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.

becaplermin gel

; Regranex topical preparation containing 0.01% recombinant human platelet-derived growth factor; adjunct treatment for chronic full-thickness wounds, e.g. diabetic foot ulcers
References in periodicals archive ?
WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY: An increased rate of mortality secondary to malignancy was observed in patients treated with three or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study.
Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.
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.
Those calling for the new category cite drugs on the market that are also available in cosmetic form, including lactic acid (known as Lac Hydrin in prescription form), and the drug Regranex.
Regranex (Johnson and Johnson Wound Management) is currently the only growth factor on the market and is approved for the treatment of diabetic foot ulcers.
A recombinant platelet-derived growth factor, Regranex, (Ortho-McNeil Pharmaceuticals Inc, Raritan, NJ) is FDA-approved and is now widely used.
REGRANEX Gel, approved by the FDA in 1997, is the first prescription biologic that actively stimulates the body to grow new tissue and help heal diabetic foot ulcers.
Regranex contains the same synthetic protein that is found in Augment, but is topically administered onto open skin sores daily for weeks to months compared to the one-time implantation of Augment during foot and ankle fusion surgery.
115 Smith & Nephew's Regranex (becaplermin) Gel 0.
The study compared cancer incidence and cancer mortality among 1,622 patients treated with Regranex with those of 2,809 similar patients not treated with Regranex.