Leuprolide acetate 11.25mg; depot susp for IM inj; preservative-free. Give as single IM inj into gluteal area, anterior thigh or deltoid. ≥18yrs: 11.25mg once (3-month course). Do not split doses.
Leuprolide acetate 3.75mg; depot susp for IM inj; preservative-free. Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. ≥18yrs: 3.75mg once a month for up to 3 ...
PSA <0.2 ng/mL: Treatment was suspended at week 37 and PSA was monitored with treatment reinitiated if PSA rose again PSA >0.2 ng/mL: Treatment was continued PSA progression (HR 0.07, 95% CI 0.03–0.14 ...
This drug approval followed the publication of the EMBARK trial, a randomized phase III trial of biochemically recurrent patients who had high-risk disease, defined by a PSA doubling time (PSADT) ≤9 ...