Regranex (becaplermin) Side Effects, Warnings, and Drug Interactions

Regranex (becaplermin) is a recombinant human platelet-derived growth factor used to treat and promote healing of lower extremity diabetic ulcers. 

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 people with diabetes. This can lead to serious bacterial infections within the ulcers, which can spread and necessitate amputation of the foot or leg. 

Regranex acts along with naturally-occurring platelet-derived growth factors (PDGF) to expedite the recruitment of cells to the ulcer, promote the division of cells and the formation of new skin. Regranex is the first drug that can be applied directly to the ulcer that is designed to promote healing. 

Common side effects of Regranex include application site reactions including:

• rash,
• redness, and
• skin ulcer with possible infection and pain. 

Serious side effects of Regranex include:

• an increased risk of developing cancer or
• dying from cancer in patients who already have cancer. 

There are no listed drug interactions of Regranex. Tell your doctor all medications and supplements you use. 

Regranex has not been well studied in pregnant women. Regranex may be used during pregnancy if the physician feels the benefits of using the drug outweigh the unknown risks to the developing fetus. 

It is unknown if Regranex is secreted in breast milk. Regranex should be used with caution while breastfeeding.

• The most common side effect of becaplermin is a rash that can develop on the skin where it is applied.
• Other important side effects caused by the drug include redness of the skin called erythema, a skin ulcer with possible infection and pain at the location where the drug is applied.
• An increased risk of developing cancer or dying from cancer has been reported with becaplermin use. The drug should be used with caution in individuals with a history of cancer.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• In clinical trials, erythematous rashes occurred in 2% of subjects treated with Regranex (and good ulcer care) or placebo (and good ulcer care), and none in subjects receiving good ulcer care alone. Subjects treated with Regranex did not develop neutralizing antibodies against becaplermin.
• In a retrospective follow-up study of 491 of 651 subjects (75%) from two randomized, controlled trials of another formulation of becaplermin gel 0.01%, the subjects were followed for a median of approximately 20 months to evaluate safety and recurrence of healed diabetic lower extremity ulcers. Eight of 291 subjects (2.7%) from the becaplermin gel group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval [CI], 0.6-12.8). The types of cancers varied and all were remote from the treatment site.

Postmarketing Experience

Because post-approval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug. The following adverse reactions have been identified during post approval use of Regranex.

• Increased rate of death from systemic malignancies in patients dispensed 3 or more tubes of Regranex was observed in one of three retrospective postmarketing studies.
• Burning sensation and erythema at the site of application have been reported.

It is not known if Regranex interacts with other topical medications applied to the ulcer site. The use of Regranex with other topical drugs has not been studied.