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Link to SmPC can be found at the bottom of the page or by clicking HERE. Adverse Event Reporting details can be found on each page or by clicking HERE.
Introducing ORGOVYX®, the One & Only oral ADT for advanced hormone-sensitive prostate cancer.1,2
Achieve rapid, sustained and surge-free testosterone suppression.3
Convenient dosing that fits into patients’ daily routines.1
Initiate ORGOVYX® with a loading dose of 360 mg (three tablets) on the first day, followed thereafter by a 120 mg (one tablet) dose taken once daily at approximately the same time each day.1
Tablets shown are not to size.
It’s important to advise patients that they should swallow their tablets whole. The tablet can be taken with or without food and with some liquid.1
ORGOVYX® does not require dose adjustment in elderly patients or patients with mild/moderate renal or hepatic impairment.
Caution is warranted in patients with severe renal impairment.1
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 the regular dosing schedule should be resumed the following day.1
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 by a dose of 120 mg once daily.1
Co-administration of ORGOVYX® with oral P-glycoprotein (P-gp) inhibitors or combined P-gp and strong cytochrome P450 (CYP) 3A inducers is not recommended.1
If co-administration is required, dose modifications may be necessary.1
Please refer to the SmPC before prescribing.
ORGOVYX® is contraindicated in patients with hypersensitivity to relugolix or any of the following excipients:1
Prior to prescribing ORGOVYX®, patients should be assessed for cardiovascular and bone density risk factors.1
The benefit-risk ratio, including the potential for Torsade de points, should be assessed in patients with a history of risk factors for QT prolongation or in patients receiving concomitant medicinal products that may prolong the QT interval, prior to initiating ORGOVYX®.1
Caution is warranted in patients with severe renal impairment upon administration of a 120 mg dose of ORGOVYX® once daily.1
It is also recommended to monitor liver function in patients with known or suspected hepatic disorder and prostate-specific antigen (PSA) in all patients, where clinically appropriate.1
The most commonly observed adverse reactions during ORGOVYX® therapy (≥10% incidence) include:1
Please refer to the SmPC for further information and for a full list of adverse events associated with ORGOVYX® therapy.
*ADT, Androgen Deprivation Therapy.
CYP, cytochrome P450.
FAQs, Frequently Asked Questions.
P-gp, P-glycoprotein.
PSA, prostate-specific antigen.
SmPC, Summary of Product Characteristics.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. You can report side effects directly via the HPRA website www.hpra.ie, by emailing the HPRA Pharmacovigilance department at medsafety@hpra.ie, or by calling the HPRA on 01 676 4971. Please also report side effects to Accord Healthcare Ireland Ltd, by emailing medinfo@accord-healthcare.com or by calling 0044 (0) 1271 385257. By reporting side effects you can help provide more information on the safety of this medicine.
ORGOVYX® (relugolix) Summary of Product Characteristics (SmPC) available HERE. Prescription Only Medicine.
IE-Onc-Org-01432 | Date of preparation: January 2025
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