Indications 

Vyloma Cream is prescribed to treat typical actinic keratoses (AK), characterized by rough, scaly patches, on the entire face or balding scalp in adults with a healthy immune system. 

In addition, Vyloma Cream is indicated for treating external genital and perianal warts (EGW), in individuals aged 12 years or older. 

As an immune response modifier, Vyloma Cream boosts the body’s immune system to treat genital and anal warts, but it does not cure them and may not prevent new ones from developing during treatment. The precise mechanism by which Vyloma Cream treats AK remains unknown. 

Uses and Dosage 

Before the initial use of Vyloma Cream and with each prescription refill, carefully read the medication guide and patient information leaflet given by your pharmacist. If any sections are unclear, seek guidance from your doctor or pharmacist. 

Vyloma Cream is intended for topical use only and should not be used orally, in the eyes, inside the anus or vagina. 

Vyloma Cream is supplied in a pump. Upon initial use, prime the pump by pressing the top repeatedly until the cream dispenses. Discard the primed cream into a tissue. The pump is now primed and ready for use throughout your treatment. No further priming is necessary. 

The usual regimen of Vyloma Cream is listed below, if your doctor prescribes differently, adhere to their instruction strictly: 

• For actinic keratoses treatment: 
  • Apply the cream once daily before bedtime to the affected skin area (entire face or balding scalp) 
  • Complete two 2-week treatment cycles, separated by a 2-week no-treatment period 
  • Do not extend the treatment period beyond two cycles, even if doses are missed or rest periods are taken 
  • Continue treatment for the full course, even if all actinic keratoses seem to be resolved 
  • Limit each daily application to no more than two actuations of the pump 
• For external genital warts treatment: 
  • Apply the cream once daily before bedtime to the affected wart areas 
  • Continue the treatment until total clearance of genital/perianal warts or for up to 8 weeks 
  • Limit each daily application to no more than one actuation of the pump 

To properly apply Vyloma Cream, follow these steps: 

1. Begin by washing your hands thoroughly. 
2. Wash the area where the cream will be applied using mild soap and water and allow the area to dry. 
3. Dispense the cream onto your hand or fingertip and apply a thin layer to the affected area(s). Rub the cream in thoroughly. 
   • Refrain from applying the cream to the lips and nostrils and avoid contact with the eyes. If contact occurs, rinse the contacted area with water immediately. 
   • For uncircumcised males treating warts under the foreskin, retract the foreskin and clean it before and during treatment. 
   • Female patients treating genital warts should apply the cream around the vaginal opening, avoiding insertion into the vagina. 
4. After application, wash your hands thoroughly. 
5. Leave the cream on the affected area(s) for approximately 8 hours. 
6. Wash the treated area(s) with mild soap and water after the 8-hour period. 

Avoid covering the treated area with bandages or closed dressings. If needed, cotton gauze dressings are permissible.  

Following the cream’s application to the genital or perianal area, cotton underwear can be worn. 

For optimal outcomes, use Vyloma Cream exactly as directed. Apply it at the same times daily throughout the entire prescribed course. 

Avoid excessive application of the cream; use only the amount necessary to cover the treatment area. Overuse or prolonged application of this cream can elevate the risk of severe skin reactions and other potential side effects. 

Side Effects 

Common Side Effects 

• Local skin reactions: 
  • Skin redness 
  • Scabbing 
  • Crusting 
  • Flaking 
  • Scaling 
  • Dryness 
  • Swelling 
• Headache 
• Itching of the treated area 
• Tiredness 
• Nausea 
• Skin irritation 
• Pain in the treatment area 

Inform your doctor if any of these common side effects persist or intensify. 

Serious Side Effects 

• Local Skin Reactions: 
  • Skin drainage (weeping) or erosion of the outer skin layer 
  • Vulvar swelling (in females) 
• Flu-like Symptoms: 
  • Tiredness 
  • Nausea 
  • Vomiting 
  • Fever 
  • Chills 
  • Muscle pain 
  • Joint pain 

Call your doctor immediately if you experience any of the serious side effects listed above. 

This list does not cover all potential side effects of Vyloma Cream. Inform your doctor if any other side effects emerge. 

Cautions 

Before using Vyloma Cream, inform your doctor if you: 

• Experience immune system issues 
• Are currently undergoing or have undergone treatment for actinic keratosis with other medications or surgery 
  • Refrain from using Vyloma Cream until fully healed from previous treatments 
• Have other skin conditions or sunburn 
• Have any additional medical conditions 
• Are pregnant or considering pregnancy 
  • Consult your healthcare provider as the impact of Vyloma Cream on unborn babies is not known 
• Are breastfeeding or planning to breastfeed 
  • Discuss with your healthcare provider the best feeding approach if using Vyloma Cream 

Disclose all your medications to your doctor, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements to prevent potential drug interaction with Vyloma Cream. 

Refrain from using sunlamps, tanning beds, or exposing yourself to sunlight while undergoing Vyloma Cream treatment. If you must go outdoors during the day, apply sunscreen and wear protective clothing. 

Do not engage in any sexual activity involving the genital or perianal skin while using Vyloma Cream, as it may compromise the effectiveness of condoms and vaginal diaphragms in preventing pregnancy.