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.

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