Becaplermin

What is Becaplermin?

• Becaplermin (Regranex) is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ulcers. It is also known as platelet-derived growth factor BB.

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Becaplermin 3D

What are the uses of this medicine?

• Becaplermin (Regranex) is a prescription medicine that is used with good ulcer care practice for the treatment of 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 and feet.

Limitations of use:

• It is not known if Regranex is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation).
• The effects of Regranex on exposed joints, tendons, ligaments, and bone have not been established in humans.
• Regranex is not intended to be used in wounds that close by primary intention.

How does this medicine work?

• Regranex has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a cancer at the application site.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• medications that are applied to the ulcer

Is this medicine FDA approved?

• Initial U.S. Approval: 1997

How should this medicine be used?

Recommended dosage:

• The amount of Regranex you will apply will depend on the size of your ulcer.
• Your healthcare provider should check the size of your ulcer every 1 to 2 weeks.
• Your healthcare provider may change the amount of Regranex to be applied to your ulcer as the size of your ulcer changes.
• To calculate the length of Regranex to apply, measure the greatest length of the ulcer by greatest width of the ulcer in either inches or centimeters.

Formula to Calculate Length of Gel to Be Applied Daily

Tube Size	Formula
15 g Tube	Inches: ulcer length × ulcer width × 0.6
15 g Tube	Centimeters: ulcer length × ulcer width ÷ 4

Administration:

• Becaplermin comes as a gel to apply to the skin.
• It is usually applied once a day to the ulcer.
• Do not use more or less of it or use it more often than prescribed by your doctor.
• Using more gel than your doctor prescribed will not help your ulcer heal faster.
• For topical use; not for oral, ophthalmic or intravaginal use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gel: 0.01%

This medicine is available in fallowing brand namesː

• Regranex

What side effects can this medication cause?

The most common side effects of this medicine include:

• red skin rashes

Regranex may cause serious side effects, including:

• Risk of cancer
• Application site reactions

What special precautions should I follow?

• Regranex contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The benefits and risks of Regranex treatment should be carefully evaluated before prescribing in patients with known malignancy.
• If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (e.g. patch testing) as dictated by clinical circumstances.
• Advise patients that it is important to use Regranex together with a good ulcer care program, including a strict non-weight-bearing program.
• Advise patients to store Regranex in the refrigerator and not to freeze Regranex.
• There are no data on the presence of becaplermin in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of Regranex to lactating women.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There are no data on the effects of Regranex overdose.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Regranex use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: becaplermin
• Inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection.

Who manufactures and distributes this medicine?

Manufactured and marketed by:

• Smith & Nephew, Inc., Fort Worth, TX
• Regranex® is a registered trademark of Smith & Nephew, Inc.

What should I know about storage and disposal of this medication?

• Store Regranex in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze Regranex.
• Do not use Regranex after the expiration date on the bottom (sealed end) of the tube.
• Throw away your Regranex that is out of date or no longer needed for your treatment.

• Dailymed label info on Becaplermin
• FDA Becaplermin

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