becaplermin, Regranex (cont.)

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STORAGE: Becaplermin should be stored in a refrigerator at 2 C to 8 C (36 F to 46 F). It should not be frozen and should not be used after the expiration date imprinted on the tube.

PRESCRIBED FOR: Becaplermin is used to treat diabetic ulcers of the lower limbs (foot, ankle and leg) along with usual ulcer care which includes debridement (removal of dead tissue), reduction of pressure on the ulcer, and control of infection.

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. TFormula for determine amount of becaplermin gel to administer is:

  • for a 15 g tube: length of ulcer x width x 0.6 = length of gel (inches) or length of ulcer x width ÷ 4 = length of gel (cm)
  • for a 2 g tube: length of ulcer x width 1.3 = length of gel (inches) or length of ulcer x width ÷ 2 = length of gel (cm)

To apply becaplermin gel, hands should first be thoroughly washed. The tip of the tube should not be allowed to contact the ulcer site or any other surface and become contaminated. The cap on the tube should be closed tightly after each use. The calculated amount of gel should be applied once a day. If a dose is missed, twice the dose should not be applied the next day. The gel should be spread evenly over the ulcerated area to a thickness of approximately 1/16 of an inch with a cotton swab, tongue depressor or other applicator.

DRUG INTERACTIONS: Interactions between becaplermin and other drugs have not been studied.

PREGNANCY: There are no adequate studies of becaplermin in pregnant women. Becaplermin may be used during pregnancy if the physician feels the unknown risks are justified.

NURSING MOTHERS: It is unknown if becaplermin is secreted in breast milk. Therefore, the risk 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, propylparabens, 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.

In a small post-marketing study the risk of death from cancer was three times higher in patients treated with becaplermin. It should be used with caution in patients with cancer.

Reference: FDA Prescribing Information

Medically Reviewed by a Doctor on 3/21/2013

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