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • topiramate

              topiramate will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For patients with ED, monitor response carefully because of potential for decreased effectiveness.

            • torsemide

              avanafil increases effects of torsemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • trandolapril

              avanafil increases effects of trandolapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • triamterene

              avanafil increases effects of triamterene by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • valsartan

              avanafil increases effects of valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • verapamil

              verapamil will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            • zafirlukast

              zafirlukast will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

            Minor (2)

            • amobarbital

              amobarbital will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ranolazine

              ranolazine will increase the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. CYP3A4 inhibitors may reduce avanafil clearance increasing systemic exposure to avanafil; increased levels may result in increased associated adverse events; the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours for patients taking concomitant moderate CYP3A4 inhibitors

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            Adverse Effects

            >2%

            Headache (5.6%)

            Flushing (3.5%)

            Nasal congestion (2.1%)

            Nasopharyngitis (3.4%)

            Back pain (2.5%)

            Upper respiratory infection (<2%)

            Bronchitis (<2%)

            Influenza (<2%)

            Sinusitis (<2%)

            Sinus congestion (<2%)

            Hypertension (<2%)

            Dyspepsia (<2%)

            Nausea (<2%)

            Constipation (<2%)

            Rash (<2%)

            <1%

            Peripheral edema

            Fatigue

            Angina

            Deep vein thrombosis

            Palpitations

            Gastritis

            Gastroesophageal reflux disease

            Hypoglycemia

            Hyperglycemia

            Oropharyngeal pain

            Stomach discomfort

            Vomiting

            Depression

            Insomnia

            Cough

            Dyspnea exertional

            Epistaxis

            Wheezing

            Pruritus

            Urinary tract infection

            Pollakiuria

            Nephrolithiasis

            Hematuria

            Increased erection

            Balanitis

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            Warnings

            Contraindications

            Hypersensitivity

            Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

            Coadministration with nitrates

            • Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
            • Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
            • A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

            Cautions

            Potential for cardiovascular risk during sexual activity in patients with underlying cardiovascular conditions

            Monitor patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis)

            Dose should not exceed 50 mg/24hr when taking avanafil concomitantly with moderate CYP3A4 inhibitors

            Initiate therapy at 50 mg/24hr if coadministered with antihypertensive medications like alpha-blockers

            Priapism may occur especially in patients with predisposed conditions (eg, sickle cell anemia, multiple myeloma, or leukemia)

            Discontinue therapy if sudden loss of vision in one or both eyes occur (could be a sign of non-arteritic anterior ischemic optic neuropathy)

            Safety and efficacy not established in patients with hereditary retinal disorders, including retinitis pigmentosa (use not recommended)

            Sudden hearing loss may occur; discontinue therapy if tinnitus symptoms occur

            Alcohol may increase risk for orthostatic hypotension; may increase heart rate and cause dizziness and headache

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Safety and efficacy not established

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Sexual stimulation causes nitric oxide to be released in the corpus cavernosum; nitric oxide activates the enzyme guanylate cyclase, which in turn increases cGMP levels; increase in cGMP levels causes smooth muscle relaxation.

            Phosphodiesterase type 5 inhibitors enhance the effects of nitric oxide in smooth muscle relaxation of the corpus cavernosum by inhibiting the degradation of cGMP.

            Pharmacokinetics

            Half-life elimination: 5 hr

            Peak Plasma Time: 30-45 min

            Protein Bound: 99%

            Metabolism: Liver (via CYP3A4 [major] and CYP2C [minor])

            Metabolites: M4 (4% active) and M16 (inactive) are the major circulating metabolites

            Excretion: Feces (62%); urine (21%); semen (<0.0002%)

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            Administration

            Instructions

            May take with or without food

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Stendra oral
            -
            200 mg tablet
            Stendra oral
            -
            50 mg tablet
            Stendra oral
            -
            100 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            avanafil oral

            AVANAFIL - ORAL

            (a-VAN-a-fil)

            COMMON BRAND NAME(S): Stendra

            USES: Avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, avanafil works by increasing blood flow to the penis to help a man get and keep an erection.This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking avanafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually as needed. This medication is available in different doses. Depending on your dose, take avanafil about 15 minutes or 30 minutes before sexual activity. Follow your doctor's instructions carefully on how many minutes before sexual activity you should take this medication. Do not take more than once daily.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if your condition does not improve.

            SIDE EFFECTS: Headache, flushing, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking avanafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking avanafil and get medical help right away if these effects occur.In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking avanafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease (dialysis), liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not usually used in women. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: riociguat.Avanafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use avanafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of avanafil to minimize your risk of low blood pressure.Other medications can affect the removal of avanafil from your body, which may affect how avanafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), nefazodone, ribociclib, rifampin, among others.Do not take this medication with any other product that contains avanafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil, vardenafil).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.

            MISSED DOSE: Not applicable.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.