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:


How Supplied:

Tabs—30; Blister pack—9