becaplermin, Regranex

 Indications

Treatment of lower extremity diabetic neuropathic ulcers

extending to subcut tissue or beyond and having

adequate blood supply.

Action

Promotes chemotaxis of cells involved in wound repair

and enhances formation of granulation tissue. Therapeutic

Effects: Improved healing.

Pharmacokinetics

Absorption: Minimal absorption (3%).

Distribution: Action is primarily local.

Metabolism and Excretion: Unknown.

Half-life: Unknown.

TIME/ACTION PROFILE (improvement in

ulcer healing)

ROUTE ONSET PEAK DURATION

Topical within 10 wk unknown unknown

Contraindications/Precautions

Contraindicated in: Known hypersensitivity to becaplermin

or parabens; Known neoplasm at site of application;

Wounds that close by primary intention.

Use Cautiously in: Known malignancy; OB, Lactation,

Pedi: Safety not established.

Adverse Reactions/Side Effects

Derm: erythematous rash at application site. Misc:

MALIGNANCY (MAY LEAD TOqMORTALITY, ESPECIALLY WITH

USE OF 3 TUBES).

Interactions

Drug-Drug: None known.

Route/Dosage

Topical (Adults): Length of gel in inches from 15- or

7.5-g tubelength  width of ulcer area  0.6; from

the 2-g tubelength  width of ulcer area  1.3.

Length of gel in centimeters from 15- or 7.5-g tube

length  width of ulcer area4; from the 2-g tube

length  width of ulcer area2; for 12 hr each day.

Availability

Gel: 100 mcg/g (0.01%) in 2-, 7.5-, and 15-g tubes.