Prostate and other male cancers:
Indications for: ORGOVYX
Advanced prostate cancer.
Swallow whole. Initially 360mg on the first day, then 120mg once daily. If treatment is interrupted for >7days, restart at 360mg on the first day, then 120mg once daily. Avoid concomitant oral P-gp inhibitors; if unavoidable, take Orgovyx first and separate dosing by ≥6hrs; may interrupt Orgovyx for up to 2 weeks for a short treatment with certain P-gp inhibitors. Avoid concomitant with combined P-gp and strong CYP3A inducers; if unavoidable, increase Orgovyx dose to 240mg once daily. After discontinuation of combined inducers, resume at 120mg once daily.
Congenital long QT syndrome. CHF. Correct electrolyte abnormalities. Consider periodic monitoring of ECGs and electrolytes. Monitor serum PSA periodically; if PSA increases, measure serum testosterone levels. Embryo-fetal toxicity. Advise males with female partners of reproductive potential to use effective contraception during and for 2 weeks after the last dose. Pregnancy. Nursing mothers.
Caution with concomitant drugs known to prolong the QT interval. Potentiated by P-gp inhibitors; avoid (see Adults). Antagonized by combined P-gp and strong CYP3A inducers; avoid (see Adults). May affect results of diagnostic tests of the pituitary gonadotropic and gonadal functions during and after Orgovyx.
Hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, increased ALT/AST, fatigue, constipation, diarrhea.
Generic Drug Availability:
Tabs—30; Blister pack—9