GENERIC NAME: becaplermin
BRAND NAME: Regranex
DRUG CLASS AND MECHANISM: Becaplermin is a gel applied
topically to diabetic ulcers in the lower limbs (foot, ankle, and
leg) to promote healing of the ulcers. It belongs to a class of drugs
called platelet-derived growth factors or PDGFs. Designed to mimic
naturally-occurring PDGF, becaplermin is man-made using recombinant
DNA technology. Becaplermin, or as it also is known, recombinant
human PDGF (rhPDGF-BB), is active early in the process of ulcer
healing. Wound and ulcer healing is a three-phased process that the
body initiates after an injury to the skin occurs. The process
begins with the first phase, inflammation. In this phase, blood flow
and fluid increase around the site of the ulcer. If there is bleeding
from injured blood vessels, platelets from the blood invade the site
of the ulcer and cause the blood to clot. This stops the bleeding.
Platelets also release chemical messengers (proteins) called platelet-
derived growth factors (PDGFs). These PDGFs send signals to cells
around the ulcer and recruit them to the site of the ulcer where they
initiate the second phase of the healing process, called
proliferation. In this phase scar tissue forms, and the remaining
cells of the normal skin divide and produce new cells to replaced the
damaged cells.
Diabetic ulcers heal slowly and sometimes not at all because the
healing process is impaired, probably because blood flow to the skin
is reduced in diabetics. This can lead to serious bacterial
infections within the ulcers which can spread and necessitate
amputation of the foot or leg. Becaplermin acts along with naturally-
occurring PDGF to expedite the recruitment of cells to the ulcer. It
promotes the division of cells and the formation of new skin.
Remodeling, the third and final phase of wound healing, restructures
the healed ulcer, and the scar tissue that has formed is broken
down. As a result of remodeling, the new skin assumes the appearance
of the old skin.
Becaplermin is the first drug that can be applied directly to the
ulcer that is designed to promote healing. It was approved by the
FDA on December 16, 1997.
GENERIC AVAILABLE: no
PRESCRIPTION: yes
PREPARATIONS: Becaplermin is a gel, containing
preservatives, supplied in tubes of 2gm, 7.5gm and 15gm. Each gram
of gel contains 100mcg of becaplermin.
STORAGE: Becaplermin should be stored in a refrigerator at
2-8°C (36-46°F). It should not be frozen and should not be
used after the expiration date imprinted on the tube.
PRESCRIBED FOR: Along with a plan for ulcer care which
includes debridement (removal of dead tissue), reduction of pressure
on the ulcer, and control of infection, becaplermin is used to treat
diabetic ulcers of the lower limbs (foot, ankle and leg).
DOSING: The amount of becaplermin that is applied to the
ulcer depends on the size of the ulcer. Thus, the amount to apply is
determined by measuring the greatest length and width of the ulcer
and then applying the amount that is recommended by the directions
that accompany each tube of becaplermin.
To apply becaplermin gel, thoroughly wash hands. Do not allow the
tip of the tube to contact the ulcer site or any other surface.
Recap the tube tightly after each use. Apply the calculated amount
of gel once a day. If a dose is missed, do not apply twice the dose
the next day. Spread the gel evenly over the ulcerated area to a
thickness of approximately 1/16 of an inch. Use a cotton swab,
tongue depressor or other device to apply becaplermin.
DRUG INTERACTIONS: To date, no formal studies to evaluate
drug interactions of becaplermin with other drugs have been
conducted.
PREGNANCY: There are no adequate studies of becaplermin in
pregnant women. Becaplermin may be used in pregnancy if the
physician feels the unknown risks are justified.
NURSING MOTHERS: It is unknown if becaplermin is
secreted in breast milk; therefore, the safety to a nursing infant when the
mother is using becaplermin is unknown.
SIDE EFFECTS AND PRECAUTIONS: Becaplermin is well-
tolerated. In studies, about 2% of patients using becaplermin or a placebo gel
alone developed a rash as compared to no rashes with good
ulcer care alone. Thus, the rash probably is due to the
preservatives (methylparabens, proylparabens, or m-cresol) rather
than the rhPDGF-BB in the Regranex. If a rash occurs, the medical
personnel who are supervising the ulcer care should be contacted.
In all studies, complications such as inflammation or infection of
the skin and osteomyelitis (infection of the bone underlying the
skin) occurred equally in patients receiving becaplermin, placebo
gel, or good ulcer care alone.
Last Editorial Review: 11/28/1999 7:43:00 PM
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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