100 mg and 150 mg film-coated tablets
olaparib
What Lynparza is and what it is used for
What Lynparza is and how it works
Lynparza contains the active substance olaparib. Olaparib is a type of anticancer medicine called 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-based chemotherapy, or
- search for faulty DNA repair genes, such as BRCA (BRöstCAncer) genes.
What Lynparza is used for
Lynparza is used to treat
- a type of ovarian cancer ( BRCA- mutated) that has responded to standard treatment with platinum- based chemotherapy .
- A test is used to find out if you have BRCA -muted ovarian cancer.
- recurrent ovarian cancer (recurrent). It can be used after the cancer has responded to a previous standard treatment with platinum- based chemotherapy .
- a type of ovarian cancer (HRD ‑ positive defined by a BRCA‑ mutation or genomic instability) that has responded to standard treatment with platinum- based chemotherapy and bevacizumab. Lynparza is used with bevacizumab.
- a special type of breast cancer ( BRCA -mutated, HER2 -negative) that has spread outside the original tumor one. You should have received chemotherapy either before or after your cancer has spread.
- A test is used to find out if you have BRCA -muted breast cancer.
- a type of pancreatic cancer ( BRCA‑ mutated) that has responded to standard treatment with platinum- based chemotherapy .
- A test is used to find out if you have BRCA -muted pancreatic cancer.
- a type of prostate cancer ( BRCA‑ mutated) that has spread beyond the original tumor one and no longer responds to medical or surgical treatment to lower testosterone . You should have received certain hormonal treatments, such as enzalutamide or abiraterone acetate.
- A test is used to find out if you have BRCA ‑muted prostate cancer.
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 further questions on the use of this product, ask your doctor.
What you need to 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 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 cautions
Talk to a doctor, pharmacist, or nurse before or during treatment with Lynparza
- if you have low blood cell counts during blood tests. It can be a low number of red or white blood cells , or a low number of platelets . Read more in section 4 about these side effects . It describes the signs and symptoms you need to be aware of (eg fever or infection , bruising or bleeding). In rare cases, this may be a sign of more serious bone marrow problems , such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- if you experience new or worsening symptoms in the form of shortness of breath, coughing or wheezing. A small number of patients treated with Lynparza have developed inflammation of the lungs ( pneumonitis ). Pneumonitis is a serious condition that often requires hospitalization.
If you think any of these apply to you, talk to your doctor, pharmacist, or nurse before or during treatment with Lynparza.
Sampling and inspections
Before and during treatment with Lynparza, your doctor will check your blood.
Blood samples are taken
- before treatment
- every month during the first year of treatment
- at regular intervals, as determined by the doctor, after the first year of treatment.
If your blood levels get low, you may need a blood transfusion (then you will receive new blood or a blood-based product from a blood 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 also applies to over-the-counter medicines and herbal medicines. Lynparza can affect the way some other medicines work. 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 medicine
- a vaccine or drug that inhibits the immune system, as you may need close monitoring
- itraconazole, fluconazole – used against fungal infections
- telithromycin, clarithromycin, erythromycin – used against bacterial infections
- protease inhibitors fortified with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine, efavirenz – used against viral infections including HIV
- rifampicin, rifapentin, rifabutin – used against bacterial infections including tuberculosis
- phenytoin , carbamazepine, phenobarbital – used as sedatives or to treat seizures and epilepsy
- herbal medicine 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
- dabigatran – a blood thinner
- glibenclamide, metformin , repaglinide – used to treat diabetes
- ergot alkaloids – used to treat migraines and headaches
- fentanyl – used to treat pain caused by cancer
- pimozide, quetiapine – used to treat mental illness
- cisapride – used to treat stomach problems
- colchicine – used to treat gout
- ciclosporin, sirolimus, tacrolimus – used to suppress the body’s immune system
- methotrexate – used to treat cancer, rheumatism 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 may affect Lynparza.
Lynparza with drink
Do not drink grapefruit juice while you are being treated with Lynparza. It may affect the effectiveness of the medicine.
Contraceptives, pregnancy and lactation
Female patients
- You must not take Lynparza if you are pregnant or could become pregnant. This is because the medicine can harm the unborn baby.
- You must not become pregnant while taking this medicine. If you have sex, use two effective contraceptives during treatment and for 1 month after taking the last dose of Lynparza. It is not known if Lynparza can affect the effects of certain hormonal pills . Tell your doctor if you are taking hormonal pills , as your doctor may recommend the addition of a non-hormonal method of contraception.
- Before starting Lynparza, a pregnancy test should be performed. It is also done at regular intervals during treatment and 1 month after you have taken the last dose of Lynparza. If you become pregnant during this time, talk to your doctor immediately.
- It is not known if Lynparza passes into breast milk. You should not breast-feed while taking Lynparza and for 1 month after taking the last dose of Lynparza. If you are planning to breast-feed, talk to your doctor.
Male patients
- You must use a condom when you have sex with a female partner, even if she is pregnant, during treatment and for three months after the last dose of one of Lynparza. It is not known if Lynparza is transferred to semen.
- Your female partner must also use reliable contraception.
- You must not donate semen during treatment and for three months after the last dose of one of Lynparza.
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 any tools or machines.
Information on other ingredients of this medicine
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg or 150 mg tablet, ie essentially ‘sodium-free’.
How to take Lynparza
Your doctor has prescribed Lynparza film-coated tablets for you. Note that Lynparza is also available as a 50 mg capsule.
- The doses of Lynparza tablets and capsules are not the same.
- If you take the wrong dose or a capsule instead of a tablet, it may 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. If you are not sure, talk to your doctor, pharmacist, or nurse.
How to take the medicine
- 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 split the tablets as this may affect how quickly the medicine is released into the body.
How much to take
- Your doctor will tell you how many tablets of Lynparza to take. It is important that you take the full recommended dose each day. Continue to do this according to the instructions of a doctor, pharmacist or nurse.
- The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day – a total of 4 tablets each day.
The doctor may prescribe a different dose of
- you have kidney problems. You will be asked to take 200 mg (2 x 100 mg tablets) twice daily – a total of 4 tablets each day.
- you are taking certain medicines that may affect Lynparza (see section 2).
- you get some side effects while taking Lynparza (see section 4). The doctor may reduce the dose one or stop the treatment, either for a short time or permanently.
If you take more Lynparza than you should
If you have taken more Lynparza than your usual dose, contact your doctor or nearest hospital immediately.
If you forget to take Lynparza
If you forget to take Lynparza, take the next dose as usual at the scheduled time. Do not take a double dose (two doses at the same time) to compensate for a missed dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of these side effects are
Very common (may affect more than 1 in 10 people)
- shortness of breath, feeling of extreme fatigue, paleness or rapid pulse – these may be symptoms of decreased red blood cell count ( anemia ).
Uncommon (may affect up to 1 in 100 people)
- allergic reaction (eg swelling of the face, lips, tongue or throat, hives, difficulty breathing or swallowing, dizziness – these are signs and symptoms of hypersensitivity reactions ).
- severe bone marrow problems ( myelodysplastic syndrome or acute myeloid leukemia ). See section 2.
Other side effects include
Very common (may affect more than 1 in 10 people)
- nausea
- vomiting
- fatigue or weakness
- stomach problems or heartburn ( dyspepsia )
- reduced appetite
- headache
- altered taste experience ( dysgeusia )
- dizziness
- cough
- respiratory distress
- diarrhea – if the diarrhea becomes severe, tell your doctor immediately.
Very common side effects are those that can show up in blood tests
- decreased number of platelets in the blood ( thrombocytopenia ) – you may notice the following symptoms
- bruising or bleeding that lasts longer than usual if you injure yourself
- low white blood cell count ( leukopenia and neutropenia ) which may reduce your ability to fight infection and may be associated with fever.
Common (may affect up to 1 in 10 people)
- rash or itchy rash on swollen, red skin ( dermatitis )
- soreness in the mouth ( stomatitis )
- pain in the abdomen below the ribs (pain in the upper abdomen).
Common side effects are those that can show up in blood tests
- low white blood cell count (lymphopenia) which may reduce your ability to fight infection and may be associated with fever
- increase in blood creatinine – this test is used to check how the kidneys are working.
Uncommon side effects can be seen in blood tests
- increased size of the red blood cells (gives no symptoms).
Rare (may affect up to 1 in 1,000 people)
- painful inflammation of the adipose tissue under the skin (erythema nodosum).
Your doctor will test your blood every month during the first year of treatment and thereafter regularly. Your doctor will tell you if there are any changes in your blood tests that may need to be treated.
If you notice any side effects not listed in this leaflet, you should contact your doctor immediately.
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 and blister after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage temperature.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is olaparib.
- Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
- Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
Other ingredients (excipients) are
- Tablet core: copovidone, colloidal anhydrous silica, mannitol, sodium stearyl fumarate .
- Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172) (150 mg tablets only).
See section 2 “Information on other ingredients of this medicine”.
What the medicine looks like and contents of the pack
Lynparza 100 mg tablets are yellow to dark yellow, oval, biconvex, film-coated tablets, marked with “OP100” on one side and nothing on the other.
Lynparza 150 mg tablets are green to gray-green, oval, biconvex, film-coated tablets, marked with “OP150” on one side and nothing on the other.
Lynparza is supplied in packs of 56 film-coated tablets (7 blisters of 8 tablets each) or multipacks of 112 (2 packs of 56) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
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