What Xtandi is used for and how to use it
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Xtandi - Consumer Medicine Information

Manufacture: Astellas
Country: Canada
Condition: Prostate Cancer
Class: Antiandrogens, Hormones/antineoplastics
Form: Capsules
Ingredients: enzalutamide, caprylocaproyl macrogolglycerides, butylhydroxyanisole (E320), butylhydroxytoluene (E321)gelatin, sorbitol sorbitan solution, glycerol, titanium dioxide (E171), purified water,

(enzalutamide capsules)

About this medication

What the medication is used for:

Xtandi is used to treat prostate cancer that has spread to other parts of the body in patients who are receiving drugs to lower the testosterone level or have had surgical removal of the testicles. These patients may have also received prior cancer treatment withdocetaxel.

What it does:

Xtandi blocks the activity of androgens (like testosterone), which can slow the growth of prostate cancer.

When it should not be used:

  • If you are allergic to enzalutamide or to any of the ingredients in the formulation (see What the nonmedicinal ingredients are).
  • If you are or may become pregnant.
  • If you are breast-feeding.
  • What the medicinal ingredient is:

    enzalutamide

    What the nonmedicinal ingredients are:

    caprylocaproyl macrogolglycerides, butylhydroxyanisole (E320), butylhydroxytoluene (E321)

    Capsule Shell: gelatin, sorbitol sorbitan solution, glycerol, titanium dioxide (E171), purified water

    Printing ink: ethanol, ethyl acetate, propylene glycol, iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonia solution concentrated

    What dosage forms it comes in:

    Xtandi is available as a 40 mg white to off-white, oblong, liquid filled, soft capsule. The letters “ENZ” are printed in black on each capsule.

    Warning and precautions

                      Serious Warnings and Precautions
    Xtandi should only be prescribed by a doctor experienced with the treatment of prostate cancer.
    Clinically significant adverse events:
    • Seizures (see Seizures section, below).
    • Posterior Reversible Encephalopathy Syndrome
      (PRES, see PRES section below)

    Be careful if you are engaging in activities that require mental concentration or where sudden loss of consciousness could cause serious harm to others (e.g., driving or operating tools or machines).

    BEFORE you use Xtandi talk to your doctor or pharmacist:

    • If you have history of seizures or are at a high risk of seizures (see below paragraph on situations in which you may have a higher risk of seizures).
    • If you have problems with your liver or kidneys.
    • If you have any heart disorder, including an irregular heartbeat, an abnormal electrical signal called "prolongation of the QT interval" or a known history of QT interval prolongation.
    • If you have high blood pressure. Xtandi can raise blood pressure. Your doctor will measure your blood pressure before starting treatment with Xtandi and periodically during treatment.
    • If you have a personal history of fainting spells.
    • If you 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).
    • About all medicines (including natural health products) you have recently taken or are currently taking.

    You should not start or stop Xtandi before you talk to your healthcare provider that prescribed you Xtandi.

    Men who are sexually active with a pregnant woman must use a condom during and for three months after treatment with Xtandi. If their sexual partner may become pregnant, a condom and another form of birth control must be used during and for three months after treatment.

    Xtandi should not be given to patients less than 18 years of age.

    Seizures

    Xtandi has been shown to cause seizures in about 9 of every 1,000 people who had received prior cancer treatment with docetaxel, and in about 1 of every 1,000 people who had not received chemotherapy.

    Posterior Reversible Encephalopathy Syndrome (PRES)

    Reversible swelling in the rear part of the brain that can be associated with high blood pressure and can lead to headache, loss of speech or vision, confusion and/or seizure.

    Tell your doctor, pharmacist or nurse

    if you are taking any of the following medicines. When taken at the same time as Xtandi, these medicines may increase the risk of 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 medicines for the treatment of pain (e.g. meperidine)

    Some situations in which you may have a higher risk of seizures include:

    • If you had earlier episodes of seizures
    • If you drink very large amounts of alcohol either regularly or from time to time
    • If you have had a serious head injury or a history of head trauma
    • If you have had certain kinds of stroke
    • If you have had a brain tumour or metastases of cancer in the brain
    • If you are taking a medicine that can cause seizures or medicines that can lower the susceptibility for having seizures

    If you have a seizure during treatment: Stop taking Xtandi and see your doctor, pharmacist or nurse as soon as possible.

    Interactions whith medication

    Certain medicines may interact with Xtandi. These include drugs used to:

    • Treat bacterial infections (e.g. clarithromycin)
    • Treat anxiety or depression (e.g. diazepam)
    • Treat psychosis (e.g. diazepam, haloperidol, midazolam)
    • Treat gout (colchicine)
    • Lower cholesterol (e.g. atorvastatin, simvastatin)
    • Treat heart conditions and lower blood pressure (e.g. bisoprolol, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
    • Treat serious disease related to inflammation (e.g. dexamethasone, prednisone)
    • Prevent the rejection of organ transplants (e.g. cyclosporine, tacrolimus)
    • Treat HIV infection (e.g. indinavir, ritonavir)
    • Treat epilepsy (e.g. phenobarbitone, phenytoin)
    • Prevent blood clots (e.g. acenocoumarol, dabigatran etexilate, warfarin)
    • Treat cancer (e.g. cabazitaxel, irinotecan, sunitinib)
    • Treat pain (e.g. fentanyl, tramadol)
    • Treat thyroid conditions (e.g. levothyroxine)

    Tell your doctor, pharmacist or nurse if you are taking any of the medicines listed above. You should check with your doctor, pharmacist, or nurse before taking any other medications with Xtandi. The dose of any other medicines that you are taking may need to be changed.

    Proper use of this medication

    Usual dose:

    The usual dose is 160 mg per day (4 capsules). The dose should be taken at the same time each day. Swallow the capsules whole with water. This medicine can be taken with or without food.

    Overdose:

    If you take more drug than prescribed, stop taking Xtandi and contact your doctor. You may be at increased risk for seizure.

    In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

    Missed Dose:

    • If you forget to take Xtandi at the usual time, take your usual dose as soon as you remember.
    • If you forget to take Xtandi for the whole day, take your usual dose the following day.
    • If you forget to take Xtandi for more than one day, talk to your doctor without delay.

    Do not take a double dose to make up for the dose you forgot.

    Side effects and what to do about them

    Like all medicines, Xtandi can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

    Very Common side effects (affects more than 1 in 10 people):

    • Fatigue
    • High blood pressure
    • Headache
    • Hot flush

    Common side effects (affects less than 1 in 10 people):

    • Falls
    • Bone fractures
    • Feeling anxious
    • Forgetfulness
    • Inability to remember and to solve problems
    • Reduced concentration
    • Disturbance in attention
    • Dry skin, itching
    • Breast enlargement in men
    • Bruise
    • Nose bleed
    • Shingles
    • Dizziness
    • Flu like symptoms
    • Drowsiness
    • Uncontrollable urge to move a part of the body, usually the leg (restless leg syndrome)

    Uncommon side effects (affects less than 1 in 100 people):

    • Hallucinations
    • Bleeding in digestive tract
    • Infection
    • Seizure
    • Low white blood cell count

    Reported from post-marketing with unknown frequency:

    • Posterior Reversible Encephalopathy Syndrome (PRES): symptoms include seizure, worsening headache, consciousness impairment (including confusion, tiredness, or coma), blindness or other vision problems.

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

    Approximately 9 in every 1,000 people taking Xtandi are at risk of having a seizure, if they have received prior docetaxel therapy whereas the risk is approximately 1 in every 1,000 people who have not received prior docetaxel therapy. Seizures are more likely if you take more than the recommended dose of this medicine, if you take some other medicines, or if you are at higher than usual risk of seizures (see Warnings and Precautions).

    Tell your doctor or pharmacist if you have any side effects while taking Xtandi. This includes any side effects not listed above.

    Serious side effects, how often they happen and what to do about them

    Symptom / effectTalk with your doctor or
    pharmacist
    Stop taking
    drug and
    call your
    doctor or
    pharmacist
    Only if
    severe
    In all cases
    Uncommon (may affect 0.1% to 1% of people)
    Seizure
    Reported from post-marketing (unknown frequency)
    Reversible swelling in
    the rear part of the
    brain that can be
    associated with high
    blood pressure and can
    lead to headache, loss
    of speech or vision,
    confusion and/or
    seizure

    This is not a complete list of side effects. For any unexpected effects while taking Xtandi, contact your doctor or pharmacist.

    How to store it

    Store between 15°C - 30°C. Keep out of the reach of children.

    REPORTING SUSPECTED SIDE EFFECTS

    You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
    • Report online at www.healthcanada.gc.ca/medeffect
    • Call toll-free at 1-866-234-2345
    • Complete a Canada Vigilance Reporting Form and:
      • Fax toll-free to 1-866-678-6789, or
      • Mail to: Canada Vigilance Program
                        Health Canada
                        Postal Locator 0701D
                        Ottawa, ON K1A 0K9

      Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
      www.healthcanada.gc.ca/medeffect.


    NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

    More information

    This document plus the full product monograph, prepared for health professionals can be found at:
    http://www.astellas.ca/

    or by contacting the sponsor, Astellas Pharma Canada, Inc., at:
    1-888-338-1824.