Roxus® (vardenafil HCl) Nasal Spray: Important Safety Information

Proper Administration of Roxus

• Prime before first use: Remove the cap and clip, then spray 3-4 times into the air until a fine, even mist appears.
• Position: Tilt your head slightly forward, not back. Aim the nozzle toward the outer wall of the nostril, away from the septum.
• Spray: Breathe in gently as you press. Do not sniff hard.
• After each spray: Pinch your nostrils closed for 30-60 seconds. Do not sniff hard or blow your nose right after use.
• Dose: 5 mg (two full sprays, one in each nostril). Do not take more than one dose in a 24-hour period.
• What to expect: Mild stinging or burning, sneezing, or brief congestion may occur after the first use. These effects are localized to the nose and typically resolve within 3–5 minutes. Do not take an additional dose if sneezing occurs. These reactions are common with initial use and generally become less noticeable or resolve altogether with continued use.
• Drip down the throat: This usually means your head was tilted too far back. Tilt slightly forward next time.
• Feel nothing? Make sure the bottle is primed and your nasal passage is clear. Gently blowing your nose beforehand can help.

Who Should Not Use Roxus®

Do not use Roxus® if you:

• Take any nitrate or nitric oxide donor, or riociguat
• Are allergic to vardenafil or any ingredient in Roxus®
• Have been told by your provider not to have sexual activity because of a heart or cardiovascular condition
• Have not been evaluated and prescribed Roxus® by a licensed healthcare provider

Tell Your Provider Before Using Roxus® If You

• Have heart disease, chest pain, irregular heartbeat, uncontrolled high or low blood pressure, or had a heart attack or stroke in the last 6 months
• Have congenital long QT syndrome, or take a Class IA or Class III antiarrhythmic medicine
• Take an alpha-blocker (such as tamsulosin), which can cause a severe drop in blood pressure
• Have a history of priapism, sickle cell anemia, multiple myeloma, leukemia, or a penis deformity such as Peyronie's disease
• Have a history of vision loss (including NAION) or retinitis pigmentosa, or a history of sudden hearing loss
• Have liver or kidney disease
• Have chronic nasal congestion, sinus problems, nasal polyps, or recent nasal surgery
• Take any other medication for erectile challenges

How to Use Roxus®

• Use only as needed before sexual activity or arousal, exactly as your provider directs. It is not a daily medicine.
• Suggested dose: 5 mg, which is 2 sprays (one 2.5 mg spray in each nostril).
• Do not use more than prescribed or more than once in 24 hours unless your provider tells you otherwise.

Possible Side Effects

Common: headache, flushing, nasal irritation or congestion, runny nose, dizziness, indigestion

This is not a complete list. Roxus® is not risk-free, and side effects can occur even when used as directed.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Storage

Store at room temperature, upright, away from heat and direct sunlight. Do not freeze. Keep tightly closed and out of reach of children and pets. Do not share Roxus® with anyone else.

Questions or Concerns?

Contact Strive Pharmacy at 855-405-5993 about usage, interactions, side effects, package tampering, missing shipments, or storage concerns during transit.

Strive Pharmacy is licensed and regulated by the Missouri Board of Pharmacy, 3605 MO Blvd., Jefferson City, MO 65109. Phone: 573-751-0091.