Patient Information Leaflet

Orgovyx 120 mg film-coated tablets

relugolix
This medicinal product is subject to additional monitoring. This will allow rapid identification
of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of
section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Orgovyx is and what it is used for
What you need to know before taking Orgovyx
How to take Orgovyx
Possible side effects
How to store Orgovyx
Contents of the pack and other information

1. What Orgovyx is and what it is used for

Orgovyx contains the active substance relugolix. It is used to treat adult patients with advanced prostate cancer that responds to hormonal therapy.
Relugolix works by blocking a step in the process that signals the testes to produce testosterone (the male sex hormone). Since testosterone can stimulate the growth of prostate cancer, relugolix prevents the growth and division of prostate cancer cells by reducing testosterone to very low levels.

2. What you need to know before taking Orgovyx

Do not take Orgovyx

if you are allergic to relugolix or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Orgovyx if any of the following apply to you:

Heart circulation disorders such as heart rhythm problems (arrhythmia). The risk of heart rhythm problems may increase during treatment with Orgovyx. Your doctor may monitor your body electrolytes and the electrical activity of your heart during treatment with Orgovyx.
Inform your doctor immediately if you experience signs or symptoms such as dizziness, fainting, sensation of rapid or irregular heartbeat (palpitations), or chest pain. These may be symptoms of serious heart rhythm problems.
Liver disease. Liver function may need to be monitored. The use of Orgovyx has not been studied in patients with severe liver disease.
Kidney disease.
Osteoporosis or any disease affecting bone strength. Low testosterone levels can lead to thinning of the bones.
Monitoring of your disease with a blood test for prostate-specific antigen (PSA).

Children and adolescents
Orgovyx must not be used in children and adolescents under 18 years of age.
Other medicines and Orgovyx
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Orgovyx may interfere with certain medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines, such as methadone [used to relieve pain and as part of opioid addiction treatment], moxifloxacin [an antibiotic], antipsychotics used for severe mental illnesses.
Other medicines may interfere with the absorption of relugolix, resulting in increased blood levels (which may increase side effects) or decreased blood levels (which may reduce the effectiveness of Orgovyx). Examples of medicines that may interact with Orgovyx include:

Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital).
Some medicines used to treat bacterial infections (e.g. rifampicin, azithromycin, erythromycin, clarithromycin, gentamicin, tetracycline).
Some medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
Some medicines used to treat prostate cancer (e.g. apalutamide).
Herbal remedies containing St. John’s wort (Hypericum perforatum).
Some medicines used to treat high blood pressure (e.g. carvedilol, verapamil).
Some medicines used to treat arrhythmias (e.g. amiodarone, dronedarone, propafenone, quinidine).
Some medicines used to treat angina (e.g. ranolazine).
Some medicines used as immunosuppressants (e.g. ciclosporin).
Some medicines used to treat HIV infections (e.g. ritonavir [or combinations containing ritonavir], efavirenz).
Some medicines used to treat hepatitis C (e.g. telaprevir).

Therefore, your doctor may adjust your medications, change the timing of administration of certain medicines, modify the dose of your medicines, or increase the dose of Orgovyx.
Pregnancy, breastfeeding, and fertility
Orgovyx is intended for use in men with prostate cancer. This medicine may affect male fertility.
This medicine is not indicated for use in women who are or could be fertile. It is not used in women who are pregnant or who may become pregnant, or who are breastfeeding.

Information for men:
If you have sexual intercourse with a woman of childbearing potential, use a condom and another effective contraceptive method used by your partner during treatment and for 2 weeks after treatment with this medicine to prevent pregnancy.
If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.

Driving and using machines
Fatigue and dizziness are very common (fatigue) and common (dizziness) side effects that may impair your ability to drive or operate machinery. These side effects may be due to the treatment or to the underlying disease.
Orgovyx contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Orgovyx

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Three tablets on the first day of treatment.
Afterwards, one tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose if necessary.

Swallow the tablets whole. The tablets can be taken with or without food, with a little liquid.
If you take more Orgovyx than you should
No cases of serious harmful effects related to taking multiple doses of this medicine at the same time have been reported. If you have taken too many Orgovyx tablets or if you discover that a child has taken some, contact your doctor as soon as possible. Take the medicine with you so you can show it to the doctor.
If you forget to take Orgovyx
If you realize you missed a dose less than 12 hours after your usual dosing time, take it as soon as you remember, then continue taking the following tablets the next day as usual. If you missed a dose by more than 12 hours, do not take it. Take only the next dose the following day as usual.
If you stop taking Orgovyx
If you wish to stop treatment with this medicine, discuss it with your doctor first. Your doctor will explain the consequences of stopping treatment and discuss alternative options with you.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects may be serious.
Seek urgent medical attention if you develop:

Rapid swelling of the face, mouth, lips, tongue, throat, abdomen, arms or legs (angioedema) (uncommon: may affect up to 1 in 100 people).

The following side effects have been reported with Orgovyx and are listed according to their frequency:

Very common (may affect more than 1 in 10 people):

hot flush
diarrhoea
constipation
muscle and joint pain
fatigue

Common (may affect up to 1 in 10 people):

low red blood cell count (anaemia)
breast enlargement in men (gynaecomastia)
insomnia
depression
dizziness
headache
high blood pressure
stomach discomfort including nausea
increased sweating
skin rash
reduced sexual interest
weight gain
increased blood sugar levels
increased levels of fats (triglycerides) in the blood
increased cholesterol levels in the blood

Uncommon (may affect up to 1 in 100 people):

thinning of the bones (osteoporosis)
increased liver enzymes
hives (urticaria)
heart attack

Not known (frequency cannot be estimated from available data):

changes in electrocardiogram (ECG) (prolongation of the QT interval)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system (reazioni-avverse). Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Orgovyx

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the label of the bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Orgovyx contains

The active substance is relugolix.
The other ingredients are mannitol (E421), sodium starch glycolate (E468), hypromellose (E463), magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), iron oxide red (E172), carnauba wax (E903).

See “Orgovyx contains sodium” in section 2 for more information.
Description of the appearance of Orgovyx and contents of the pack
Orgovyx film-coated tablets are light red, almond-shaped
(11 mm [length] × 8 mm [width]) with “R” on one side and “120” on the other. Orgovyx is
available in a white plastic bottle containing 30 film-coated tablets and in packs of 30 film-coated tablets and 90 film-coated tablets (3 bottles of
30 film-coated tablets). Each bottle also contains a desiccant to help keep the medicine dry (protect it from moisture). Do not remove the desiccant from the
bottle. Each bottle is closed with a child-resistant cap sealed by induction.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IS / IT / LT / LV / LU / MT /
NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu .