The FDA has given its first-ever approval of a new medication to treat Peyronie’s disease. The agency’s approval of collagenase clostridium histolyticum (Xiaflex) calls for for a maximum of four treatment cycles. Each cycle consists of two injections and one penile remodeling procedure performed by a healthcare professional.

The injected drug will be available for restricted use due to significant risk for “serious penile injury,” the FDA said. Both the health care professional and the associated facility must be certified for use, the agency noted.

The most common side effects associated with the use of Xiaflex are swelling and pain in the penis. There is a risk for serious problems, including penile fracture, and the drug should be given by a health care professional with experience in treating male urological diseases, the FDA said

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Xiaflex is marketed by Auxilium Pharmaceuticals, based in Chesterbrook, Penn.