Regranex (Becaplermin) - Topical

What Is Regranex?

Regranex (becaplermin) is a prescription gel used to treat diabetic neuropathic ulcers in people 16 and older. Regranex is important in people who have diabetes, as the impact of hyperglycemia (high blood sugar) over time can cause nerve damage, leading to numbness.

Regranex is categorized as a human platelet-derived growth factor (PDGF), a type of protein that influences wound-healing cells to go to the injured site and multiply.

As a result, Regranex is used to treat ulcers in the lower extremities—like the legs, ankles, and feet.

However, these affected areas must have good blood flow to them. Thus, this medication can only be used in addition to good ulcer care practices, which include getting rid of dead skin, relieving pressure on the ulcerated area, and controlling the infection.

While no generic version is available, Regranex is available as a topical gel product that is applied to the ulcer.

Drug Facts

Generic Name: Becaplermin

Brand Name(s): Regranex

Drug Availability: Prescription

Administration Route: Topical

Therapeutic Classification: Wound care agent

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Becaplermin

Dosage Form(s): Gel

What Is Regranex Used For?

The Food and Drug Administration (FDA) approved Regranex for use in people who have diabetes and develop ulcers from nerve damage. These ulcers might affect the fatty layer or a deeper area underneath the skin.

The FDA approved Regranex for these ulcers in the lower extremities only in addition to good ulcer care practices.

For an individual with diabetes, less feeling in their body as a product of nerve damage create a higher chance of injury.

Once injured, you might be unaware of any blisters, which may worsen into ulcers that affect the subcutaneous (fatty) layer or a deeper area underneath your skin. When you become aware of your ulcer, it may take a long time for it to get better.

In the United States (U.S.), more than 34 million people have diabetes. Additionally, another 88 million adults have prediabetes.

In people with diabetes, high blood sugar over long periods may lead to nerve damage. An estimated 50% of people with diabetes have nerve damage that can lead to numbness and a higher risk of ulcers.

How to Use Regranex

Before using Regranex, the prescriber or wound caregiver will need to measure the length and the width of the ulcer in inches or centimeters.

If the ulcer was measured in inches, then the following formula is used to determine the length of medication to use from the Regranex tube of gel:

Ulcer length x ulcer width x 0.6.

If the ulcer was measured in centimeters, then another formula is used to calculate the length of gel to use from the Regranex tube:

Ulcer length x ulcer width ÷ 4.

After knowing how much medication to use, wash your hands before squeezing the calculated length of Regranex gel from the tube onto a clean surface—like wax paper. If necessary, use a ruler to measure. Make sure not to touch the tip of the gel tube on anything.

Next, use a clean cotton swab to transfer the measured Regranex gel onto the ulcer and evenly spread the medication over the ulcer.

Then, use saline to dampen a gauze dressing before covering the ulcer for 12 hours. Wash your hands.

After 12 hours, throw away the gauze and rinse the ulcer with saline or water to remove the Regranex gel from the ulcer.

Cover the ulcer with another saline-moistened gauze until the next day. Remember to wash your hands again.

Only use Regranex once daily for 12 hours at a time. The healthcare provider and wound caregiver will need to measure the wound every week or every two weeks to recalculate the amount of Regranex gel to use.

Storage

Regranex is a non-controlled prescription. Therefore, your healthcare provider can give you as many refills as necessary for up to a full year from the originally written date on the prescription.

However, your healthcare provider might only give you a limited number of refills for the following reasons:

  • The daily amount of Regranex gel to use might change every few weeks because the ulcer size might also change every few weeks.
  • Within 20 weeks of using Regranex, your healthcare provider will want to see you. Typically, the ulcer completely heals within 20 weeks. Once the ulcer is completely healed, your healthcare provider will stop the medication. If your ulcer isn’t at least 30% smaller by 10 weeks or isn’t completely healed at 20 weeks, your healthcare provider will discuss the next steps, which may include discontinuing Regranex treatment.

When you get Regranex from the pharmacy, store the medication in the refrigerator, which is between 36 to 46 degrees F. Don’t freeze this medication.

If you’re going to travel with Regranex, learn about the regulations of your final destination. In general, however, you will usually need to keep Regranex in its original container—with your name on it—from the pharmacy. Also, make a copy of your Regranex prescription.

Additionally, since this medication needs to be refrigerated, you will need a cooler pack as part of your carry-on items.

How Long Does Regranex Take to Work?

Since the healthcare provider or wound caregiver needs to check the wound size every week to every two weeks, you might notice a change in the ulcer size within one to two weeks.

What Are the Side Effects of Regranex?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effects of Regranex include red skin rashes. If you experience any reactions—like a burning feeling—on the skin where the medication was placed, notify your healthcare provider.

Severe Side Effects

Regranex is linked to cancer at locations away from where the medication was used. Therefore, the manufacturer—Smith & Nephew—recommends that you and your healthcare provider weigh the risks and benefits before using this medication.

If you suspect you have cancer in areas different from where the gel was applied, immediately inform your healthcare provider.

Long-Term Side Effects

Regranex use might raise your risk of cancer in areas away from where the gel was originally used. If you suspect that you are experiencing this, talk with your healthcare provider right away.

Report Side Effects

Regranex may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program online or by phone (800-332-1088).

Dosage: How Much Regranex Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

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.

Modifications

Potential users should be aware of the following before beginning Regranex:

Children: There is limited safety and effectiveness data for Regranex in children younger than 16.

Pregnant or nursing people: There is limited information about the safety and effectiveness of Regranex during pregnancy or nursing. Therefore, consult your healthcare provider before starting Regranex if you plan on becoming pregnant or breastfeeding your child during treatment to determine if the benefits outweigh any potential risks.

Older adults: Among people receiving any dose of Regranex gel in clinical studies of diabetic lower extremity ulcers, 150 people were 65 or older, and the results showed no overall differences in safety or effectiveness were observed between people younger than 65 versus people older than 65.

Missed Dose

If you accidentally forget to apply Regranex for the day, don’t try to use extra gel to make up for the missed dose. Instead, wait until the next scheduled time on the following day to apply the Regranex gel again.

Overdose: What Happens If I Take Too Much Regranex?

If you are concerned that you used too much Regranex, let your healthcare provider know or call the Poison Control Center. However, there is currently no available overdose information on Regranex.

What Happens If I Overdose on Regranex?

If you think you or someone else may have overdosed on Regranex, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after using Regranex, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

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.

What Are Reasons I Shouldn't Take Regranex?

If you have cancer in the area that Regranex was applied, the manufacturer recommends against using Regranex.

Because the FDA only approved Regranex for the treatment of diabetic neuropathic ulcers in the lower extremities, this gel shouldn’t be used for the following:

What Other Medications May Interact With Regranex?

Because the manufacturer did not publish sufficient research regarding the effects of Regranex in combination with other topical medications, there is limited information on what other drug therapies may interact with Regranex.

Therefore, consult with your healthcare provider to determine what other medications or healthcare treatments may pose a risk when used in tandem with Regranex.

What Medications Are Similar?

Regranex is the only PDGF medication that is FDA-approved to treat diabetic neuropathic ulcers in the lower extremities.

Frequently Asked Questions

  • Where is Regranex available?

    Regranex is available with a prescription from your healthcare provider. Most local retail pharmacies can carry Regranex. If the pharmacy doesn’t have the medication in stock, the pharmacy will typically be able to order the gel for you.

  • How much does Regranex cost?

    Since Regranex is a brand-name medication, it’s typically expensive. If cost is a concern, the manufacturer does offer a Patient Assistance Program (PAP) and a Copay Assistance Program. You can also talk to your healthcare provider or pharmacist for information about other cost assistance options.

  • Is there any support to help me understand Regranex’s complicated directions?

    The manufacturer offers Regranex360, which is a full-service program to help answer any questions—like medication directions. The program is available at 1-888-734-7263.

    This program can also help with insurance issues and forward your healthcare provider’s Regranex prescription to a pharmacy that has experience filling Regranex. Regranex360 will also assist you with medication delivery logistics.

How Can I Stay Healthy While Using Regranex?

If you are using Regranex, then you've probably had diabetes for at least the past few years.

After having high blood sugar over a long period, you can experience damaged nerves, which can lead to numbness and ulcers.

As your ulcer is healing, consider the following to help prevent additional nerve damage:

  • Limit alcohol intake.
  • Eat a healthy diet.
  • Take medications as recommended by your healthcare provider.
  • Try to achieve a blood pressure of less than 140/90 millimeters of mercury, or pick another goal that you and your healthcare provider decide on.
  • Quit smoking.

To prevent foot ulcers, the following are some tips for healthy feet:

  • Check and wash feet every day
  • Don’t try to remove corns or calluses by yourself
  • Don’t walk barefoot
  • Ask your healthcare provider to check your feet during your appointments
  • Wear comfortable shoes

Once your ulcer completely heals, try to exercise regularly and achieve a healthy weight.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

12 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  7. Centers for Disease Control and Prevention. National diabetes statistics report.

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By Ross Phan, PharmD, BCACP, BCGP, BCPS
Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.