Details for: VYLOMA
Company: BAUSCH HEALTH, CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02365561 | VYLOMA | IMIQUIMOD | 3.75 % / W/W | CREAM | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VYLOMA is the brand name for imiquimod cream, 3.75%. It is used for the treatment of external genital and perianal warts/condyloma acuminata, whether present at the start of therapy or emerging during therapy, in immunocompetent adults.
What it does
VYLOMA Cream is an immune response modifier. VYLOMA Cream is a medicine that works by stimulating your body’s own immune response.
When it should not be used
Do not use VYLOMA if you are allergic to imiquimod, or other medications that contain imiquimod (e.g. ALDARA), or any of the other ingredients in VYLOMA (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
Imiquimod.
What the non-medicinal ingredients are
Isostearic Acid, Cetyl Alcohol, Stearyl Alcohol, White Petrolatum, Polysorbate 60, Sorbitan Monostearate, Glycerin, Xanthan Gum, Purified Water, Benzyl Alcohol, Methylparaben, and Propylparaben.
What dosage form it comes in
VYLOMA Cream contains 37.5 mg imiquimod per gram (3.75% w/w) and is supplied in a pump which contain 7.5 g of the cream and deliver 235 mg of the cream per actuation.
Warnings and precautions
- VYLOMA should not be used in patients under 18 years of age
- Avoid exposure to of treated area(s) sunlight, sunlamp or tanning-bed during the treatment with VYLOMA.
- VYLOMA may cause severe skin reactions
- VYLOMA may also cause flu-like symptoms before or during local skin reactions
- VYLOMA may weaken condoms and vaginal diaphragms. An alternative form of contraception (birth control) should be used while using VYLOMA.
- It is not known whether VYLOMA has any effect on the transmission of warts. It is important to practice safe sex. Sexual contact (genital, oral, anal) should be avoided while the cream is on the skin. Talk to your doctor about safe sex practices
BEFORE you use VYLOMA™ talk to your doctor or pharmacist if:
- you have or had other skin cancers or other growths on your body
- you are immunocompromised (have weak immune system)
- if you are using other immunosuppressive drugs (See Interactions With This Medication)
- you have or have had any other treatment for your external genital/perianal warts, such as freezing or surgery
- you are pregnant or planning to become pregnant
- you are breastfeeding or planning to breastfeed
Interactions with this medication
Tell your doctor or pharmacist about all the medicines you take or have taken, including prescription and non-prescription medicines, vitamins, herbal supplements and immunosuppressants such as tacrolimus, pimecrolimus, cyclosporine, mycophenolate mofetil and methotrexate. Drug interaction studies have not been done with VYLOMA. It is not known if VYLOMA Cream and other medicines can affect each other.
Proper use of this medication
Use VYLOMA Cream exactly as prescribed by your doctor. Do not use VYLOMA Cream until your doctor has shown you the right way to use it. VYLOMA Cream is not for oral, ophthalmic, intra-anal, or intravaginal use.
Usual Dose
Apply VYLOMA Cream to the external genital/perianal warts
once a day just before bedtime.
VYLOMA Cream should be used for up to 8 weeks. If there is
no improvement, contact your doctor.
How to apply VYLOMA Cream pump:
- Wash the area to be treated with mild soap and water. Allow the area to dry.
- Uncircumcised males treating warts under their penis foreskin must pull their foreskin back and clean before treatment and clean daily during the weeks of treatment.
- Wash your hands
- Before using the pump for the first time only, remove the cap and prime the pump by pressing the top of the pump all the way down (one or more times as needed) until the product appears. Discard this portion of the product
- Apply a thin layer of VYLOMA Cream only to affected area(s) to be treated. Do not use more than one full pump actuation for each daily application
- Rub the cream in all the way to the affected area or areas.
- Do not get VYLOMA Cream in or around your eyes or mouth. If you get VYLOMA Cream in your mouth or in your eyes rinse well with water immediately.
- Do not get VYLOMA in the anus when applying to perianal warts.
- Female patients treating genital warts must be careful when applying VYLOMA Cream around the vaginal opening. Female patients should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can cause pain or swelling and may cause problems passing urine. Do not put VYLOMA Cream in your vagina.
- Do not cover the treated area(s) with an airtight bandage. Cotton gauze dressings can be used. Cotton underwear can be worn after applying VYLOMA Cream to the genital or perianal area.
- After applying VYLOMA Cream, wash your hands well with soap and water.
- Leave the cream on the affected area(s) for about 8 hours or as instructed by your doctor. Do not bathe or get the treated area(s) wet before the right time has passed. Do not leave VYLOMA Cream on your skin longer than prescribed.
- After about 8 hours, wash the treated area(s) with mild soap and water.
- When you have completed all of your doses as instructed, safely throw the pump away so that children and pets cannot get it.
Overdose
Missed Dose
If you forget to apply VYLOMA Cream, continue on your regular schedule and do not make up the missed dose(s). Do not double dose(s). Treatment should not be extended beyond 8 weeks due to missed doses or rest periods.
Side effects and what to do about them
Common side effects with VYLOMA Cream may include skin reactions at the treatment site such as:
- redness
- swelling
- a sore, blister, or ulcer
- pain
- irritation
- bleeding
- discharge
- skin that becomes hard or thickened
- skin peeling
- scabbing and crusting
- itching
- burning
- changes in skin color that do not always go away
During treatment and until the skin has healed, your skin in the treatment area is likely to appear noticeably different from normal skin. Side effects at the site where VYLOMA Cream is applied are common. Sometimes the side effects go outside of the area where VYLOMA Cream was applied. Patients should be aware that new warts may develop during treatment, as VYLOMA Cream may not be a cure. You have a higher chance for severe skin reactions if you use too much VYLOMA Cream or use it the wrong way. Stop VYLOMA Cream right away and call your healthcare provider if you get any skin reactions that affect your daily activities, or that do not go away. Sometimes, VYLOMA Cream must be stopped for a while to allow your skin to heal. Talk to your healthcare provider if you have questions about your treatment or skin reactions.
If the reactions seem excessive, if either skin breaks down or sores develop during the first week of treatment, if flu-like symptoms develop or if you begin to not feel well at any time, stop applying VYLOMA Cream and contact your healthcare provider.
Hypersensitivity (allergic) reactions have been reported for patients using imiquimod cream. If you develop allergic symptoms such as difficulty breathing, edema (swelling of mouth, throat, extremities), skin rash or skin reaction, discontinue the product, rinse off the cream, and contact your doctor immediately. These are not all the side effects of VYLOMA Cream. For more information, ask your healthcare provider or pharmacist.
How to store
Store VYLOMA Cream between 15-25° C. Do not freeze.
Safely throw away VYLOMA Cream that is out of date or that
you do not need.
Keep VYLOMA Cream and all medicines out of the reach of
children.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be requested by contacting the sponsor,
Bausch Health, Canada Inc., at: 1-800-361-4261.
This leaflet was prepared by:
Bausch Health, Canada Inc.
Laval, Quebec
H7L 4A8
Last revised: June 28, 2019