Description and Brand Names

US Brand Name

  1. Regranex

Descriptions


Becaplermin is used with other ulcer care practices (eg, proper wound care) to treat deep skin ulcers (sores), usually in the lower leg, in patients with diabetes mellitus and who have good blood supply to the legs. Becaplermin works by stimulating the wound to heal. It is very important to use other methods for good wound care when using becaplermin.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Gel/Jelly

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of becaplermin in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of becaplermin in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Cancer, any type—Use with caution. May make this condition worse.
  • Poor blood flow to your lower legs and feet—Use with caution. May increase risk for more side effects.
  • Skin cancer or tumor at the application site—Should not be used in patients with this condition.
  • 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 doctor—Use of becaplermin is not recommended because these wounds require a sterile product.

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Use this medicine only on your skin and only on the area prescribed by your doctor. Do not get it into your eyes, nose, mouth, or vagina. You should not use this medicine on any other rashes, sores, or cuts. If it does get on these areas, rinse it off right away.

To use the gel:

  • Your doctor will tell you how much medicine to use. Depending on how quickly your skin ulcer heals, your doctor may change the dose of your medicine. Use of more medicine than your doctor prescribed will not help your skin ulcer heal more quickly.
  • Wash your hands before and after using this medicine.
  • Squeeze the gel onto a clean surface that will not absorb the medicine (eg, wax paper). Do not apply the medicine directly from the tube onto the skin.
  • Use a cotton swab, tongue depressor, or other applicator aid to spread an thin, even layer of gel over the surface of the skin ulcer.
  • Cover the skin ulcer with a gauze dressing that has been moistened with saline solution. Leave the skin ulcer covered for 12 hours. After 12 hours, remove the gauze. Carefully rinse the skin ulcer with saline or water to remove any medicine that remains. Do not apply more medicine. Put another saline-moistened gauze dressing on the area for the next 12 hours.
  • To keep the medicine as germ-free as possible, do not touch the tip of the tube to any surface (including the skin ulcer). Keep the tube tightly closed when you are not using it. Use a cotton swab, tongue depressor, or other application aid when you apply this medicine.

Dosing

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (gel):
    • For diabetic skin ulcers:
      • Adults and children 16 years of age and older—Apply to the affected area once a day and leave it on for 12 hours. The amount applied will change each week or every other week, depending on the changing size of the skin ulcer.
      • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

This medicine should not be used after the expiration date. The date can be found at the bottom of the tube.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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

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

It is important to use the proper amount and not to use more than prescribed. Using too much of this medicine may increase your risk of having cancer away from the application site. Your doctor will decide if you should continue to use this medicine based on how well your skin ulcer has healed.

If burning, itching, redness, skin rash, swelling, or soreness at the application site occurs, check with your doctor right away.

Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Rash or redness of the skin near the skin ulcer

Incidence not known

  1. Burning sensation at the application site
  2. unusually warm skin

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.