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Drug overview for PODOFILOX (podofilox):
Generic name: PODOFILOX (poh-DOFF-ih-lox)
Drug class:
Therapeutic class: Dermatological
Podofilox, also known as podophyllotoxin, is an antimitotic agent.
Podofilox is used topically for the treatment of external genital and perianal exophytic warts (condylomata acuminata) caused by human papillomavirus (HPV). Podofilox has not been evaluated for the topical treatment of verruca vulgaris (common warts). Podofilox has been used topically for the treatment of molluscum contagiosum+, but safety and efficacy of the drug for this cutaneous viral infection have not been established.
Generic name: PODOFILOX (poh-DOFF-ih-lox)
Drug class:
Therapeutic class: Dermatological
Podofilox, also known as podophyllotoxin, is an antimitotic agent.
Podofilox is used topically for the treatment of external genital and perianal exophytic warts (condylomata acuminata) caused by human papillomavirus (HPV). Podofilox has not been evaluated for the topical treatment of verruca vulgaris (common warts). Podofilox has been used topically for the treatment of molluscum contagiosum+, but safety and efficacy of the drug for this cutaneous viral infection have not been established.
DRUG IMAGES
PODOFILOX 0.5% TOPICAL SOLN
The following indications for PODOFILOX (podofilox) have been approved by the FDA:
Indications:
External condylomata acuminata
Professional Synonyms:
External condyloma acuminatum
Indications:
External condylomata acuminata
Professional Synonyms:
External condyloma acuminatum
The following dosing information is available for 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.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PODOFILOX 0.5% TOPICAL SOLN | Maintenance | Adults apply by topical route 2 times per day for 3 days then stop for 4 days. (repeat 7day cycle until no visible wart tissue/max of four cycles) |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PODOFILOX 0.5% TOPICAL SOLN | Maintenance | Adults apply by topical route 2 times per day for 3 days then stop for 4 days. (repeat 7day cycle until no visible wart tissue/max of four cycles) |
The following drug interaction information is available for PODOFILOX (podofilox):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PODOFILOX (podofilox):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for PODOFILOX (podofilox):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blistering skin Paresthesia Superficial skin ulcer |
None. |
| Rare/Very Rare |
|---|
| None. |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Chafing Dizziness Dry skin Headache disorder Insomnia Pruritus of skin Skin inflammation Stinging of skin |
Dyschromia Hematuria Hemorrhage Skin rash Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for PODOFILOX (podofilox):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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 Geriatric Use information available for this drug.
The following prioritized warning is available for PODOFILOX (podofilox):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PODOFILOX (podofilox)'s list of indications:
| External condylomata acuminata | |
| A63.0 | Anogenital (venereal) warts |
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