Orgovyx 120 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orgovyx 120 mg film-coated tablets

Relugolix

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end contains information on how to report these adverse reactions.

Read all of this leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Orgovyx is and what it is used for
2. What you need to know before taking Orgovyx
3. How to take Orgovyx
4. Possible adverse reactions
5. How to store Orgovyx
6. 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 for the treatment of adult patients with advanced prostate cancer that responds to hormone 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, reducing it to very low levels prevents prostate cancer cells from growing and dividing.

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 starting to take Orgovyx if you have any of the following:

• Heart circulation conditions, such as heart rhythm problems (arrhythmia). The risk of heart rhythm problems may increase with the use of Orgovyx. During treatment with Orgovyx, your doctor may monitor the salt levels in your body (electrolytes) and the electrical activity of your heart.
• Immediately inform your doctor if you experience signs or symptoms such as dizziness, fainting, sensation that your heart is beating strongly or rapidly (palpitations), or chest pain. These may be symptoms of serious heart rhythm problems.
• Liver disease. It may be necessary to monitor your liver function. The use of Orgovyx has not been studied in patients with severe liver disease.
• Kidney (renal) disease.
• Osteoporosis or any condition affecting bone strength. Reduced testosterone levels may cause bones to become thinner.
• 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

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 together with other drugs such as methadone (used to relieve pain and as part of addiction detoxification treatment), moxifloxacin (an antibiotic), and antipsychotics (used to treat serious mental illnesses).

Other medicines may interfere with the absorption of relugolix and either increase levels in the blood—potentially increasing side effects—or decrease them—reducing the effectiveness of Orgovyx. 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 medicines containing St. John’s wort (Hypericum perforatum).
• Some medicines used to treat high blood pressure (e.g., carvedilol, verapamil).
• Some medicines used to treat arrhythmia (e.g., amiodarone, dronedarone, propafenone, quinidine).
• Some medicines used to treat angina pectoris (e.g., ranolazine).
• Some medicines used as immunosuppressants (e.g., cyclosporine).
• Some medicines used to treat human immunodeficiency virus (HIV) infection (e.g., ritonavir [or combinations containing ritonavir], efavirenz).
• Some medicines used to treat hepatitis C virus (HCV) infection (e.g., telaprevir).

Therefore, your doctor may adjust your medications, change the timing of administration, adjust doses, or increase the dose of Orgovyx.

Pregnancy, breastfeeding, and fertility

Orgovyx is indicated for use in men with prostate cancer. This medicine may affect male fertility.

This medicine is not indicated for use in women who could become pregnant. It is not used in women who are or may be pregnant or who are breastfeeding.

• Information for men:
• if you have sexual intercourse with a woman who could become pregnant, use a condom and another effective contraceptive method used by your partner during treatment and for 2 weeks after stopping this medicine to prevent pregnancy.
• if you have sexual intercourse with a pregnant woman, use a condom to protect the fetus.

Driving and use of machines

Fatigue and dizziness are very common (fatigue) and common (dizziness) adverse effects that may affect your ability to drive and operate machinery. These adverse effects may be due to the treatment or to the effects of the underlying disease.

Orgovyx contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Orgovyx

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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 your dose if necessary.

The tablet should be swallowed whole. Tablets may be taken with or without food and with a little liquid.

If you take more Orgovyx than you should

There are no reports of serious harmful effects caused by taking several doses of this medicine at once. If you have taken too many Orgovyx tablets, or find that a child has taken some, consult your doctor as soon as possible. Take the medicine along to show the doctor.

If you forget to take Orgovyx

If you remember you have missed a dose less than 12 hours after the usual time you would have taken it, take it as soon as you remember and then continue taking the following tablets at the usual time. If you remember more than 12 hours after the usual time, do not take the missed dose. Simply take the next dose the following day as usual.

If you stop taking Orgovyx

If you wish to stop treatment with this medicine, speak to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other options with you.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects can 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 adverse effects have been reported with Orgovyx, listed according to their frequency of occurrence.

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

• Hot flushes
• 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)
• Sleeplessness
• Depression
• Dizziness
• Headache
• High blood pressure
• Stomach discomfort, including feeling sick (nausea)
• Increased sweating
• Rash
• Decreased interest in sex
• Weight gain
• Increased blood sugar levels
• Increased levels of fat in the blood (triglycerides)
• 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

Frequency not known (frequency cannot be estimated from available data):

• Changes in electrocardiogram (ECG) (prolongation of the QT interval)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in

Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orgovyx

• The active substance is relugolix.
• The other components are: mannitol (E421), sodium carboxymethyl starch (E468), hypromellose (E464), magnesium stearate (E572), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), and carnauba wax (E903).

For further information, see "Orgovyx contains sodium" in section 2.

What Orgovyx looks like and contents of the pack

Orgovyx film-coated tablets are light red, almond-shaped (11 mm [length] × 8 mm [width]), with an "R" on one side and "120" on the other. Orgovyx is supplied in a white plastic bottle containing 30 or 90 film-coated tablets, in pack sizes of 30 film-coated tablets and 90 film-coated tablets (in 3 bottles of 30 film-coated tablets or 1 bottle of 90 film-coated tablets). Each bottle also contains a desiccant to help keep the medicine dry (to protect it from moisture); do not remove the desiccant from the bottle. Each bottle is sealed with an induction seal and child-resistant cap.

Orgovyx film-coated tablets are also supplied in Alu/Alu blisters containing 30 and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th floor,

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

You can request further information about this medicine by contacting the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.