Patient

Patient Eligibility & Prescribing Considerations

Consider Roxus for Patients Who:

Have not achieved adequate response with oral PDE-5 inhibitors

Desire greater spontaneity in treatment

Experience delayed onset with oral medications

Have difficulty swallowing tablets (dysphagia)

Experienced significant side effects from oral PDE-5 inhibitors

Examples:

Approved therapies have been trialed and failed to achieve adequate clinical response.

Treatment offers a different mechanism of action or formulation addressing a unique clinical need.

Patient requires specific formulation or delivery route (e.g., intranasal) not available among approved products.

Approved therapies not tolerated due to adverse effects or contraindications.

Patient has complex comorbidities limiting use of standard therapies.

Access via 503A Compounding Pharmacy

Section 503A of the Federal Food, Drug, and Cosmetic Act allows licensed pharmacists to compound customized medications for individual patients based on a valid prescription. This pathway enables access to formulations not commercially available while maintaining strict quality and safety standards.

Prescribing Process

Step 01

Establish medical benefit for compounded
formulation

Step 02

Write prescription specifying: Roxus® (vardenafil HCL 5mg nasal spray) / Quantity and refills as appropriate

Step 03

Patient obtains medication from
503A pharmacy

Step 04

Standard follow-up
and monitoring

Step 05

Report any adverse events to the prescribing clinician

Key Points

No prior authorization required

Prescribed like any compounded medication

Patient pays out-of-pocket

Licensed 503A pharmacies

Indication:

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

Contraindications

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

Warnings and Precautions

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.

Drug Interactions:

  • 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.

Adverse Effects:

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.

Dosage:

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.