Patient Medication Information: uses, side effects, how to take - Nubeqa
What is NUBEQA used for:
NUBEQA is used in adults to treat prostate cancer that:
- has not spread to other parts of the body, and no longer responds to a medicine or surgery that lowers testosterone, or
- has spread to other parts of the body (metastatic) and still responds to a medicine or surgery that lowers testosterone. For these patients, NUBEQA may also be used with another drug called docetaxel.
NUBEQA has not been studied in patients with low risk of the cancer spreading to other parts of the body. Talk to your healthcare professional if you have any questions about this.
How NUBEQA works:
NUBEQA contains darolutamide. Darolutamide works by blocking the activity of androgens (like testosterone). This will slow the spread of your prostate cancer and the start of disease symptoms.
The ingredients in NUBEQA are:
Medicinal ingredients: darolutamide
Non-medicinal ingredients: calcium hydrogen phosphate, croscarmellose sodium, hypromellose 15 cP, lactose monohydrate, macrogol 3350, magnesium stearate, povidone K 30, titanium dioxide
NUBEQA comes in the following dosage form:
Tablet (film-coated): 300 mg
Do not use NUBEQA if:
- you are allergic to darolutamide or any of the other ingredients in this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NUBEQA. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure, diabetes, or high levels of fat in your blood (dyslipidemia).
- have a history of seizures
- suffer from a lactose intolerance. This is because NUBEQA contains lactose.
- have or have had liver or kidney problems.
Other warnings you should know about:
Liver Problems: Taking NUBEQA may affect your liver. Tell your doctor right away if you notice any of the following changes:
- abdominal discomfort or loss of appetite
- feeling sick (nausea) or vomiting
- yellowing of the skin or eyes
- darkening of the urine
Fertility:
- NUBEQA may affect your ability to have a child. Talk to your doctor if this is a concern for you.
- Do NOT donate sperm while taking NUBEQA and for 3 months after stopping NUBEQA.
Sexual Health:
- If you have a sexual partner who may become pregnant, you must use highly effective birth control during treatment and for 3 months after your treatment.
- If you have a sexual partner who is pregnant, you must use a condom during treatment and for 3 months after the last dose. NUBEQA may harm the unborn baby or make the pregnant individual lose the baby.
- Talk with your healthcare professional if you have questions about birth control.
- If your sexual partner becomes pregnant while you are taking NUBEQA, tell your healthcare professional right away.
Pregnancy and breast-feeding:
- NUBEQA is NOT to be used in individuals who are or may become pregnant. NUBEQA can harm the unborn baby or make a pregnant individual lose the baby.
- NUBEQA is NOT to be used in individuals who are breast-feeding. This is because it may get into breast milk and harm the baby.
Children and adolescents:
- NUBEQA is NOT for use in patients under the age of 18 years.
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with NUBEQA to monitor your health. They may:
- Check for signs and symptoms of heart problems
- Do blood tests to check your liver health
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NUBEQA:
- rifampicin – used to treat bacterial infections
- carbamazepine, phenobarbital – used to treat epilepsy
- St. John's Wort (hypericum perforatum) – an herbal product used mainly to treat depression
- rosuvastatin, fluvastatin, and atorvastatin – used to treat high cholesterol
- methotrexate – used to treat severe joint inflammation, severe cases of the skin disease psoriasis, and cancers
- sulfasalazine – used to treat inflammatory bowel disease
- itraconazole – used to treat fungal infections
How to take NUBEQA:
- Always take exactly as your healthcare professional tells you. Check with your doctor or pharmacist if you are not sure.
Take your prescribed dose twice a day with food (a snack or meal) at about the same time each day.
- Do NOT stop taking NUBEQA without talking to your doctor first.
- Swallow the tablets whole.
- Your doctor may also prescribe a gonadotropin-releasing hormone (GnRH) analog therapy while you are taking NUBEQA, unless you have had surgical castration. This is a surgery to remove your testicles in order to lower the amount of testosterone in your body.
- You may also receive docetaxel. Your healthcare professional will tell you how and when you will get it.
Usual dose:
Usual daily adult dose:
1200 mg (600 mg twice daily): Take two 300 mg tablets (600 mg) by mouth twice a day. This is a total daily dose of 1200 mg.
Your doctor may reduce your NUBEQA dose if needed.
Reduced daily adult dose:
600 mg (300 mg twice daily): Take one 300 mg tablet by mouth twice a day. This is a total daily dose of 600 mg.
Overdose:
If you think you, or a person you are caring for, have taken too much NUBEQA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you are late in taking NUBEQA, take it as soon as you remember before the next scheduled dose. Do NOT take a double dose to make up for the missed dose.
Possible side effects from using NUBEQA:
These are not all the possible side effects you may feel when taking NUBEQA. Some of these side effects may occur when taking NUBEQA or when taking NUBEQA with docetaxel. If you experience any side effects not listed here, contact your healthcare professional.
- fatigue (tiredness)
- rash
- pain in arms and legs or joints
- bone fracture
- constipation
- weight gain
- decreased appetite
- high blood pressure
- frequent urination
- hot flashes
- sleeplessness
NUBEQA may cause abnormal blood test results. This includes abnormal blood cell counts, blood sugar, calcium and liver enzymes. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| Very Common | ||||||
| Hemorrhage (bleeding): nose bleeds, blood in urine, dark tarry stool or bright red blood in your stool | ✓ | |||||
| Common | ||||||
| Arrhythmia: rapid, slow, or irregular heartbeat | ✓ | |||||
| Cardiac problems (including heart attack, heart disease and heart failure): pressure or pain in your chest or arms that may spread to neck, jaw or back, chest pain or discomfort or shortness of breath at rest or with activity, changes in heart rate, dizziness or lightheadedness, nausea | ✓ | |||||
| Pneumonia (infection in the lungs): shortness of breath. Difficult and painful breathing, cough, wheezing, or fever | ✓ | |||||
| Uncommon | ||||||
| Seizure (convulsion): uncontrollable shaking with or without loss of consciousness | ✓ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store bottles or blisters at room temperature (15°C to 30°C).
- Do NOT use this medicine after the expiry date stated on the product labels.
- Use this medicine only for 3 months after you first open the bottle. The medicine may not be as effective after 3 months.
- Keep the bottle tightly closed after you first open it.
- Do NOT throw away any medicines in the garbage, down the sink or in the toilet. Ask your pharmacist how to throw away expired or unused NUBEQA. These measures will help protect the environment.
- Keep out of sight and reach of children.
If you want more information about NUBEQA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website http://www.bayer.ca or by calling Bayer Medical Information at 1-800-265-7382 or emailing canada.medinfo@bayer.com.
Bayer Inc.
2920 Matheson Blvd East
Mississauga, Ontario
L4W 5R6 Canada
Date of Authorization: 2025-08-18
© 2025, Bayer Inc.
® TM see www.bayer.ca/tm-mc