TM Owner Sumitomo Pharma
Orgovyx 120mg Tablet
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Indications & Clinical Uses
- Orgovyx 120 mg tablets contain relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, used in adult men for the treatment of advanced prostate cancer.
- It works by rapidly lowering testosterone, the hormone that fuels most prostate cancer growth, without the initial testosterone surge ("flare") seen with older injectable GnRH agonists such as leuprolide.
- Orgovyx is approved in the United States and is not intended for use in women or children under any circumstances.
- Treatment begins with a single 360 mg loading dose on day one, followed by 120 mg once daily thereafter, and is continued for as long as the prescribing oncologist or urologist determines hormone therapy is needed for that individual's cancer.
- It should not be confused with GnRH antagonists used for female reproductive conditions, which are different drugs for different indications.
Side Effects
- There is no boxed warning for Orgovyx.
- Very common effects, each affecting more than 1 in 10 men, include hot flushes (over half of men), raised blood sugar, raised triglycerides, musculoskeletal pain, low haemoglobin, elevated liver enzymes, tiredness, constipation and diarrhoea.
- Because Orgovyx lowers testosterone, it can cause loss of bone density over time and can prolong the heart's QT interval, increasing the risk of an irregular heartbeat, particularly in men with a personal or family history of long QT syndrome or who take other QT-prolonging medicines.
- Serious but less common events reported include heart attack, irregular heart rhythm, and reduced kidney function.
- Seek urgent medical attention for chest pain, palpitations, fainting, or sudden swelling, and tell your healthcare provider promptly about any new or worsening heart symptoms during treatment.
Precautions & Warnings
- Orgovyx is for oral use only and must be swallowed whole; it should not be used in women or children.
- Men with a history of heart disease, risk factors for QT prolongation, or an electrolyte imbalance should have this assessed before starting, and electrolytes should be corrected as needed during treatment.
- Men whose female partners could become pregnant must use effective contraception during treatment and for two weeks after the final dose, because Orgovyx can cause harm to a developing fetus.
- Bone mineral density can decrease during long-term androgen deprivation, so bone health should be monitored, especially with prolonged use.
- Liver enzymes, blood sugar and cholesterol levels should be checked periodically, as androgen deprivation therapy can worsen diabetes and cardiovascular risk factors.
- Discontinue Orgovyx if a serious hypersensitivity reaction, including angioedema, occurs.
Avoid Interactions
- Orgovyx absorption is reduced by P-glycoprotein (P-gp) inhibitors, such as certain antifungal, antibiotic and heart-rhythm medicines; these should generally be avoided, and if unavoidable, taken at least six hours apart from Orgovyx.
- Combined P-gp and strong CYP3A4 inducers, such as rifampin or St John's Wort, can lower relugolix levels and may require an increased Orgovyx dose of 240 mg once daily.
- Other medicines that prolong the QT interval, including certain antibiotics, antiarrhythmics and antidepressants, should be used cautiously alongside Orgovyx because the combined effect on heart rhythm can be greater.
- Tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product, herbal remedy and supplement you take, since dose timing or dose adjustments may be needed to keep the medicine working as intended.
References
Frequently Asked Questions
Orgovyx (relugolix) is an oral hormone therapy for advanced prostate cancer in adult men. It lowers testosterone, which drives most prostate cancer growth, and is used only in men - never in women or children.
Treatment starts with three 120 mg tablets (360 mg) on day one, then one 120 mg tablet once daily afterward, swallowed whole with or without food. Take it at about the same time each day for as long as your cancer doctor prescribes.
Hot flushes affect over half of men; raised blood sugar, raised triglycerides, joint or muscle pain, fatigue and low haemoglobin are also common. Orgovyx can prolong the heart's QT interval, so report chest pain, palpitations or fainting straight away.
Avoid P-glycoprotein inhibitor drugs, such as some antifungals and heart medicines, which raise relugolix levels; if needed, separate dosing by 6 hours. Also avoid other medicines that prolong the QT interval, and use effective contraception if your partner could become pregnant.
Take the missed dose as soon as you remember that same day; if a full day is missed, restart with the usual once-daily 120 mg dose the next day without doubling up. Consistent daily dosing keeps testosterone suppressed.
Orgovyx can prolong the QT interval and raise cardiovascular risk, especially in men with heart disease or electrolyte imbalances. Tell your healthcare provider about any heart rhythm problems before starting, and about all other medicines that affect heart rhythm.
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