Podofilox Gel: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Podofilox Gel (generic name: podofilox) is a prescription keratolytic agent applied to the skin to treat external genital and anal warts caused by HPV. It works by slowly killing wart cells so the tissue dies and falls away over several treatment cycles. In clinical studies, about one in four to more than one in three patients had complete wart clearing after four weeks of use. It is applied in a specific twice-daily cycle and carries warnings about irritation, flammability, and use only on identified warts.

What is Podofilox Gel

Podofilox gel is a prescription medicine used on the skin to treat genital and anal warts caused by human papillomavirus (HPV). It belongs to a drug class called keratolytic agents (antimitotic drugs). It comes as a gel that is applied directly to the warts.

Podofilox Gel uses

• Treats external genital warts and warts around the anus (anogenital warts)
• Not for use on warts inside the body, such as on mucous membranes, in the urethra, rectum, or vagina

Benefits of Podofilox Gel

• Causes visible wart tissue to die off and disappear over several treatment cycles
• About one in four to more than one in three patients had complete clearing of warts after 4 weeks in clinical studies

How Podofilox Gel works

Podofilox works by slowly killing the cells that make up the wart, causing the tissue to die and eventually fall away.

Podofilox Gel dosage

Wash your hands thoroughly before and after each application. Apply the gel only to the warts your doctor has pointed out, using the applicator tip or your finger, and avoid getting the gel on healthy surrounding skin. If a wart is in a skin fold, gently spread the skin apart to reach it; a hand mirror can help. Let the gel dry completely before letting treated skin folds touch each other again.

Apply the gel once in the morning and once in the evening for three days in a row, then stop for four days — this is one treatment week. Do not apply more often or for more days in a row than directed, since this will not work better and may increase side effects. Do not have sexual intercourse on the days you are applying the gel. This treatment week can be repeated for up to four cycles total if warts remain. If warts have not cleared after four treatment weeks, stop use and contact your doctor.

Do not wash the gel off the wart area unless you have excessive pain, burning, or itching. If you miss a dose, apply it as soon as you remember, but if it is almost time for your next dose, skip the missed one — do not double up. Keep the gel away from your eyes, mouth, and nose; if it gets in your eyes, flush right away with plenty of water and get medical help. This product is flammable — keep away from open flame and do not use while smoking.

Available forms and strengths

• Gel
• Solution (liquid)

Side effects of Podofilox Gel

Common

• Burning or stinging at the application site
• Itching
• Pain
• Redness
• Inflammation
• Erosion of skin
• Headache

Serious

• Bleeding where the drug is used
• Swelling where the drug is used
• Excessive pain, burning, or itching
• Signs of a severe allergic reaction such as rash, hives, itching, blistered or peeling skin, wheezing, tightness in the chest or throat, trouble breathing or swallowing, or swelling of the face, lips, tongue, or throat

Warnings and precautions

• Getting a correct diagnosis of your skin condition is very important before starting treatment.
• This medicine is for use on the skin only — avoid getting it in your eyes. If it does get in your eyes, flush them right away with a lot of water and get medical help.
• This gel product can catch fire. Keep it away from open flames or heat sources.
• Do not use this medicine on any warts other than the ones your doctor identified, and do not use it for any other skin condition.
• Genital warts are contagious and can be passed to or from a sexual partner. Make sure your partner is checked for genital warts, and avoid sexual intercourse on the days you are applying the gel.
• Do not apply to the eyes, mouth, vagina, urethra, rectum, or other mucous membranes.
• Avoid use during pregnancy unless specifically advised by a doctor; adequate human pregnancy data are unavailable and potential fetal risk exists.
• It is unknown whether podofilox passes into human milk; discuss treatment with a healthcare professional.
• Wash hands before and after application.
• Do not apply more than twice daily or for more than 3 consecutive days. Using more does not improve effectiveness and can increase adverse effects and absorption.
• Safety and effectiveness have not been established in pediatric patients.
• If there is no improvement after 4 weeks, discontinue treatment and consult your healthcare provider for alternative treatment.

Storage

• Store at 20-25°C (68-77°F).
• Avoid excessive heat. Do not freeze.
• Keep out of reach of children.
• Keep lid tightly closed.
• Protect from heat or open flame.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

When to see a doctor

• Stop using the gel and contact your doctor right away if you have bleeding, swelling, or excessive pain, burning, or itching where the medicine was applied.
• Get medical help right away if you notice signs of a serious allergic reaction, such as rash, hives, itching, swollen or blistered skin, wheezing, tightness in the chest or throat, or trouble breathing or swallowing.
• If the warts have not gone away after four weeks of treatment, stop using the medicine and talk to your doctor about other treatment options.
• If the medicine gets in your eyes, flush them right away with plenty of water and get medical help immediately.
• If you think you or someone else has swallowed this medicine, contact your local poison control center or get emergency medical care right away.

Alternatives

• Cryotherapy
• Trichloroacetic acid (TCA)
• Imiquimod 3.75%