Erleada 60 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Erleada 60 mg film-coated tablets

apalutamide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Erleada is and what it is used for
2. What you need to know before taking Erleada
3. How to take Erleada
4. Possible side effects
5. How to store Erleada
6. Contents of the pack and other information

1. What Erleada is and what it is used for

What Erleada is

Erleada is a cancer medicine that contains the active substance apalutamide.

What Erleada is used for

It is used to treat adult men with prostate cancer that:

• has spread to other parts of the body and still responds to medical or surgical treatments that lower testosterone levels (also called hormone-sensitive prostate cancer).
• has not spread to other parts of the body and no longer responds to medical or surgical treatments that lower testosterone levels (also called non-metastatic castration-resistant prostate cancer).

How Erleada works

Erleada works by blocking the activity of hormones called androgens (such as testosterone). Androgens can cause cancer growth. By blocking the effect of androgens, apalutamide causes prostate cancer cells to stop growing and dividing.

2. What you need to know before taking Erleada

Do not take Erleada

• if you are allergic to apalutamide or any of the other ingredients of this medicine (listed in section 6);
• if you are a woman who is pregnant or could become pregnant (for more information, see the Pregnancy and contraception section below).

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if:

• you have ever had seizures or epileptic fits.
• you are taking any medicine to prevent blood clots (such as warfarin, acenocoumarol).
• you have any heart or blood vessel disease, including heart rhythm problems (arrhythmia).
• you have ever had a widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS) or severe skin rash, peeling skin, blisters and/or mouth ulcers (Stevens-Johnson syndrome/toxic epidermal necrolysis or SJS/TEN) after taking Erleada or other related medicines.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Falls and bone fractures

Falls have been observed in patients taking Erleada. Take special precautions to reduce the risk of falls. Bone fractures have been observed in patients taking this medicine.

Heart disease, stroke, or mini-stroke

Some people have experienced blockage of arteries in the heart or brain, which may be fatal, during treatment with Erleada.

Your doctor will monitor you for signs and symptoms of heart or brain problems during treatment with this medicine.

Call your doctor or go immediately to the nearest emergency center if you experience:

• chest pain or discomfort at rest or during activity, or
• shortness of breath, or
• muscle weakness/paralysis anywhere in the body, or
• difficulty speaking.

If you are taking any medication, consult your doctor or pharmacist to determine whether they are associated with an increased risk of seizures, bleeding, or heart problems.

Severe cutaneous adverse reactions (SCARs)

Cases of severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS) or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported with the use of Erleada. DRESS may present as a widespread rash, high body temperature, and swollen lymph nodes. SJS/TEN may initially appear on the trunk as red, target-shaped spots or circular patches, often with central blisters. In addition, mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and potentially life-threatening or fatal complications.

If you develop a severe rash or any of these skin symptoms, stop taking this medicine immediately and contact your doctor or seek medical help right away.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine. See section 4, “Serious adverse effects,” for more information.

Interstitial lung disease

Cases of interstitial lung disease (non-infectious inflammation in the lungs that may result in permanent damage), including fatal cases, have been reported in patients taking Erleada. Symptoms of interstitial lung disease include cough and shortness of breath, sometimes with fever, not caused by physical exertion. If you experience symptoms that could indicate interstitial lung disease, seek medical help immediately.

Children and adolescents

This medicine must not be used in children or adolescents under 18 years of age.

If a child or young person accidentally takes this medicine:

• go immediately to the hospital
• bring this leaflet with you to show the emergency doctor.

Other medicines and Erleada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, as Erleada may affect how other medicines work. Likewise, other medicines may affect how Erleada works.

Specifically, inform your doctor if you are taking medicines for:

• lowering blood lipid levels (such as gemfibrozil)
• treating bacterial infections (such as moxifloxacin, clarithromycin)
• treating fungal infections (such as itraconazole, ketoconazole)
• treating HIV infection (such as ritonavir, efavirenz, darunavir)
• treating anxiety (such as midazolam, diazepam)
• treating epilepsy (such as phenytoin, valproic acid)
• treating gastroesophageal reflux disease (conditions with too much acid in the stomach) (such as omeprazole)
• preventing blood clots (such as warfarin, clopidogrel, dabigatran etexilate)
• treating pollen allergy and allergies (such as fexofenadine)
• lowering cholesterol (such as "statins" like rosuvastatin, simvastatin)
• treating heart problems or lowering blood pressure (such as digoxin, felodipine)
• treating heart rhythm problems (such as quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
• treating thyroid disorders (such as levothyroxine)
• treating gout (such as colchicine)
• lowering blood sugar (such as repaglinide)
• treating cancer (such as lapatinib, methotrexate)
• treating opioid dependence or pain (such as methadone)
• treating serious mental illnesses (such as haloperidol)

You should make a list of the names of all medicines you are taking and show it to your doctor or pharmacist when starting a new medicine. Inform your doctor that you are taking Erleada if your doctor plans to start any new treatment. It may be necessary to adjust the dose of Erleada or any of the other medicines you are taking.

Information on pregnancy and contraception for men and women

Information for women

• Pregnant women, women who could become pregnant, or women who are breastfeeding must not take Erleada. This medicine may harm the unborn baby.

Information for men: follow these recommendations during treatment and for 3 months after stopping it

• If you have sexual intercourse with a pregnant woman: use a condom to protect the unborn baby.
• If you have sexual intercourse with a woman who could become pregnant: use a condom and another highly effective method of contraception.

Use contraception during treatment and for 3 months after stopping Erleada. Consult your doctor if you have any questions about contraception.

This medicine may reduce male fertility.

Driving and using machines

It is unlikely that Erleada will affect your ability to drive or operate tools or machinery.

Side effects of this medicine include seizures. If you have an increased risk of seizures (see section 2, 'Warnings and precautions'), consult your doctor.

Erleada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 240 mg dose (4 tablets); essentially, it is "sodium-free".

3. How to take Erleada

Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor may prescribe other medications while you are taking Erleada.

How much to take

The recommended dose of this medicine is 240 mg (four 60 mg tablets) once daily.

How to take Erleada

• Take this medicine by mouth.
• You may take this medicine with food or between meals.
• Swallow each tablet whole to ensure you receive the full dose. Do not crush or split the tablets.

If you cannot swallow the tablets whole

• If you cannot swallow this medicine whole, you may:

• Mix it with one of the following non-carbonated liquids or soft foods: orange juice, green tea, apple sauce, drinkable yogurt, or additional water, as follows:

• Place the prescribed full dose of Erleada in a cup. Do not crush or split the tablets.

• Add approximately 20 ml (4 teaspoons) of non-carbonated water to completely cover the tablets.

• Wait 2 minutes until the tablets break apart and disperse, then stir the mixture.

• Add 30 ml (6 teaspoons or 2 tablespoons) of one of the following non-carbonated liquids or soft foods: orange juice, green tea, apple sauce, drinkable yogurt, or additional water, and stir the mixture.

• Swallow the mixture immediately.

• Rinse the cup with sufficient water to ensure you take the complete dose and drink it immediately.

• Do not store the medicine/food mixture for later use.

• Feeding tube: This medicine can also be administered through certain feeding tubes. Ask your doctor for specific instructions on how to properly administer the tablets through a feeding tube.

If you take more Erleada than you should

If you take more than you should, stop taking this medicine and contact your doctor immediately. You may be at increased risk of experiencing side effects.

If you forget to take Erleada

If you forget to take this medicine, take your usual dose as soon as you remember on the same day.

• If you forget to take this medicine for the entire day, take your usual dose the next day.
• If you forget to take this medicine for more than one day, consult your doctor immediately.
• Do not take a double dose to make up for missed doses.

If you stop taking Erleada

Do not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Stop taking Erleada and seek immediate medical attention if you notice any of the following symptoms:

• widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
• flat, red, target-like or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Immediately inform your doctor if you experience any of the following serious adverse effects; your doctor may discontinue treatment:

Very common: may affect more than 1 in 10 people

• falls or fractures (broken bones). Your doctor may monitor you more closely if you are at risk of fractures.

Common: may affect up to 1 in 10 people

• heart disease, stroke, or mini-stroke. Your doctor will monitor you for signs and symptoms of heart or brain problems during treatment. Call your doctor or go immediately to the nearest emergency center if you experience chest pain or discomfort at rest or during activity, shortness of breath, or if you develop muscle weakness/paralysis anywhere in the body or difficulty speaking during treatment with Erleada.

Uncommon: may affect up to 1 in 100 people

• epileptic seizure or convulsion. Your doctor will discontinue treatment with this medicine if you have a seizure during treatment.
• restless legs syndrome (urge to move the legs to relieve painful or unusual sensations, usually occurring at night)

Not known: frequency cannot be estimated from available data

• cough and shortness of breath, possibly accompanied by fever, not caused by physical activity (lung inflammation, known as interstitial lung disease)

Immediately inform your doctor if you experience any of the serious adverse effects listed above.

Adverse effects include

Tell your doctor if you notice any of the following adverse effects:

Very common (may affect more than 1 in 10 people):

• feeling very tired
• joint pain
• skin rash
• decreased appetite
• high blood pressure
• hot flushes
• diarrhea
• bone fractures
• falls
• weight loss

Common (may affect up to 1 in 10 people):

• muscle spasms
• itching
• hair loss
• altered sense of taste
• blood tests showing high cholesterol levels
• blood tests showing high levels of a type of fat known as "triglycerides"
• heart disease
• stroke or mini-stroke caused by insufficient blood flow to part of the brain
• underactive thyroid gland, which may make you feel more tired and sluggish in the mornings; blood tests may also show an underactive thyroid.

Uncommon (may affect up to 1 in 100 people):

• seizure/fit

Not known (frequency cannot be estimated from available data):

• abnormal heart activity on an ECG (electrocardiogram)
• widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
• flat, red, target-like or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers, which may be preceded by fever and flu-like symptoms. These severe skin rashes may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Erleada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging (blister, inner carton, outer carton, bottle, and box) after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Erleada

• The active substance is apalutamide. Each film-coated tablet contains 60 mg of apalutamide.
• The other components of the tablet core are colloidal anhydrous silica, sodium croscarmellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The film coating contains iron oxide black (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide (E171) (see Section 2, Erleada contains sodium).

Appearance of the product and contents of the pack

Erleada film-coated tablets are oblong, slightly yellowish to greyish-green film-coated tablets (17 mm long by 9 mm wide), with “AR 60” engraved on one side.

The tablets may be supplied in a bottle or in a carton. Only certain pack sizes may be marketed.

Bottle

The tablets are supplied in a plastic bottle with a child-resistant safety closure. Each bottle contains 120 tablets and a total of 6 g of desiccant. Each carton contains one bottle. Keep in the original packaging. Do not ingest or discard the desiccant.

28-day pack

Each 28-day pack contains 112 film-coated tablets in 4 cardboard boxes, each containing 28 film-coated tablets.

30-day pack

Each 30-day pack contains 120 film-coated tablets in 5 cardboard boxes, each containing 24 film-coated tablets.

Marketing Authorisation Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer

Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100, Italy

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.eu游戏副本, and on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).