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Octreotide: (Moderate) Use octreotide with caution in combination with vardenafil. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. Arrhythmias, sinus bradycardia, and conduction disturbances have occurred during octreotide therapy.

Since bradycardia is a risk factor for development of torsade de pointes (TdP), the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval. Ofloxacin: (Moderate) Ofloxacin should be used cautiously with vardenafil as concurrent use may increase the risk of QT prolongation. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. Quinolones have been associated with a risk of QT prolongation and TdP.

Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.

Olanzapine: (Moderate) Caution is advised when administering olanzapine with vardenafil as concurrent use may increase the risk of QT prolongation. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in the QTc interval. Ombitasvir; Paritaprevir; Ritonavir: (Major) Coadministration of ritonavir with vardenafil results in a 20% decrease in ritonavir AUC and a 49-fold increase in vardenafil AUC. Substantially increased vardenafil plasma concentrations may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

If coadministered, use vardenafil at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring for adverse reactions.

Vardenafil orally disintegrating tablets provide increased exposure as compared to the regular tablets; therefore, use of the orally disintegrating tablets with ritonavir is not recommended.

In addition, both ritonavir and vardenafil are associated with QT prolongation; concomitant use increases the risk of QT prolongation. Ondansetron: (Major) Due to a possible risk for QT prolongation and torsade de pointes (TdP), ondansetron and vardenafil should be used together cautiously. Ondansetron has been associated with a dose-related increase in the QT interval and postmarketing reports of TdP.

If ondansetron and another drug that prolongs the QT interval must be coadministered, ECG monitoring is recommended.

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

Oritavancin: (Minor) Vardenafil is metabolized by CYP3A4; oritavancin is a weak CYP3A4 inducer. Plasma concentrations and efficacy of vardenafil may be reduced if these drugs are administered concurrently.

Osimertinib: (Major) Avoid coadministration of vardenafil with osimertinib if possible due to the risk of QT prolongation and torsade de pointes (TdP). If concomitant use is unavoidable, periodically monitor ECGs for QT prolongation and monitor electrolytes; an interruption of osimertinib therapy with dose reduction or discontinuation of therapy may be necessary if QT prolongation occurs.

Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Vardenafil is associated with QTc prolongation at both therapeutic and supratherapeutic doses.

Oxaliplatin: (Major) Monitor electrolytes and ECGs for QT prolongation if coadministration of vardenafil with oxaliplatin is necessary; correct electrolyte abnormalities prior to administration of oxaliplatin. Vardenafil is associated with QT prolongation at both therapeutic and supratherapeutic doses. QT prolongation and ventricular arrhythmias including fatal torsade de pointes have also been reported with oxaliplatin use in postmarketing experience. Paliperidone: (Major) Paliperidone has been associated

with

since

Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

If coadministration is necessary and the patient has known risk factors for cardiac disease or arrhythmias, close monitoring is essential. Panobinostat: (Major) QT prolongation has been reported with panobinostat therapy in patients with multiple myeloma in a clinical trial; use of panobinostat with other agents that prolong the QT interval is not recommended.

Obtain an electrocardiogram at baseline and periodically during treatment. Hold panobinostat if the QTcF increases to >= 480 milliseconds during therapy; permanently discontinue if QT prolongation does not resolve.

Drugs with a possible risk for QT prolongation and torsade de pointes that should be used cautiously and with close monitoring with panobinostat include vardenafil.

Pasireotide: (Moderate) Pasireotide should be used cautiously and with close monitoring with vardenafil as coadministration may have additive effects on the prolongation of the QT interval.

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. QT prolongation has also occurred with pasireotide at therapeutic and supra-therapeutic doses. Pazopanib: (Major) Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). The effect of vardenafil on the QT interval should be considered when prescribing the drug. Inhibitors of CYP3A4 can reduce vardenafil clearance. Increased systemic exposure to vardenafil may result in an increase in vardenafil-induced adverse effects. Therefore, it is advisable to closely monitor for adverse events when vardenafil is coadministered with drugs that inhibit CYP3A4 and prolong the QT interval, including pazopanib. Pentamidine: (Major) Pentamidine has been associated with QT prolongation.

Drugs with a possible risk for QT prolongation and torsades de pointes (TdP) that should be used cautiously with pentamidine include vardenafil. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produce an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

When vardenafil was given with prescriptive doses of another agent known to prolong the QT interval, an additive effect on the QT interval was observed. Perphenazine: (Minor) Use vardenafil with caution in combination with perphenazine due to increased risk of QT prolongation. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. Perphenazine is associated

with

Phenoxybenzamine: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of vardenafil.

Conversely, patients already receiving an optimized dose of vardenafil should be started on the lowest dose of the alpha-blocker; increases in the alpha-blocker dose should be done in a stepwise fashion. Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of vardenafil and an alpha-blocker.

Phentolamine: (Moderate) Due to

the

Conversely, patients already receiving an optimized dose of vardenafil

should

Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be decreased in patients receiving phosphodiesterase inhibitors. Monitor patients for decreased pressor effect if these agents are administered concomitantly.

Phenylephrine; Promethazine: (Moderate) The therapeutic effect of phenylephrine may be decreased in patients receiving phosphodiesterase inhibitors.

Monitor patients for decreased pressor effect if these agents are administered concomitantly.

(Moderate) Use

vardenafil

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.

Phenytoin: (Minor) Vardenafil is metabolized by cytochrome P450 3A4. It can be expected that concomitant administration of CYP3A4 enzyme-inducers, such as phenytoin, will decrease plasma levels of vardenafil, however, no interaction studies have been performed. Pimavanserin: (Major) Pimavanserin may cause QT prolongation and should generally be avoided in patients receiving other medications known to prolong the QT interval. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produce an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

When vardenafil (10 mg) was given with gatifloxacin (400 mg), an additive effect on the QT interval was observed. The effect of vardenafil on the QT interval should be considered when prescribing the drug.

Coadministration may increase the risk for QT prolongation. Pimozide: (Severe) Pimozide is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Because of the potential for TdP, use of vardenafil with pimozide is contraindicated. Pitolisant: (Major) Avoid coadministration of pitolisant with vardenafil as concurrent use may increase the risk of QT prolongation.

Both

therapeutic

Posaconazole: (Severe) Concurrent use of posaconazole and vardenafil is contraindicated due to the risk of life threatening arrhythmias such as torsade de pointes (TdP). Posaconazole is a potent inhibitor of CYP3A4, an isoenzyme responsible for the metabolism of vardenafil. These drugs used in combination may result in elevated vardenafil plasma concentrations, causing an increased risk for vardenafil-related adverse events, such as QT prolongation. Additionally, posaconazole has been associated with prolongation of the QT interval as well as rare cases of TdP; avoid use with other drugs that may prolong the QT interval and are metabolized through CYP3A4, such as vardenafil. Prazosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of vardenafil.

Conversely, patients already receiving an optimized dose of vardenafil should be started on the lowest dose of the alpha-blocker; increases in the alpha-blocker dose should be done in a stepwise fashion.

Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of vardenafil and an alpha-blocker.

Primaquine: (Moderate) Due to the potential for QT interval prolongation with primaquine, caution is advised with vardenafil and other drugs that prolong the QT interval. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval.

Procainamide: (Major) The manufacturer recommends that vardenafil be avoided in patients taking Class IA antiarrhythmics (disopyramide, procainamide, and quinidine). Class IA antiarrhythmics are associated with QT prolongation and torsades de pointes (TdP). Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction) The effect of vardenafil on the QT interval should be considered when prescribing the drug. Prochlorperazine: (Minor) Use vardenafil with caution in combination with prochlorperazine due to increased risk of QT prolongation. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval.

Prochlorperazine is also associated with a possible risk for QT prolongation. Promethazine: (Moderate) Use vardenafil with caution in combination with promethazine due to increased risk of QT prolongation.

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval.

Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.

Propafenone: (Major) Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

When vardenafil (10 mg) was given with gatifloxacin (400 mg), an additive effect on the QT interval was observed.

The effect of vardenafil on the QT interval should be considered when prescribing the drug. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with vardenafil include propafenone. Propafenone is a Class IC antiarrhythmic which increases the QT interval, but largely due to prolongation of the QRS interval. Quetiapine: (Major) Limited data, including some case reports, suggest that quetiapine may be associated with a significant prolongation of the QTc interval in rare instances.

According to the manufacturer, use of quetiapine should be avoided in combination with drugs known to increase the QT interval.

Drugs with a possible risk for QT prolongation and torsade de pointes (TdP) that should be used cautiously with quetiapine include vardenafil.

Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). Quinidine: (Major) The manufacturer recommends that vardenafil be avoided in patients taking Class IA antiarrhythmics (disopyramide, procainamide, and quinidine). Class IA antiarrhythmics are associated with QT prolongation and torsades de pointes (TdP). Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction) The effect of vardenafil on the QT interval should be considered when prescribing the drug.

Quinine: (Major) Concurrent use of quinine and vardenafil should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Quinine has been associated with prolongation of the QT interval and rare cases of TdP.

Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil also produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

In addition, concentrations of vardenafil may be increased with concomitant use of quinine.

Vardenafil is a CYP3A4 substrate and quinine is a CYP3A4 inhibitor.

Ranolazine: (Major) Ranolazine is associated with dose- and plasma concentration-related increases in the QTc interval. The mean increase in QTc is about 6 milliseconds, measured at the tmax of the maximum dosage (1000 mg PO twice daily).

However, in 5% of the population studied, increases in the QTc of at least 15 milliseconds have been reported. Although there are no studies examining the effects of ranolazine in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation.

In addition, in vitro studies indicate that ranolazine and its metabolite are inhibitors of CYP3A isoenzymes. Drugs that are CYP3A4 substrates that also have a possible risk for QT prolongation and TdP that should be used cautiously with ranolazine include vardenafil. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction).

Ribociclib: (Major) Avoid coadministration of ribociclib with vardenafil due to an increased risk for QT prolongation and torsade de pointes (TdP).

Systemic exposure of vardenafil may also be increased resulting in increase in treatment-related adverse reactions. Ribociclib is a strong CYP3A4 inhibitor that has been shown to prolong the QT interval in a concentration-dependent manner. Vardenafil is a sensitive CYP3A4 substrate also associated with QT prolongation at both therapeutic and supratherapeutic doses. Concomitant use may increase the risk for QT prolongation.

Ribociclib; Letrozole: (Major) Avoid coadministration of ribociclib with vardenafil due to an increased risk for QT prolongation and torsade de pointes (TdP). Systemic exposure of vardenafil may also be increased resulting in increase in treatment-related adverse reactions.

Ribociclib is a strong CYP3A4 inhibitor that has been shown to prolong the QT interval in a concentration-dependent manner. Vardenafil is a sensitive CYP3A4 substrate also associated with QT prolongation at both therapeutic and supratherapeutic doses.

Concomitant use may increase the risk for QT prolongation. Rifabutin: (Minor) Vardenafil is metabolized by cytochrome P450 3A4. It can be expected that concomitant administration of CYP3A4 enzyme-inducers, like the rifamycins, will decrease plasma levels of vardenafil.

Rifampin: (Minor) Vardenafil is metabolized by cytochrome P450 3A4. It can be expected that concomitant administration of CYP3A4 enzyme-inducers, like the rifamycins, will decrease plasma levels of vardenafil. Rifamycins: (Minor) Vardenafil is metabolized by cytochrome P450 3A4.

It can be expected that concomitant administration of CYP3A4 enzyme-inducers, like the rifamycins, will decrease plasma levels of vardenafil. Rifapentine: (Minor) Vardenafil is metabolized by cytochrome P450 3A4.

It can be expected that concomitant administration of CYP3A4 enzyme-inducers, like the rifamycins, will decrease plasma levels of vardenafil. Rilpivirine: (Moderate) Due to the potential for QT prolongation and torsade de pointes (TdP), caution is advised when administering rilpivirine with vardenafil.

Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval. Supratherapeutic

doses