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  • CLASSES

    Topical Antivirals

    DEA CLASS

    Rx

    DESCRIPTION

    Topical mitotic agent used to treat external genital and perianal warts (i.e., condylomata acuminata) caused by human papillomavirus (HPV); does not eradicate HPV; included by the CDC as a first-line therapy for external genital warts; self-administered by patient.

    COMMON BRAND NAMES

    Condylox

    HOW SUPPLIED

    Condylox/Podofilox Topical Gel: 0.5%
    Condylox/Podofilox Topical Sol: 0.5%

    DOSAGE & INDICATIONS

    For the treatment of external warts (condylomata acuminata) due to human papillomavirus (HPV) infection.
    NOTE: The 0.5% gel may be used to treat external genital or perianal warts. The 0.5% topical solution may be used to treat external genital warts; however, it is not indicated for use in the perianal area.
    Topical dosage (0.5% topical solution, Condylox solution)
    Adults

    Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 mL/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

    Infants†, Children† and Adolescents†

    Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 mL/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

    Topical dosage (0.5% topical gel, Condylox gel)
    Adults

    Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 g gel/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

    Infants†, Children† and Adolescents†

    Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 g gel/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

    MAXIMUM DOSAGE

    Adults

    0.5 g/day for topical gel or 0.5 ml/day for topical solution; limit treatment area to <= 10 cm2 of wart tissue (gel or solution).

    Elderly

    0.5 g/day for topical gel or 0.5 ml/day for topical solution; limit treatment area to <= 10 cm2 of wart tissue (gel or solution).

    Adolescents

    Safety and efficacy have not been established; 0.5 g/day for topical gel or 0.5 ml/day for topical solution has been used off-label.

    Children

    Safety and efficacy have not been established; 0.5 g/day for topical gel or 0.5 ml/day for topical solution has been used off-label.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    ADMINISTRATION

    For storage information, see the specific product information within the How supplied section.

    Topical Administration

    •Podofilox is for external topical use to the affected skin only; do not ingest and do not get in the eyes.

    Other Topical Formulations

    •Topical gel: Apply gel using the applicator supplied or by fingertip. May be used in the genital or perianal area.
    •Topical solution: Apply solution using the applicator supplied or a cotton-tipped applicator. Touch the drug-dampened applicator to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, dispose of the used applicator and wash hands. Podofilox solution is not suitable for use in the perianal area.

    STORAGE

    Condylox:
    - Avoid excessive heat (above 104 degrees F)
    - Do not freeze
    - Flammable, keep away from heat and flame
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Safety and efficacy of podofilox have not been established in adolescents and children < 18 years of age.

    Accidental exposure, ocular exposure

    Podofilox is contraindicated in patients who have a podophyllum hypersensitivity or intolerance to podofilox or any components contained in the topical gel or solution. Podofilox should only be used for external warts; it has not been evaluated for the treatment of warts occurring inside the mucous membranes of the genital area (i.e., urethral, intravaginal, cervical, or rectal). Podofilox solution has not been evaluated for use in the treatment of warts occurring in the perianal area. Avoid accidental exposure to healthy skin areas, avoid ocular exposure, and do not administer internally.

    Pregnancy

    Guidelines recommend against use of podofilox during pregnancy. The manufacturer recommends use only if the potential benefits justify the potential risks to the fetus. No adequate and well-controlled studies have been conducted in pregnant women. In animal studies, use of systemic podofilox was found to be embryotoxic in rats at doses 19-times the maximum recommended human dose (RHD); however, the drugs was not teratogenic when given topically to pregnant rabbits at doses 2-times the RHD for 13 days. Because genital warts can proliferate and become friable during pregnancy, consideration can be given to their removal during pregnancy. HPV types 6 and 11 can cause respiratory papillomatosis in infants and children. The route of transmission (i.e., transplacental, perinatal, or postnatal) is not completely understood. In rats, podofilox did not appear to impair fertility when administered topically at doses corresponding to the recommended human daily dose.

    Breast-feeding

    According to the manufacturer, a decision should be made whether to discontinue podofilox or to discontinue nursing, taking into account the importance of the drug to the mother. It is not known if podofilox is distributed into the human milk. However, in pharmacokinetic studies, topical application of podofilox to external genitalia did not result in detectable serum levels and the drug did not accumulate after multiple treatments. Therefore, it is unlikely that a clinically significant amount of drug would be present in breast-milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    phimosis / Delayed / 0-5.0

    Moderate

    skin erosion / Delayed / 0-67.0
    bleeding / Early / 0-19.0
    hematuria / Delayed / 0-5.0
    dyspareunia / Delayed / 0-5.0
    edema / Delayed / 0-5.0
    skin ulcer / Delayed / 0-5.0
    erythema / Early / 5.0-5.0

    Mild

    pruritus / Rapid / 0-65.0
    headache / Early / 7.0-7.0
    skin discoloration / Delayed / 0-5.0
    xerosis / Delayed / 0-5.0
    rash / Early / 0-5.0
    nausea / Early / 0-5.0
    vomiting / Early / 0-5.0
    dizziness / Early / 0-5.0
    insomnia / Early / 0-5.0
    skin irritation / Early / Incidence not known

    DRUG INTERACTIONS

    Imiquimod: (Minor) While no drug interactions have been reported with imiquimod, there is no clinical experience with imiquimod cream therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs, such as podofilox. Therefore, imiquimod cream administration is not recommended until skin is healed from any previous topical drug treatments or surgery.
    Podophyllum: (Minor) No drug interactions of clinical significance have been noted for podofilox. While no drug interactions have been reported, there is no clinical experience with podofilox immediately following the treatment of genital/perianal warts with other cutaneously applied drugs like podophyllum resin. Therefore, podofilox administration is not recommended until genital and/or perianal tissue is healed from any previous topical drug treatment or surgery.

    PREGNANCY AND LACTATION

    Pregnancy

    Guidelines recommend against use of podofilox during pregnancy. The manufacturer recommends use only if the potential benefits justify the potential risks to the fetus. No adequate and well-controlled studies have been conducted in pregnant women. In animal studies, use of systemic podofilox was found to be embryotoxic in rats at doses 19-times the maximum recommended human dose (RHD); however, the drugs was not teratogenic when given topically to pregnant rabbits at doses 2-times the RHD for 13 days. Because genital warts can proliferate and become friable during pregnancy, consideration can be given to their removal during pregnancy. HPV types 6 and 11 can cause respiratory papillomatosis in infants and children. The route of transmission (i.e., transplacental, perinatal, or postnatal) is not completely understood. In rats, podofilox did not appear to impair fertility when administered topically at doses corresponding to the recommended human daily dose.

    According to the manufacturer, a decision should be made whether to discontinue podofilox or to discontinue nursing, taking into account the importance of the drug to the mother. It is not known if podofilox is distributed into the human milk. However, in pharmacokinetic studies, topical application of podofilox to external genitalia did not result in detectable serum levels and the drug did not accumulate after multiple treatments. Therefore, it is unlikely that a clinically significant amount of drug would be present in breast-milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: The exact mechanism of action of podofilox in treating condylomata acuminata is not known, but it causes visible necrosis of the wart tissue. Podofilox potently inhibits cell mitosis. It acts by binding to tubulin to prevent the formation of microtubules, which results in mitotic arrest. It exerts a variety of biological effects including attenuation of nucleoside transport damage to the endothelium of small blood vessels, reduction of the lymphocyte response to mitogens, induction of interleukin-1 and interleukin-2, enhancement of macrophage growth, stifling of immune responses, and inhibition of macrophage metabolism.

    PHARMACOKINETICS

    Podofilox is for external topical use only.  The elimination half-life of podofilox ranges from 1.0 to 4.5 hours. Podofilox does not accumulate after multiple treatments.

    Topical Route

    When applied topically at a dosage of 0.1—1.5 ml of the 0.5% solution, peak serum concentrations of 1—17 ng/ml occur within 1—2 hours after application. Topical application of 0.5 ml of the 0.5% solution to the external genitalia does not result in detectable podofilox serum concentrations.