40 mg and 80 mg film-coated tablets
enzalutamide
What Xtandi is and what it is used for
Xtandi contains the active substance enzalutamide. Xtandi is used to treat adult men with prostate cancer who:
- no longer responding to hormone therapy or surgical treatment to lower testosterone levels
or
- has spread to other parts of the body and is responding to hormone therapy or surgery to lower testosterone levels.
How Xtandi works
Xtandi is a medicine that works by blocking the activity of hormones called androgens (eg testosterone ). By blocking androgens, enzalutamide prevents prostate cancer cells from growing and dividing.
What you need to know before you take Xtandi
Do not take Xtandi
- If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6)
- If you are pregnant or may become pregnant (see “Pregnancy, breastfeeding and fertility”)
Warnings and precautions
Seizures
Seizures were reported in 5 out of 1,000 people taking Xtandi and fewer than 3 out of 1,000 people taking a placebo (see “Other medicines and Xtandi” below and section 4, “Possible side effects”).
If you are taking medicines that can cause convulsions or that can increase the likelihood of convulsions (see “Other medicines and Xtandi” below).
If you have a seizure during treatment:
Contact your doctor as soon as possible. Your doctor may decide that you should stop taking Xtandi.
Posterior reversible encephalopathy syndrome (PRES)
There have been rare reports of PRES, a rare and transient condition affecting the brain in patients treated with Xtandi. If you have seizures, worsening headaches, become confused, blind, or have other problems with your vision, contact your doctor as soon as possible (see also section 4 “Possible side effects”).
Risk of new cancer (secondary malignancies )
There have been reports of new (other) cancers such as bladder and colon cancer in patients treated with Xtandi.
Contact your doctor as soon as possible if you have signs of bleeding in the gastrointestinal tract, blood in the urine, or if you often feel an urgent need to urinate while taking Xtandi.
Talk to your doctor before taking Xtandi
- if you are taking any medicine that prevents the blood from clotting (eg warfarin, acenocoumarol, clopidogrel)
- if you are being treated with chemotherapy such as docetaxel
- if you have problems with your liver
- if you have problems with your kidneys.
Tell your doctor if you have any of the following:
Cardiovascular disease including heart rhythm disturbances ( arrhythmia ), or if you are taking medication for this. The risk of heart rhythm disturbances may be increased when taking Xtandi.
If you are allergic to enzalutamide, it may cause a rash or swelling of the face, tongue, lips, or throat. Do not take Xtandi if you are allergic to enzalutamide or any of the other ingredients of this medicine.
Severe skin rashes or scaly skin, blisters, and/or sores in the mouth have been reported in association with treatment with Xtandi. Seek medical attention immediately if you experience any of these symptoms.
If any of the above apply to you or if you are not sure, talk to your doctor before taking this medicine.
Children and young people
This medicine should not be used by children or adolescents.
Other medicines and Xtandi
Tell your doctor if you are taking, have recently taken, or might take any other medicines. You need to know the names of the medicines you take. Keep a list of them with you to show your doctor when you are prescribed a new medicine. You should not start or stop taking any medicine before talking to the doctor who prescribed you Xtandi.
Tell your doctor if you are taking any of the following medicines. When taken at the same time as Xtandi, these medicines can increase the risk of seizures:
- Certain medicines are used to treat asthma and other respiratory diseases (eg aminophylline, theophylline).
- Medicines used to treat certain mental illnesses such as depression and schizophrenia (eg clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
- Certain medicines to treat pain (eg pethidine).
Tell your doctor if you are taking any of the following medicines. These medicines can affect the effect of Xtandi, or Xtandi can affect the effectiveness of these medicines.
This includes certain medicines used to:
- Lower cholesterol et (e.g. gemfibrozil, atorvastatin, simvastatin )
- Treat pain (eg, fentanyl , tramadol)
- Treat cancer (eg cabazitaxel)
- Treat epilepsy (eg, carbamazepine, clonazepam, phenytoin, primidone, valproic acid )
- Treat certain psychiatric disorders such as severe anxiety or schizophrenia (eg diazepam, midazolam, haloperidol )
- Treat sleep disorders (eg zolpidem)
- Treat heart problems or lower blood pressure etc (eg bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
- Treat severe inflammatory diseases (eg dexamethasone, prednisolone )
- Treat HIV infection (eg, indinavir , ritonavir)
- Treat bacterial infections (eg, clarithromycin, doxycycline )
- Treat thyroid disorders (eg levothyroxine)
- Treat gout (eg, colchicine)
- Treat stomach disorders (eg omeprazole)
- Prevent heart disease or stroke (eg dabigatran etexilate)
- Prevent organ rejection (eg tacrolimus)
Xtandi may affect certain other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines [eg methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for serious mental illness)].
Tell your doctor if you are taking any of the medicines listed above. The dose of Xtandi or any other medicine you are taking may need to be changed.
Pregnancy, breastfeeding, and fertility
- Xtandi is not intended for use by women. This medicine can cause harm to the unborn baby or potentially cause a miscarriage if taken by women who are pregnant. It must not be taken by women who are pregnant, may become pregnant, or are breastfeeding.
- This drug may affect male fertility.
- If you have sex with a woman who could become pregnant, use a condom and other effective contraception during treatment and for 3 months after treatment with this medicine. If you have sex with a pregnant woman, use a condom to protect the unborn child.
- Female caregivers, read section 3, “How to take Xtandi,” for information on handling and use.
Driving ability and use of machinery
Xtandi may have a moderate effect on the ability to drive and use machines. Seizures have been reported in patients taking Xtandi.
If you have an increased risk of seizures, talk to your doctor.
Xtandi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to take Xtandi
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
The recommended dose is 160 mg (four 40 mg tablets or two 80 mg tablets) taken at the same time once daily.
Ingestion of Xtandi
- Swallow the tablets whole with water.
- The tablets should not be split, crushed, or chewed before swallowing.
- Xtandi can be taken with or without food.
- Xtandi should not be handled by anyone other than the patient or their caregiver. Women who are or may become pregnant should not handle broken or damaged Xtandi tablets without protection, e.g. gloves.
The doctor may also prescribe other medicines while you are taking Xtandi.
If you have taken too much Xtandi
If you have taken more tablets than prescribed, stop taking Xtandi and contact your doctor. You may have an increased risk of seizures or other side effects.
If you forget to take Xtandi
- 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 an entire day, take your usual dose the next day.
- If you forget to take Xtandi for more than one day, contact your doctor immediately.
- Do not take a double dose to make up for a missed dose.
If you stop taking Xtandi
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seizures
Seizures were reported in 5 out of 1,000 people taking Xtandi and in fewer than 3 out of 1,000 people taking the placebo.
Seizures are more likely if you take more than the recommended dose of one of these medicines, if you take certain other medicines, or if you have a higher-than-usual risk of seizures.
If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you should stop taking Xtandi.
Posterior reversible encephalopathy syndrome (PRES)
There have been rare reports of PRES (which may affect up to 1 in 1,000 people), a rare and transient condition affecting the brain in patients treated with Xtandi. If you experience seizures, worsening headaches, confusion, blindness, or other vision problems, see a doctor as soon as possible.
Other possible side effects are:
Very common (may affect more than 1 in 10 people)
Fatigue falls, fractures, hot flashes, high blood pressure
Common (may affect up to 1 in 10 people)
Headache, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries of the heart ( ischemic heart disease), breast enlargement in men ( gynaecomastia ), symptoms of restless legs syndrome (an uncontrollable urge to move part of the body, usually the legs), reduced ability to concentrate, forgetfulness, altered sense of taste
Uncommon (may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, low white blood cell count
Frequency not known (frequency cannot be calculated from available data)
Muscle aches, muscle cramps, muscle weakness, back pain, changes ( QT prolongation) in the EKG ( electrocardiogram ), upset stomach including nausea, a skin reaction that causes red dots or spots that may look like a target or a “bull’s eye” with a dark red center surrounding of lighter red rings (erythema multiforme), rash, vomiting, swelling of the face, lips, tongue and/or throat, reduced number of blood platelets (which increases the risk of bleeding or bruising), diarrhea
How to store Xtandi
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the wallet packaging and the outer carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is enzalutamide.
One Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
One Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Other ingredients in the film-coated tablets are:
- Tablet core: hypromellose acetate succinate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, croscarmellose sodium, magnesium stearate.
- Tablet coating: hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).
Appearance and package sizes of the medicine
Xtandi 40 mg film-coated tablets are yellow, round film-coated tablets imprinted with “E 40”. Each carton contains 112 tablets in 4 wallet packs of 28 tablets each.
Xtandi 80 mg film-coated tablets are yellow, oval film-coated tablets imprinted with “E 80”. Each carton contains 56 tablets in 4 wallet packs of 14 tablets each.
Astellas Pharma Europe BV
Sylviusweg 62
2333 BE Leiden
Netherlands