The Medical Procedures Center, P.C.

"We treat people, not just problems."

John L. Pfenninger, M.D.

Lori Oswald, P.A.-C.

4800 N. Saginaw Road, Midland, MI 48640

(989) 631-4545

Visit our Website at http://www.MPCenter.net

EFUDEX PROTOCOL

As your doctor has explained, it is important to treat genital warts. Recent research indicates they are associated with cervical cancer in women. Women also have an increased risk of vaginal cancer and vulvar cancer, especially if they smoke, but less than cervical cancer. In men, there may be a slightly increased incidence of penile cancer and rectal cancer. Although treatment with freezing or surgery can protect the cervix 97% of the time, it is very difficult to treat warts in other areas. Many experts feel that the warts in these other areas are only put "in remission" and can recur anytime no matter which treatment is used.

One of the drugs that has been used for your condition is called EFUDEX. It is a cream that has been approved for 15-20 years for use on the skin for several different pre-cancerous lesions. HOWEVER, THE FDA HAS NOT APPROVED EFUDEX FOR THE TREATMENT OF WARTS. You should know that even though many leaders in the field have used it for 15 years or more, it still must be considered somewhat experimental for warts.

After evaluation by colposcopy or androscopy, you and your partner may both need to be treated. There should be approximately a 75% chance of the visible warts going away following this protocol. Approximately 4-8 weeks after starting Efudex, you will need to be re-examined. If you are found to be free of warts at the repeat exam, you will then need to use the Efudex once a month for six months. Other topical medicines are also available and may be used for you. They include Condylox and Aldara. The doctor may also recommend a variety of surgical procedures.

For Women:

You will need to use 1/3 of a vaginal applicator of 5% Efudex cream (1.5g) in the vagina at bedtime ONCE A WEEK FOR TEN WEEKS. You may notice that two to three days after use, there may be some irritation, redness, swelling, and even some discharge. Nothing need be done unless you are extremely uncomfortable. You may want to put on some Vaseline ointment or Cortaid cream (over-the-counter) and apply it around the irritated areas on the outside of the vagina. If this does not help, you can call our office for further instructions. It is probably best to wear a pad to bed at night on the nights that you use the Efudex cream in the vagina. You may want to douche it out the following morning. You can shower or bathe as usual. Intercourse is permitted when you are comfortable. Be sure to immediately wash off any cream that you may get on your hands or it will also cause irritation. If your doctor has indicated, you may want to put a very slight amount of the cream around the rectum to cure the warts there also. Two weeks after stopping the medication (three months after starting), you will need to be rechecked with the colposcope by your doctor. DO NOT USE THE CREAM IF YOU ARE PREGNANT. If you had cryocautery (freezing), begin four weeks after having it done. DO NOT USE THIS CREAM MORE THAN ONCE PER WEEK UNLESS INSTRUCTED TO DO SO.

For Men:

Most likely if you have warts, they will be on the penis, on the sacs, and occasionally also around the rectum. Your doctor will describe to you exactly where he wants you to put the cream. You will also be using 5% Efudex cream. YOU WILL NEED TO APPLY IT ONLY ONCE A WEEK FOR TEN WEEKS. You can apply a little around the rectum if you have been told to do so by your doctor. Use very little cream since this will cause a lot of irritation in some people (most men use 1 to 1-1/2 tubes in 10 weeks). If you do not have a severe reaction, it is OK to apply the cream on the penis and the rectum all on the same night. If there is going to be a reaction, it usually occurs on the third or fourth day after application. You can use Vaseline or Cortaid cream or ointment to calm it down. It is also permissible to use ibuprofen to control the pain. If there is little reaction when using the cream every seven days, try using it every six days.

After using the medication for ten weeks, you will need to wait two weeks before being rechecked by your doctor with the androscope. If he does not find any residual warts, you will need to use this cream in the same manner once a month for six months. If warts are found, your doctor will instruct you as to what you should do next. If you and your partner are being treated at the same time, you do not need to use a condom. If your partner is not being treated, use a condom to protect her.

Generally the penis tolerates the medication well, but the sacs are very sensitive. You may want to protect the sacs by using an athletic supporter and cutting out an opening for the penis. In this way you can put the cream on the penis more frequently than the sacs and limit the reaction on the sacs.

SUMMARY

INSTRUCTIONS FOR USE OF 5-FU (EFUDEX®) CREAM

General Instructions:

Do not use the 5-FU cream if you are pregnant.
Use adequate birth control to prevent pregnancy!
Avoid sex during the nights of treatment.
Have your sexual partner wear a condom during intercourse while being treated.
If the treated area is irritated, hold further applications of 5-FU until the irritation has subsided.
If you experience severe irritation, please call us.
Your condition is probably contagious. Examination of your sexual partner may be beneficial.
Please call us if you need any of the prescription medications mentioned below.
Stop smoking.
Eat 5 helpings of fruits and vegetables per day.
Take a good multivitamin with folic acid.
Be monogamous.
Women need to be sure they get regular pap smears.
Call for the results of any biopsies in 2 weeks.

Vaginal Lesions:

Insert an Ortho contraceptive cream applicator 1/3 full of 5-FU cream deeply into the vagina once a week at bedtime for 10 weeks.
Anticipate a watery discharge during the time of treatment.

Urethral Lesions:

Apply a small amount of 5-FU cream (usually no more than 1/4" out of the tube) with a cotton-tipped applicator to the urethral opening and (if instructed) into the urethra once weekly at bedtime for 10 weeks. Men may need to do this twice a day for a week.
Anticipate irritation or burning during urination. If troublesome, apply 2% lidocaine jelly with a cotton-tipped applicator every 1-2 hours as necessary.

Vulvar (lips) and Penile Skin/Scrotal Lesions:

Cleanse and dry the vulva (genital lips) carefully. Use a hair dryer to assure dryness.
Apply a small amount of 5-FU cream (1/4-1/2" out of the tube) and massage into affected skin at bedtime once a week for 10 weeks.
Cleanse and dry the treated area the next morning.
Anticipate some irritation. If troublesome, take sitz baths three times a day and after each urination; apply Tucks® pads to the irritated area as needed.

Perianal and Anorectal Lesions:

Cleanse and dry the anus carefully.
Apply a small amount of 5-FU cream (1/4-1/2" out of the tube) and massage into affected skin at bedtime once a week for 10 weeks.
Cleanse and dry the treated area the next morning.
Take Doxidan® capsules 100 mg. orally twice a day to keep stools soft.
Anticipate anal/rectal irritation. If troublesome, apply Proctofoam HC® or Anusol HC® suppositories or cream and/or take sitz baths three times a day and after each bowel movement.