Apo-Enzalutamide: Uses, Side Effects and Dosage

Serious Warnings and Precautions

Only take APO-ENZALUTAMIDE under the care of a healthcare professional experienced with the treatment of prostate cancer.

APO-ENZALUTAMIDE can cause serious side effects, which may include:

• Seizures
• Posterior Reversible Encephalopathy Syndrome (reversible swelling in the back of the brain).

What APO-ENZALUTAMIDE is used for:

APO-ENZALUTAMIDE is used to treat prostate cancer that has spread to other parts of the body in men who:

• are receiving but no longer responding to hormone treatment or surgery to lower testosterone. They may have also received a cancer treatment with a drug called docetaxel.
• still respond to hormone treatment or surgery that lowers testosterone.

APO-ENZALUTAMIDE is used to treat prostate cancer that has not spread to other parts of the body in men who:

• no longer respond to hormone treatment or surgery that lowers testosterone. APO-ENZALUTAMIDE has not been studied in patients with low risk of the cancer spreading to other parts of the body.

• are at a high risk of cancer spreading to other parts of the body, and:

  • have not yet received hormone treatment or surgery that lowers testosterone; or
  • continue to respond to hormone treatment or surgery that lowers testosterone.

How APO-ENZALUTAMIDE works:

APO-ENZALUTAMIDE blocks the activity of hormones called androgens (like testosterone). This can slow the growth of prostate cancer.

The ingredients in APO-ENZALUTAMIDE are:

Medicinal ingredients: enzalutamide

Non-medicinal ingredients: butylated hydroxyanisole, butylated hydroxytoluene and caprylocaproyl polyoxylglycerides.

Capsule shell: gelatin, glycerin, purified water, sorbitol sorbitan solution, and titanium dioxide. Printing ink: ammonium hydroxide, ethanol and ethyl acetate, ferrosoferric oxide, hypromellose, polyvinyl acetate phthalate and propylene glycol.

APO-ENZALUTAMIDE comes in the following dosage forms:

Capsules: 40 mg

Do not use APO-ENZALUTAMIDE if:

• you are allergic to enzalutamide or to any other ingredients in APO-ENZALUTAMIDE

• you are or may become pregnant

• you are breast-feeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-ENZALUTAMIDE. Talk about any health conditions or problems you may have, including if you:

• have history of seizures or are at a high risk of seizures. This is because APO-ENZALUTAMIDE may increase your risk of seizures. Some situations in which you may have a higher risk of seizures include if you:

  • had earlier episodes of seizures
  • drink very large amounts of alcohol either regularly or from time to time
  • have had a serious head injury
  • have had a stroke or mini stroke
  • have had a brain tumour or spreading of cancer to the brain
  • are taking a medicine that can cause seizures or increase your chance of having seizures (see section The following may interact with APO-ENZALUTAMIDE below for information about these medicines)
• have liver problems
• have kidney problems
• have or had any heart disorder, including irregular heartbeat, an abnormal electrical signal called “prolongation of the QT interval”
• have high blood pressure. APO-ENZALUTAMIDE can increase your blood pressure. Your healthcare professional will measure your blood pressure before starting treatment with APO-ENZALUTAMIDE and periodically during treatment
• have a history of fainting spells
• have a risk for falls or broken bones
• have electrolyte disturbances (e.g. low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g. vomiting, diarrhea, dehydration, eating disorder)
• have fructose intolerance, which is a rare hereditary problem. This is because APO-ENZALUTAMIDE contains sorbitol

Other warnings you should know about:

• Birth control

During treatment with APO-ENZALUTAMIDE, use effective birth control each time you have sex with women who are pregnant, possibly pregnant, or who could become pregnant. Continue using birth control for at least three months after treatment.

• Driving and using machines

APO-ENZALUTAMIDE may affect your ability to drive and use machines. Before engaging in activities that require special attention, wait until you know how APO-ENZALUTAMIDE affects you.

• Women, children and adolescents

APO-ENZALUTAMIDE is NOT for use in women and patients younger than 18 years of age.

• Difficulty swallowing related to capsule size

There have been reports of some patients choking due to capsule size of APO-ENZALUTAMIDE. Swallow the capsules whole with a sufficient amount of water.

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 APO-ENZALUTAMIDE:

• Antibiotics used to treat bacterial infections (e.g. clarithromycin, doxycycline)
• Medicines used to treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, haloperidol, midazolam)
• Medicines used to treat gout (colchicine)
• Medicines used to lower cholesterol (e.g. atorvastatin, simvastatin)
• Medicines used to treat heart conditions and lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• Medicines used to treat serious disease related to inflammation (e.g. dexamethasone, prednisone)
• Medicines used to prevent the rejection of organ transplants (e.g. cyclosporine, tacrolimus)
• Medicines used to treat HIV infection (e.g. indinavir, ritonavir)
• Medicines used to treat epilepsy (e.g. carbamazepine, clonazepam phenobarbital, phenytoin, primidone, valproic acid)
• Medicines used to prevent blood clots (e.g. acenocoumarol, dabigatran etexilate, warfarin, clopidogrel)
• Medicines used to treat cancer (e.g. cabazitaxel, irinotecan, sunitinib)
• Medicines used to treat pain (e.g. fentanyl, tramadol)
• Medicines used to treat thyroid conditions (e.g. levothyroxine)
• Medicines used to treat stomach disorders (e.g. omeprazole)

Also, the following list includes some, but not all medicines that may interact with APO-ENZALUTAMIDE to increase your risk of having a seizure:

• Certain medicines used to treat asthma and other respiratory diseases (e.g. aminophylline, theophylline)
• Medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine, venlafaxine)
• Certain opioids used to treat pain (e.g. meperidine)

You should check with your healthcare professional before taking any other medicines with APO-ENZALUTAMIDE. The dose of any other medicines that you are taking may need to be changed.

How to take APO-ENZALUTAMIDE:

• Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Take each dose at the same time each day.

• Take with or without food.

• Swallow the capsules whole with a sufficient amount of water.
• Do NOT chew, dissolve or open the capsules.
• Do NOT start or stop APO-ENZALUTAMIDE before you talk to your healthcare professional.

Instructions for handling APO-ENZALUTAMIDE

• APO-ENZALUTAMIDE should not be handled by persons other than the patient or their caregivers.
• Women who are or may become pregnant should NOT handle damaged or opened APO-ENZALUTAMIDE capsules without protection (e.g. gloves). APO-ENZALUTAMIDE might harm your unborn baby.

Usual dose:

The usual dose is 160 mg (4 capsules) taken once a day.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-ENZALUTAMIDE, 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 forget to take APO-ENZALUTAMIDE at the usual time, take your usual dose as soon as you remember.
• If you forget to take APO-ENZALUTAMIDE for the whole day, take your usual dose the following day.
• If you forget to take APO-ENZALUTAMIDE for more than one day, talk to your healthcare professional right away.
• Do NOT take a double dose to make up for the dose you forgot.

Possible side effects from using APO-ENZALUTAMIDE:

These are not all the possible side effects you may have when taking APO-ENZALUTAMIDE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Back pain
• Breast swelling in males
• Bruising
• Change in sense of taste
• Constipation
• Decreased appetite
• Diarrhea
• Difficulty swallowing the APO-ENZALUTAMIDE capsule, including choking
• Disturbance in attention
• Dizziness / vertigo
• Drowsiness
• Dry skin, itching
• Feeling anxious
• Feeling tired (fatigue)
• Flu-like symptoms
• Forgetfulness
• Hallucinations
• Having trouble remembering and solving problems
• Headache
• Hot flush
• Joint Pain
• Low white blood cell count (shown in blood tests)
• Nausea
• Nose bleed
• Rash
• Reduced concentration
• Shingles
• Uncontrollable urge to move a part of the body, usually the leg (restless leg syndrome)
• Vomiting
• Weight loss

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations, or fainting, you should seek immediate medical attention.

APO-ENZALUTAMIDE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 15°C to 30°C. Keep out of the reach and sight of children.

If you want more information about APO-ENZALUTAMIDE:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Date of Authorization: 2026-03-30