becaplermin (Rx)

Brand and Other Names:Regranex Gel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical gel

  • 0.01%

Diabetic Neuropathic Ulcers

Indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply; use adjunctively to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief, and infection control

Amount to be applied will vary depending upon size of ulcer area

Formula in inches per tube size

  • 15 g tube: Length of ulcer × width × 0.6 = Length of gel (inches)
  • 2 g tube: Length of ulcer × width × 1.3 = Length of gel (inches)

Formula in centimeters per tube size

  • 15 g tube: Length of ulcer × width ÷ 4 = Length of gel (cm)
  • 2 g tube: Length of ulcer × width ÷ 2 = Length of gel (cm)

Dosing Considerations

Efficacy not established for treatment of pressure ulcers and venous stasis ulcers

Efficacy not evaluated for treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification) or ischemic diabetic ulcers

Effects on exposed joints, tendons, ligaments, and bone have not been established in humans

Nonsterile, low bioburden, preserved product; therefore, it should not be used in wounds that close by primary intention

<16 years: Safety and efficacy not established

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Adverse Effects

1-10%

Erythema

Skin rash

<1%

Ulcer infection

Tunneling of ulcer

Skin ulceration

Local pain

Postmarketing Reports

Burning sensation at site of application

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Warnings

Contraindications

Hypersensitivity

Neoplasm at application site

Cautions

Malignancies distant from the site of application have occurred in patients using becaplermin gel a clinical study and in postmarketing use contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis; evaluate benefits and risks 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 (eg, patch testing) according to clinical circumstances

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Pregnancy & Lactation

Pregnancy

No data are available

Animal reproduction studies have not been conducted

Lactation

No data are available; developmental and health benefits of breastfeeding should be considered along with the lactating woman’s clinical need for the drug and any potential adverse effects on the breastfed child from becaplermin

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant human platelet-derived growth factor; promotes chemotactic recruitment and proliferation of cells involved in wound repair and enhances granulation tissue formation

Pharmacokinetics

Onset of action: Within 8 weeks (15% completely healed); within 10 weeks (25% completely healed)

Distribution: Binds to normal skin and granulation tissue

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Administration

Topical Administration

Squeeze calculated length of gel onto clean surface, then spread evenly over ulcer using cotton swab, tongue depressor or similar implement

Cover gel with saline-moistened dressing for 12 hr; then rinse off residual gel with saline and apply new saline-moistened dressing (no gel)

Remeasure ulcer weekly or biweekly to adjust dosage

If ulcer size not decreased 30% in 10 weeks, or not healed in 20 weeks, reassess continued treatment with becaplermin

Storage

Refrigerate at 2-8°C (36-46°F

Do not freeze

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Regranex topical
-
0.01 % gel

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
becaplermin topical

BECAPLERMIN GEL - TOPICAL

(be-KAP-ler-min)

COMMON BRAND NAME(S): Regranex

USES: This medication is used to treat certain foot/leg ulcers in people with diabetes. It is used along with good foot/leg care (e.g., keeping pressure off the wound) to help the ulcer heal completely. Becaplermin works by attracting certain natural substances to the ulcer that help wound healing.

HOW TO USE: Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using becaplermin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Wash hands thoroughly before applying this medicine. To avoid contaminating the container tip, do not touch it to the skin or any other surface. Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.The amount of the medication applied is based on the size of the ulcer. Your doctor or wound specialist should adjust your dose every 1 to 2 weeks.Squeeze the prescribed amount of medication onto a clean, firm, and non-absorbent surface (e.g., waxed paper). Use a clean applicator (such as a cotton swab, tongue depressor) to apply a thin layer of the medication evenly over the ulcer, usually once daily or as directed by your doctor.Cover the ulcer with wound dressing as directed by your doctor. After 12 hours, remove the dressing, rinse the ulcer, and apply new dressing on the ulcer. Do not apply more medication at this time.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Use this medication until the ulcer heals completely.Do not apply a thick layer of the medication or use more of the medication than directed. This will not increase the effects of the medication or help the wound heal faster and may increase the risk of side effects. Talk to your doctor for more details.Tell your doctor if your condition worsens, does not improve after 10 weeks, or does not heal completely after 20 weeks.

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using becaplermin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as parabens), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (especially in the ulcer area).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current wound only. Do not use it later for another wound unless told to do so by your doctor. A different medication may be necessary in that case.Good foot care can help reduce the chances of foot ulcers. Wash your feet daily and check for cuts, sores, or blisters. Keep your toenails neat and trimmed. Choose shoes that are well-fitting, and always wear socks with your shoes.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store in the refrigerator. Do not freeze. Keep tube tightly closed. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2019. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.