LYNPARZA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lynparza 100 mg film-coated tablets

Lynparza 150 mg film-coated tablets

olaparib

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lynparza and what is it used for
2. What you need to know before you take Lynparza
3. How to take Lynparza
4. Possible side effects
5. Storage of 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 a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).

PARP inhibitors can destroy cancer cells that are unable to repair DNA damage. These specific cancer cells can be identified:

• by their response to platinum-based chemotherapy, or
• by looking for defective DNA repair genes, such as the BRCA(BReast CAncer) genes.

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

What is Lynparza used for

Lynparza is used to treat

• a type of ovarian cancer (with BRCAmutation) that has responded to first-line treatment with standard platinum-based chemotherapy.

• A test is used to determine if you have ovarian cancer with a BRCAmutation.

• ovarian cancer that has come back (recurrent).It can be used after the tumor has responded to previous treatment with standard platinum-based chemotherapy.
• a type of ovarian cancer (HRD positive defined by a BRCAmutation or genomic instability) that has responded to first-line 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 (the treatment given after surgery is called adjuvant therapy). You should have received chemotherapy before or after surgery. If your cancer is hormone receptor-positive, your doctor may also prescribe hormonal treatment for you.

• A test is used to determine if you have BRCA-mutated breast cancer.

• a type of breast cancer (BRCA-mutated, HER2-negative) that has spread beyond the original tumor.You should have received chemotherapy, either before or after the cancer has spread.

• A test is used to determine if you have BRCA-mutated cancer.

• a type of pancreatic cancer (BRCA-mutated) that has responded to first-line treatment with standard platinum-based chemotherapy.

• A test is used to determine if you have pancreatic cancer with a BRCAmutation.

• a type of prostate cancer (with BRCAmutations) that has spread beyond the original tumor and is no longer responding to medical or surgical treatment to lower testosterone levels.You should have received certain hormonal treatments, such as enzalutamide or abiraterone acetate.

• A test is used to determine if you have prostate cancer with a BRCAmutation.

• a type of prostate cancer that has spread to other parts of the body (metastatic) beyond the original tumor and is no longer responding to medical or surgical treatment that lowers testosterone.Lynparza is used in combination with another cancer medicine called abiraterone, along with the steroid medicine prednisone or prednisolone.

• a type of uterine cancer (endometrial cancer with MMR competence) that has spread beyond the original tumor or has come back (recurrent).Lynparza is used in combination 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 if you have endometrial cancer with MMR competence.

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

2. What you need to know before you take 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 breast-feeding (see section 2 of this leaflet for more information)

Do not take Lynparza if any of the above applies 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 starting or during treatment with Lynparza

• if you have a low blood count in your blood tests. These can be low counts of red or white blood cells, or a low platelet count. See section 4 for more information on these side effects, including signs and symptoms you need to pay attention to (e.g., fever or infection, bruising or bleeding). In a small number of patients, these can be a sign of a more serious bone marrow problem, such as “Myelodysplastic Syndrome” (MDS) or “Acute Myeloid Leukemia” (AML). When Lynparza is used in combination with another cancer medicine (durvalumab), a low blood count may be a sign of “pure red cell aplasia” (PRCA), a condition in which red blood cells are not produced, or “autoimmune hemolytic anemia” (AIHA), excessive destruction of red blood cells.

• if you notice any new symptoms or worsening of difficulty breathing, coughing, or wheezing (a whistling sound when breathing). A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis). Pneumonitis is a serious disease that often requires hospital treatment.

• if you experience any new symptoms or worsening of pain or swelling in a limb, difficulty breathing, chest pain, faster than normal breathing, or faster than normal heartbeat. A small number of patients treated with Lynparza developed a blood clot in a deep vein, usually in the leg (deep vein thrombosis), or a clot in the lungs (pulmonary embolism).

• if you notice yellowing of the skin or the whites of the eyes, unusually dark urine (brown color), pain in the right side of the stomach (abdomen), tiredness, decreased appetite, or unexplained nausea and vomiting, contact your doctor immediately, as this may indicate liver problems.

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

Tests and checks

Your doctor will do blood tests before and during treatment with Lynparza.

You will have a blood test

• before starting treatment
• every month, during the first year of treatment
• at regular intervals, decided by your doctor, after the first year of treatment.

If your blood count drops to a low level, you may need a blood transfusion (where you are given new blood or blood 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, including those obtained without a prescription and herbal medicines. This is because Lynparza may affect the way some medicines work and some medicines may have an effect on Lynparza.

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

• any other cancer medicine
• 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 sedatives or to treat seizures (convulsions) and epilepsy
• herbal remedies containing St. John's Wort (Hypericum perforatum) - used mainly for depression

• digoxin, diltiazem, furosemide, verapamil, valsartan - used to treat heart disease or high blood pressure
• bosentan - used to treat pulmonary arterial hypertension
• statins, e.g., 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
• cyclosporin, 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 medicines or any other medicine. The medicines listed above may not be the only ones that could affect Lynparza.

Taking Lynparza with drinks

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

Contraception, pregnancy, and breastfeeding

Female patients

• Do not take Lynparza if you are pregnant or think you may be pregnant, as it may harm the unborn baby.
• Do not become pregnant while taking this medicine. If you have sex, you must 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 if Lynparza can affect the effectiveness of some hormonal contraceptives. Tell your doctor if you are taking a hormonal contraceptive, as your doctor may recommend that you also use a non-hormonal contraceptive method.
• A pregnancy test must be done before you start taking Lynparza and at regular intervals during treatment and 6 months after taking the last dose of Lynparza. If you become pregnant during this period, you must tell your doctor immediately.
• It is not known if Lynparza passes into breast milk. Do not breast-feed if you are taking Lynparza, and do not breast-feed for 1 month after taking the last dose of this medicine. If you plan to breast-feed, tell your doctor.

Male patients

• You must use a condom when you have sex with a female partner, even if she is pregnant, while you are taking Lynparza and for 3 months after taking the last dose. It is not known if Lynparza passes into semen.
• Your female partner must also use an effective method of contraception.
• Do not donate sperm while you are taking Lynparza and for 3 months after taking the last dose.

Driving and using machines

Lynparza may affect 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 about other ingredients in this medicine

This medicine contains less than 1 mmol of sodium (23 mg) per 100 mg or 150 mg tablet; this is essentially “sodium-free”.

3. How to take Lynparza

Follow the instructions for taking this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse again.

How to take

• Swallow the 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 can affect how quickly the medicine gets into your body.

How much to take

• Your doctor will tell you how many Lynparza tablets to take. It is important that you take the total recommended dose each day. Keep doing this 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 kidney problems. You will be told to take 200 mg (2 x 100 mg tablets) twice a day - a total of 4 tablets a day.
• you are taking certain medicines that may affect Lynparza (see section 2).
• you have certain side effects while taking Lynparza (see section 4). Your doctor may reduce 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 usual dose, talk to a doctor or go to a hospital immediately.

If you forget to take Lynparza

If you forget to take Lynparza, you should take the next dose at the usual time. Do not take a double dose (two doses at the same time) to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you notice any of the following

Adverse effects reported in clinical trials with patients who received Lynparza alone:

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

• feeling of shortness of breath, feeling very tired, pale skin or rapid heartbeat - these may be symptoms of a decrease in the number of red blood cells (anemia).

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).
• rash with itching over swollen and reddened skin (dermatitis).

• serious bone marrow problems (myelodysplastic syndrome or acute myeloid leukemia). See section 2 (may affect more than 1 in 100 people throughout their lives).

• inflammation of the lungs, which can cause cough with fever and difficulty breathing (pneumonitis).

Other adverse effects include

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

• nausea
• vomiting
• feeling tired or weak (fatigue)
• indigestion or stomach burning (dyspepsia)
• loss of appetite
• headache
• changes in the taste of food (dysgeusia)
• feeling dizzy
• cough
• difficulty breathing (dyspnea)
• diarrhea - if it becomes severe, report to your doctor immediately.

Adverse effects very commonthat may be found in blood test results

• low white blood cell count (leukopenia or neutropenia) that may decrease your ability to fight infections and may be accompanied by fever.

Common(may affect up to 1 in 10 people)

• rash
• mouth pain (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 can cause symptoms such as pain or swelling of the legs, or a blood clot in the lungs (pulmonary embolism) that can cause symptoms such as difficulty breathing, chest pain, faster breathing than normal, or faster heartbeats than normal.

Adverse effects commonthat may be found in blood test results

• low white blood cell count (lymphopenia) that may decrease your ability to fight infections and may be accompanied by fever
• decrease in the number of platelets in the blood (thrombocytopenia) - you may notice the following symptoms

• bruises or bleeding for longer than normal if injured

• increase in blood creatinine - this test is used to check kidney function.
• abnormal liver function tests

Adverse effects uncommonthat may be found in blood test results

• increase in red blood cell size (not associated with any symptoms).

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

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

Frequency Not Known(cannot be estimated from the available data)

• signs of liver problems, such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach area (abdomen), dark urine (brown color), decreased appetite, fatigue

Adverse effects reported in a clinical trial with patients who received Lynparza and durvalumab after initial treatment with chemotherapy (carboplatin and paclitaxel) with durvalumab, which occurred more frequently than in patients who received Lynparza alone:

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

• decrease in the number of platelets in the blood (thrombocytopenia) - you may notice the following symptoms
• • bruises or bleeding for longer than normal if injured
• rash

Adverse effects common(may affect up to 1 in 10 people) when using Lynparza with durvalumab

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

In addition, the following adverse effects were reported in patients who received Lynparza with durvalumab:

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

• lack of production of red blood cells (pure red cell aplasia), which may be associated with symptoms of difficulty breathing, fatigue, pale skin, or rapid heartbeats.

Your doctor will perform a blood test every month during the first year of treatment and at regular intervals after this. Your doctor will indicate if there is any change in your blood test that may require treatment.

If you observe any adverse effect not mentioned in this prospectus, contact your doctor immediately.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lynparza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lynparza

The active ingredient is olaparib.

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

The other ingredients (excipients) are

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

See Section 2 "Information on other ingredients present in this medicine"

Appearance of the Product and Package Contents

The 100 mg Lynparza tablets are film-coated, yellow to dark yellow, oval, biconvex, marked with "OP100" on one side and smooth on the other.

The 150 mg Lynparza tablets are film-coated, green to greenish-gray, oval, biconvex, marked with "OP150" on one side and smooth on the other.

Lynparza is presented in packages containing 56 film-coated tablets (7 blisters of 8 tablets each) or multiple packages containing 112 (2 packages of 56) film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.