BECAPLERMIN

BECAPLERMIN
(be-cap'ler-min)
Regranex
Classifications: growth factor;
Therapeutic:growth factor

Pregnancy Category: C

Availability

100 mcg/g gel

Action

Recombinant human platelet-derived growth factor B in a topical gel. It induces fibroblast proliferation in new granulation tissue.

Therapeutic Effect

Becaplermin enhances formation of new granulation tissue. It is effective against diabetic neuropathic ulcers that involve subcutaneous or deeper tissue and also have an adequate blood supply.

Uses

Lower-extremity diabetic neuropathic ulcers.

Contraindications

Hypersensitivity to drug or any component in formulation; neoplasms at site of application; wounds that close by primary intention; pregnancy (category C), lactation.

Cautious Use

Concurrent use of corticosteroids, cancer chemotherapy, or other immunosuppressive agents; ulcer wounds related to arterial or venous insufficiency; thermal, electrical, or radiation burns at wound site; malignancy.

Route & Dosage

Diabetic Neuropathic Ulcers
Adult: Topical Calculate the length of gel based on ulcer size and apply once/d until healed

Administration

Topical
  • Squeeze calculated length of gel onto clean, firm, nonabsorbable surface.
  • Apply even layer to ulcer area with clean tongue depressor or cotton swab and cover with saline-moistened dressing. After 12 h, remove dressing, clean ulcer by rinsing with water or saline to remove residual gel, and apply new saline-moistened dressing without becaplermin for next 12 h. Repeat cycle.
  • Apply only to ulcers with good blood supply.
  • Dosage calculation: Measure greatest length (L) and greatest width (W) of ulcer in inches or centimeters; using 15- or 7.5-g tube multiply (L x W) x 0.6 for dose in inches or (L x W)/4 for dose in cm; using 2-g tube multiply (L x W) x 1.3 for dose in inches or (L x W)/2 for dose in cm.
  • Recalculate weekly/biweekly the amount of drug needed.
  • Store at 2°–8° C (36°–46° F). Do not freeze and do not use beyond expiration date.

Adverse Effects (≥1%)

Skin: Erythematous rash.

Pharmacokinetics

Absorption: <3% absorbed into systemic circulation.

Nursing Implications

Assessment & Drug Effects

  • Therapeutic effectiveness: 30% decrease in ulcer size after 10 wk or complete healing after 20 wk.
  • Monitor for and report appearance of erythematous rash.

Patient & Family Education

  • Consult wound care provider who typically recalculates dosage weekly/biweekly.
  • Follow directions for application carefully. Gel may be measured out on waxed paper.
  • Wash hands prior to application and do not allow tip of tube to contact ulcer or any surface.
  • Report worsening ulceration or development of skin rash.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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