Imiquimod 3.75% (Vyloma)

1. Health Canada Product Monograph — Imiquimod 3.75%

• Topical treatment of external genital and perianal warts (condyloma acuminata) in immunocompetent adults.
• Intended for use by the patient at home, after the diagnosis has been confirmed by a clinician.
• Not authorized for use in immunosuppressed patients; safety and effectiveness have not been established in this population.

• Animal reproduction studies did not show birth defects, but there are no adequate, well-controlled studies in pregnant women.
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus; discuss alternatives such as trichloroacetic acid, which is considered safe in pregnancy, with the prescriber first.

• It is not known whether topically applied imiquimod passes into breast milk. Use with caution while breastfeeding, and avoid applying the cream to any area that could have direct skin contact with the infant.

• No overall differences in safety or effectiveness have been observed between older and younger adults; monitor as in any patient given the possibility of greater skin sensitivity in some older individuals.

• Not authorized for use in patients under 18 years of age; safety and effectiveness in children have not been established.

• Apply a thin layer of cream to the external genital and/or perianal wart area once daily, immediately before bedtime.
• Continue nightly application for up to 8 weeks, or until the warts have completely cleared, whichever comes first — do not exceed 8 weeks of continuous use without reassessment.
• Wash hands thoroughly before and after application.
• Leave the cream on the skin overnight; wash the treated area with mild soap and water approximately 8 hours after application, in the morning.
• Apply only to the affected area; avoid application to open wounds, cuts, or abrasions, and avoid contact with the eyes, lips, and nostrils.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Topical overuse (applying more than the recommended thin layer, or applying more frequently than once daily) increases the risk of severe local skin reactions; there is no established systemic overdose syndrome with correct topical use given minimal systemic absorption.
• Accidental oral ingestion should be treated as a potential exposure — contact Poison Control for guidance.

• Local application-site reactions: redness, itching, burning, pain, and irritation at and around the treatment site — these are expected and reflect the drug's immune-stimulating mechanism, but should be reported if severe.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Severe local skin reactions, including erosion, ulceration, or blistering, which may require a treatment break or discontinuation.
• Flu-like systemic symptoms (fatigue, fever, myalgia) can occur, though less frequently than with the 5% strength, reflecting some systemic immune activation.
• Rare hypersensitivity reactions.

• Use with caution in patients with pre-existing autoimmune conditions, given the drug's immune-stimulating mechanism.
• Avoid use on broken or inflamed skin beyond the wart itself, which increases irritation and absorption.

• Known hypersensitivity to imiquimod or any component of the cream.

• No clinically significant systemic drug interactions have been established, given minimal systemic absorption with correct topical use.
• Product interaction: may weaken latex condoms and vaginal diaphragms — an alternative barrier method should be used during treatment.

• None known.

• Apply at bedtime and leave on overnight; wash off approximately 8 hours later, in the morning.

• Store at room temperature. Discard any unused portion of an opened single-use packet after application — do not reuse a partially used packet.

• Apply once daily at bedtime and wash off after about 8 hours; use for up to 8 weeks or until the warts clear, whichever is first.
• This cream does not eliminate the HPV infection itself — new warts can still appear, and the wart can still be transmitted to a partner during treatment and after clearance.
• May weaken condoms and diaphragms — use an alternative barrier method during treatment.
• Do not use during pregnancy unless your prescriber has specifically advised it.
• Stop treatment and contact your pharmacist or prescriber if you develop severe redness, blistering, or open sores at the application site.