Becaplermin
Also known as: becaplermin gel, PDGF-BB gel, Regranex, rhPDGF-BB
Summary
Becaplermin (Regranex) is a recombinant human PDGF-BB approved for adjunctive treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood supply. It is available as a topical gel (0.01%) and promotes wound healing by enhancing the chemotactic recruitment and proliferation of wound-healing cells.
Mechanism of Action
Becaplermin is a recombinant human platelet-derived growth factor (PDGF-BB) that binds to PDGF beta-receptors, stimulating chemotaxis and proliferation of cells involved in wound repair, including fibroblasts, smooth muscle cells, and monocytes, thereby promoting granulation tissue formation and wound healing.
Routes of Administration
Goals & Uses
- Diabetic foot ulcer healingWound HealingHigh
- Granulation tissue formationTissue RepairHigh
- Chronic wound managementWound HealingModerate
Contraindications
- Hypersensitivity to becaplermin or parabensAllergic/immunologicHigh
- Neoplasm at application siteOncologicHigh
- Application near wounds with inadequate blood supplyVascularModerate
Adverse Effects
- Skin irritationDermatologicCommon
- Local erythemaDermatologicCommon
- Increased cancer mortality riskOncologicRare
- Infection at wound siteInfectiousUncommon
Drug Interactions
- Topical antiseptics (e.g., povidone-iodine, hydrogen peroxide)Moderate
Population Constraints
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Patients with History of MalignancyOncologyRelative
Regulatory Status
- European UnionWithdrawnMarketing authorization was withdrawn in the EU; no longer commercially available in European markets
- United StatesApprovedApproved: Lower extremity diabetic neuropathic ulcers extending into subcutaneous tissue or beyond with adequate blood supplyFDA approved 1997; Boxed Warning added 2008 for increased cancer mortality risk with use of ≥3 tubes
- United KingdomUnknownPost-Brexit status uncertain; product availability limited
FDA approved in 1997. The FDA added a Boxed Warning in 2008 regarding an increased risk of cancer mortality in patients who use three or more tubes of the product. Use is contraindicated in known neoplasms at the application site.
Evidence & Sources
No sources recorded yet.