ORGOVYX Film-coated tablet Ref.[50889] Active ingredients: Relugolix

Treatment with Orgovyx should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.

Posology

Treatment with Orgovyx should be initiated with a loading dose of 360 mg (three tablets) on the first day, followed by a 120 mg (one tablet) dose taken once daily at approximately the same time each day.

Because relugolix does not induce an increase in testosterone concentrations, it is not necessary to add an anti-androgen as surge protection at initiation of therapy.

Dose modification for use with P-gp inhibitors

Co-administration of Orgovyx with oral P-glycoprotein (P-gp) inhibitors must be avoided. If co-administration is unavoidable, Orgovyx should be taken first and dosing should be separated by at least 6 hours (see section 4.5). Treatment with Orgovyx may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required.

Dose modification for use with combined P-gp and strong CYP3A inducers

Co-administration of Orgovyx with combined P-gp and strong cytochrome P450 (CYP) 3A inducers must be avoided. If co-administration is unavoidable, the dose of Orgovyx must be increased to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, the recommended 120 mg dose of Orgovyx once daily must be resumed (see section 4.5).

Missed doses

If a dose is missed, Orgovyx must be taken as soon as the patient remembers. If the dose was missed by more than 12 hours, the missed dose must not be taken and regular dosing schedule should be resumed the following day.

If treatment with Orgovyx is interrupted for greater than 7 days, Orgovyx must be restarted with a loading dose of 360 mg on the first day, followed with a dose of 120 mg once daily.

Special populations

Elderly

No dose adjustment in elderly patients is required (see section 5.2).

Renal impairment

No dose adjustment in patients with mild, or moderate renal impairment is required. Caution is warranted in patients with severe renal impairment (see sections 4.4 and 5.2).

Hepatic impairment

No dose adjustment in patients with mild or moderate hepatic impairment is required (see sections 4.4 and 5.2).

Paediatric population

There is no relevant use of Orgovyx in children and adolescents under 18 years of age for the indication of treatment of advanced hormone-sensitive prostate cancer.

Method of administration

Oral use.

Orgovyx can be taken with or without food (see section 5.2). Tablets should be taken with some liquid as needed and should be swallowed whole.

There is no known specific antidote for overdose with Orgovyx. In the event of an overdose, Orgovyx should be stopped and general supportive measures should be undertaken until any clinical toxicity has diminished or resolved, taking into consideration the half-life of 61.5 hours. Adverse reactions in the event of an overdose have not yet been observed; it is expected that such reactions would resemble the adverse reactions listed in section 4.8. It is not known if relugolix is removed by haemodialysis.

3 years.

This medicinal product does not require any special storage conditions.

Orgovyx film-coated tablets are supplied in a bottle. Each high-density polyethylene (HDPE) bottle contains 30 film-coated tablets and a desiccant and is closed with a child-resistant induction seal polypropylene (PP) cap.

Pack sizes of 30 and 90 (3 packs of 30) film-coated tablets.

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.