Professional Information
Becaplermin (Topical)
VA CLASSIFICATION
Primary: DE900
Commonly used brand name(s): Regranex.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Biological response modifier (topical)—
platelet-derived growth factor (topical)—
Indications
Accepted
Ulcers, dermal (treatment)—Becaplermin is indicated in the treatment of neuropathic diabetic ulcers of the lower extremities that extend into the subcutaneous tissue or beyond when the ulcer has an adequate blood supply. It is used adjunctively with optimal wound care procedures that include initial sharp debridement, infection control, and pressure relief. {01}
—Use of becaplermin in the treatment of ulcers unrelated to diabetes mellitus or in ischemic or dermal ulcers that do not extend into the subcutaneous tissue (Stage I or II, International Association of Enterostomal Therapy [IAET] staging classification) has not been evaluated {01}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Source—
Becaplermin is a recombinant human platelet-derived growth factor (rhPDGF-BB) produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor into the yeast, Saccharomyces cerevisiae {01}.
Chemical group—
Becaplermin is a homodimer composed of two identical polypeptide chains bound together by disulfide bonds {01}.
Molecular weight—
Approximately 30,000 {02}
Mechanism of action/Effect:
Similar in action to endogenous platelet-derived growth factor, becaplermin forms granulation tissue in diabetic ulcers, healing them by promoting the chemotatic recruitment and proliferation of cells involved in wound repair {01}.
Absorption:
Apparent minimal systemic absorption {01}.
Precautions to Consider
Cross-sensitivity and/or related problems
Allergy to product components, including parabens and metacresol {01}.
Carcinogenicity/Tumorigenicity
Carcinogenesis studies have not been done in humans or animals {01}.
Mutagenicity
Becaplermin is not mutagenic according to the following in vitro tests: bacterial or mammalian cell point mutation, chromosomal aberration for bacterial and mammalian cell point mutation, and chromosomal aberration and DNA damage/repair. Becaplermin is not mutagenic according to an in vivo assay for the induction of micronuclei in mouse bone marrow cells. {01}
Pregnancy/Reproduction
Pregnancy—
No adequate or well-controlled studies have been done in pregnant women {01}.
Reproductive studies have not been done in animals {01}.
FDA Pregnancy Category C {01}.
Breast-feeding
It is not known if becaplermin is distributed into breast milk. Problems in humans have not been documented {01}.
Pediatrics
No information is available on the relationship of age to the effects of becaplermin in pediatrics patients 16 years of age or over. Safety and efficacy have not been established in children up to 16 years of age {01}.
Geriatrics
No information is available on the relationship of age to the effects of becaplermin in geriatric patients {01}.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problems exist:
» Skin neoplasms (use of becaplermin is not recommended with skin neoplasms at the site of application {01})
» Wounds closed by primary intention (becaplermin is a preserved, nonsterile product and is not recommended for wounds requiring a sterile product, such as wounds intentionally closed {01})
Risk-benefit should be considered when the following medical problems exist
Wounds showing exposed joints, tendons, ligaments, or bone (effects of becaplermin in these types of wounds in humans have not been clinically assessed; however, animal studies show histologic changes indicative of stimulated connective tissue growth and accelerated bone remodeling as shown by periosteal hyperplasia, subperiosteal bone resorption, and exostosis {01})
Sensitivity to becaplermin or allergy to parabens or metacresol{01}
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
Regular visits to health care provider (becaplermin requires that the dose be recalculated weekly or biweekly according to the rate of change in the width and length of the diabetic ulcer {01})
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence less frequent
Erythematous rash, local (reddened skin near ulcer; skin rash near ulcer)—incidence of 2%
Note: Local erythematous rashes occurred at the same rate in patients using either becaplermin or placebo gel, but this effect did not occur for patients using only good ulcer care {01}.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Becaplermin (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to becaplermin or allergy to parabens or metacresol
Other medical problems, especially skin neoplasms or wounds closed by primary intention
Proper use of this medication
» Reading patient directions that come with medication carefully before using
» Importance of not contaminating medication; not placing the tube"s tip onto the ulcer or on any other object
» Proper administration:
• Washing hands before administering
• Measuring proper amount as indicated by health care professional, according to ulcer size and tube size; expecting a change in dose weekly or biweekly
• Measuring dose carefully and accurately on a nonabsorbent surface, such as wax paper, and transferring to ulcer using an applicator aid, such as a cotton swab or tongue depressor
• Applying dose to ulcer in a leveled, thin, and continuous layer
• Applying a gauze pad moistened with 0.9% Sodium Chloride Irrigation USP to protect ulcer after applying becaplermin
• Removing remaining medication in ulcer by washing with water or 0.9% Sodium Chloride Irrigation USP after 12 hours
• Keeping the ulcer from becoming too dry. At the time of dressing changes, the bandage may need to be moistened with 0.9% Sodium Chloride Irrigation USP to prevent injury to healing tissues
• Placing a new gauze pad moistened with 0.9% Sodium Chloride Irrigation USP or moisture dressing on ulcer to protect it for 12 hours until the time of the next dose of becaplermin
» Proper dosing
Missed dose: Use the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
» Proper storage
Precautions while using this medication
» Regular visits to physician
» Importance of using becaplermin with a good ulcer care program, including avoiding bearing weight on affected extremity
Discussing continuing use of becaplermin with physician if ulcer is not improved by 30% in 10 weeks or there is no apparent improvement in ulcer healing beyond 20 weeks
Understanding importance of using proper amounts, not using more than prescribed
Not using medication beyond the expiration date that is imprinted on the crimped portion of the bottom of the tube
Side/adverse effects
Signs of potential side effects, especially erythematous rash, local
General Dosing Information
Continuing becaplermin treatment should be reconsidered if the ulcer is not reduced in size by 30% within 10 weeks of treatment or complete healing has not occurred in 20 weeks. When expected reduction in ulcer size occurs successfully, the treatment is continued until the ulcer is completely healed. {01}
Becaplermin should be used within a good ulcer care regimen that includes educating the patient not to bear weight on the affected extremity {01}. This frequently requires the use of crutches or a wheelchair.
The gel is measured on a clean, nonabsorbent surface (for example, wax paper) and transferred to the ulcer using an applicator aid (for example, cotton swab or tongue depressor). The gel is spread as a thin, continuous film of one-sixteenth inch thickness onto the ulcer, covered with a gauze pad moistened with 0.9% Sodium Chloride Irrigation USP for 12 hours, then removed by washing any residual gel from ulcer with water or 0.9% Sodium Chloride Irrigation USP. Until time of next application of becaplermin in 24 hours, the ulcer is covered for 12 hours with a new gauze pad moistened with 0.9% Sodium Chloride Irrigation USP or with a moisture dressing. {01}
Each square inch of ulcer surface area requires that 1.3 inches of gel be taken from a 2-gram tube or that a 0.6-inch length of gel be taken from a 7.5-gram tube or 15-gram tube {01}. The formulas for dose calculations when measuring in inches include: • For a 2-gram tube: (ulcer length in inches)(ulcer width in inches)(1.3) {01}
• For 7.5-gram and 15-gram tubes: (ulcer length in inches)(ulcer width in inches)(0.6) {01}
Alternatively, each square centimeter of ulcer surface area requires that 0.5 centimeter length of gel be taken from a 2-gram tube or that 0.25 centimeter length of gel be taken from a 7.5-gram tube or 15-gram tube. The formulas for dose calculations when measuring in centimeters include: • For a 2-gram tube: (ulcer length in centimeters)(ulcer width in centimeters)/2 {01}.
• For 7.5-gram and 15-gram tubes: (ulcer length in centimeters)(ulcer width in centimeters)/4 {01}.
It is not known if use of other topical medications during the day will interfere with the use of becaplermin {01}.
Topical Dosage Forms
BECAPLERMIN GEL
Usual adult dose
Ulcers, dermal
Topical, an amount of gel to be applied once a day for twelve hours is calculated weekly or biweekly, depending on the rate at which the ulcer changes, as measured in length and width {01}.
Usual pediatric dose
Children up to 16 years of age: Safety and efficacy have not been established {01}.
Children 16 years of age and over: See Usual adult dose {01}.
Usual geriatric dose
See Usual adult dose .
Strength(s) usually available
U.S.—
0.01% (Rx) [Regranex{01} (glacial acetic acid) (l-lysine hydrochloride) (metacresol) (methylparaben) (propylparaben) (sodium acetate trihydrate) (sodium chloride) (Water for Injection USP)]
Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Protect from freezing. {01}
Auxiliary labeling:
• For external use only.
• Refrigerate. Do not freeze.
Developed: 03/30/1998
References
- Regranex package insert (McNeil Pharmaceuticals—US), Rev 1/98, Rec 1/98.
- Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1997. p. 81.
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