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 skinulcers, 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 useother methods for good skin ulcer care when using becaplermin.

Becaplermin is available only with your doctor's prescription, in the followingdosage 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 followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to becaplermin, parabens, or metacresol. Also tell yourhealth care professional if you are allergic to any other substances, suchas foods, preservatives, or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Breast-feeding?It is not known whether becaplermin passes intothe breast milk. However, this medicine has not been reported to cause problemsin nursing babies.

Children?Although there is no specific information comparinguse of becaplermin in children 16 years of age or older with use in otherage groups, this medicine is not expected to cause different side effectsor problems in children than it does in adults. This medicine has not beenstudied in children up to 16 years of age.

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

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

Other medical problems?The presence of other medicalproblems may affect the use of becaplermin. Make sure you tell your doctorif you have any other medical problems, especially:

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

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

Proper Use of This Medicine

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

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

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

• Wash your hands before preparing your dose.
• The proper amount to measure depends on the size of the tube youare using and the size of the skin ulcer. You should expect the dose to changeeach week or every other week, depending on the rate your skin ulcer changesin size.
• Measure the proper amount carefully onto a clean surface such aswax paper. Then, transfer the medicine to your skin ulcer by using an applicatoraid, such as a cotton swab or tongue depressor.
• Spread the medicine on your skin ulcer as a thin (about 1/16th ofan 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 IrrigationUSP to help remove the bandage and prevent injury to the healing ulcer.
• Wet a new gauze pad with 0.9% Sodium Chloride Irrigation USP. Applyit on top of your skin ulcer that no longer has the medicine on it and wait12 hours before applying the medicine again. Therefore, the medicine is reappliedevery 24 hours, with a change in the wound dressing in between applications.

Dosing?The dose of becaplermin will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 amountof gel once a day and leave it on for twelve hours. The amount applied willchange each week or every other week, depending on the changing size of theskin ulcer.
    • Children up to 16 years of age?Use and dose must be determinedby the doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Yourdoctor should check your progress at regular visitsto make sure that this medicine does not cause unwanted effects. As your skinulcer changes in size, your doctor may change your doseweekly or every other week.

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

Discuss with your doctor whether you should continue the medicine if yourskin ulcer is not reduced by 30% in 10 weeks or your skin ulcer does not improveafter 20 weeks. If your skin ulcer does improve, your doctor may keep youon 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 ifit is out of date. The expiration date is located stamped on the crimped portionat the bottom of the tube.

Side Effects of This Medicine

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

Check with your doctor as soon as possibleif the following side effect occurs:

Less common

Reddened skin near ulcer; skin rashnear ulcer

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