Composition: Becaplermin 100mg/g.
Presentation: Clear, colourless to straw-coloured gel.
Storage and stability: Use within six weeks after first opening. Store at 2-8C. Do not freeze.
Action: Becaplermin is a recombinant human platelet derived growth factor-BB (rhPDGF-BB). The biological activity of becaplermin includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair. The predominant effect is to enhance the formation of granulation tissue.
Indications: In association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5cm2.
Contraindications: Known hypersensitivity to any ingredient. Known neoplasm at or near the site of application.
Dosage and administration: The gel should be applied once daily as a continuous thin layer to the entire ulcerated area using a clean application aid. The site of application should then be covered by a moist saline gauze dressing that maintains a moist wound healing environment. The product should not be used with occlusive dressings. Therapy should be continued to a maximum of 20 weeks as long as healing progress is seen on periodic evaluations. Always use in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/or infected tissue), additional debridement as necessary and a non-weight bearing regimen to alleviate pressure on the ulcer. See summary of product characteristics for details.
Overdosage: No untoward systemic events are expected.
Precautions: Safety and effectiveness have not been established in children and adolescents below the age of 18 years . Use with caution in patients with known malignancies since becaplermin is a growth factor.
Drug interactions: It is recommended that the gel should not be applied to the ulcer site in conjunction with other topical medications.
Side effects: Infection, skin ulceration, skin disorder, including erythema and pain, bullous eruption and oedema were reported in clinical trials. The adverse events are not clearly related to therapy.
Net price: 15g tube £275.
Supplier: Janssen-Cilag Ltd, PO Box 79, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ. Tel 01494 567567, fax 01494 567568.
Legal class: POM.