Prostate and other male cancers:
Indications for: ORGOVYX
Advanced prostate cancer.
Adult Dosage:
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.
Children Dosage:
Not established.
ORGOVYX Warnings/Precautions:
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.
ORGOVYX Classification:
GnRH antagonist.
ORGOVYX Interactions:
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.
Adverse Reactions:
Hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, increased ALT/AST, fatigue, constipation, diarrhea.
Generic Drug Availability:
NO
How Supplied:
Tabs—30; Blister pack—9
