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Recombinant Human Platelet-Derived Growth Factor (rhPDGF-BB) Pregnancy: Avoid — PDGF may affect fetal tissue growth; insufficient data.

Becaplermin (Recombinant PDGF — Chronic Wounds)

Brand names: Regranex

Adult dose

Dose: Apply thin layer (approximately 1.5 cm ribbon of gel per 2 cm² of wound) once daily to clean wound; cover with moist dressing. Dose calculated by wound area (cm²): length × width × 0.6 for tube size
Route: Topical (apply to debrided wound surface — not to intact skin)
Frequency: Once daily
Max: No absolute maximum — dose by wound area; reassess at 10 weeks
Recombinant PDGF-BB gel — promotes fibroblast proliferation, angiogenesis, and collagen deposition. Licensed for diabetic neuropathic foot ulcers. Requires adequate blood supply (ABI ≥0.6 or TBI >0.45); contraindicated in arterial/ischaemic wounds. Used in burns units for chronic post-burn wounds and skin graft donor sites that fail to heal.

Paediatric dose

Route: Topical
Frequency: Once daily
Max: By wound area as per adult
Not licensed in children — limited paediatric data. Off-label use for chronic paediatric wounds in specialist centres.

Dose adjustments

Renal

Not applicable — topical use with minimal systemic absorption.

Hepatic

Not applicable.

Clinical pearls

  • MHRA 2008 cancer warning: post-marketing surveillance identified excess cancer mortality in patients applying ≥3 tubes — absolute risk small but significant relative increase. MHRA now restricts to single course for wounds not adequately managed with other interventions; reassess at 10 weeks. Prescribers must document benefit-risk discussion
  • Wound bed preparation essential: debride all necrotic tissue before applying; optimal for clean, granulating, well-vascularised wounds. Apply once daily, leave for 12 hours, then rinse and apply moist saline dressing for 12 hours — alternating dry and wet periods
  • Cost-effectiveness: becaplermin gel is expensive; standard wound management (moist wound healing, larval debridement, negative pressure wound therapy) should be optimised before using. NICE clinical evidence review suggests selective use in diabetic foot ulcers with confirmed venous/arterial perfusion

Contraindications

  • Ischaemic wounds with ABI <0.6 (arterial insufficiency — PDGF cannot work without adequate blood supply)
  • Malignant wounds or known neoplasm at application site
  • Active osteomyelitis (not effective in bone infection)
  • Hypersensitivity to parabens or components of gel

Side effects

  • Increased cancer risk (MHRA 2008 warning): post-marketing data suggests increased incidence of remote malignancies in patients using becaplermin — cancer rates approximately 3× higher with ≥3 tubes; restrict to clean, well-vascularised wounds
  • Erythema and pain at application site
  • Infection risk (moist wound environment)
  • Oedema

Interactions

  • No pharmacological drug interactions — topical use

Monitoring

  • Wound dimensions weekly (reduction in area = healing response)
  • ABI or TBI (blood supply adequacy before and during treatment)
  • Signs of infection (erythema, exudate, odour)
  • Malignancy vigilance (new or changing skin lesions during treatment)

Reference: BNFc; BNF 90; MHRA Drug Safety Update 2008 (cancer risk); Regranex SPC; NICE Diabetic Foot Ulcer Guidelines NG19; Bhansali et al. Wound Repair Regen 2009. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.