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

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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.
QL Quantity Limits
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.
OR Other Restrictions
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.