ROXUS® (vardenafil HCL nasal spray) is indicated for the treatment of erectile dysfunction (ED).

Use of vardenafil, including ROXUS, is contraindicated in patients taking organic nitrates or nitric oxide donors.

The warnings and precautions for vardenafil tablets apply equally to ROXUS nasal spray:

• Priapism: Erections lasting over 4 hours require immediate medical intervention.
• Sudden Hearing Loss: Discontinue use and seek immediate medical attention if sudden hearing loss occurs.
• Effects on the Eye: Discontinue use and seek immediate medical attention if sudden vision loss occurs, potentially indicating NAION.
• QT Prolongation: Avoid use in patients with QT prolongation or those taking class IA or III antiarrhythmics.
• Hepatic Impairment: Not recommended for patients with severe hepatic impairment. Reduced dose advised for moderate impairment.
• Renal Impairment: Not recommended for patients on dialysis; no data available for renal impairment use.
• Pregnancy and Lactation: Classified as Pregnancy Category B. Not indicated for use in women. No data on excretion in breast milk.
• Paediatric Use: Not indicated for use in patients under 18 years.
• Management of Overdose: There is no specific antidote for vardenafil overdose. Management should involve standard supportive care. Renal dialysis is unlikely to be effective due to high plasma protein binding.

• Nitrates: Concurrent use with organic nitrates is contraindicated due to severe hypotension risk.
• Alpha-Blockers: Use with caution due to potential for significant hypotension.
• Antihypertensives: May enhance blood pressure-lowering effects.
• CYP3A4 Inhibitors: Potent inhibitors (e.g., ketoconazole, indinavir, ritonavir) and moderate inhibitors (e.g., erythromycin, azithromycin) increase vardenafil levels and prolong its half-life. Dosage adjustments or avoidance are recommended.
• Antiarrhythmics: Patients on class IA or III antiarrhythmics should avoid vardenafil.

Common side effects include headache, flushing, rhinitis, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, and nausea. Rare cases of vision loss (NAION), sudden hearing loss, and prolonged erections (priapism) have been reported.

ROXUS is administered via a nasal spray device, delivering 2.5 mg of vardenafil hydrochloride per spray. The recommended dosage is 2 sprays (one per nostril). ROXUS is a prescription medicine.

IFU date: 22 May 2024. Edition 1.1 Roxus® is a registered trade mark of LTR Pharma Ltd.