Podofilox

This medication is used on the skin to treat external genital warts. Podofilox is made from the resin found in the roots of the podophyllum plant. It works as a keratolytic agent to soften and break down the skin, making it easier to infiltrate and kill diseased cells, which prevents them from reproducing.

• Read the Patient Information Leaflet before you start using Podofilox gel and each time you get a refill. Request a callback from your medical provider if you have any questions.
• This medication is for topical use only. Apply it on the warts once in the morning and again in the evening for 3 days, which should then be followed by a 4-day rest period.
• If the warts do not go away, then this cycle is repeated up to 4 times. Contact your medical provider for other options if the warts do not go away after 4 weeks of treatment.
• To apply, use the provided applicator tip or your finger. Apply a small amount of medication to the wart to cover it. Allow the gel to dry.
• Wash your hands thoroughly after application. Be careful with this medication because it can irritate normal skin around the application site.
• Do not use large amounts or apply the medication more often/use it for a longer period than directed. Your condition will not clear up faster. Instead, the chance of experiencing side effects may be increased.
• Avoid contact with the eyes and mucous membranes. If contact occurs, immediately wash with plenty of water and contact your medical provider.

• Swelling, pain, burning, itching, peeling skin, small sores or headaches may occur. If any of these effects continue or worsen, seek immediate medical attention.
• Remember that this medication has been prescribed because your medical provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
• Tell your medical provider right away if this serious side effect occurs, including localized bleeding.

• A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

  • Rash
  • Itching/swelling (especially of the face/tongue/throat)
  • Severe dizziness
  • Trouble breathing

• This is not a complete list of possible side effects. If you notice other effects not listed above, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

• Before taking Podofilox, tell your medical provider if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Request a callback from your medical provider for more details.
• Before using this medication, tell your medical provider about your family medical history, especially if it includes skin cancer.
• This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your medical provider. If you become pregnant or think you may be pregnant, tell your OB-GYN right away.
• It is unknown if this drug passes into breast milk. Consult your OB-GYN before breastfeeding.
• Some strains of HPV can cause cervical cancer. This treatment does not eliminate that risk or  remove any abnormal cervical cells that may be precancerous or cancerous. Let your OB-GYN know you are taking this medication and request a PAP smear to screen for abnormal cells that need to be treated to prevent cervical cancer.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your medical provider. Do not start, stop or change the dosage of any medicines without your medical provider's approval.

• This medication is prescribed for your current condition only. Do not use it later for another skin problem unless directed by your medical provider. A different medication may be necessary in those cases.
• Do not share this medication with others.
• This medication is not a cure. New warts or return of old warts may occur, especially in the first 3 months after treatment. Follow-up medical visits may be periodically necessary to monitor your progress or check for side effects. Consult your medical provider for more details.
• Refrain from sexual intercourse on the days you apply this drug. Using condoms may help prevent the spread of genital warts to your partner.

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

• Store at room temperature between 59-86 degrees F (15-30 degrees C).
• Keep away from heat or open flame. Do not freeze.
• Replace the cap tightly after use.
• Do not store it in the bathroom.
• Keep all medications away from children and pets.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.