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becaplermin (Rx)Brand and Other Names:Regranex Gel

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

gel

  • 0.01%
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Diabetic Neuropathic Ulcers

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)

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 hours; then rinse off residual gel with saline & apply new saline-moistened dressing (no gel)

Re-measure ulcer weekly or bi-weekly to adjust dosage

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

<16 years old: Safety & efficacy not established

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Adverse Effects

1-10%

Erythema

Skin rash

<1%

Ulcer infection

Tunneling of ulcer

Skin ulceration

Local pain

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Warnings

Black Box Warnings

An increased risk of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin gel in a postmarketing retrospective cohort study. It should only be used when the benefits can be expected to outweigh the risks. This drug should be used with caution in patients with known malignancy.

Contraindications

Hypersensitivity

Neoplasm at application site

Cautions

Malignancy

Increased risk of cancers if exposed to 3 or more tubes

Do not use on self-healing wounds

Store in fridge; do NOT freeze

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

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 PDGF-BB; stimulates chemotactic recruitment of wound-healing cells; promotes angiogenesis and induces fibroblast proliferation and differentiation to promote wound healing; granulation tissue enhancer

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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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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