Podofilox Gel

• Tell all of your health care providers that you take podofilox gel. This includes your doctors, nurses, pharmacists, and dentists.
• Do not have any kind of sex when this medicine is on your genital or anal skin.
• Do not use podofilox gel for longer than you were told by your doctor.
• If your signs do not get better or if they get worse within 4 weeks, talk with your doctor.
• People using this medicine may get skin reactions where podofilox gel is used. These reactions may include burning or stinging, itching, pain, redness, bleeding, or swelling. Call your doctor if you have skin reactions that are very bad, bother you, or do not go away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

In the first multicenter clinical study in 326 patients with anogenital warts, Podofilox Gel 0.5% and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with Podofilox Gel 0.5%. Patients applied Podofilox Gel 0.5% twice daily for three consecutive days followed by a 4 day “rest” period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with Podofilox Gel 0.5%.

In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, Condylox (podofilox) Topical Solution 0.5% was compared with Podofilox Gel 0.5% for efficacy. As in the first clinical trial, patients applied Podofilox Gel 0.5% twice daily for three consecutive days followed by a four day “rest” period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with Podofilox Gel 0.5%.

Podofilox Gel 0.5% 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 0.5%.

Podofilox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Podofilox Gel 0.5% 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.

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. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Podofilox Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm2 or less of wart tissue and to no more than 0.5 g of the gel per day.

Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.

Podofilox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. Store at controlled room temperature between 20°- 25°C (68°- 77°F).
Avoid excessive heat. Do not freeze.

Keep out of reach of children.

Rx only

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8. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix: Effect of long term application. Arch Path 73:481-485, 1962.

9. Thiersch JB. Effect of podophyllin (P) and podophylotoxine (PT.) on the rat litter in utero. Soc Exptl Biol Med Proc. 113:124-127, 1963.

10. Savel H.: Clinical experience with intravenous podophyllotoxin. Proc Amer Assoc Cancer Res, 1964; 5: 56.

11. Cassidy DE, Dewry J and Fanning JP: Podophyllum toxicity: A report of a fatal case and a review of the literature. J Toxicol Clinic Toxicol 1982: 19: 35-44.

Mfd. for: Watson Laboratories, Inc.
               Corona, CA 92880 USA

Mfd. by: DPT Laboratories, Ltd.
              San Antonio, TX 78215 USA

Revised: May 2008
128864-0508
S0508