Podofilox
Generic: PODOFILOX
Basic Information
Manufacturer
Padagis US LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
d2e70c5e-d4a9-4295-9eff-517ffb974e61
Indications & Usage
INDICATIONS AND USAGE Podofilox gel is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts).
This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ).
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.
Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.
This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ).
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.
Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.
Warnings
WARNINGS Correct diagnosis of the lesions to be treated is essential.
See the Diagnosis subsection of the INDICATIONS AND USAGE section.
Podofilox gel is intended for cutaneous use only.
Avoid contact with the eyes.
If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.
Drug Product is Flammable.
Keep Away from Open Flame.
See the Diagnosis subsection of the INDICATIONS AND USAGE section.
Podofilox gel is intended for cutaneous use only.
Avoid contact with the eyes.
If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.
Drug Product is Flammable.
Keep Away from Open Flame.
Adverse Reactions
ADVERSE REACTIONS In clinical trials with podofilox gel, 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.
Severe reactions were most frequent within the first 2 weeks of treatment.
Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.
The most common systemic adverse event reported during the clinical studies was headache (7%).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period.
Severe reactions were most frequent within the first 2 weeks of treatment.
Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.
The most common systemic adverse event reported during the clinical studies was headache (7%).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.