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Prescribing Information is available in the header below. Adverse Event Reporting can be found at the bottom of the webpage.
- For the treatment of adult patients with advanced hormone-sensitive prostate cancer.1
- For the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.1
- As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer1
Dosing
Convenient dosing that fits into patients daily routines.1
Starting Dose
Tablets shown are not to size
Starting Dose
Tablets shown are not to size
ORGOVYX® Is Administered Orally
Dose Adjustment
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 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 (Great Britain) before prescribing
Safety Information
Contraindications
Carnauba wax (E903)
Contraindications
Safety Information
Special Warnings and Precautions for Use
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
Contraindications
The most commonly observed adverse reactions during ORGOVYX® therapy (≥10% incidence) include:1
Diarrhoea
Constipation
Musculoskeletal
pain
Please refer to the SmPC (Great Britain) for a full list of adverse events associated with ORGOVYX® therapy.
Resources
Resources for Healthcare Professionals
Resources for Healthcare Professional’s Patients
This guide contains important information about ORGOVYX® (relugolix) that the patient and the patient’s family can download
Frequently asked question
ORGOVYX® (relugolix) is a luteinising hormone-releasing hormone (LHRH) receptor antagonist indicated in Great Britain for:
- For the treatment of adult patients with advanced hormone-sensitive prostate cancer.1
- For the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.1
- As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer1
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® (relugolix) is a nonpeptide LHRH receptor antagonist that competitively binds to LHRH receptors in the anterior pituitary gland, preventing native LHRH from binding and signalling the secretion of luteinising hormone (LH) and follicle-stimulating hormone (FSH). Consequently, the production of testosterone from the testes is reduced.1
In humans, FSH and LH concentrations rapidly decline upon initiating treatment with ORGOVYX® and testosterone concentrations are suppressed to below physiologic concentrations.1
Treatment with ORGOVYX® is not associated with an initial testosterone surge and therefore helps avoid potential clinical flare.1
ORGOVYX® is contraindicated in patients with severe hypersensitivity to relugolix or any of the following excipients:1
- Mannitol (E421)
- Sodium starch glycolate (E468)
- Hydroxypropyl cellulose (E463)
- Magnesium stearate (E572)
- Hypromellose (E464)
- Titanium dioxide (E171)
- Iron oxide red (E172)
- Carnauba wax (E903)
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.
References
- ORGOVYX® Summary of Product Characteristics.
- Shore ND, et al. N Engl J Med. 2020;382(4):2187–2196.
Acronyms *
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Accord-UK Ltd on 01271 385257 or email medinfo@accord-healthcare.com.
UK-05491 | May 2024
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