Regranex (Becaplermin) - Complete Drug Information

Regranex (Becaplermin) is a drug that is used in the treatment of diabetic foot ulcers. It promotes angiogenesis, plateletets and fibroblasts proliferation, induces the formation of granulation tissue, and helps in wound healing.

It is used as an adjunctive treatment of diabetic neuropathic ulcers of the lower extremities that have an adequate blood supply and that extend into the subcutaneous tissue or beyond.
Limitations of use:
- Its efficacy has not been determined for venous or pressure ulcers.
- It has not been studied in the following patient groups:
  - those with superficial diabetic neuropathic ulcers
  - Ulcers that do not extend through the dermis into the subcutaneous tissue (Stage I or II, International Association of Enterostomal Therapy [IAET] staging classification)
  - ischemic diabetic ulcers.

Treatment response is best when good glycemic control is achieved preferably with insulin. Symptomatic treatment like pregabalin, duloxetine or gabapentin may be required.

Regranex (Becaplermin) Dose in Adults

Regranex (Becaplermin) use in the treatment of lower extremity of diabetic ulcers:

Topical:
- An appropriate amount of the gel should be applied over the ulcer once a day with a cotton swab, or a tongue depressor. The quantity depends on the size of the ulcer.

Note: If the size of the ulcer does not decrease by 30% after ten weeks of treatment or complete healing does not occurr in 20 weeks, the patient should be re-evaulated and the decision to continue treatment should be made with experts.

Estimation of gel requirement:
- To calculate the amount of the gel needed to cover the ulcer, measure the greatest length and the greatest width of the ulcer.
- The drug requirement should be recalculated every 1 - 2 weeks (because of the change in the ulcer area).
- Centimeters:
  - 15 g tube:
    - [ulcer length (cm) x width (cm)] divided by 4 = length of gel (cm)
- Inches:
  - 15 g tube:
    - [length (in) x width (in)] x 0.6 = length of gel (in)

Regranex (Becaplermin) Dose in Childrens

Use in the treatment of lower extremity of Diabetic ulcers:

Adolescents ≥16 years:
- Refer to adult dosing.

Regranex (Becaplermin) pregnancy Risk factor: Undefined

Data regarding its use in pregnancy is limited.

Becaplermin use during breast feeding:

Excretion of becaplermin into breastmilk is not known.
Benefits of treatment and risks of drug exposure in the child should be weighed.

Regranex dose in kidney disease:

The manufacturer does not recommend any dose adjustment in patients with liver disease. Systemic absorption is unlikely.

Regranex dose in liver disease:

The manufacturer does not recommend any dose adjustment in patients with liver disease. Systemic absorption is unlikely.

Common Side Effects of Regranex (Becaplermin) Include:

Dermatologic:
- Erythematous rash

Contraindication to Regranex (Becaplermin) Include:

Malignant growth at the site of application of Regranex.

Warnings and Precautions

Application site reactions:
- Irritation of the skin may occur that may be due to parabens or m-cresol.
- In severe cases, the drug should be discontinued.
Malignancy:
- Different malignancies have been reported with its use, although, all of them were remote from the sit of application of Regranex.
- It should be used with caution in patients with malignancies.

Monitor:

Ulcer volume (pressure ulcers)
Wound area
Evidence of closure
Drainage (diabetic ulcers)
Cinical features of toxicity (erythema, local infections)

How to administer Regranex (Becaplermin)?

It is recommended only for topical use. (Oral, intravaginal, and ophthalmic use should be avoided).
An appropriate amount of gel should be spread over the ulcer area in a thin and continuous layer.
The area should be covered with a saline moistened dressing and left for about 12 hours.
The dressings should be removed after 12 hours and the area rinsed with saline or water to remove the residual becaplermin gel.
The area should be covered with a saline moistened dressing without the medicine for the rest of the day.
The treatment should continue once a day until the ulcer is completely healed.

Mechanism of action of Regranex (Becaplermin):

Becaplermin is a recombinant B-isoform homodimer of human platelet-derived growth factor (rPDGF-BB) that stimulates the formation of new granulation tissue, induces the proliferation of fibroblasts and its differentiation to promote wound healing. It also promotes angiogenesis.