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|Regranex Topical

BECAPLERMIN (Topical)

Some commonly used brand names are:

In the U.S.—

• Regranex

Category

• Biological response modifier (topical)
• platelet-derived growth factor (topical)

Description

Becaplermin (be-KAP-ler-min) is used to treat skin ulcers, usually on the lower leg, in patients with type 2 diabetes mellitus. It works by locally stimulating the wound to heal. It is important to use other methods for good skin ulcer care when using becaplermin.

Becaplermin is available only with your doctor"s prescription, in the following dosage form(s):

• Topical
• Gel (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For becaplermin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to becaplermin, parabens, or metacresol. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether becaplermin passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Although there is no specific information comparing use of becaplermin in children 16 years of age or older with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. This medicine has not been studied in children up to 16 years of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of becaplermin in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

Other medical problems—The presence of other medical problems may affect the use of becaplermin. Make sure you tell your doctor if you have any other medical problems, especially:

• Skin cancer or tumors at the site of the ulcer—Use of becaplermin is not recommended because its effect on these conditions is not known
• Wounds that show exposed joints, tendons, ligaments, or bone—Use of becaplermin is not recommended because it is not known if it would work for these conditions

• Wounds that are closed manually by your health care professional—Use of becaplermin is not recommended because these wounds require a sterile product

Proper Use of This Medicine

To make using becaplermin as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of becaplermin. Read this paper carefully and ask your health care professional for any additional information or explanation.

It is important to prevent the tip of the tube from touching the skin ulcer or any other object to keep the medicine from becoming impure and a possible source of infection.

There are several important steps that will help you apply your medicine properly .

• Wash your hands before preparing your dose.
• The proper amount to measure depends on the size of the tube you are using and the size of the skin ulcer. You should expect the dose to change each week or every other week, depending on the rate your skin ulcer changes in size.
• Measure the proper amount carefully onto a clean surface such as wax paper. Then, transfer the medicine to your skin ulcer by using an applicator aid, such as a cotton swab or tongue depressor.
• Spread the medicine on your skin ulcer as a thin (about 1/16th of an inch), even, continuous film.
• After wetting a gauze pad with 0.9% Sodium Chloride Irrigation USP, apply it on top of your medicated skin ulcer.
• After 12 hours, remove the medicine left on the skin ulcer with 0.9% Sodium Chloride Irrigation USP or water.
• Keep the ulcer from becoming too dry. When changing the dressing, the existing bandage may need to be wetted with 0.9% Sodium Chloride Irrigation USP to help remove the bandage and prevent injury to the healing ulcer.
• Wet a new gauze pad with 0.9% Sodium Chloride Irrigation USP. Apply it on top of your skin ulcer that no longer has the medicine on it and wait 12 hours before applying the medicine again. Therefore, the medicine is reapplied every 24 hours, with a change in the wound dressing in between applications.

Dosing—The dose of becaplermin will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average dose of becaplermin. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage form (gel):
  • For skin ulcers caused by type 2 diabetes mellitus:
    • Adults and children 16 years of age and over—Apply an amount of gel once a day and leave it on for twelve hours. The amount applied will change each week or every other week, depending on the changing size of the skin ulcer.
    • Children up to 16 years of age—Use and dose must be determined by the doctor.

Missed dose—If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. As your skin ulcer changes in size, your doctor may change your dose weekly or every other week .

Becaplermin works best when used with other methods for good skin ulcer care , such as not bearing weight on the leg that has the skin ulcer. Your doctor will discuss these methods with you.

Discuss with your doctor whether you should continue the medicine if your skin ulcer is not reduced by 30% in 10 weeks or your skin ulcer does not improve after 20 weeks. If your skin ulcer does improve, your doctor may keep you on the medicine until your skin ulcer is completely healed.

It is important to use the proper amount and not to use more than prescribed.

Check the expiration date before using becaplermin and do not use it if it is out of date. The expiration date is located stamped on the crimped portion at the bottom of the tube.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 03/30/1998

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