REGRANEX® Gel is the only medicine of its kind
approved by the Food and Drug Administration
(FDA) for the treatment of diabetic foot sores.
How will my doctor treat my diabetic foot sore?
Your doctor will probably treat your sore, or DFU, using "good wound care," which could include one or more of these methods:
Sometimes, even when you and your doctor try these or other methods, some sores still won't heal. That's where a prescription medicine comes in.
REGRANEX® Gel is effective
When combined with other methods that your doctor uses to heal your diabetic foot sore, REGRANEX® Gel can speed the healing process.
What you need to know about REGRANEX® Gel
People who use 3 or more tubes of REGRANEX® Gel may have an increased risk of death from cancer.
- You should talk with your doctor about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX® Gel
- If you already have cancer, you and your doctor should carefully consider whether you will use REGRANEX® Gel
SPEAK up. Make sure all of your questions get answered at your doctor visits. Take notes, bring a loved one with you, and repeat back what the doctor says to help you remember important things.
TAKE an active role in making sure all your doctors—primary care, diabetes specialist, and foot doctor—talk to each other.
EXAMINE your feet every day. Because people with diabetes are sometimes unable to feel pain or tenderness in their feet, look for other signs like redness, swelling, and warmth.
PRACTICE good blood sugar control. It is important to keep a close eye on your blood glucose level because that plays a role in healing and preventing sores.
SEE your doctor. He or she needs to check on your sore every week or every other week to monitor your healing progress and to decide how much REGRANEX® Gel you need to apply, because the amount may change over time.
Important Safety Information
People who use 3 or more tubes of REGRANEX® (becaplermin) Gel may have an increased risk of death from cancer.
- You should talk with your healthcare provider about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX® Gel
- If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX® Gel
REGRANEX® (becaplermin) Gel is a man-made protein medicine that is used with other ulcer care practices (such as good wound care) to treat diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs.
- It is not known if REGRANEX® Gel is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation)
- It is not known if REGRANEX® Gel is safe and effective in children under 16 years of age
Do not use REGRANEX® Gel if you have a skin tumor at the area where you apply the product.
Before you use REGRANEX® Gel, tell your healthcare provider if you:
- Have cancer
- Have poor blood flow to your legs and feet
- Have allergies to any of the ingredients in REGRANEX® Gel. See the Medication Guide for a complete list of ingredients
- Have any other medical conditions
- Are pregnant or plan to become pregnant. It is not known if REGRANEX® Gel will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if REGRANEX® Gel passes into your breast milk
- Take any medicines (including prescription and non-prescription medicines, vitamins, and herbal supplements). Especially tell your healthcare provider if you apply other medicines to diabetic ulcers of your legs or feet
If you decide to use REGRANEX® Gel, use the product exactly as your healthcare provider tells you to use it. This includes
following your healthcare provider's instructions about not putting weight on the affected leg and foot (non-weight bearing).
- REGRANEX® Gel is for use on skin ulcers only. Do not use REGRANEX® Gel in your mouth, eyes, or vagina
- See the Medication Guide for more information REGRANEX® Gel may cause serious side effects
- People who use 3 or more tubes of REGRANEX® Gel may have an increased risk of death from cancer
- Common side effects of REGRANEX® Gel include:
- — Red skin rash
- — Burning at the application site
- Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of REGRANEX® Gel. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/medwatch or at 1-800-FDA-1088. You may also report side effects to Smith & Nephew at 1-800-441-8227
Keep REGRANEX® Gel and all medicines out of the reach of children. Do not use REGRANEX® Gel for a condition for which it was not prescribed.
Do not give REGRANEX® Gel to other people, even if they have the same symptoms that you have. It may harm them.
Read the Medication Guide before you start using REGRANEX® Gel and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.