Patient leaflet - Enzalutamide 40 mg soft capsules
1. What Enzalutamide is and what it is used for
Enzalutamide contains the active substance enzalutamide. This medicine 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.
How Enzalutamide works
Enzalutamide 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.
2. What you need to know before you take Enzalutamide
Do not take Enzalutamide
- 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’).
Warnings and precautions
Seizures
Seizures were reported in 5 in every 1,000 people taking enzalutamide and fewer than one in every 1,000 people taking placebo (see ‘Other medicines and Enzalutamide’ 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 Enzalutamide’ below)
If you have a seizure during treatment:
See your doctor as soon as possible. Your doctor may decide that you should stop taking this medicine Posterior reversible encephalopathy syndrome (PRES)
There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with enzalutamide. 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 enzalutamide.
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 Enzalutamide.
Talk to your doctor before taking Enzalutamide:
- 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 Enzalutamide.
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 this medicine.
Serious skin rash or skin peeling, blistering and/or mouth sores have been reported in association with enzalutamide treatment. Seek medical attention immediately if you notice any of these symptoms.
If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Children and adolescents
This medicine is not for use in children and adolescents.
Other medicines and Enzalutamide
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 this medicine.
Tell your doctor if you are taking any of the following medicines. When taken at the same time as Enzalutamide, 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 Enzalutamide, or Enzalutamide 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)
Enzalutamide 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 Enzalutamide or any other medicines that you are taking may need to be changed.
Pregnancy, breast-feeding and fertility
- Enzalutamide is not for use in women. This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant. It must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
- 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 Enzalutamide’ for handling and use.
Driving and using machines
Enzalutamide may have moderate influence on the ability to drive and use machines. Seizures have been reported in patients taking enzalutamide. If you are at higher risk of seizures, talk to your doctor.
Enzalutamide contains sorbitol
This medicine contains 91.6 mg sorbitol in each capsule. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
3. How to take Enzalutamide
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. Taking Enzalutamide
- Swallow the soft capsules whole with water.
- Do not chew, dissolve or open the soft capsules before swallowing.
This medicine can be taken with or without food.
Enzalutamide should not be handled by persons other than the patient and his caregivers.
Women who are or may become pregnant should not handle damaged or opened enzalutamide capsules without wearing protection like gloves.
Your doctor may also prescribe other medicines while you are taking Enzalutamide.
If you take more Enzalutamide than you should
If you take more soft capsules than prescribed, stop taking Enzalutamide and contact your doctor. You may have an increased risk of seizure or other side effects.
If you forget to take Enzalutamide
- If you forget to take Enzalutamide at the usual time, take your usual dose as soon as you remember.
- If you forget to take Enzalutamide for the whole day, take your usual dose the following day. - If you forget to take Enzalutamide for more than one day, talk to your doctor immediately. - Do not take a double dose to make up for the dose you forgot.
If you stop taking Enzalutamide
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seizures
Seizures were reported in 5 in every 1,000 people taking enzalutamide, and in fewer than one 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.
If you have a seizure, see your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide.
Posterior Reversible Encephalopathy Syndrome (PRES)
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 enzalutamide. If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Other possible side effects include:
Very common (may affect more than 1 in 10 people):
- Tiredness
- Fall, broken bones
- Hot flushes
- High blood pressure
Common (may affect up to 1 in 10 people):
- Headache
- Feeling anxious
- Dry skin, itching
- Difficulty remembering
- Blockage of the arteries in the heart (ischemic heart disease)
- Breast enlargement in men (gynaecomastia)
- Restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg) - Reduced concentration
- Forgetfulness
- Change in sense of taste
Uncommon (may affect up to 1 in 100 people):
- Hallucinations
- Difficulty thinking clearly
- Low white blood cell count
Not known (frequency cannot be estimated from the available data):
- 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
Reporting of side effects
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Enzalutamide
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 blister 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.
6. Contents of the pack and other information
What Enzalutamide contains
- The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide. - The other ingredients of the soft capsule are: caprylocaproyl macrogolglycerides, butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
- The ingredients of the soft capsule shell are: gelatin, sorbitol, liquid partially dehydrated (see section 2), glycerol (E422), titanium dioxide (E171), and purified water. What Enzalutamide looks like and contents of the pack
- Enzalutamide soft capsules are white to off-white opaque, oblong-shaped, 22.0 (± 2.5) mm long and 9.5 (± 2.5) mm wide and containing colourless to slightly yellow, transparent liquid. - Each carton contains blisters of 4 soft capsules each in pack sizes of 28, 112, 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta.