Overview
11 DESCRIPTION REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae .
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action REGRANEX has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue. 12.2 Pharmacodynamics Clinical pharmacodynamic studies have not been conducted. 12.3 Pharmacokinetics Ten subjects with Stage III or IV [as defined in the International Association of Enterostomal Therapy (IAET) guide to chronic wound staging] lower extremity diabetic ulcers received topical applications of becaplermin gel 0.01% at a dose range of 0.32–2.95 mcg/kg (7 mcg/cm 2 ) daily for 14 days.
Indications
- 1 INDICATIONS AND USAGE REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see Clinical Studies ( 14.
Common Doses
- 15 g
- 0.65 g
- 0.25 g
Dosage
2 DOSAGE AND ADMINISTRATION REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use. The amount of REGRANEX to be applied depends upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2.
Contraindications
- 4 CONTRAINDICATIONS REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application. Known neoplasm(s) at the site(s) of application ( 4 )
Side Effects
- 6 ADVERSE REACTIONS Erythematous rashes occurred in 2% of patients treated with REGRANEX. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Lynch Regenerative Medicine, LLC at 1-888-576-7343 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
- 7 DRUG INTERACTIONS It is not known if REGRANEX interacts with other topical medications applied to the ulcer site. The use of REGRANEX with other topical drugs has not been studied.