Lynparza

Package leaflet: Information for the patient

Lynparza 100 mg film-coated tablets, 150 mg film-coated tablets

olaparib
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What is Lynparza and what is it used for

What is Lynparza and how does it work
Lynparza contains the active substance olaparib. Olaparib is an anticancer medicine known as a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase enzyme).
PARP inhibitors can destroy tumour cells that are unable to repair DNA damage. These specific tumour cells can be identified based on:

• response to platinum-based chemotherapy, or
• testing for defective DNA repair genes, such as BRCA genes (BReast CAncer – breast cancer gene).

When Lynparza is given in combination with abiraterone (an androgen receptor signalling inhibitor), this combination may help enhance the anticancer effect in prostate cancer cells, both with and without defective DNA repair genes (e.g. BRCA genes).
What Lynparza is used for
Lynparza is used to treat:

• A type of ovarian cancer ( BRCA -mutated) that has responded to initial platinum-based standard chemotherapy. A test is used to determine whether you have a BRCA-mutated ovarian cancer.
• Recurrent (relapsed) ovarian cancer. It may be used when the cancer has responded to a previous course of platinum-based standard chemotherapy.
• A type of ovarian cancer (HRD-positive, defined by the presence of a BRCA mutation or genomic instability) that has responded to initial treatment with standard platinum-based chemotherapy and bevacizumab. Lynparza is used in combination with bevacizumab.
• A type of breast cancer ( BRCA -mutated, HER2-negative) when the cancer has not spread to other parts of the body and treatment is to be given after surgery (treatment after surgery is called adjuvant therapy). You must have received chemotherapy medicines before or after surgery. If the cancer is hormone receptor-positive, your doctor may also prescribe hormonal treatment. A test is used to determine whether you have a BRCA-mutated breast cancer.
• A type of breast cancer ( BRCA -mutated, HER2-negative) that has spread beyond its original site. You must have received chemotherapy medicines before or after the cancer spread. A test is used to determine whether you have a BRCA-mutated breast cancer.
• A type of pancreatic cancer ( BRCA -mutated) that has responded to first-line platinum-based standard chemotherapy. A test is used to determine whether you have a BRCA-mutated pancreatic cancer.
• A type of prostate cancer ( BRCA -mutated) that has spread beyond the original tumour and no longer responds to medical or surgical treatments aimed at reducing testosterone levels. You must have previously received certain hormonal treatments, such as enzalutamide or abiraterone acetate. A test is used to determine whether you have a BRCA-mutated prostate cancer.
• A type of prostate cancer that has spread to other parts of the body (metastatic), beyond the original tumour, and no longer responds to medical or surgical treatments to reduce testosterone levels. Lynparza is used in combination with another anticancer medicine called abiraterone, together with the steroid medicine prednisone or prednisolone.
• A type of endometrial cancer (MMR- proficient endometrial cancer) that has spread beyond the original tumour or has recurred (relapsed). Lynparza is used together with durvalumab if the cancer has not progressed after initial treatment with chemotherapy (carboplatin and paclitaxel) in combination with durvalumab. A test is used to determine whether you have an MMR-proficient endometrial cancer.

When Lynparza is administered in combination with other anticancer medicines, it is important to also read the package leaflets of these other medicines. If you have any questions, please consult your doctor.

2. What you should know before taking Lynparza

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 breastfeeding (for further information see section 2)

You must not use Lynparza if you fall into any of the conditions described above. If you have any doubts, consult 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 a low number of blood cells in laboratory tests. This may include low red blood cells, white blood cells, or platelets. For further information about these side effects, see section 4, including signs and symptoms you should pay attention to (for example, fever or infection, bruising or bleeding). In a small number of patients, these may be signs of more serious bone marrow-related problems such as 'myelodysplastic syndrome' (MDS) or 'acute myeloid leukaemia' (AML). When Lynparza is used in combination with another anticancer medicine (durvalumab), a low number of blood cells may indicate 'pure red cell aplasia' (PRCA), a condition in which red blood cells are not produced, or 'autoimmune haemolytic anaemia' (AIHA), an excessive breakdown of red blood cells.
• if you develop new symptoms or worsening of symptoms such as shortness of breath, cough, or wheezing. A small number of patients treated with Lynparza have reported inflammation of the lungs (pneumonitis). Pneumonitis is a serious illness that often requires hospital treatment.
• if you develop new symptoms or worsening symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, faster breathing than normal, or faster heartbeat than normal. In a small number of patients treated with Lynparza, blood clots in a deep vein, usually in the leg (venous thrombosis), or blood clots in the lungs (pulmonary embolism) have been reported.
• if you notice yellowing of the skin or whites of the eyes, unusually dark-coloured urine (brown), pain on the right side of the abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting, contact your doctor immediately as these may be signs of liver problems.

If you think you fall into any of the conditions described above, consult your doctor, pharmacist, or nurse before or during treatment with Lynparza.
Tests and examinations
Your doctor will monitor your blood tests before and during treatment with Lynparza.
You will have blood tests

• before starting treatment
• every month during the first year of treatment
• at regular intervals determined by your doctor after the first year of treatment. If your blood cell count drops to a low level, you may need a blood transfusion (blood or blood components 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, including those obtained without a prescription and herbal products, as Lynparza may affect how some medicines work.
In addition, some medicines may affect how Lynparza works.
Tell your doctor, pharmacist, or nurse if you are taking or plan to take any of the following medicines:

• any other anticancer medicine
• a vaccine or a medicine that suppresses the immune system, as careful monitoring may be required
• itraconazole, fluconazole – used to treat fungal infections
• telithromycin, clarithromycin, erythromycin – used to treat bacterial infections
• ritonavir- or cobicistat-boosted protease inhibitors, boceprevir, telaprevir, nevirapine, efavirenz – used to treat viral infections, including HIV infection
• rifampicin, rifapentine, rifabutin – used to treat bacterial infections, including tuberculosis
• phenytoin, carbamazepine, phenobarbital – used as sedatives or to treat seizures and epilepsy
• herbal remedies containing St John's wort (Hypericum perforatum) – mainly used to treat depression
• digoxin, diltiazem, furosemide, verapamil, valsartan – used to treat heart conditions or high blood pressure
• bosentan – used to treat pulmonary arterial hypertension
• statins, for example simvastatin, pravastatin, rosuvastatin – used to lower cholesterol levels in the blood
• dabigatran – used to thin the blood
• glibenclamide, metformin, repaglinide – used to treat diabetes
• ergot alkaloids – used to treat migraine and headache
• fentanyl – used to treat cancer-related pain
• pimozide, quetiapine – used to treat mental health conditions
• cisapride – used to treat stomach problems
• colchicine – used to treat gout
• ciclosporin, sirolimus, tacrolimus – used to suppress the immune system
• methotrexate – used to treat cancer, rheumatoid arthritis, and psoriasis.

Inform your doctor, pharmacist, or nurse if you are taking any of the medicines listed above or any other medicine. The medicines listed in this leaflet are probably not the only ones that may interact with Lynparza.
Lynparza with beverages
Do not drink grapefruit juice during treatment with Lynparza. It may affect how the medicine works.
Contraception, pregnancy, and breastfeeding
Female patients

• You must not take Lynparza if you are pregnant or suspect you may be pregnant. This is because it may harm the unborn baby.
• You must avoid becoming pregnant during treatment with this medicine. If you have sexual intercourse, you must use two effective methods of contraception during treatment with this medicine and for 6 months after taking the last dose of Lynparza. It is not known whether Lynparza affects the effectiveness of some hormonal contraceptives. Inform your doctor if you are using a hormonal contraceptive, as they may recommend adding a non-hormonal contraceptive method.
• You must have a pregnancy test before starting Lynparza, at regular intervals during treatment, and for 6 months after taking the last dose of Lynparza. If you become pregnant during this period, you must consult your doctor immediately.
• It is not known whether Lynparza passes into breast milk. You must not breastfeed during treatment with Lynparza and for 1 month after taking the last dose of Lynparza. Inform your doctor if you intend to breastfeed.

Male patients

• You must use a condom when having sexual intercourse with a female partner, even if she is pregnant, during treatment with Lynparza and for 3 months after the last dose of Lynparza. It is not known whether Lynparza passes into semen.
• Your female partner should also use a reliable method of contraception.
• You must not donate sperm during treatment with Lynparza and for 3 months after the last dose.

Driving and using machines
Lynparza may affect your ability to drive or operate machinery. If you experience dizziness, weakness, or fatigue during treatment with Lynparza, you must not drive or operate tools or machinery.
Information about other ingredients of this medicine
This medicine contains less than 1 mmol of sodium (23 mg) per 100 mg or 150 mg tablet, i.e., it is essentially "sodium-free".

3. How to take Lynparza

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

How to take this medicine

• Lynparza tablets must be swallowed whole, with or without food.
• Lynparza should be taken once in the morning and once in the evening.
• Do not chew, crush, dissolve, or split the tablets, as this may affect the rate at which the medicine is absorbed into the body.

What is the dose to take

• Your doctor will tell you how many Lynparza tablets to take. It is important to take the recommended total daily dose every day. You must continue treatment for the duration indicated by your doctor, pharmacist, or nurse.
• The usual recommended dose is 300 mg (2 tablets of 150 mg) twice daily – for a total of 4 tablets per day.

Your doctor may prescribe a different dose if

• you have kidney problems. You will need to take 200 mg (2 tablets of 100 mg) twice daily – for a total of 4 tablets per day.
• you are taking certain medicines that may interact with Lynparza (see section 2).
• you experience certain side effects during treatment with Lynparza (see section 4). Your doctor may reduce the dose, or temporarily or permanently stop treatment.

If you take more Lynparza than you should
If you take more Lynparza than the prescribed dose, contact your doctor or the nearest hospital immediately.

If you forget to take Lynparza
If you forget to take Lynparza, take your next dose at the usual scheduled time. Do not take a double dose (two doses at once) to make up for the missed dose.

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 everyone experiences them.
Contact your doctor immediately if you notice any of the following side effects.

Side effects reported in clinical studies of patients treated with Lynparza as monotherapy:

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

• shortness of breath, extreme tiredness, pale skin, or rapid heartbeat – these may be symptoms of a reduced 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 may be signs and symptoms of hypersensitivity reactions).
• itchy rash or swollen and red skin (dermatitis).
• serious problems with the bone marrow (myelodysplastic syndrome or acute myeloid leukaemia). See section 2 (may affect more than 1 in 100 people at some point in life).
• inflammation of the lungs, which may cause cough with fever and difficulty breathing (pneumonitis).

Other side effects include
Very common (may affect more than 1 in 10 people)

• nausea
• vomiting
• feeling tired or weak (fatigue)
• indigestion or heartburn (dyspepsia)
• loss of appetite
• headache
• altered taste (dysgeusia)
• dizziness
• cough
• shortness of breath (dyspnoea)
• diarrhoea – if you have severe diarrhoea, contact your doctor immediately.

Very common side effects that may be detected by blood tests

• decrease in the number of white blood cells (leukopenia or neutropenia), which may reduce your ability to fight infections and may be associated with fever.

Common (may affect up to 1 in 10 people)

• skin rash
• mouth ulcers (stomatitis)
• pain in the upper abdomen under the ribs (upper abdominal pain)
• a blood clot in a deep vein, usually in the leg (venous thrombosis), which may cause symptoms such as leg pain or swelling, or a clot in the lungs (pulmonary embolism), which may cause symptoms such as shortness of breath, chest pain, breathing faster than normal, or faster heart rate.

Common side effects that may be detected by blood tests

• decrease in the number of white blood cells (lymphopenia), which may reduce your ability to fight infections and may be associated with fever
• decrease in the number of platelets in the blood (thrombocytopenia) – this may result in symptoms such as bruising or bleeding for a longer time than usual when injured
• increased blood creatinine – this test is used to check kidney function
• abnormal liver function tests

Uncommon side effects that may be detected by blood tests

• increase in the size of red blood cells (not associated with other symptoms)

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

• swelling of the face (angioedema)
• painful inflammation of fatty tissue under the skin (erythema nodosum)

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

• signs of liver problems, such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the abdomen, dark-coloured (brown) urine, loss of appetite, tiredness.

Side effects reported in clinical studies of patients treated with Lynparza in combination with durvalumab following initial chemotherapy treatment (carboplatin and paclitaxel) with durvalumab, which occurred more frequently than in patients receiving Lynparza as monotherapy:

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

• decrease in the number of platelets in the blood (thrombocytopenia) – this may result in symptoms such as bruising or bleeding for a longer time than usual when injured
• skin rash

Common (may affect up to 1 in 10 people) when Lynparza is used in combination with durvalumab

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

In addition, the following side effects have been reported in patients treated with Lynparza in combination with durvalumab:

Common (may affect up to 1 in 10 people)

• failure to produce red blood cells (red cell aplasia), which may be associated with symptoms such as shortness of breath, fatigue, paleness, and/or rapid heartbeat

Your doctor will prescribe monthly blood tests for the first year of treatment and then at regular intervals thereafter. Your doctor will inform you of any abnormalities in blood tests that may require treatment.
If you experience any side effect not listed in this leaflet, contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lynparza

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 after Exp. and on the blister
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
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 Lynparza contains
The active substance is olaparib.

• Each Lynparza 100 mg film-coated tablet contains 100 mg of olaparib.
• Each Lynparza 150 mg film-coated tablet contains 150 mg of olaparib.

The other ingredients (excipients) are

• Tablet core: copovidone, anhydrous colloidal silica, mannitol, sodium stearyl fumarate.
• Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172) (only for 150 mg tablets).

See section 2 “Information on other ingredients of this medicinal product”.
Description of the appearance of Lynparza and package contents
Lynparza 100 mg tablets are film-coated, biconvex, oval tablets, yellow to dark yellow in colour, with “OP100” engraved on one side and smooth on the other side.
Lynparza 150 mg tablets are film-coated, biconvex, oval tablets, green to green/grey in colour, with “OP150” engraved on one side and smooth on the other side.
Lynparza is supplied in packages containing 56 film-coated tablets (7 blisters with 8 tablets each) or in multiple packages containing 112 tablets (2 packages of 56) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZenecaLietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенекаБългарияЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600
Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100
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