Akeega

Package leaflet: Information for the user

Akeega 50 mg/500 mg film-coated tablets

niraparib/abiraterone acetate
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Akeega is and what it is used for

Akeega is a medicine that contains two active substances: niraparib and abiraterone acetate, and it works in two different ways.
Akeega is used to treat adult men with prostate cancer who have mutations in certain genes, and in whom the prostate cancer has spread to other parts of the body (also called metastatic prostate cancer).
Niraparib is a type of anticancer 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 are unable to repair their DNA and die. In this way, PARP inhibitors help control the tumour.
Abiraterone stops the body from producing testosterone, which can slow down the growth of prostate cancer.
Together with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, excessive fluid buildup in the body (fluid retention), or low levels of a chemical substance, potassium, in the blood.

2. What you should know before taking Akeega

Do not take Akeega:

• if you are allergic to niraparib or abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6)
• if you are a woman who is pregnant or who may become pregnant
• if you have severe liver impairment
• in combination with Ra-223 treatment (used to treat prostate cancer), as this may increase the risk of bone fractures or death.

Do not take this medicine if you fall into any of these categories. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking or while taking this medicine if you have:

• low blood cell counts. Signs and symptoms to monitor include fatigue, fever or infection, and unusual bruising or bleeding. Akeega may also reduce blood cell counts. Your doctor will regularly perform blood tests throughout your treatment;
• high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels may increase the risk of heart rhythm disturbances), other heart or blood vessel problems (in the past), irregular or rapid heartbeat, shortness of breath, rapid weight gain, or swelling in the feet, ankles, or legs. Your doctor will regularly monitor your blood pressure throughout treatment;
• headache, vision changes, confusion, or seizures. These may be signs of a rare neurological side effect called reversible posterior encephalopathy syndrome, which has been associated with niraparib, one of the active substances in Akeega;
• high fever, fatigue, and other signs and symptoms of a serious infection;
• blood clots in the lungs or legs (currently or in the past);
• liver problems;
• high or low blood sugar levels;
• muscle weakness and/or muscle pain.

If you fall into any of the above conditions (or have any doubts), consult your doctor or pharmacist before taking this medicine.

If you develop persistently abnormal blood cell counts during Akeega treatment, this could be a sign of more serious bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia. Your doctor may request a bone marrow examination to check for these conditions.

Before taking Akeega, consult your doctor or pharmacist also about:

• the potential effect of Akeega on bones;
• the use of prednisone or prednisolone (another medicine you must take with Akeega).

If you have any doubts about whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Akeega may affect the liver, even if you do not experience symptoms of liver problems. While taking this medicine, your doctor will periodically perform blood tests to monitor for any liver effects.

Children and adolescents

This medicine is not intended for use in children and adolescents. If Akeega is accidentally ingested by a child or adolescent, seek immediate hospital care and bring this leaflet to show the emergency doctor.

Other medicines and Akeega

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Akeega may affect how some other medicines work. Additionally, some other medicines may affect how Akeega works.

Treatment with medicines that suppress testosterone production in the body may increase the risk of heart rhythm disturbances. Inform your doctor if you are taking medicines:

• to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol);
• known to increase the risk of heart rhythm disturbances (e.g., methadone), used to relieve pain and for the treatment of opioid addiction; moxifloxacin, an antibiotic; antipsychotics, used for severe mental illnesses.

Inform your doctor if you are taking any of the medicines listed above.

Akeega and food

• This medicine must not be taken with food (see section 3 “How to take Akeega”), as this may increase the risk of side effects.

Pregnancy and breastfeeding

Akeega is not indicated for use in women.

• This medicine may harm the fetus if taken by pregnant women.
• Pregnant women or women who may become pregnant must wear gloves when handling Akeega.

Contraception for men using Akeega

• If you have sexual intercourse with a woman of childbearing age, you must use a condom and an effective contraceptive method. Use contraceptive methods during treatment and for 4 months after treatment ends. Consult your doctor for any questions about contraception.
• If you have sexual intercourse with a pregnant woman, use a condom to protect the fetus.

Driving and using machines

Taking Akeega may cause weakness, lack of concentration, fatigue, or dizziness. This may affect your ability to drive or operate machinery. Exercise caution when driving or using machines.

Akeega contains lactose and sodium

• Akeega contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free.”

3. How to take Akeega

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take
The recommended dose is 200 mg/1,000 mg once daily.

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 a meal (see section 2 “Akeega with food”).
• Swallow the tablets whole with water. Do not break, crush, or chew the tablets. This ensures the medicine works as effectively as possible.
• Akeega is taken together with a medicine called prednisone or prednisolone.
  • Take prednisone or prednisolone exactly as directed by your doctor.
  • You must take prednisone or prednisolone every day while you are taking Akeega.
  • The dose of prednisone or prednisolone may need to be adjusted in case of a medical emergency. Your doctor will inform you if you need to change the dose of prednisone or prednisolone.
  • 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 prescribed, contact your doctor immediately. 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, contact your doctor immediately.
Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult 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 questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• bruising or bleeding that lasts longer than usual after an injury: these may be signs of a low platelet count (thrombocytopenia)
• shortness of breath, feeling extremely tired, paleness, or rapid heartbeat: these may be signs of a low red blood cell count (anaemia)
• fever or infection: a low white blood cell count (neutropenia) can increase the risk of infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning when urinating. Some infections may be severe and may lead to death
• muscle weakness, muscle spasms, or a pounding sensation in the heart (palpitations): these may be signs of low potassium levels in the blood (hypokalaemia)

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

• increased levels of the enzyme alkaline phosphatase in the blood.

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

• reduced blood cell counts due to bone marrow problems or blood cancer originating in the bone marrow, myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).

Not known (frequency not defined) – not reported with use of Akeega but reported with use of
niraparib or abiraterone acetate (components of Akeega)

• allergic reaction (including a severe allergic reaction which may be life-threatening); signs include: itchy rash (urticaria) and swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing and collapse or loss of consciousness
• sudden increase in blood pressure: this may be a medical emergency that could cause organ damage or be life-threatening.

Other side effects
If you experience any other side effects, contact your doctor. These may include:
Very common (may affect more than 1 in 10 people):

• urinary tract infection
• infection of nose, throat or chest
• low white blood cell count (leucopenia), detected in blood tests
• low levels of a type of white blood cells (lymphopenia), detected in blood tests
• high blood pressure
• reduced appetite
• difficulty falling asleep (insomnia)
• dizziness
• headache
• shortness of breath
• stomach ache
• constipation
• nausea
• vomiting
• feeling extremely weak or tired
• high blood sugar levels
• weight loss
• swelling, including swelling of hands, ankles or feet
• increased levels of creatinine in the blood
• feeling hot or sweating
• cough
• diarrhoea
• muscle and joint pain

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

• pneumonia
• increased levels of a type of fat in the blood (triglycerides, cholesterol)
• depression
• anxiety
• rapid heartbeat
• sensation of rapid, irregular, or forceful heartbeat in the chest (palpitations)
• heart failure causing shortness of breath and leg swelling
• abnormal heart rhythm, including atrial fibrillation
• chest discomfort, often felt after physical activity
• blood clot in the lungs, causing chest pain and shortness of breath
• indigestion
• abdominal swelling
• mouth ulcers
• dry mouth
• rash
• blood in the urine
• increased levels of aspartate aminotransferase in the blood
• increased levels of alanine aminotransferase in the blood
• bone fractures
• infection of the stomach and intestine
• feeling confused
• feeling very sleepy and reduced energy
• altered sense of taste
• nosebleeds
• inflammation of the stomach lining
• high levels of "bilirubin" in the blood
• itching
• increased skin sensitivity to sunlight
• sudden kidney damage, possibly reversible
• chest pain not related to the heart
• difficulty thinking, remembering information, or solving problems (cognitive disorder)
• severe infection (sepsis)

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

• eye inflammation (conjunctivitis)
• ECG (electrocardiogram) abnormalities, which may indicate heart problems
• inflammation of the protective mucous membranes of body cavities, such as nose, mouth, or digestive system
• increased levels of gamma-glutamyl transferase in the blood
• skin infection
• allergic reaction
• heart attack
• lung inflammation
• liver failure
• inflammation of the liver (hepatitis)
• bleeding inside the urethra (the tube that carries urine from the bladder)
• chest pain

Not known (frequency not defined) – not reported with use of Akeega but reported with use of
niraparib or abiraterone acetate (components of Akeega)

• low levels of all types of blood cells (pancytopenia)
• neurological condition with symptoms including seizures, headache, confusion, and vision changes (reversible posterior encephalopathy syndrome, PRES), which is a medical emergency that may lead to organ damage or be life-threatening
• problems with the adrenal glands (related to salt and water imbalances) leading to reduced hormone production, causing symptoms such as weakness, fatigue, reduced appetite, nausea, dehydration, and skin changes
• lung inflammation caused by an allergic reaction (allergic alveolitis)
• muscle disease (myopathy), which may cause weakness, stiffness, or muscle spasms
• breakdown of muscle tissue (rhabdomyolysis), which may cause muscle cramps or pain, fatigue, and dark urine

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akeega

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister foil,
inner carton, outer carton and box) after "Exp.". The expiry date refers to the last
day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Akeega contains

• The active substances are niraparib and abiraterone acetate. Each film-coated tablet contains 50 mg of niraparib and 500 mg of abiraterone acetate.
• The other components of the tablet core are: anhydrous colloidal silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The film coating contains: black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), sodium lauryl sulfate, glycerol monocaprylocaprate, polyvinyl alcohol, talc, and titanium dioxide (E171) (see section 2, Akeega contains lactose and sodium).

Description of the appearance of Akeega and contents of the pack
Akeega film-coated tablets are yellowish-orange to yellowish-brown in colour,
oval-shaped, with “N 50 A” engraved on one side and smooth on the other side.
The 28-day pack contains 56 film-coated tablets in two cardboard boxes,
each containing 28 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 further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
“Dzhonson & Dzhonsъn Bălgariya” EOOD Janssen-Cilag NV
Tel.: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247/+49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Farmakeutiki Monoprosopi EPE Janssen-Cilag Pharma GmbH
Tel: +30 210 80 90 000 Tel: +43 1 610 300

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800 688 777/+39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Varnavas Hadjipanagis Ltd Janssen-Cilag AB
Tel: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Package leaflet: information for the user

Akeega 100 mg/500 mg film-coated tablets

niraparib/abiraterone acetate
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Akeega is and what it is used for

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 mutations in certain genes, and in whom the prostate cancer has spread to other parts of the body (also called metastatic prostate cancer).
Niraparib is a type of anticancer 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 are unable to repair their DNA and die. In this way, PARP inhibitors help control the tumour.
Abiraterone stops the body from producing testosterone, which can slow down the growth of prostate cancer.
Together with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, excessive fluid retention in the body, or low levels of a chemical substance, potassium, in the blood.

2. What you should know before taking Akeega

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 pregnant or who may become pregnant
• if you have severe liver damage
• in combination with treatment with Ra-223 (used to treat prostate cancer), as this may increase the risk of bone fractures or death.

Do not take this medicine if you fall into any of these categories. If you have any doubts, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine or while you are taking it if you have:

• low blood cell counts. Signs and symptoms to monitor include fatigue, fever or infection, and unusual bruising or bleeding. Akeega may also reduce blood cell counts. Your doctor will regularly perform blood tests throughout your treatment;
• high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels may increase the risk of heart rhythm disturbances), other heart or blood vessel problems (current or past), irregular or rapid heartbeat, shortness of breath, rapid weight gain, or swelling in the feet, ankles, or legs. Your doctor will regularly monitor your blood pressure throughout treatment;
• headache, vision changes, confusion, or seizures. These may be signs of a rare neurological side effect called reversible posterior encephalopathy syndrome, which has been associated with the use of niraparib, an active substance in Akeega;
• high fever, fatigue, and other signs and symptoms of a serious infection;
• blood clots in the lungs or legs (currently or in the past);
• liver problems;
• high or low blood sugar levels;
• muscle weakness and/or muscle pain.

If you fall into any of the above conditions (or have any doubts), consult your doctor or pharmacist before taking this medicine.
If you develop persistently abnormal blood cell counts during treatment with Akeega, this could be a sign of more serious bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia. Your doctor may require a bone marrow examination to check for these conditions.
Before taking Akeeah, consult your doctor or pharmacist also about:

• the effect Akeega may have on your bones
• taking prednisone or prednisolone (another medicine you must take with Akeega).

If you have any doubts about whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.
Blood monitoring
Akeega may affect the liver, although you may not experience symptoms of liver problems. While taking this medicine, your doctor will periodically perform blood tests to monitor for any liver effects.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Akeega is accidentally ingested by a child or adolescent, seek immediate hospital care and bring this leaflet to show the emergency doctor.
Other medicines and Akeega
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Akeega may affect how some other medicines work. In addition, some other medicines may affect how Akeega works.
Treatment with medicines that suppress testosterone production in the body may increase the risk of heart rhythm disturbances. Inform your doctor if you are taking medicines:

• to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol)
• known to increase the risk of heart rhythm disturbances (e.g., methadone), used to relieve pain and for treatment of opioid dependence; moxifloxacin, an antibiotic; antipsychotics, used for severe mental illnesses.

Inform your doctor if you are taking any of the medicines listed above.
Akeega and food

• This medicine should not be taken with food (see section 3 “How to take Akeega”), as this may increase the risk of side effects.

Pregnancy and breastfeeding
Akeega is not indicated for use in women.

• This medicine may harm the fetus if taken during pregnancy.
• Pregnant women or women who may become pregnant must wear gloves when handling Akeega. Contraceptive measures for men taking Akeega
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and an effective contraceptive method. Use contraceptive methods during treatment and for 4 months after treatment ends. Consult your doctor for any questions about contraceptive methods.
• If you have sexual intercourse with a pregnant woman, use a condom to protect the fetus.

Driving and using machines
Taking Akeega may cause weakness, lack of concentration, fatigue, or dizziness. This may affect your ability to drive or operate machinery. Exercise caution when driving or using machines.
Akeega contains lactose and sodium

• Akeega contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Akeega

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take
The recommended dose is 200 mg/1,000 mg once daily.

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 a meal (see section 2 “Akeega with food”).
• Swallow the tablets whole with water. Do not break, crush, or chew the tablets. This ensures the medicine works as effectively as possible.
• Akeega is taken together with a medicine called prednisone or prednisolone.
  • Take prednisone or prednisolone exactly as your doctor has instructed.
  • You must take prednisone or prednisolone every day while you are taking Akeega.
  • The dose of prednisone or prednisolone may need to be adjusted in case of a medical emergency. Your doctor will inform you if you need to change the dose of prednisone or prednisolone.
  • 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 a higher risk of experiencing 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, contact your doctor immediately.
Do not take a double dose to make up for a forgotten dose.
If you have any questions about 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 questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop taking Akeega and contact your doctor immediately if you experience any of the following symptoms:

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

• Bruising or bleeding that lasts longer than usual after an injury: these may be signs of a low platelet count (thrombocytopenia)
• Shortness of breath, feeling extremely tired, paleness, or rapid heartbeat: these may be signs of a low red blood cell count (anaemia)
• Fever or infection: a low white blood cell count (neutropenia) can increase the risk of infection. Signs may include fever, chills, feeling weak or confused, cough, or pain or a burning sensation when passing urine. Some infections can be severe and may lead to death
• Muscle weakness, muscle spasms, or a sensation of pounding heartbeat (palpitations): these may be signs of low potassium levels in the blood (hypokalaemia)

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

• Increased levels of the enzyme alkaline phosphatase in the blood.

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

• Reduced blood cell counts due to bone marrow problems or blood cancer originating in the bone marrow, myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).

Not known (frequency not defined) – not reported with the use of Akeega, but reported with the use of niraparib or abiraterone acetate (components of Akeega):

• Allergic reaction (including a severe allergic reaction that may be life-threatening); signs include itchy rash (urticaria), swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing, collapse, or loss of consciousness
• Sudden increase in blood pressure: this may be a medical emergency that could lead to organ damage or be life-threatening.

Other side effects
If you experience any other side effects, contact your doctor. These may include:

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

• Urinary tract infection
• Infection of the nose, throat, or chest
• Low white blood cell count (leucopenia), detected in blood tests
• Low levels of a type of white blood cells (lymphopenia), detected in blood tests
• High blood pressure
• Reduced appetite
• Difficulty falling asleep (insomnia)
• Dizziness
• Headache
• Shortness of breath
• Stomach pain
• Constipation
• Nausea
• Vomiting
• Feeling extremely weak or tired
• High blood sugar levels
• Weight loss
• Swelling, including of hands, ankles, or feet
• Increased levels of creatinine in the blood
• Feeling hot or sweating
• Cough
• Diarrhoea
• Muscle and joint pain

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

• Pneumonia
• Increased levels of a type of fat in the blood (triglycerides, cholesterol)
• Depression
• Anxiety
• Rapid heartbeat
• Sensation of rapid, irregular, or forceful heartbeat (palpitations)
• Heart failure causing shortness of breath and leg swelling
• Irregular heartbeat (atrial fibrillation)
• Abnormal heart rhythm, including atrial fibrillation
• Chest discomfort, often felt after physical activity
• Blood clot in the lungs causing chest pain and shortness of breath
• Indigestion
• Abdominal swelling
• Mouth ulcers
• Dry mouth
• Rash
• Blood in the urine
• Increased levels of aspartate aminotransferase in the blood
• Increased levels of alanine aminotransferase in the blood
• Bone fractures
• Stomach and intestinal infection
• Feeling confused
• Feeling very sleepy and reduced energy
• Altered sense of taste
• Nosebleeds
• Inflammation of the stomach lining (gastritis)
• High levels of "bilirubin" in the blood
• Itching
• Increased skin sensitivity to sunlight
• Sudden kidney damage, possibly reversible
• Chest pain not related to the heart
• Difficulty thinking, remembering information, or solving problems (cognitive disorder)
• Severe infection (sepsis)

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

• Eye inflammation (conjunctivitis)
• Abnormal ECG (electrocardiogram) findings, which may indicate heart problems
• Inflammation of the protective mucous membranes of body cavities such as nose, mouth, or digestive tract
• Increased levels of gamma-glutamyl transferase in the blood
• Skin infection
• Allergic reaction
• Heart attack
• Lung inflammation
• Liver failure
• Inflammation of the liver (hepatitis)
• Bleeding inside the urethra (the tube that carries urine from the bladder)
• Chest pain

Not known (frequency not defined) – not reported with the use of Akeega, but reported with the use of niraparib or abiraterone acetate (components of Akeega):

• Low levels of all types of blood cells (pancytopenia)
• A neurological condition with symptoms including seizures, headache, confusion, and vision changes (reversible posterior encephalopathy syndrome, PRES), which is a medical emergency that may lead to organ damage or be life-threatening
• Problems with the adrenal glands (related to salt and water imbalances) leading to reduced hormone production, causing symptoms such as weakness, fatigue, reduced appetite, nausea, dehydration, and skin changes
• Lung inflammation caused by an allergic reaction (allergic alveolitis)
• Muscle disease (myopathy), which may cause weakness, stiffness, or muscle spasms
• Breakdown of muscle tissue (rhabdomyolysis), which may cause muscle cramps or pain, fatigue, and dark urine

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akeega

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister foil,
inner carton, outer carton and box) after "Exp.". The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Akeega contains

• The active substances are niraparib and abiraterone acetate. Each film-coated tablet contains 100 mg of niraparib and 500 mg of abiraterone acetate.
• The other components of the tablet core are: anhydrous colloidal silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The film coating contains: red iron oxide (E172) and yellow iron oxide (E172), sodium lauryl sulfate, glycerol monocaprylocaprate, polyvinyl alcohol, talc and titanium dioxide (E171) (see section 2, Akeega contains lactose and sodium).

Description of the appearance of Akeega and contents of the pack
The film-coated tablets of Akeega are orange-coloured, oval-shaped, with “N100 A” engraved on one side and smooth on the other side.
Each 28-day pack contains 56 film-coated tablets in two cardboard cartons, each containing 28 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Tel: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800 688 777/+39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.