Akeega 50 mg/500 mg/100 mg Film-Coated Tablets

AKEEGA is a medicine 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) and in whom chemotherapy is not clinically indicated.

AKEEGA is a dual action medicine that contains two active substances: niraparib and abiraterone acetate, and works in two different ways.

Niraparib is a type of anti-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 control of 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 (medicine which can inhibit growth of prostate cancer cells).

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 moderate or severe liver damage.
• with prednisone or prednisolone in combination with Radium (RA)-223.

Warnings and precautions

Take special care with AKEEGA:

• if you have low blood-cell count on testing. AKEEGA lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia). Signs and symptoms that you need to look out for include fatigue, fever or infection, and abnormal bruising or bleeding (see section 4 for more information). Your doctor will test your blood regularly throughout your treatment.
• if you have been told you have 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, have shortness of breath, have gained weight rapidly, or have swelling in the feet, ankles, or legs. Your doctor will measure your blood pressure regularly throughout your treatment. He or she may also give you medicine to treat high blood pressure and adjust your AKEEGA dose, if necessary. Your doctor may advise home blood pressure monitoring and instructions on when to contact him or her in case of a rise in blood pressure.
• if you have headaches, vision changes, confusion, or seizure, please contact your doctor. A rare neurological side effect named Posterior Reversible Encephalopathy Syndrome (PRES) (condition characterized by: headache, siezures, altered consciousness and visual distrubances) has been associated with the niraparib component of AKEEGA.
• If you have blood clots in the lungs, or have had them in the past.
• if you have liver problems.
• if you have high or low levels of sugar in the blood (see section 4).
• if you have low blood-cell counts, as 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.
• about the need to take this medicine with prednisone or prednisolone. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents

This medicine is not for use in children and adolescents.

Do not share medicines prescribed for you with any other person. Always take AKEEGA exactly as your doctor or pharmacist 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 AKEEGA by mouth.

• Do not take AKEEGA with food.
• Take AKEEGA tablets as a single dose once daily on an empty stomach.
• AKEEGA must be taken at least two hours after eating and food must not be eaten for at least one hour after taking AKEEGA.
• Taking AKEEGA with food causes more of this medicine to be absorbed by the body than is needed and this may cause side effects.
• Swallow the tablets whole with water.
• Do not break, crush or chew the tablets.
• 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 change 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 healthcare provider may do blood tests to check for side effects. Your doctor will tell you how long your treatment with AKEEGA will last. Do not stop any treatment unless your doctor tells you to do so. If you have the impression that the effect of AKEEGA is too strong or too weak, tell your doctor or pharmacist.

If you take more AKEEGA than you should

If you take more AKEEGA than you should, talk to your doctor or pharmacist. You may have an increased risk of side effects. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take AKEEGA

• If you forget to take AKEEGA or prednisone or prednisolone, take your normal dose as soon as possible on the same day.
• Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.
• If you forget to take AKEEGA or prednisone or prednisolone for more than one day, talk to your doctor without delay.

Do not take a double dose to make up for forgotten individual doses.

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 or pharmacist.

AKEEGA can cause side effects. Not all side effects reported for AKEEGA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AKEEGA, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking AKEEGA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• 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.
• 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 (anemia).
• 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.
• A sudden increase in blood pressure, which may be a medical emergency that could lead to organ damage or can be life-threatening.
• Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low.
• Chest pain, shortness of breath, rapid breathing, and fast heartbeat. These may be signs of blood clots in the lungs (pulmonary embolism).
• A 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.
• Low levels of sugar in the blood with symptoms including confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness or unusual anxiety.

These are all serious side effects. If you have them, you may have had a serious reaction to AKEEGA. You may need urgent medical attention or hospitalisation.

Other side effects include:

Frequent side effects

• 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
• pneumonia
• 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

- Store all medicines out of reach of children.

- Store at or below 30 °C. Keep well closed.

- Do not use this medicine after the expiry date stated on the container (blister foil, inner wallet, outer wallet, and carton). The expiry date refers to the last day of that month.

- This medicine does not require any special storage conditions.

- Return all unused medicines to your pharmacist.

- Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). These measures will help protect the environment.