Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - akeega

Document Subject

Generated Narrative: MedicinalProductDefinition mp5caa393121d9756e15d948c90dc0e334

identifier: http://ema.europa.eu/identifier/EU/1/23/1722/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Akeega 50 mg/500 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5caa393121d9756e15d948c90dc0e334

identifier: http://ema.europa.eu/identifier/EU/1/23/1722/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - akeega

Attesters

What is in this leaflet

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

Akeega is a medicine that contains two active substances: niraparib and abiraterone acetate, and works in two different ways. Akeega is used to treat adult men with prostate cancer who have changes in certain genes and whose prostate cancer has spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (also called metastatic castration-resistant prostate cancer). Niraparib is a type of cancer medicine called a PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA. When PARP is blocked, cancer cells cannot repair their DNA, resulting in tumour cell death and helping to control the cancer. Abiraterone stops your body from making testosterone; this can slow the growth of prostate cancer. When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.

Do not take Akeega:

if you are allergic to niraparib or abiraterone acetate or any of the other ingredients of this medicine - listed in section 6.
if you are a woman who is or can become pregnant.

if you have severe liver damage.

in combination with Ra-223 treatment (which is used to treat prostate cancer). This is because of a possible increase in the risk of bone fracture or death. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk to your doctor or pharmacist before or while taking this medicine if you have:

low blood cell counts. Signs and symptoms you need to look out for include fatigue, fever or infection, and abnormal bruising or bleeding. Akeega may also lower your blood cell counts. Your doctor will test your blood regularly throughout your treatment.

high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems), have had other heart or blood vessel problems, have an irregular or rapid heart rate, shortness of breath, gained weight rapidly, or swelling in the feet, ankles, or legs. Your doctor will measure your blood pressure regularly throughout your treatment.

headaches, vision changes, confusion, or seizure. These may be signs of a rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) that has been associated with use of niraparib, an active ingredient of Akeega.

high fever, fatigue and other signs and symptoms of severe infection.

blood clots in the lungs, or have had them in the past.

liver problems.

low or high levels of sugar in the blood.

muscle weakness and/or muscle pain. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine. If you develop low blood-cell counts for a long period of time while taking Akeega, this may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may want to test your bone marrow to check for these problems. Before taking Akeega, also talk to your doctor or pharmacist about:

the effect Akeega may have on your bones.

taking prednisone or prednisolone (another medicine you must take with Akeega) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Blood monitoring Akeega may affect your liver, but you may not notice any symptoms of liver problems. When you are taking this medicine, your doctor will therefore check your blood periodically to look for any effects on your liver. Children and adolescents This medicine is not for use in children and adolescents. If Akeega is accidentally swallowed by a child or adolescent, take them to the hospital immediately and take this package leaflet with you to show to the emergency doctor. Other medicines and Akeega Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Akeega can affect the way some other medicines work. Also, some other medicines can affect the way Akeega works. Treatment with medicines that stop the body from producing testosterone, may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine:

to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);

known to increase the risk of heart rhythm problems (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. Akeega with food

This medicine must not be taken with food (see section 3, Taking Akeega ), as this may increase your risk of side effects. Pregnancy and breast-feeding Akeega is not for use in women.

This medicine may cause harm to the unborn child if it is taken by women who are pregnant.

Women who are pregnant or who may become pregnant should wear gloves if they need to touch or handle Akeega. Contraception for men using Akeega

If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method. Use contraception during treatment and for 4 months after stopping. Talk to your doctor if you have any questions about contraception.

If you are having sex with a pregnant woman, use a condom to protect the unborn child. Driving and using machines Taking Akeega may make you feel weak, unfocused, tired or dizzy. This may influence your ability to drive and use machines. Use caution when driving or using machines. Akeega contains lactose and sodium

Akeega contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take The recommended starting dose is 200 mg/1 000 mg once a day. Taking Akeega

Take this medicine by mouth.

Do not take Akeega with food.

Take Akeega tablets as a single dose once daily on an empty stomach at least one hour before or at least two hours after eating (see section 2, Akeega with food ).

Swallow the tablets whole with water. Do not break, crush, or chew the tablets. This will ensure the medicine works as well as possible.

Akeega is taken with a medicine called prednisone or prednisolone.* Take the prednisone or prednisolone exactly as your doctor has told you.* You need to take prednisone or prednisolone every day while you are taking Akeega.* The amount of prednisone or prednisolone you take may need to be changed if you have a medical emergency. Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to. Your doctor may also prescribe other medicines while you are taking Akeega. If you take more Akeega than you should If you take more tablets than you should contact your doctor. You may have an increased risk of side effects. If you forget to take Akeega If you forget to take Akeega or prednisone or prednisolone, take your usual dose as soon as you remember on the same day. If you forget to take Akeega or prednisone or prednisolone for more than one day - talk to your doctor straight away. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. If you stop taking Akeega Do not stop taking Akeega or prednisone or prednisolone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Stop taking Akeega and seek medical attention immediately if you notice any of the following symptoms: Very common (may affect more than 1 in 10 people)

Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia).

Being short of breath, feeling very tired, having pale skin, or fast heartbeat - these may be signs of a low red blood cell count (anaemia).

Fever or infection low white blood cell count (neutropenia) can increase your risk for infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine. Some infections can be serious and may lead to death.

Muscle weakness, muscle twitching or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low (hypokalaemia).

Increased level of the enzyme alkaline phosphatase in the blood Not known (cannot be estimated) not reported with the use of Akeega but reported with use of niraparib or abiraterone acetate (components of Akeega)

Allergic reaction (including severe allergic reaction that can be life-threatening). Signs include: raised and itchy rash (hives) and swelling-sometimes of the face or mouth (angioedema), causing difficulty in breathing, and collapse or loss of consciousness.

A sudden increase in blood pressure, which may be a medical emergency that could lead to organ damage or can be life-threatening. Other side effects Talk to your doctor if you get any other side effects. These can include: Very common (may affect more than 1 in 10 people):

urinary tract infection

low number of white blood cells (leukopenia), seen in blood tests

decreased appetite

difficulty sleeping (insomnia)

feeling dizzy

shortness of breath

constipation

feeling sick (nausea)

vomiting

back pain

joint pain

feeling very tired

feeling weak

weight loss

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

pneumoniae

lung infection (bronchitis)

infection of the nose and throat (nasopharyngitis)

low number of a type of white blood cell (lymphopenia), seen in blood tests

high level of a type of fat (hypertriglyceridemia) in the blood

depression

feeling anxious

headache

fast heart beat

fast or uneven heart beat (palpitations)

irregular heart beat (atrial fibrillation)

heart failure, causing shortness of breath and swollen legs

heart attack

cough

blood clot in the lungs, causing chest pain and shortness of breath

inflamed lungs

stomach pain

indigestion

diarrhoea

bloating

sores in the mouth

dry mouth

inflamed liver (hepatitis) based on blood tests

skin rash

muscle aches

blood in the urine

swollen hands, ankles, or feet

increased level of creatinine in the blood

increased level of the enzyme aspartate aminotransferase in the blood

increased level of the enzyme alanine aminotransferase in the blood Uncommon (may affect up to 1 in 100 people):

severe infection (sepsis) that spreads from the urinary tract throughout the body

inflamed eye (conjunctivitis)

feeling confused

difficulty thinking, remembering information, or solving problems (cognitive impairment)

change in sense of taste

chest discomfort, often brought on by physical activity

abnormal ECG (electrocardiogram), which could be a sign of heart problems

nose bleeds

inflammation of the protective linings in the body cavities, such as the nose, mouth, or digestive system

sudden liver failure

increased sensitivity of the skin to sunlight

increased level of gamma-glutamyltransferase in the blood Not known (cannot be estimated) not reported with the use of Akeega but reported with use of niraparib or abiraterone acetate (components of Akeega)

low numbers of all types of blood cells (pancytopenia)

brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (posterior reversible encephalopathy syndrome or PRES), which is a medical emergency that could lead to organ damage or can be life-threatening

adrenal gland problems (related to salt and water problems) where too little hormone is produced which may cause problems like weakness, tiredness, loss of appetite, nausea, dehydration and skin changes

inflamed lungs caused by an allergic reaction (allergic alveolitis)

muscle disease (myopathy), which may cause muscle weakness, stiffness or spasms

breakdown of muscle tissue (rhabdomyolysis), which may cause muscle cramps or pains, tiredness and dark urine Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 container (blister foil, inner wallet, outer wallet, and 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 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.

What Akeega contains

The active substances are niraparib and abiraterone acetate. Each film-coated tablet contains 50 mg niraparib and 500 mg abiraterone acetate.

The other ingredients of the tablet core are colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The film-coating contains iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), sodium lauryl sulphate, glycerol monocaprylocaprate, polyvinyl alcohol, talc, and titanium dioxide (E171) (see section 2, Akeega contains lactose and sodium). What Akeega looks like and contents of the pack Akeega film-coated tablets are yellowish orange to yellowish brown oval tablet, debossed with N A on one side and plain on the other side. Each 28-day carton contains 56 film-coated tablets in two cardboard wallet packs of 28 film-coated tablets each. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Cilag SpA Via C. Janssen, Borgo San Michele Latina 04Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in MM/YYYY. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: