olaparib

Trade Name:

Lynparza®

Other Names:

Lynparza®

Appearance:

tablet

Monograph Name:

olaparib

Monograph Body:

Drug Monograph

A - Drug Name

olaparib

COMMON TRADE NAME(S): Lynparza®

B - Mechanism of Action and Pharmacokinetics

Olaparib is a selective inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2 and PARP-3) involved in DNA repair. Olaparib has been shown to inhibit the growth of solid tumours, especially those deficient in BRCA function (e.g., BRCA mutation-positive ovarian tumours).

Absorption

Olaparib is absorbed rapidly with peak concentration achieved 1.5 hours after a single dose.

Effects with food

Co-administration with food slowed the rate of absorption but did not significantly affect the extent of absorption

Distribution

PPB

82%

Metabolism

Olaparib is extensively metabolized in the liver by CYP3A isoenzymes. It is currently unknown whether metabolites are active.

Elimination

Half-life

terminal elimination: approx. 15 hours

Feces

42% in 7 days

Urine

44% in 7 days

C - Indications and Status

Health Canada Approvals:

Ovarian cancer
Breast cancer
Prostate cancer
Pancreatic cancer

Refer to the product monograph for a full list of approved indications and details.

D - Adverse Effects

Emetogenic Potential:

Low – No routine prophylaxis; PRN recommended

Extravasation Potential: Not applicable

The following adverse effects were reported in patients in the phase III trial comparing olaparib monotherapy to placebo in patients with ovarian, fallopian tube or primary peritoneal cancer who responded to first-line platinum-based chemotherapy. Severe adverse effects from other studies or post-marketing are also included.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Venous thromboembolism (2%) (8% in mCRPC)	E
Dermatological	Rash (10%)	E
Gastrointestinal	Abdominal pain (18%)	E
	Anorexia (20%)	E
	Constipation (28%)	E
	Diarrhea (34%) (3% severe)	E
	Dyspepsia (17%)	E
	Mucositis (11%)	E
	Nausea, vomiting (77%) (1% severe)	I E
General	Fatigue (64%) (4% severe)	E
Hematological	Myelosuppression ± infection, bleeding (39%) (22% severe; including anemia)	E
Hepatobiliary	Hepatotoxicity (rare)	E
Hypersensitivity	Hypersensitivity (2%)	I
Neoplastic	Secondary malignancy (1%) (MDS, AML)	D L
Nervous System	Dizziness (20%)	E
	Dysgeusia (26%)	E
	Headache (23%)	E
Renal	Creatinine increased (8%)	E
Respiratory	Cough, dyspnea (18%)	E
	Pneumonitis (rare)	E D

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for olaparib include nausea, vomiting, fatigue, myelosuppression ± infection, bleeding, diarrhea, constipation, dysgeusia, headache, anorexia, dizziness and abdominal pain.

Nausea and vomiting were generally reported with early onsets, but most of these events improved over time without intervention.

Myelodysplastic syndrome (MDS) and/or Acute myeloid leukemia (AML) have been reported rarely and were fatal in most cases. Affected patients received olaparib for less than 6 months to over 4 years and had other contributing factors, including previous treatment with DNA damaging agents (radiation, platins, etc.). Most were in germline BRCA mutation carriers and some had a history of previous cancer or bone marrow dysplasia. In the SOLO2 study, patients with BRCAm platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum chemotherapy had a higher incidence (8%) of MDS/AML.

Severe myelosuppression has been reported, including hemorrhagic stroke associated with thrombocytopenia. Anemia is the most common severe adverse effect reported in clinical trials. Levels appeared to return to normal after treatment discontinuation and did not appear to have any clinical consequences.

Pneumonitis, including fatal cases, have been reported rarely.

Cases of drug-induced liver injury (DILI) have been observed during post-marketing.

Venous thromboembolic events, including pulmonary embolism have been observed and had no consistent clinical pattern. A higher incidence was reported in patients with metastatic castration resistant prostate cancer who received olaparib with androgen deprivation therapy (ADT), compared with other indications. Monitoring is recommended and treatment may be necessary.

E - Dosing

Refer to protocol by which the patient is being treated.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Various treatment indications require a validated test to determine BRCA or ATM mutation status. Refer to the product monograph for details.

In ovarian cancer, treatment should start no later than 8 weeks after completion of platinum-containing chemotherapy. (Refer to EAP for detailed funding criteria).

In metastatic castration-resistant prostate cancer (mCRPC), patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have had bilateral orchiectomy.

For adjuvant treatment of HER2-negative high risk early breast cancer, continue concurrent endocrine therapy in patients with hormone receptor positive breast cancer as per clinical guidelines. Start olaparib at least 2 weeks (no more than 12 weeks) after completion of the last treatment, including surgery, chemotherapy, or radiation therapy (Refer to CADTH recommendations).

Patients should have recovered from prior hematologic toxicities before starting olaparib (Hgb, ANC and platelets ≤ grade 1).

Adults:

Oral: 300 mg BID

Dosage with Toxicity:

Dose Level	Olaparib Dose
0	300 mg BID
-1	250 mg BID
-2	200 mg BID
-3	Discontinue

Toxicity	Severity	Action
Platelets or ANC	≥ Grade 3 or blood transfusion dependence	Hold up to 4 weeks* and monitor CBC. Then, may consider dose reduction.
Hemoglobin	≥ Grade 3 or blood transfusion dependence	Hold up to 4 weeks* and monitor CBC. Then, consider a dose reduction after severe anemia, to avoid multiple transfusions.
Signs and symptoms of pneumonitis	Any	Hold and investigate. If confirmed, discontinue and treat appropriately.
Hepatotoxicity	Any	Hold and investigate. Consider discontinuing if severe drug-induced liver injury and manage appropriately.
MDS, AML or other clonal disorders		Hold and investigate. If confirmed, discontinue and treat appropriately.
Other non-hematologic	Grade 3 or 4	Hold up to 4 weeks** Upon recovery, consider dose reduction.

*Hold until ≤ grade 1. If blood parameters remain abnormal after 4 weeks, bone marrow analysis and/or blood cytogenetic analysis are recommended.

**Hold until ≤ grade 1. If toxicity recurs, reduce an additional dose level. Discontinue if more than 2 dose reductions are required.

Dosage with Hepatic Impairment:

Hepatic Impairment	Olaparib Dose
Child-Pugh A or B	No dose adjustment required
Child-Pugh C	Not recommended (not studied)

Dosage with Renal Impairment:

Creatinine Clearance (mL/min)	Olaparib Dose
> 50	No dose adjustment required
31-50	200 mg BID
≤ 30 or end stage renal disease	Not recommended (limited data)

Dosage in the elderly:

Dose adjustment is not required. There is limited data in patients aged 75 and older.

Children:

Safety and efficacy have not been established in pediatric patients.

F - Administration Guidelines

Olaparib can be taken with or without food.
Tablets should be swallowed whole and not chewed, crushed, dissolved or divided.
Avoid grapefruit, starfruit, pomegranate, Seville oranges, their juices or products during treatment.
If a dose is missed, the next dose should be taken at the regular scheduled time. A double dose should not be taken to make up for forgotten tablets.
Store between 2 to 30^oC in original packaging to protect from moisture.

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to this drug or any of its components

Other Warnings/Precautions:

Do not co-administer with other myelosuppressive agents.
Use with caution in patients who have received prior DNA damaging agents. MDS and AML have been reported.
Use with caution in patients with lung cancer or metastases to the lungs, underlying pulmonary disease, smoking history and/or previous chemotherapy and radiotherapy as these patients are at increased risk of pneumonitis
Patients experiencing fatigue and dizziness should use caution when driving or operating machines.

Other Drug Properties:

Carcinogenicity: Probable

Carcinogenicity studies have not been performed; however, secondary hematologic malignancies have been reported.

Pregnancy and Lactation:

Clastogenicity: Yes
Fetotoxicity: Documented in animals
Teratogenicity: Documented in animals
Embryotoxicity: Documented in animals
Pregnancy:
- Olaparib is not recommended for use in pregnancy.
- Adequate contraception should be used by patients who can become pregnant and their partners during treatment, and for 6 months after the last dose. Consider an additional non-hormonal (e.g., barrier) method of contraception as it is uncertain whether olaparib reduces the effectiveness of hormonal contraceptives. For patients with hormone dependent cancer, consider two non-hormonal contraceptive methods.
- Adequate contraception should be used by patients who produce sperm and their partners during treatment, and for 3 months after the last dose.
- Patients should not donate sperm during therapy and for 3 months after the last dose; it is unknown whether olaparib is found in seminal fluid.
Breastfeeding:
Breastfeeding is not recommended during treatment and for 1 month after the last dose.
Fertility effects: Probable

Documented in animal studies with female animals

H - Interactions

Olaparib is primarily metabolized by CYP3A and is susceptible to inhibitors and inducers of this isoenzyme. Olaparib is a substrate and inhibitor of MDR1 and a weak inhibitor of BCRP.

The possibility of CYP2C9 induction by olaparib and reduced substrate exposure (including hormonal contraceptives) cannot be excluded. Consider an additional non-hormonal (e.g., barrier) method of contraception. For women with hormone dependent cancer, consider two non-hormonal contraceptive methods.

AGENT	EFFECT	MECHANISM	MANAGEMENT
CYP3A inducers (i.e. phenytoin, rifampin, dexamethasone, carbamazepine, phenobarbital, St. John’s Wort, etc)	↓ olaparib concentration and/or efficacy	↑ metabolism of olaparib	Co-administration with strong and moderate CYP3A inducers is not recommended. There is potential for substantially decreased olaparib efficacy with strong inducers.
CYP3A inhibitors (i.e. ketoconazole, clarithromycin, ritonavir, fruit or juice from grapefruit, Seville oranges, pomegranate or starfruit)	↑ olaparib concentration and/or toxicity	↓ metabolism of olaparib	Co-administration with strong and moderate CYP3A inhibitors is not recommended. If the combination cannot be avoided, the dose of olaparib should be reduced to 100 mg bid (strong) or 150 mg bid (moderate).
CYP3A4 substrates (e.g. cyclosporine, pimozide, tacrolimus, triazolo-benzodiazepines, dihydropyridine calcium-channel blockers, certain HMG-CoA reductase inhibitors)	↑ substrate exposure	Olaparib is predicted to be a weak inhibitor of CYP3A4 in vitro	Caution and monitor closely, especially with narrow therapeutic window substrates.
CYP 2B6 substrates (i.e. bupropion, cyclophosphamide, selegiline)	↓ substrate exposure	Olaparib induces CYP2B6 in vitro	Caution and monitor closely
Substrates of hepatic uptake transporters OATP1B1, OCT1 (e.g. bosentan, repaglinide, statins, metformin)	↑ substrate exposure	Olaparib inhibits OATP1B1, OCT1 in vitro	Caution and monitor closely, especially in combination with statins.
Substrates of renal uptake transporters OCT2, OAT3, MATE1, MATE2K (e.g. furosemide, methotrexate, metformin, cisplatin)	↑ substrate exposure	Olaparib inhibits renal uptake transporters in vitro	Caution and monitor closely
Myelosuppressive anticancer agents	potentiation and prolongation of myelosuppression	Additive	Avoid combining with other myelosuppressive agents

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
CBC	Baseline and monthly for the first 12 months, then periodically thereafter, and as clinically indicated
Liver function tests	Baseline and as clinically indicated
Renal function tests	Baseline and as clinically indicated
Clinical toxicity assessment for nausea and other GI and respiratory effects, fatigue, anemia, MDS, infection, bleeding and venous thromboembolism	At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

olaparib - For the maintenance treatment of BRCA-mutated, high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients, based on criteria
olaparib - For the treatment of metastatic castration resistant prostate cancer (mCRPC), based on criteria
olaparib - For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative high risk early breast cancer, based on criteria
olaparib - In combination with abiraterone, and prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC), based on criteria

K - References

CADTH reimbursement recommendation: Olaparib (adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative high risk early breast cancer). March 2023.

De Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med 2020 May 28;382(22):2091-2102.Golan T, Hammel P, Reni M, et al. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med 2019 Jul 25;381(4):317-27.

Golan T, Hammel P, Reni M, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med 2019 Jul 25;381(4):317-27.

Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61.

Moore K, Colombo N, Scambia G et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 2018;379:2495-505.

Product information: Lynparza (Olaparib). AstraZeneca AB. August 20, 2024.

Product monograph: Lynparza (olaparib tablets). AstraZeneca Canada Inc., September 27, 2024.

Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul 25 (published online).

Robson M, Im SA, Senkus E, et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med 2017;377(6):523-33.

Tew WP, Lacchetti C, Ellis A, et al. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline. J Clin Oncol 2020 Oct 20;38(30):3468-93.

Winship AL, Griffiths M, Requesens CL, et al. The PARP inhibitor, olaparib, depletes the ovarian reserve in mice: implications for fertility preservation. Hum Reprod 2020 Aug 1;35(8):1864-1874.

December 2024 Updated Adverse effects, Dosing, and Pregnancy/lactation sections

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.

References:

Golan T, Hammel P, Reni M, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med 2019 Jul 25;381(4):317-27.

Moore K, Colombo N, Scambia G et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 2018;379:2495-505.

Product information: Lynparza (Olaparib). AstraZeneca AB. August 20, 2024.

Product monograph: Lynparza (olaparib tablets). AstraZeneca Canada Inc., September 27, 2024.

Robson M, Im SA, Senkus E, et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med 2017;377(6):523-33.

Tew WP, Lacchetti C, Ellis A, et al. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline. J Clin Oncol 2020 Oct 20;38(30):3468-93.

Winship AL, Griffiths M, Requesens CL, et al. The PARP inhibitor, olaparib, depletes the ovarian reserve in mice: implications for fertility preservation. Hum Reprod 2020 Aug 1;35(8):1864-1874.

Info Sheet Name:

olaparib tablet (patient)

Info Sheet Introduction:

For treating certain types of ovarian, breast, prostate or pancreatic cancers

Info Sheet Date: Mardi, janvier 7, 2025 Info Sheet body:

olaparib

Pronunciation:

oh LAP a rib

Other Name(s):

Lynparza®

Appearance:

tablet

This handout gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on medication

This handout was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

Who do I contact if I have questions or need help?

My cancer health care provider is: _____________________________________________

During the day I should contact: _______________________________________________

Evenings, weekends and holidays: _____________________________________________

This page gives general information about this cancer medication.

You will learn:

who to contact for help
what the medication is
how it is given
what to expect while on this medication

This information was created by Ontario Health (Cancer Care Ontario) together with patients and their caregivers who have also gone through cancer treatment. It is meant to help support you through your cancer treatment and answer some of your questions.

This information does not replace the advice of your health care team. Always talk to your health care team about your treatment.

What is this treatment for?

For treating certain types of ovarian, breast, prostate or pancreatic cancers

What should I do before I start this treatment?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:

lung problems,
a history of smoking,
liver problems, or
any allergies.

Remember to:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.

How is this treatment given?

This medication is usually taken twice daily by mouth at about the same time each morning and evening.
Take this medication with or without food.
Tablets should be swallowed whole and not chewed, crushed, dissolved or divided.
If you miss a dose, take your next dose at the usual time. Do not double the dose to make up for a missed dose.
If you vomit (throw up) after taking your medication, talk to your health care team about what to do.

Warning: If you take too much of this medication by accident, or if you think a child or a pet may have swallowed your medication, you must call the Ontario Poison Control Center right away at: 1-800-268-9017.

Other medications you may be given with this treatment

To Prevent or Treat Nausea and Vomiting

Anti-nausea medications are used to prevent or stop nausea (feeling like throwing up) and vomiting (throwing up) before they start. You may be given these medications.

Anti-nausea medications to prevent nausea and vomiting before they start include ondansetron (Zofran®), granisetron (Kytril®), or others.

If you already have nausea and/or vomiting, some anti-nausea medication can stop them from getting worse. You may be given anti-nausea medications to have at home in case you start to feel nausea or if you vomit.

Anti-nausea medications to stop nausea and vomiting include prochlorperazine (Stemetil®), metoclopramide (Maxeran®), or others.

DO this while on treatment

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

DO talk to your health care team about your risk of getting other cancers after this treatment.

DO NOT do this while on treatment

Stop Icon

DO NOT use tobacco products (such as smoking cigarettes or vaping) or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

DO NOT take any other medications, such as vitamins, over-the-counter (non-prescription) drugs, or natural health products without checking with your health care team.

DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.

DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. These may increase the quantity of the medication in your blood and increase the side effects.

DO NOT drive, operate machinery or do any tasks that need you to be alert if you feel tired or dizzy.

DO this while on treatment

Check Mark Icon

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

DO talk to your health care team about your risk of getting other cancers after this treatment.

DO NOT do this while on treatment

Stop Icon

DO NOT use tobacco products (such as smoking cigarettes or vaping) or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

DO NOT take any other medications, such as vitamins, over-the-counter (non-prescription) drugs, or natural health products without checking with your health care team.

DO NOT start any complementary or alternative therapies, such as acupuncture or homeopathic medications, without checking with your health care team.

DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while on this treatment. These may increase the quantity of the medication in your blood and increase the side effects.

DO NOT drive, operate machinery or do any tasks that need you to be alert if you feel tired or dizzy.

Will this treatment interact with other medications or natural health products?

Yes, this medication can interact with other medications, vitamins, foods and natural health products. Interactions can make this medication not work as well or cause severe side effects.

Tell your health care team about all of your:

prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements

Check with your health care team before starting or stopping any of them.

Talk to your health care team BEFORE taking or using these :

Anti-inflammatory medications such as ibuprofen (Advil^® or Motrin^®), naproxen (Aleve^®) or Aspirin^®.
Over-the-counter products such as dimenhydrinate (Gravol^®)
Natural health products such as St. John’s Wort
Supplements such as vitamin C
Grapefruit juice
Alcoholic drinks
Tobacco
All other drugs, such as marijuana or cannabis (medical or recreational)

What to do if you feel unwell, have pain, a headache or a fever

Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol^®) or ibuprofen (Advil^®)).
- Fever can be a sign of infection that may need treatment right away.
- If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.

How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
OR
- 38.0°C (100.4°F) or higher for at least one hour.

If you do have a fever:

Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
Ask your health care team for the Fever pamphlet for more information.

If you do not have a fever but have mild symptoms such as headache or mild pain:

Ask your health care team about the right medication for you. Acetaminophen (Tylenol^®) is a safe choice for most people.

Talk to your health care team before you start taking ibuprofen (Advil^®, Motrin^®), naproxen (Aleve^®) or ASA (Aspirin^®), as they may increase your chance of bleeding or interact with your cancer treatment.

Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

How will this treatment affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this medication may affect your sexual health.
How this medication may affect your ability to have a baby, if this applies to you.

This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance you may become pregnant, you and your partner together must use 2 effective forms of birth control at the same time until 6 months after your last dose. Talk to your health care team about which birth control options are best for you.
If you are a patient that can get somebody pregnant, you and your partner together must use 2 effective forms of birth control at the same time until 3 months after your last dose. Talk to your health care team about which birth control options are best for you.
This medication may make hormonal birth control, such as birth control pills, less effective (not work as well). If you choose to use a hormonal birth control, make sure you also use a barrier or non-hormonal birth control method (such as condoms). Talk to your health care team about the best birth control options for you.
Do not breastfeed while on this treatment and for 1 month after your last dose.

How to safely store and handle this medication

Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.

Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.

How to safely touch oral anti-cancer medication

If you are a patient:

Wash your hands before and after touching your oral anti-cancer medication.
Swallow each pill whole. Do not crush or chew your pills.

If you are a caregiver:

Wear nitrile or latex gloves when touching tablets, capsules or liquids.
Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the oral anti-cancer medication.
Throw out your gloves after each use. Do not re-use gloves.
Do not touch oral anti-cancer medications if you are pregnant or breastfeeding.

What to do if anti-cancer medication gets on your skin or in your eyes

If medication gets on your skin:

Wash your skin with a lot of soap and water.
If your skin gets red or irritated, talk to your health care team.

If medication gets in your eyes:

Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.

What are the side effects of this treatment?

The following table lists side effects that you may have when getting olaparib tablets. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on olaparib tablets.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
Nausea and vomiting (Generally mild) What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. If you were given anti-nausea medication(s), take them as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe.
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. Ask your health care team for the Fatigue pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Anemia (low red blood cells) (May be severe) What to look for? You may feel more tired or weaker than normal. Pale skin and cold hands and feet. You may feel short of breath, dizzy or lightheaded. This may occur in days to weeks after your treatment starts. What to do? If your health care team has told you that you have anemia (low red blood cells): Rest often and eat well. Light exercise, such as walking may help. You may need medication or a blood transfusion. If it is very bad, your doctor may need to make changes to your treatment regimen.	Talk to your health care team if it does not improve or if it is severe.
Low neutrophils (white blood cells) in the blood (neutropenia) (May be severe) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen). Do not eat or drink anything hot or cold right before taking your temperature. You have a fever if your temperature taken in your mouth (oral temperature) is: 38.3°C (100.9°F) or higher at any time OR 38.0°C (100.4°F) or higher for at least one hour. What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.	If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.
Low platelets in the blood (May be severe) When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding red or pink coloured urine (pee) What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.	Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away.
Diarrhea What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol, until your diarrhea has stopped. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day).
Constipation What to look for? Having bowel movements (going poo) less often than normal. Small hard stools (poo) that look like pellets. The need to push hard and strain to have any stool (poo) come out. Stomach ache or cramps. A bloated belly, feeling of fullness, or discomfort. Leaking of watery stools (poo). Lots of gas or burping. Nausea or vomiting. What to do? To help prevent constipation: Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains. Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less. Be Active. Exercise can help to keep you regular. If you take opioid pain medication, ask your health care team if eating more fibre is right for you. To help treat constipation: If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do. Ask your health care team for the Constipation Pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.
Taste changes What to look for? Food and drinks may taste different than usual. What to do? Eat foods that are easy to chew, such as scrambled eggs, pasta, soups, cooked vegetables. Taste foods at different temperatures, since the flavour may change. Try different forms of foods, like fresh, frozen or canned. Experiment with non-spicy foods, spices and seasonings.	Talk to your health care team if it does not improve or if it is severe.

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Headache What to look for? Mild headache. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.
Low appetite What to look for? Loss of interest in food or not feeling hungry. Weight loss. What to do? Try to eat your favourite foods. Eat small meals throughout the day. You may need to take meal supplements to help keep your weight up. Talk to your health care team if you have no appetite. Ask your health care team for the Loss of Appetite pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe.
Dizziness What to look for? You may feel light-headed and like you might faint (pass out). What to do? Lay down right away so you do not fall. Slowly get up and start moving once you feel better. Do not drive a motor vehicle or use machinery if you feel dizzy.	Talk to your health care team if it does not improve or if it is severe.
Cough and feeling short of breath What to look for? You may have a cough and feel short of breath. Symptoms that commonly occur with a cough are: Wheezing or a whistling breathing Runny nose Sore throat Heartburn Weight loss Fever and chills Rarely this may be severe with chest pain, trouble breathing or coughing up blood. What to do? Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?". If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away. If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.	Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away.
Heartburn; stomach upset; bloating What to look for? Pain or burning in the middle or top part of your chest. It may get worse when you are lying down or bending over or when you swallow. A bitter or acidic taste in your mouth. What to do? Drink clear liquids and eat small meals. Do not eat acidic, fatty or spicy foods. Limit caffeine (like coffee, tea) and avoid alcohol. Avoid smoking or being around tobacco. Sit up or stand after eating. Do not lie down. Raise the head of your bed six to eight inches. You may need to use extra pillows to do this.	Talk to your health care team if it does not improve or if it is severe.
Mouth sores What to look for? Round, painful, white or gray sores inside your mouth that can occur on the tongue, lips, gums, or inside your cheeks. In more severe cases they may make it hard to swallow, eat or brush your teeth. They may last for 3 days or longer. What to do? To help prevent mouth sores: Take care of your mouth by gently brushing and flossing regularly. Rinse your mouth often with a homemade mouthwash. To make a homemade mouthwash, mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water. Do not use store-bought mouthwashes, especially those with alcohol, because they may irritate your mouth. If you have mouth sores: Avoid hot, spicy, acidic, hard or crunchy foods. Your doctor may prescribe a special mouthwash to relieve mouth sores and prevent infection. Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow. Ask your health care team for the Oral Care (Mouth Care) pamphlet for more information.	Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow.
Rash; dry, itchy skin What to look for? You may have cracked, rough, flaking or peeling areas of the skin. Your skin may look red and feel warm, like a sunburn. Your skin may itch, burn, sting or feel very tender when touched. What to do? To prevent and treat dry skin: Use fragrance-free skin moisturizer. Protect your skin from the sun and the cold. Use sunscreen with UVA and UVB protection and a SPF of at least 30. Avoid perfumed products and lotions that contain alcohol. Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less. Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.	Talk to your health care team if it does not improve or if it is severe.

Other rare, but serious side effects are possible with this treatment.

If you have any of the following, talk to your cancer health care team or get emergency medical help right away:

Symptoms of an allergic reaction such as fever, flushing, itchiness, rash, swollen lips, face or tongue, wheezing, chest and throat tightness. These may occur shortly after the medication is taken
Pain, swelling and hardening of a vein in the arm or leg
Yellowish skin or eyes, unusually dark pee or pain on the right side of your belly

For more information on how to manage your symptoms ask your health care provider, or visit: https://www.cancercareontario.ca/symptoms.

Notes

January 2025 Updated "What are the side effects of this treatment? section

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

olaparib tablet patient.pdf Info Sheet (French):

olaparib tablet pour le patient.pdf Monograph:

olaparib.pdf Funding Program: Exceptional Access Program Funding Instance:

olaparib - For the maintenance treatment of BRCA-mutated, high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients, based on criteria
olaparib - For the treatment of metastatic castration resistant prostate cancer (mCRPC), based on criteria
olaparib - For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative high risk early breast cancer, based on criteria
olaparib - In combination with abiraterone, and prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC), based on criteria

Phonetic Spelling:

oh LAP a rib

Cancer Type: Breast Genitourinary Prostate Gynecologic Ovary Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Lundi, décembre 23, 2024 Universal Date: 2025-01-07 00:00:00 AddThis: Title URL: olaparib Drug Display Status: Active Revision Summary:
Drug Monograph: Updated Adverse effects, Dosing, and Pregnancy/lactation sections
Patient Info Sheet EN: Updated "What are the side effects of this treatment? section
Patient Info Sheet FR: Updated "What are the side effects of this treatment?" section (Mise à jour de la section « Quels sont les effets secondaires de ce traitement? »)