An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin gel in a postmarketing retrospective cohort study. Becaplermin gel should only be used when the benefits can be expected to outweigh the risks and should be used with caution in patients with known malignancy .
Wound Care Agent
Platelet Derived Growth Factor
Becaplermin is used to treat skin ulcers, usually on the lower leg, in patients with type 2 diabetes mellitus. It works by stimulating the wound to heal. It is important to use other methods for good skin ulcer care when using becaplermin.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of becaplermin in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of becaplermin in the elderly.
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.
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:
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.
This medicine comes with a Medication Guide and patient instructions. 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 in your eyes, nose, mouth, or vagina. You should not use on any other rashes, sores, or cuts. If it does get on these areas, rinse it off right away.
It is important to prevent the tip of the tube from touching the skin ulcer or any other object. This will keep the medicine from being contaminated and a possible source of infection.
To use the gel:
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.
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.
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.
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 each week 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 in size 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 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. 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, stop using this medicine and check with your doctor right away.
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:
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.