Xtandi
enzalutamide
enzalutamide
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in
this leaflet. See section 4.
What Xtandi is and what it is used for
What you need to know before you take Xtandi
How to take Xtandi
Possible side effects
How to store Xtandi
Contents of the pack and other information
Xtandi contains the active substance enzalutamide. Xtandi is used to treat adult men with prostate cancer that:
No longer responds to a hormone therapy or surgical treatment to lower testosterone Or
Has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone.
Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.
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, breast-feeding and fertility’)
Seizures
Seizures were reported in 5 in every 1,000 people taking Xtandi, and fewer than 3 in every 1,000
people taking placebo (see ‘Other medicines and Xtandi’ below and section 4 ‘Possible side effects’).
If you are taking a medicine that can cause seizures or that can increase the susceptibility for having
seizures (see ‘Other medicines and Xtandi’ below).
If you have a seizure during treatment:
See 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, reversible condition involving the brain, in patients treated with Xtandi. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible. (See also section 4 ‘Possible side effects’).
Risk of new cancers (second primary malignancies)
There have been reports of new (second) cancers including cancer of the bladder and colon in patients treated with Xtandi.
See your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in the urine, or frequently feel an urgent need to urinate when taking Xtandi.
Talk to your doctor before taking Xtandi
If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
If you use chemotherapy like docetaxel
If you have problems with your liver
If you have problems with your kidneys
Please tell your doctor if you have any of the following:
Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Xtandi.
If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat. If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Xtandi.
Serious skin rash or skin peeling, blistering and/or mouth sores have been reported in association with Xtandi treatment. Seek medical attention immediately if you notice any of these symptoms.
This medicine is not for use in children and adolescents.
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 to your doctor when you are prescribed a new medicine. You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Tell your doctor 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).
Certain medicines for the treatment of pain (e.g. pethidine).
Tell your doctor if you are taking the following medicines. These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
This includes certain medicines used to:
Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin)
Treat pain (e.g. fentanyl, tramadol)
Treat cancer (e.g. cabazitaxel)
Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
Treat sleep disorders (e.g. zolpidem)
Treat heart conditions or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone)
Treat HIV infection (e.g. indinavir, ritonavir)
Treat bacterial infections (e.g. clarithromycin, doxycycline)
Treat thyroid disorders (e.g. levothyroxine)
Treat gout (e.g. colchicine)
Treat stomach disorders (e.g. omeprazole)
Prevent heart conditions or strokes (e.g. dabigatran etexilate)
Prevent organ rejection (e.g. tacrolimus)
Xtandi might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].
Tell your doctor if you are taking any of the medicines listed above. The dose of Xtandi or any other medicines that you are taking may need to be changed.
This medicine could possibly have an effect on male fertility.
If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method, during treatment and for 3 months after treatment with this medicine. If you are having sex with a pregnant woman, use a condom to protect the unborn child.
Female caregivers see section 3 ‘How to take Xtandi’ for handling and use.
Xtandi may have moderate influence on the ability to drive and use machines. Seizures have been reported in patients taking Xtandi. If you are at higher risk of seizures, talk to your doctor.
This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The usual dose is 160 mg (four soft capsules), taken at the same time once a day.
Swallow the soft capsules whole with water.
Do not chew, dissolve or open the soft capsules before swallowing.
Xtandi can be taken with or without food.
Xtandi should not be handled by persons other than the patient or his caregivers. Women who are or may become pregnant should not handle damaged or opened Xtandi capsules without wearing protection like gloves.
Your doctor may also prescribe other medicines while you are taking Xtandi.
If you take more soft capsules than prescribed, stop taking Xtandi and contact your doctor. You may have an increased risk of seizure or other side effects.
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 immediately.
- Do not take a double dose to make up for the dose you forgot.
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seizures were reported in 5 in every 1,000 people taking Xtandi, and in fewer than 3 in every 1,000 people taking placebo.
Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
There have been rare reports of PRES (may affect up to 1 in 1,000 people), a rare, reversible condition involving the brain, in patients treated with Xtandi. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Tiredness, fall, broken bones, hot flushes, high blood pressure
Headache, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness, change in sense of taste
Hallucinations, difficulty thinking clearly, low white blood cell count
Muscle pain, muscle spasms, muscular weakness, back pain, changes in ECG (QT prolongation), upset stomach including feeling sick (nausea), a skin reaction that causes red spots or patches on the skin that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme), rash, being sick (vomiting), swelling of the face, lips, tongue and/or throat, reduction in blood platelets (which increases risk of bleeding or bruising), diarrhoea
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
The other ingredients of the soft capsule are caprylocaproyl macrogol-8 glycerides, butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
The ingredients of the soft capsule shell are gelatin, sorbitol sorbitan solution (see section 2), glycerol, titanium dioxide (E171), and purified water.
The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.
Xtandi soft capsules are white to off-white, oblong soft capsules (approximately 20 mm by 9 mm) with “ENZ” written on one side.
Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Astellas Pharma Europe B.V. Sylviusweg 62
2333 BE Leiden
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Biocodex UAB
Tel: + 370 37 408 681
Астелас Фарма ЕООД
Teл.: + 359 2 862 53 72
Tél/Tel: + 32 (0)2 5580710
Astellas Pharma a/s Tlf: + 45 43 430355
Astellas Pharmaceuticals AEBE Tel: + 30 210 8189900
Astellas Pharma GmbH Tel: + 49 (0)89 454401
Astellas Pharma B.V. Tel: + 31 (0)71 5455745
Biocodex OÜ
Tel: + 372 6 056 014
Astellas Pharma
Tlf: + 47 66 76 46 00
Astellas Pharmaceuticals AEBE
Τηλ: + 30 210 8189900
Astellas Pharma Ges.m.b.H. Tel: + 43 (0)1 8772668
Astellas Pharma S.A. Tel: + 34 91 4952700
Astellas Pharma Sp.z.o.o. Tel.: + 48 225451 111
Astellas Pharma S.A.S. Tél: + 33 (0)1 55917500
Astellas Farma, Lda. Tel: + 351 21 4401300
Astellas d.o.o.
Tel: + 385 1 670 01 02
S.C.Astellas Pharma SRL
Tel: + 40 (0)21 361 04 95 /96 /92
Astellas Pharma Co. Ltd. Tel: + 353 (0)1 4671555
Astellas Pharma d.o.o. Tel: + 386 14011 400
Vistor hf
Sími: + 354 535 7000
Astellas Pharma S.p.A. Tel: + 39 02 921381
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000
Astellas Pharmaceuticals AEBE
Ελλάδα
Τηλ: + 30 210 8189900
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00
Biocodex SIA
Tel: + 371 67 619365
Astellas Pharma Co., Limited Tel: +353 (0)1 4671555
Free call from Northern Ireland: 0800 783 5018