Lynparza contains the active substance olaparib. Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate‑ribose] polymerase inhibitor).

PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. These specific cancer cells can be identified by:

·            response to platinum chemotherapy, or

·            looking for faulty DNA repair genes, such as BRCA (BReast CAncer) genes.

When Lynparza is used in combination with abiraterone (an androgen receptor signalling inhibitor), the combination may help enhance anti-cancer effect in prostate cancer cells with or without faulty DNA repair genes (e.g., BRCA genes).

What Lynparza is used for

Lynparza is used:

·            for the treatment of a type of ovarian cancer (BRCA-mutated) that is newly diagnosed. It can be used once the cancer has responded to treatment with standard platinum-based chemotherapy. A test is used to determine whether you have BRCA-mutated ovarian cancer.

·            for the treatment of ovarian cancer that has come back (recurred). It can be used after the cancer has responded to previous treatment with standard platinum‑based chemotherapy.

·            A type of breast cancer (BRCA-mutated, HER2-negative) when the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery.  If your cancer is hormone-receptor positive your doctor may also prescribe hormonal treatment.

o   A test is used to find out whether you have BRCA-mutated breast cancer.

·            a certain type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour. You should have received chemotherapy medicines either before or after your cancer has spread. 

o   A test is used to find out whether you have BRCA-mutated breast cancer.

·            advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. Lynparza is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that Lynparza is right for you.

·                human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. Lynparza is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that Lynparza is right for you.

·            metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. Lynparza is used as maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that Lynparza is right for you.

·            prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). Lynparza is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure Lynparza is right for you.

·             in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an approved companion diagnostic for Lynparza.

When Lynparza is given in combination with other anti-cancer medicines it is important that you also read the package leaflets of these other medicines. If you have any questions about these medicines, ask your doctor.

Do not take Lynparza:

·            if you are allergic to olaparib or any of the other ingredients of this medicine (listed in section 6)

·            if you are breast‑feeding (see section 2 below for more information).

Do not take Lynparza if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Lynparza.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:

·            if you have low blood cell counts on testing. These may be low counts for red or white blood cells, or low platelet counts. See section 4 for more information about these side effects, including the signs and symptoms you need to look out for (for example, fever or infection, bruising or bleeding). Rarely, these may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML).

·            if you experience any new or worsening symptoms of shortness of breath, coughing, or wheezing. A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis). Pneumonitis is a serious condition that can often require hospital treatment.

·           if you experience any new or worsening symptoms of pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal or heart beats faster than normal. A small number of patients treated with Lynparza were reported to develop a blood clot in a deep vein, usually in the leg (venous thrombosis), or a clot in the lungs (pulmonary embolism).

If you think any of these may apply to you, talk to your doctor, pharmacist or nurse before or during treatment with Lynparza.

Tests and checks

Your doctor will check your blood before and during treatment with Lynparza.

You will have a blood test:

·        before treatment

·        every month for the first year of treatment

·        at regular intervals decided by your doctor after the first year of treatment.

If your blood count falls to a low level, you may need to have a blood transfusion (where you are given new blood or blood‑based products from a donor).

Other medicines and Lynparza

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Lynparza can affect the way some other medicines work. Also some other medicines can affect the way Lynparza works.

Tell your doctor, pharmacist or nurse if you are taking or are planning to take any of the following medicines:

·            any other anticancer medicines

·            a vaccine or a medicine that suppresses the immune system, as you may need to be closely monitored

·            itraconazole, fluconazole ‑ used for fungal infections

·            telithromycin, clarithromycin, erythromycin ‑ used for bacterial infections

·            protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine, efavirenz ‑ used for viral infections, including HIV

·            rifampicin, rifapentine, rifabutin ‑ used for bacterial infections, including tuberculosis (TB)

·            phenytoin, carbamazepine, phenobarbital ‑ used as a sedative or to treat fits (seizures) and epilepsy

·            herbal remedies containing St John’s Wort (Hypericum perforatum) ‑used mainly for depression

·            digoxin, diltiazem, furosemide, verapamil, valsartan ‑ used to treat heart conditions or high blood pressure

·            bosentan ‑ used to treat pulmonary artery hypertension

·            statins, for example simvastatin, pravastatin, rosuvastatin ‑ used to lower blood cholesterol levels

·            dabigatran – used to thin the blood

·            glibenclamide, metformin, repaglinide ‑ used to treat diabetes

·            ergot alkaloids ‑ used to treat migraines and headaches

·            fentanyl ‑ used to treat cancer pain

·        pimozide, quetiapine ‑ used to treat mental health problems

·        cisapride ‑ used to treat stomach problems

·        colchicine – used to treat gout

·        cyclosporine, sirolimus, tacrolimus ‑ used to suppress the immune system

·        methotrexate ‑ used to treat cancer, rheumatoid arthritis and psoriasis.

Tell your doctor, pharmacist or nurse if you are taking any of the above or any other medicines. The medicines listed here may not be the only ones that could affect Lynparza.

Lynparza with drink

Do not drink grapefruit juice while you are being treated with Lynparza. It can affect the way the medicine works.

Contraception, pregnancy and breast‑feeding

Female patients:

·            You should not take Lynparza if you are pregnant or might become pregnant. This is because it may harm an unborn baby.

·            You should not become pregnant while taking this medicine. If you are having sex, you should use two effective methods of contraception while taking this medicine and for 6 months after taking the last dose of Lynparza. It is not known whether Lynparza may affect the effectiveness of some hormonal contraceptives. Please tell your doctor if you are taking a hormonal contraceptive, as your doctor may recommend the addition of a non‑hormonal contraceptive method.

·            You should have a pregnancy test before starting Lynparza, at regular times during treatment and 6 months after taking the last dose of Lynparza. If you become pregnant during this time, you must talk to your doctor straight away.

·            It is not known whether Lynparza passes into breast milk. Do not breast‑feed if you are taking Lynparza and for 1 month after taking the last dose of Lynparza. If you are planning to breast‑feed, tell your doctor.

Male patients:

·            You must use a condom when having sex with a female partner, even if she is pregnant, while taking Lynparza and for 3 months after taking the last dose. It is not known whether Lynparza passes into semen.

·            Your female partner must also use a suitable method of contraception.

·            You must not donate sperm while taking Lynparza and for 3 months after taking the last dose.

Driving and using machines

Lynparza may influence your ability to drive and use machines. If you feel dizzy, weak, or tired while taking Lynparza, do not drive or use tools or machines.

Information on other ingredients in this medicine

This medicine contains less than 1 mmol sodium (23 mg) per 100 mg or 150 mg tablet, that is to say essentially “sodium-free”.

Your doctor has prescribed Lynparza film‑coated tablets for you. Please note Lynparza is also available as a 50 mg capsule.

·            The doses of Lynparza tablets and capsules are not the same.

·            Taking the wrong dose or a capsule instead of a tablet could lead to Lynparza not working properly or to more side effects.

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How to take

·            Swallow Lynparza tablets whole, with or without food.

·            Take Lynparza once in the morning and once in the evening.

·            Do not chew, crush, dissolve or divide the tablets as this may affect how quickly the medicine gets into your body.

How much to take

·            Your doctor will tell you how many tablets of Lynparza to take. It is important that you take the total recommended dose each day. Keep doing so for as long as your doctor, pharmacist or nurse tells you to.

·            The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day ‑ a total of 4 tablets each day.

Your doctor may prescribe a different dose if:

·            you have problems with your kidneys. You will be asked to take 200 mg (2 x 100 mg tablets) twice a day – a total of 4 tablets each day.

·            you are taking certain medicines that may affect Lynparza (see section 2).

·            you have certain side effects while you are taking Lynparza (see section 4). Your doctor may lower your dose or stop treatment, either for a short time or permanently.

If you take more Lynparza than you should

If you take more Lynparza than your normal dose, contact your doctor or the nearest hospital straight away.

If you forget to take Lynparza

If you forget to take Lynparza, take your next normal dose at its scheduled time. Do not take a double dose (two doses at the same time) 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.

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

Tell your doctor straight away if you notice any of the following:

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

·            feeling short of breath, feeling very tired, pale skin or fast heartbeat – these may be symptoms of a decrease in the number of red blood cells (anaemia).

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

·            allergic reactions (e.g., hives, difficulty breathing or swallowing, dizziness which are signs and symptoms of hypersensitivity reactions).

·            itchy rash or swollen, reddened skin (dermatitis).

·            serious problems with bone marrow (myelodysplastic syndrome or acute myeloid leukaemia). See section 2.

Other side effects include:

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

·            feeling sick (nausea)

·            being sick (vomiting)

·            feeling tired or weak (fatigue)

·            indigestion or heartburn (dyspepsia)

·            loss of appetite

·            headache

·            changes in taste of foods (dysgeusia)

·            feeling dizzy

·            cough

·            shortness of breath (dyspnoea)

·            diarrhoea ‑ if it gets severe, tell your doctor straight away.

Very common side effects that may show up in blood tests:

·       Low white blood cell count (leukopenia or neutropenia) which may decrease your ability to fight infection and may be associated with fever

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

·            rash

·            sore mouth (stomatitis).

·            pain in the stomach area under the ribs (upper abdominal pain).

·            blood clot in a deep vein, usually in the leg (venous thrombosis) that may cause symptoms such as pain or swelling of the legs, or a clot in the lungs (pulmonary embolism) that may cause symptoms such as shortness of breath, chest pain, breathing that is more rapid than normal or heart beats faster than normal.

Common side effects that may show up in blood tests:

·            low white blood cell count (lymphopenia) which may decrease your ability to fight infection and may be associated with fever

·            Decrease in the number of platelets in blood (thrombocytopenia) ‑ you may notice the following symptoms

o   bruising or bleeding for longer than usual if you hurt yourself

·            increase in blood creatinine ‑ this test is used to check how your kidneys are working.

Uncommon side effects that may show up in blood tests:

·            increase in the size of red blood cells (not associated with any symptoms).

Rare (may affect up to 1 in 1,000 people)

·        Painful inflammation of the fatty tissue under the skin (erythema nodosum).

·        Facial swelling (angioedema)

Your doctor will test your blood every month for the first year of treatment and at regular intervals after that. Your doctor will tell you if there are any changes in your blood test that might need treatment.

If you notice any side effects not listed in this leaflet, please contact your doctor straight away.

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 carton and the blister after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

Store in the original package in order to protect from moisture.

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.