Becaplermin

Category C.

Animal reproduction studies have not been conducted with becaplermin gel. It is also not known whether becaplermin gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Becaplermin gel should be given to pregnant women only if clearly needed.

It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when becaplermin gel is administered to nursing women.

Becaplermin was not genotoxic in a battery of in vitro assays (including those for bacterial and mammalian cell point mutation, chromosomal aberration, and DNA damage/repair). Becaplermin was also not mutagenic in an in vivo assay for the induction of micronuclei in mouse bone marrow cells.

Carcinogenesis and reproductive toxicity studies have not been conducted with becaplermin.

Patients receiving becaplermin gel, placebo gel, and good ulcer care alone had a similar incidence of ulcer-related adverse events such as infection, cellulitis, or osteomyelitis. However, erythematous rashes occurred in 2% of patients treated with becaplermin gel and placebo, and none in patients receiving good ulcer care alone. The incidence of cardiovascular, respiratory, musculoskeletal and central and peripheral nervous system disorders was not different across all treatment groups. Patients treated with becaplermin gel did not develop neutralizing antibodies against becaplermin.