Regranex

becaplermin

(be-kap-lerm-in) ,

Regranex

(trade name)

Classification

Therapeutic: wound ulcer decubiti healing agent
Pharmacologic: platelet derived growth factors
Pregnancy Category: C

Indications

Treatment of lower extremity diabetic neuropathic ulcers extending to subcut tissue or beyond and having adequate blood supply.

Action

Promotes chemotaxis of cells involved in wound repair and enhances formation of granulation tissue.

Therapeutic effects

Improved healing.

Pharmacokinetics

Absorption: Minimal absorption (<3%).
Distribution: Action is primarily local.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (improvement in ulcer healing)

ROUTEONSETPEAKDURATION
Topicalwithin 10 wkunknownunknown

Contraindications/Precautions

Contraindicated in: Known hypersensitivity to becaplermin or parabens;Known neoplasm at site of application;Wounds that close by primary intention.
Use Cautiously in: Known malignancy; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Dermatologic

  • erythematous rash at application site

Miscellaneous

  • malignancy (may lead to ↑ mortality, especially with use of ≥3 tubes) (life-threatening)

Interactions

Drug-Drug interaction

None known.

Route/Dosage

Topical (Adults) Length of gel in inches from 15- or 7.5-g tube = length × width of ulcer area × 0.6; from the 2-g tube = length × width of ulcer area × 1.3. Length of gel in centimeters from 15- or 7.5-g tube = length × width of ulcer area ÷ 4; from the 2-g tube = length × width of ulcer area ÷ 2; for 12 hr each day.

Availability

Gel: 100 mcg/g (0.01%) in 2-, 7.5-, and 15-g tubes

Nursing implications

Nursing assessment

  • Assess size, color, drainage, and skin surrounding wound at weekly or biweekly intervals. Amount of gel to be applied is recalculated based on wound size.

Potential Nursing Diagnoses

Impaired tissue integrity (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Topical: Calculated amount is applied as a thin layer (1/16-in. thick) and covered with a moist saline dressing for 12 hr; dressing is removed, ulcer rinsed and redressed with moist dressing without becaplermin for rest of day. Process is repeated daily.
    • Store gel in refrigerator; do not freeze. Do not use beyond expiration date on crimped end of tube.

Patient/Family Teaching

  • Instruct patient on proper technique for application. Wash hands before applying gel and use cotton swab or tongue depressor to aid in application. Tip of tube should not come in contact with ulcer or any other surface; recap tightly after each use. Squeeze calculated amount of gel onto a clean, firm, nonabsorbable surface (wax paper). Spread gel with swab or tongue depressor over the ulcer surface in an even layer to the thickness of a dime. Cover with a saline-moistened gauze dressing.
    • Do not apply more than calculated amount; has not been shown to be beneficial. If a dose is missed, apply as soon as remembered. If not remembered until next day, skip dose and return to regular dosing schedule. Do not double doses.
    • After 12 hr, rinse ulcer gently with saline or water to remove residual gel and cover with saline-moistened gauze.
  • Emphasize the importance of strict wound care and non–weight-bearing program.

Evaluation/Desired Outcomes

  • Improved healing of ulcers. If the ulcer does not decrease in size by 30% within 10 wk or if complete healing has not occurred within 20 wk, continuation of therapy should be reassessed.

becaplermin

A cicatrizant gel containing recombinant PDGF, which may improve wound healing—it stimulates migration of cells to ulcer sites, and prompts tissue growth to heal deep open wounds.
 
Indication
Diabetic foot ulcers.
 
Cons
Expensive, increased risk of cancer.

Regranex®

Becaplermin Wound care An agent used to manage diabetic neuropathic leg ulcers that extend into the dermis or beyond and have an adequate blood supply. See Diabetic ulcer.
Mentioned in ?
References in periodicals archive ?
[64] European Medicines Agency, "Assessment report for REGRANEX (International non-proprietary name: becaplermin) procedure no.
This could explain the controversies on the efficacy of topically administered GFs as demonstrated by the winding and slippery slope of Regranex development in the USA.
Smith & Nephew, the global medical technology business, today announces that REGRANEX (becaplermin) Gel, 0.01%, OASIS Wound Matrix, and OASIS Ultra Tri-Layer Matrix have been granted the American Podiatric Medical Association (APMA) Seal of Approval.
In addition, for the past 15 years, Regranex (becaplermin) has been the only pharmacologic wound-healing agent available; however, it is rarely used due a perceived lack of efficacy.
The Food and Drug Administration (FDA) approved becaplermin (Regranex, recombinant human PDGF-BB) for diabetic foot ulcer disease in 1977, which was the first angiogenesis-stimulating drug that was used as a therapeutic angiogenesis approach.
Recombinant platelet-derived growth factor (Regranex) is currently the only approved exogenously applicable drug for chronic wounds, showing promising results in wound healing of diabetic foot ulcers [66].
The wound healing therapeutics market consists of just one product Regranex. In 2008, the US Food and Drugs Administration (FDA) slapped a black box warning on the product due to concerns that large quantities could increase the risk of cancer by up to five times.
The best results were obtained with a combination of 2% SBG and carboxymethylcellulose (CMC), the latter being used in several of the commercial wound treatment hydrogels on the market, like Intrasite from Smith & Nephew (LON: SN) and in the wound healing drug Regranex. This combination product of SBG and CMC induced statistically significant improved wound healing from day 12 and onwards throughout the study (day 24) only paralleled by the positive control.
The best results were obtained with a combination of 2% SBG and carboxymethylcellulose (CMC), which is used in several of the wound-treatment hydrogels on the market, including Intrasite from Smith & Nephew (LON: SN) and Regranex.
Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use or more tubes of the product.
Under the deal, One Equity Partners would acquire a portfolio of products which include Promogran Matrix wound dressing, Tielle Hydropolymer Dressing, and Regranex Gel, a prescription treatment for lower extremity diabetic ulcers.
A sale would include such brands as Promogran Matrix wound dressing, Tielle Hydropolymer dressing and Regranex gel, a prescription treatment for lower extremity diabetic ulcers, as well as a portfolio of general wound-care products.