Prasterone: Side Effects, Uses & Monitoring

Labeled uses

Oral prasterone (200mg per day) in female patients with active systemic lupus erythematosus (SLE) has in several blinded, placebo-controlled randomized clinical studies been associated with a reduced risk of auto-immune flare, §§6.2 , 14.1.1 , a reduced risk of breast cancer and a reduced risk of death from any cause, §§6.4 , 14.2 . Patients with SLE may have depressed serum levels of 5-dehydroepiandrosterone sulfate (5-DHEAS). Oral prasterone has been shown to restore SLE patients' serum 5-DHEAS levels. Prastera® oral softgels are intended for use in patients for whom medical evaluation shows a depressed serum level of DHEA and thus a distinctive need for exogenous DHEA. Prastera® oral prasterone softgels are intended to be used under medical supervision, for a patient receiving active and ongoing medical supervision, wherein the patient obtains medical care on a recurring basis for, among other things, instructions on the use of this product. Prastera® oral prasterone softgels are intended for the dietary management of SLE by meeting the distinctive nutritional requirement of women with mild-to-moderate active SLE. Prastera® oral prasterone softgels are intended for oral intake o…