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READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE
PATIENT MEDICATION INFORMATION
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in
Canada.
LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response
or partial response) to platinum-based chemotherapy.
It has been approved with conditions. This means it has passed Health Canada’s review and
can be bought and sold in Canada, but the manufacturer has agreed to complete more studies
to make sure the drug works the way it should. For more information talk to your healthcare
professional.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious
or life-threatening illness. The drug must show promising proof that it works well, is of high
quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in
Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an
NOC/c, to complete more testing to make sure the drug works the way it should, to actively
monitor the drug’s performance after it has been sold, and to report their findings to Health
Canada.
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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LYNPARZA
olaparib capsules
Read this carefully before you start taking LYNPARZA and each time you get a refill. This
leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare
professional about your medical condition and treatment and ask if there is any new
information about LYNPARZA.
Serious Warnings and Precautions
LYNPARZA should only be prescribed by a doctor experienced in the treatment of cancer.
Serious side effects with LYNPARZA include:
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Problems with the bone marrow such as ‘myelodysplastic syndrome’ (MDS) or ‘acute
myeloid leukaemia’ (AML).
New or worsening symptoms of shortness of breath, coughing, or fever, which could
be inflammation of the lungs.
LYNPARZA can harm your unborn baby if taken during pregnancy.
What is LYNPARZA used for?
LYNPARZA is used for the treatment of ovarian cancer. It is used after the cancer has
responded to previous treatment with standard platinum-based chemotherapy.
LYNPARZA should be used in a specific group of ovarian cancer patients. These people
have mutations (changes) in certain genes called BRCA (known as the breast cancer gene). A
test is used to determine whether you have a mutation of your BRCA genes.
How does LYNPARZA work?
In patients who have mutations (changes) in certain genes called BRCA (known as the breast
cancer gene), LYNPARZA stops cancer cells from repairing damage to their DNA, which
helps to kill the cancer cells.
What are the ingredients in LYNPARZA?
Medicinal ingredients: olaparib
Non-medicinal ingredients: gellan gum, hypromellose, iron oxide black, lauroyl macrogol
glycerides, potassium acetate, shellac, titanium dioxide.
LYNPARZA comes in the following dosage forms:
Capsule: 50 mg
Do not use LYNPARZA if:
 You are allergic to olaparib or any of the other ingredients of this medicine.
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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To help avoid side effects and ensure proper use, talk to your healthcare professional
before you take LYNPARZA. Talk about any health conditions or problems you may
have, including:
 If you have low blood-cell counts on testing. These may be low red blood-cell count
(anemia), low white blood-cell count (neutropenia), or low blood-platelet count
(thrombopenia).
 If you have signs and symptoms linked to low blood cell counts. This includes
shortness of breath, fever, infection, bruising or bleeding. These may be a sign of a
more serious problem 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.
 If you have any new or worsening symptoms of shortness of breath, coughing, or
fever. These may be a sign of a more serious condition. A small number of patients
treated with LYNPARZA reported inflammation of the lungs (pneumonitis).
Pneumonitis is a serious condition that often requires hospital treatment.
 If you have liver or kidney problems.
Other warnings you should know about:
 Do not take LYNPARZA if you are taking any other anticancer medicines.
 If you are still able to get pregnant and/or breast feed, there are specific warnings you
must discuss with your healthcare professional.
- You should avoid becoming pregnant while taking LYNPARZA. You should
use effective methods of contraception while taking this medicine and for
1 month after receiving the last dose of LYNPARZA. It is not known whether
LYNPARZA may cause your birth control pill to not work as well as it should.
Please tell your doctor if you are taking the birth control pill, as your doctor
may recommend you use a back-up contraceptive method.
- It is not known whether LYNPARZA passes into breast milk. Do not breastfeed if you are taking LYNPARZA and for one month after receiving the last
dose of LYNPARZA. If you are planning to breast-feed, tell your doctor.
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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.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Some medicines can affect the levels of LYNPARZA in your body. Also, LYNPARZA can
affect the way some other medicines work. You should inform your healthcare professional if
you are taking any of the following medicines:
 ketoconazole, itraconazole, fluconazole - used to treat fungal infections.
 telithromycin, clarithromycin, erythromycin, ciprofloxacin - used to treat bacterial
infections.
 boosted protease inhibitors, ritonavir, nelfinavir, indinavir, saquinavir, cobicistat,
boceprevir, telaprevir, nevirapine, efavirenz, etravirine, amantadine - used to treat viral
infections, including HIV.
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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rifampicin, rifapentine, rifabutin - used to treat bacterial infections, including
tuberculosis (TB).
phenytoin, carbamazepine, phenobarbital - used to treat fits (seizures) and epilepsy.
St John’s Wort (Hypericum perforatum) - a herbal medicine used mainly for
depression.
modafinil - used to treat a sleep disorder called narcolepsy.
digoxin, diltiazem, furosemide, valsartan, verapamil – used to treat heart conditions or
high blood pressure.
bosentan - used to treat pulmonary artery hypertension.
statins e.g. simvastatin, pravastatin - 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 schizophrenia or bipolar disorder.
cisapride, cimetidine - used to treat stomach problems.
colchicine - used to treat gout.
cyclosporine, sirolimus, tacrolimus - used to suppress the immune system.
cisplatin - used to treat cancer.
methotrexate - used to treat cancer, rheumatoid arthritis and psoriasis.
midazolam - used to produce sleepiness and drowsiness.
loperamide - used to treat diarrhea.
How to take LYNPARZA:
 Always take LYNPARZA exactly as your doctor, pharmacist, or nurse has told you.
Check with your doctor, pharmacist, or nurse if you are not sure.
 Take LYNPARZA at least one hour after eating food. Do not eat for up to 2 hours
after taking LYNPARZA.
 Take LYNPARZA at about the same time each morning and evening.
 LYNPARZA capsules should be swallowed whole and not chewed, crushed, dissolved
or divided.
 Do not drink grapefruit juice while you are taking LYNPARZA. It can affect the way
LYNPARZA works.
Usual adult dose: The usual dose is eight 50 mg capsules (for a dose of 400 mg) taken by
mouth twice a day. This is a total of 16 capsules each day, 8 in the morning and 8 in the
evening.
Overdose:
If you think you have taken too much LYNPARZA, contact your healthcare professional,
hospital emergency department or regional Poison Control Centre immediately, even if there
are no symptoms.
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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Missed Dose:
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.
What are possible side effects from using LYNPARZA?
These are not all the possible side effects you may feel when taking LYNPARZA. If you
experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
 headache
 feeling dizzy
 loss of appetite
 feeling tired or weak
 feeling sick (nausea)
 being sick (vomiting)
 changes in the way food tastes
 indigestion or heartburn
 diarrhea - if it gets severe, tell your doctor immediately
 sore mouth
 pain in the stomach area under the ribs
LYNPARZA can cause abnormal blood test results. Your doctor will test your blood every
month for the first year of treatment and periodically thereafter. Your doctor will interpret the
results.
Serious side effects and what to do about them
Talk to your healthcare professional
Symptom / effect
Only if severe
VERY COMMON
Fever or infection - which can be
signs of low white blood cells
Being short of breath, feeling very
tired, having pale skin, or fast heart
beat - which can be signs of low
red blood cells (anaemia)
COMMON
Bruising or bleeding for longer
than usual if you hurt yourself which can be signs of low blood
platelets
Product Monograph NOC/c
In all cases
Stop taking drug and
get immediate
medical help
x
x
x
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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Serious side effects and what to do about them
Talk to your healthcare professional
Symptom / effect
Only if severe
UNCOMMON
Severe diarrhea
In all cases
Stop taking drug and
get immediate
medical help
x
RARE
New or worsening symptoms of
shortness of breath, coughing, or
fever - which may be signs of lung
inflammation
x
If you have a troublesome symptom or side effect that is not listed here or becomes bad
enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
 Online at MedEffect (www.healthcanada.gc.ca/medeffect);
 By calling 1-866-234-2345 (toll-free);
 By completing a Consumer Side Effect Reporting Form and sending it by:
Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available
at MedEffect.
NOTE: Contact your healthcare professional if you need information about how to manage
your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
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Store LYNPARZA between 2 - 25°C.
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Do not use LYNPARZA after the expiry date which is stated on the bottle after EXP.
The expiry date refers to the last day of that month.
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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.
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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Keep out of reach and sight of children.
If you want more information about LYNPARZA:
 Talk to your healthcare professional
 This Patient Medication Information leaflet provides you with the most current
information at the time of printing. Find the full product monograph that is prepared
for healthcare professionals and includes this Patient Medication Information by
visiting the Health Canada website (www.healthcanada.gc.ca); the manufacturer’s
website www.astrazeneca.ca, or by calling 1-800-668-6000.
This leaflet was prepared by AstraZeneca Canada Inc.
LYNPARZA™ and the AstraZeneca logo are trademarks of AstraZeneca AB, used under
license by AstraZeneca Canada Inc.
Last Revised: April 27, 2016
Product Monograph NOC/c
COPYRIGHT 2016 ASTRAZENECA CANADA INC.
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