Podophyllotoxin
A gel applied at home for anogenital warts on a fixed rhythm of three days on and four days off, up to four cycles.
- Class
- Antimitotic agent
- Sold as
- Sold as: Condylox, Condyline, Wartec
- Prescription only
From the approved label
Condylox
- Approved uses
- Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts).
- Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis.
- Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern.
- This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS).
- Forms and strengths
- Condylox Gel 0.5% is supplied as 3.5 grams of clear gel in aluminum tubes with an applicator tip.
- How it is taken
- The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated.
- Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days.
- This one-week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles.
- If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment.
- Must not be used when
- Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.
- Warnings and precautions
- Correct diagnosis of the lesions to be treated is essential.
- See the Diagnosis subsection of the INDICATIONS AND USAGE section.
- Condylox Gel 0.5% is intended for cutaneous use only.
- Avoid contact with the eyes.
- Common side effects
- In clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period.
- Pregnancy
- 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2, approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m 2, approximately 19 times the recommended maximum human dose).
- How it acts
- Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.
- Label holder:
- Allergan, Inc.
- Label version:
This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.
Written by us
How it works
Podophyllotoxin stops cell division in the wart tissue, which is why the label describes it as an antimitotic agent and why the treated tissue breaks down over the following days. It acts on the wart that is there and not on the virus, so the label speaks of treating anogenital warts rather than curing an infection.
Original and generic
Sold in Europe mainly as Condyline and Wartec, in the United States as Condylox. The substance is the same and off patent; what differs between countries is the form, gel or solution, and the size of the tube.
What it costs
One tube covers a course for a small area, which makes it one of the cheaper options in this part of the catalogue. Cost rises when the area is large enough to need repeat tubes across several cycles.
How to get it legally
Prescription only in Europe and the United States. The rhythm of application is what makes the prescription matter: the label sets three days of treatment followed by four days without, repeated for up to four cycles, and both the pause and the limit on cycles are part of the approved use rather than optional detail.
Questions
- Why the four days without treatment?
- The label sets the cycle that way. Treatment runs twice a day for three consecutive days, then stops for four days, and the cycle may be repeated up to four times.
- Can it be used during pregnancy?
- The label carries a warning against use in pregnancy. Anyone who is pregnant or might become pregnant should raise it before treatment starts, not after.
- What happens if warts remain after four cycles?
- The label does not extend treatment beyond that. What follows is a question for a clinician, because the options at that point are different procedures rather than more of the same gel.
Sources
- Condylox: prescribing informationDailyMed, US National Library of Medicine. Label version 29 January 2024
- Drugs@FDA: NDA020529US Food and Drug Administration
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