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Prescribing Information is available in the header below. Adverse Event Reporting can be found at the bottom of the webpage.
Convenient dosing that fits into patients daily routines.1
Tablets shown are not to size
Tablets shown are not to size
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
Please refer to the SmPC before prescribing
Carnauba wax (E903)
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
Diarrhoea
Constipation
Musculoskeletal
pain
Please refer to the SmPC for a full list of adverse events associated with ORGOVYX® therapy.
This guide contains important information about ORGOVYX® (relugolix) that the patient and the patient’s family can download
ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated in the United Kingdom:
ORGOVYX® contains the active ingredient relugolix. Each ORGOVYX® film-coated tablet contains 120 mg of relugolix.1
ORGOVYX® is administered orally. It’s important to advise patients that they should swallow their tablets whole and avoid crushing or chewing them. The tablet can be taken with or without food and with some liquid.2
Treatment should be initiated 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
ORGOVYX® is contraindicated in patients with severe hypersensitivity to relugolix or any of the following excipients:1
Co-administration of ORGOVYX® and oral P-glycoprotein (P-gp) inhibitors should be avoided. If co-administration is unavoidable, take ORGOVYX® first with the oral P-gp inhibitor taken 6 hours thereafter. Treatment with ORGOVYX® may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required.1 Co-administration of ORGOVYX® with combined P-gp and strong CYP3A inducers should 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, resume the recommended ORGOVYX® dose of 120 mg once daily.1 Please see the full SmPC for potential drug interactions.
ORGOVYX® does not require dose adjustment in elderly patients or patients with mild/moderate renal or hepatic impairment. However, caution is warranted in patients with severe renal impairment.1
Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment. The pharmacokinetics of relugolix in patients with severe hepatic impairment has not been evaluated.1
The HERO study was a multinational, randomised, open-label, Phase 3 trial to evaluate the efficacy and safety of ORGOVYX®, compared to leuprorelin, in men with advanced prostate cancer.2
Educational materials for healthcare professionals and patients can be available here.
Reporting forms and information can be found at yellowcard.mhra.gov.uk
Adverse events should also be reported to Accord-UK Ltd on 01271 385257 or email medinfo@accord-healthcare.com.
Accord-UK Ltd. Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom
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