Treating foot sores | REGRANEX◊ (becaplermin) Gel

Remember that your diabetic foot sore (or diabetic foot ulcer) will not heal overnight. But it is important that you do all you can to make sure your diabetic foot sore heals properly. That is because a diabetic foot sore that doesn’t heal can lead to further complications such as infection, hospitalization, or amputation.

Your first step in healing a diabetic foot sore is practicing good wound care. Partner with your doctor or wound care specialist to treat your diabetic foot sore in its early stages.

Good wound care involves:

Debridement

Your doctor will remove any dead tissue around the sore, because unhealthy tissue prevents healing.

Infection control

Antibiotics may be prescribed to help fight infection.

Off-loading

Pressure is taken off the sore with a special boot, crutches, cast, or therapeutic footwear to give the sore a chance to heal.

When good wound care isn’t enough

Even when you and your doctor properly care for a diabetic foot sore, it still may not heal. If your doctor is not happy with the healing of your wound, another treatment regimen will be considered. At this time, your doctor may prescribe treatment with REGRANEX Gel.

Tips to stay on track

A diabetic foot sore does not heal overnight. That is why it is very important to stay on track with treatment.

Ask for help.

Decide who is going to apply REGRANEX Gel to your sore (you or a home caregiver). Then, get everyone in your household on board with your treatment plan so they can remind you when it’s time to apply.

Set an alarm.

Your alarm clock can be a powerful reminder for when it’s time for dressing changes.

Make a note.

Write “REGRANEX Gel pm/am” on a sticky note and attach it to your refrigerator.

Go high-tech.

If you have a cell phone, you can download an app and text messaging service to help you remember when to apply REGRANEX Gel. Popular apps include MediSafe, RxmindMe™, and MedCoach™.

Use a calendar.

Keep track of your application schedule by marking the days you apply REGRANEX Gel on a calendar. You can find one in the “Tools” section of this website.

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Diabetes and foot wound problems

The effects of diabetes can slow wound healing anywhere on the body. Small cuts and blisters can easily develop into deep sores.

Learn about diabetic foot sores

Preventing diabetic foot sores

Prevention is the key to keeping healthy feet and reducing the likelihood of diabetic foot ulcers.

Learn about prevention

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 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.

Important Safety Information

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX (becaplermin) Gel, 0.01% in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.

Indication and limitations of use
REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.
The effects of REGRANEX Gel on exposed joints, tendons, ligaments, and bone have not been established in humans.
REGRANEX Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Contraindications
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of the product (eg, parabens).

Warnings and precautions
Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. REGRANEX Gel should be used with caution in patients with a known malignancy.

If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered.

Commonly observed adverse reactions
In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone.

See warnings above regarding malignancy.

Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX Gel.

Other important information
The amount of REGRANEX Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending upon the rate of change in ulcer area.

If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX Gel should be reassessed.

Pregnancy and Nursing Mothers: Pregnancy Category C. REGRANEX Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REGRANEX Gel is administered to nursing women.

Safety and effectiveness of REGRANEX Gel in pediatric patients below the age of 16 years have not been established.

Counsel patients to review the Medication Guide and to discuss any questions or concerns with their healthcare provider before starting REGRANEX Gel and at regular intervals during treatment, including when their prescription is refilled.

To report suspected adverse reactions, contact Smith & Nephew at 1-800-441-8227 or contact FDA at www.fda.gov/medwatch or at 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Medication Guide.