ORGOVYX Film-coated tablet Ref.[27984] Active ingredients: Relugolix

2.1 Recommended Dosage

Initiate treatment of ORGOVYX with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day.

ORGOVYX can be taken with or without food [see Clinical Pharmacology (12.3)]. Instruct patients to swallow tablets whole and not to crush or chew tablets.

Advise patients to take a missed dose of ORGOVYX as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose.

If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.

In patients treated with GnRH receptor agonists and antagonists for prostate cancer, treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer.

2.2 Dose Modification for Use with P-gp Inhibitors

Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first and separate dosing by at least 6 hours [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required.

2.3 Dose Modification for Use with Combined P-gp and Strong CYP3A Inducers

Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

• Store ORGOVYX at room temperature. Do not store above 30°C (86°F).
• Dispense to patients in original container only.
• For bottles, keep container tightly closed after first opening.
• Keep out of reach of children.