"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
REGRANEX (becaplermin) Gel 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 Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers [see Clinical Studies] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.
The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans, [see Nonclinical Toxicology]
REGRANEX Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that dose by primary intention.
DOSAGE AND ADMINISTRATION
The amount of REGRANEX Gel to be applied will vary depending 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.
Table 1: Formula to Calculate Length of Gel in Inches to
Be Applied Daily
|15 g tube||length X width X 0.6|
|2 g tube (physician sample)||length X width X 1 .3|
Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15gtube, or approximately 1 1/3 inch length of the gel from a 2g tube (physician sample). For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15g tubes (1 X 2 X 0.6 = 1 1 /4) and 2 3/4 inch gel length should be used for a 2g tube (1 X 2 X 1.3 = 2 3/4).
Table 2: Formula to Calculate Length of Gel in Centimeters to Be Applied Daily
|15 g tube||length X width ÷ 4|
|2 g tube (physician sample)||length X width ÷ 2|
Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15g tube, or approximately a 0.5 centimeter length of gel from a 2g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 centimeter length of gel should be used for a 15g tube [(4 X 2) ÷ 4 = 2] and a 4 centimeter length of gel should be used for a 2g tube [(4 X 2) ÷ 2 = 4].
The amount of REGRANEX Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX Gel from 15g tubes is 0.65g per inch length and 0.25g per centimeter length.
To apply REGRANEX Gel, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper. The measured REGRANEX Gel is transferred from the clean measuring surface using an application aid and then spread over the entire ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a second moist dressing (without REGRANEX Gel) for the remainder of the day. REGRANEX Gel should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX Gel should be reassessed. The step-by-step instructions for applying REGRANEX Gel for home administration are described under "Patient Counseling Information", [see PATIENT INFORMATION]
Dosage Forms and Strengths
Gel: 0.01 %; clear, colorless to straw-colored gel
REGRANEX Gel 0.01% is available in a multi-use tube in the following size:
15g tube..............NDC 0045-0810-15
REGRANEX Gel 0.01% is for external use only.
Store refrigerated at 2° - 8° C (36° - 46°F). Do not freeze. Do not use the gel after the expiration date shown at the bottom of the tube.
Manufactured by: OMJ Pharmaceuticals, Inc. San German, Puerto Rico 00683. Manufactured for: Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869. Becaplermin Concentrate provided by: Novartis NPC, 2010 Cessna Dr.,Vacaville, CA 95688. Revised: 10/2011
Last reviewed on RxList: 5/25/2012
This monograph has been modified to include the generic and brand name in many instances.
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