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.

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.

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.

Dosage: How Much Regranex Should I Take?

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.

Precautions

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:

• Other ulcers—including pressure ulcers and venous stasis ulcers
• Uncovered joints, tendons, ligaments, and bones
• Wounds that were sutured or stapled
  

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.

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.