Podofilox (podofilox)

Because of the potential for adverse local reactions, the recommended dose, frequency of application, and duration of treatment of topical podofilox should not be exceeded. There is no evidence that applying podofilox more frequently than recommended would increase efficacy; however, more frequent application would be expected to increase the risk of local adverse reactions and increase systemic absorption of the drug.

It has been recommended that the total wart area being treated should not exceed 10 cm2 and that no more than 0.5 g of the gel or 0.5 mL of the solution should be applied daily.

Podofilox is applied topically to skin as a 0.5% gel or 0.5% solution. The drug has been administered topically as a cream, but this formulation is not commercially available in the US.

Podofilox topical gel may be applied to genital and anogenital areas; the topical solution should be applied only to the genital area.

Podofilox topical gel and solution are intended for external use only, and contact with eyes should be avoided. If contact occurs, the affected eye(s) should be washed with large amounts of water and a clinician consulted.

Because podofilox appears to be less toxic than podophyllum resin, it is suitable for self-administration whereas the latter drug should be administered by a health professional. Patients self-administering podofilox should be instructed carefully regarding proper techniques for application of the drug and advised not to exceed the recommended dosage or duration of therapy. To ensure that the patient is fully aware of correct techniques and to identify which specific warts should be treated, the initial dose of podofilox preferably should be applied by the health-care provider.

Podofilox 0.5% gel should be applied to external genital and perianal warts using the applicator tip or fingers. Podofilox 0.5% solution should be applied to external genital warts using the disposable applicators supplied by the manufacturer; a new applicator should be used each time the solution is applied. Care should be taken to avoid applying podofilox to surrounding normal tissue, and the gel or solution should be allowed to dry before opposing skin surfaces are returned to their normal position.

Occlusive dressings or wrappings should not be used. Patients should be directed to wash their hands thoroughly before and after applying podofilox gel or solution. Podofilox should not be washed off the treatment area unless a severe adverse reaction (e.g., bleeding, swelling, or excessive pain, burning, itching) occurs.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

• Pregnancy

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

More Frequent

• Blistering skin
• Paresthesia
• Superficial skin ulcer

More Frequent

• Abnormal desquamation
• Chafing
• Dizziness
• Dry skin
• Headache disorder
• Insomnia
• Pruritus of skin
• Skin inflammation
• Stinging of skin

Less Frequent

• Dyschromia
• Hematuria
• Hemorrhage
• Skin rash
• Vomiting

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rabbits involving topical application of 0.5% podofilox solution in doses up to 0.21 mg/kg (2.85 mg/m2, approximately 2-5 times the maximum human dosage) once daily for 13 days did not reveal evidence of teratogenicity. However, many antimitotic agents are embryotoxic and it has been reported that podofilox was embryotoxic when administered intraperitoneally to rats in doses of 5 mg/kg (29.5 mg/m2, approximately 19 times the maximum human dose). The teratogenic and embryotoxic potential of the drug has not been evaluated following intravaginal application. There are no adequate and controlled studies using podofilox in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the possible risks to the fetus.

It is not known whether topically applied podofilox is distributed into human milk. Because of the potential for serious adverse reactions to podofilox in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.