niraparib

Trade Name:

Zejula

Appearance:

tablet or capsule

Monograph Name:

niraparib

Monograph Body:

Drug Monograph

A - Drug Name

niraparib

COMMON TRADE NAME(S): Zejula

B - Mechanism of Action and Pharmacokinetics

Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, and acts to increase the formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death. Increased cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2.

Absorption

Bioavailability

~73%

Effects with food

Administration with a high-fat, high-calorie meal resulted in a 22% decrease in C_maxcompared to fasted conditions. However, food did not significantly affect the AUC.

Peak plasma levels

C_max is reached in approximately 3 hours.

Distribution

Cross blood brain barrier?

Yes (in pre-clinical models)

PPB

83%

Metabolism

Niraparib is metabolized by carboxylesterases.

Inactive metabolites

Yes

Active metabolites

Elimination

Half-life

48 to 51 hours (approximately 2 days)

Feces

Average 38.8%; 18.7% unchanged drug from pooled samples collected over 6 days

Urine

Average 47.5%; 11% unchanged drug from pooled samples collected over 6 days

C - Indications and Status

Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer

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

D - Adverse Effects

Emetogenic Potential:

Moderate – Consider prophylaxis daily

The following table lists adverse effects that occurred in ≥ 10% of patients in a phase III placebo-controlled study for the first-line maintenance treatment of advanced ovarian cancer where patients received an individualized starting dose of niraparib. It also includes severe, life-threatening and post-marketing adverse effects from other sources. Adverse effects marked with “^” were observed in maintenance treatment of recurrent ovarian cancer.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Hypertension (17%) (9% severe)	E D L
	Palpitations (10%) ^	E
Dermatological	Photosensitivity (<10%)	E
Gastrointestinal	Abdominal pain (28%)	E
	Anorexia (19%)	E
	Constipation (33%)	E
	Diarrhea (14%)	E
	Dyspepsia (18%) ^	E
	GI obstruction (3%) (severe)	E
	Mucositis (20%) ^	E
	Nausea, vomiting (53%) (generally mild)	I E
General	Fatigue (48%)	E
Hematological	Myelosuppression ± infection (54%) (including anemia) (21% severe)	E
Hepatobiliary	↑ LFTs (8%)	E
Hypersensitivity	Hypersensitivity (<10%) (including anaphylaxis)	I E
Musculoskeletal	Musculoskeletal pain (37%)	E
Neoplastic	Leukemia (secondary) (<1%)	E D L
Nervous System	Cognitive disturbance (<10%) (including hallucinations)	E
	Dizziness (11%)	E
	Dysgeusia (10%) ^	E
	Headache (22%)	E
	Insomnia (21%)	E
	Posterior reversible encephalopathy syndrome (PRES) (<1%)	E
Renal	Other - acute kidney injury (12%) (<1% severe, including increased creatinine/urea, renal failure)	E
Reproductive and breast disorders	Hot flashes (>10%)	E D
Respiratory	Cough, dyspnea (19%)	E
	Pneumonitis (<1%)	E

* "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 niraparib include myelosuppression ± infection, nausea/vomiting, fatigue, musculoskeletal pain, constipation, abdominal pain, headache, insomnia and mucositis.

Thrombocytopenia was commonly reported, with a median time of 22 days (ranging from 15 to 335 days) from the first niraparib dose to onset, and a median duration 6 days (ranging from 1 to 374 days).

Hypertension and hypertensive crisis have been reported but rarely lead to treatment discontinuation. The median time from the first niraparib dose to onset of grade 3 or 4 hypertension was 43 days (ranging from 1 to 531 days), with a median duration 12 days (ranging from 1 to 61 days).

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) including fatal cases, have been rarely reported. The duration of niraparib treatment prior to the development of MDS/AML varied from <1 month to approximately 5 years. All patients had received prior chemotherapy with platinum-based regimens and/or other DNA-damaging agents, including radiotherapy.

E - Dosing

Refer to protocol by which 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.

Patients should have recovered from hematologic toxicities (≤ grade 1) from previous chemotherapy prior to initiating niraparib treatment.

Existing hypertension should be adequately controlled before initiating niraparib treatment.

Adults:

Epithelial ovarian, fallopian tube, or primary peritoneal cancer:

Patients <77 kg or with a platelet count <150 x 10⁹/L:*

Oral: 200 mg Daily

Patients ≥77 kg and with a platelet count ≥150 x 10⁹/L:*

Oral: 300 mg Daily

*based on pCODR, Berek et al.

Dosage with Toxicity:

Dose Level	Niraparib Dose (mg/day)
0	200	300
-1	100	200
-2	Discontinue	100
-3	Discontinue	Discontinue

Toxicity	Criteria	Action
Platelet count <100 x 10⁹/L	First occurrence	Hold. Monitor blood counts weekly* Resume at same dose or at 1 dose level ↓. If platelet count was <75 x 10⁹/L, resume at 1 dose level ↓.
Platelet count <100 x 10⁹/L	Second occurrence	Hold. Monitor blood counts weekly.* Resume at 1 dose level ↓.
Neutrophil <1 x 10⁹/L		Hold. Monitor blood counts weekly.* Resume at 1 dose level ↓.
Hemoglobin <80 g/L		Hold. Monitor blood counts weekly.* Resume at 1 dose level ↓.
Hematologic adverse reaction requiring transfusion or hematopoietic growth factor support		Hold. Consider platelet transfusion for platelets ≤10 x 10⁹/L. If other risk factors are present (e.g., coadministration of anticoagulation or antiplatelet drugs), consider interruption of concurrent therapy and/or transfuse at a higher platelet count. Resume at 1 dose level ↓.
Signs and symptoms of myelodysplastic syndrome or acute myeloid leukemia (MDS/AML)	Any	If MDS/AML is confirmed, discontinue
Hypertension	Not adequately controlled with antihypertensive therapy Or Hypertensive crisis	Discontinue
Signs and symptoms of Posterior Reversible Encephalopathy Syndrome (PRES)	Any	Treat specific symptoms and discontinue
All other non-hematologic toxicities that persists despite treatment/prophylaxis	≥ Grade 3	Hold.* Resume at same dose or at 1 dose level ↓.

*Do not restart until platelets ≥100 x 10⁹/L, ANC ≥1.5 x 10⁹/L, Hb ≥90 g/L and other toxicities have resolved. Discontinue if toxicities have not recovered within 28 days of dose interruption. If blood parameters remain abnormal after 28 days, bone marrow analysis and/or blood cytogenetic analysis are recommended.

Dosage with Hepatic Impairment:

Hepatic Impairment	Bilirubin		AST	Niraparib Dose
Mild	≤1.5xULN	and	any	No dose adjustment required
Mild	≤ULN	and	>ULN	No dose adjustment required
Moderate	>1.5 to 3 xULN	and	any	↓ 1 dose level
Moderate or Severe	>3xULN	and	any	Has not been studied

Dosage with Renal Impairment:

Creatinine Clearance (mL/min)	Niraparib Dose
≥ 30	No dose adjustment required
< 30 or ESRD	Has not been studied

Dosage in the elderly:

No dose adjustment required. No overall differences in safety and effectiveness of niraparib were observed between patients ≥ 65 years old and younger but greater sensitivity of some older patients cannot be ruled out.

Dosage based on ethnicity:

No dose adjustment required. Analyses suggested that race/ethnicity had no clinically significant effect on the pharmacokinetics of niraparib.

Children:

The safety and effectiveness of niraparib in pediatric patients have not been established.

F - Administration Guidelines

Niraparib should be taken with or without food at approximately the same time each day. (Bedtime administration may help manage nausea).
The dose should be swallowed whole, not chewed, crushed, or split.
If a dose of niraparib is missed, patients should take the next dose at the regularly scheduled time. Patients should not take an additional dose if vomiting or missed doses occur.

Store at a temperature up to 25°C.

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to the drug or to any of its components or components of the container.

Other Warnings/Precautions:

Niraparib has moderate influence on the ability to drive or use machines. Caution should be exercised when driving or operating a vehicle or potentially dangerous machinery due to fatigue and dizziness.
Patients should be counselled to avoid sun exposure when possible while on treatment.
Niraparib capsules contain tartrazine (FD&C Yellow #5), which may cause allergic-type reactions.
Niraparib capsules and tablets contain lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Other Drug Properties:

Phototoxicity: Possible

Pregnancy and Lactation:

Genotoxicity: Yes
Clastogenicity: Yes
Fetotoxicity: Yes
Teratogenicity: Probable
Pregnancy:
Niraparib is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for 6 months after the last dose.
Breastfeeding:
Breastfeeding is contraindicated during treatment and for 1 month after the last dose.
Fertility effects: Probable

Documented in animal studies with male animals

H - Interactions

No formal drug interaction studies have been performed with niraparib.

In vitro, niraparib is a:

weak inducer of CYP1A2
weak inhibitor of BCRP, P-gp and OCT1
inhibitor of MATE-1 and -2
substrate of P-gp and BCRP

In vivo, niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs).

The potential of niraparib on intestinal CYP3A4 inhibition has not been established.

Caution is recommended when niraparib is combined with active substances with CYP3A4/1A2-dependent metabolism, that undergo uptake transport by OCT1 or with known inhibitors or inducers of carboxylesterases and conjugation (UGT) pathways.

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 weekly for the first month of treatment then monthly for the next 11 months and as clinically indicated
Blood pressure and heart rate	Baseline and at minimum weekly for the first 2 months of treatment, then monthly for the first year and as clinically indicated (More frequent monitoring may be required in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension)
Clinical toxicity assessment for infection, hypersensitivity, fatigue, musculoskeletal pain, hot flashes, secondary malignancy, GI, cardiovascular, neurologic and respiratory effects	At each visit

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

Suggested Clinical Monitoring

Monitor Type	Monitor Frequency
Liver function tests	Baseline and as clinically indicated
Renal function tests	Baseline and as clinically indicated

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

niraparib - For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to clinical criteria

K - References

Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol 2018 Aug 1;29(8):1784-92.

González-Martín A et al. PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402.

Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med 2016 Dec 1;375(22):2154-64.

pCODR expert review committee: final recommendation. Niraparib (maintenance for first-line advanced ovarian cancer), April 2021.

pCODR expert review committee: final recommendation. Niraparib (maintenance for recurrent ovarian cancer), September 2020.

Prescribing Information: Zejula (niraparib). Tesaro Inc. August 2017.

Product Monograph: Zejula (niraparib). GlaxoSmithKline Inc. June 2, 2022.

March 2025 Updated Pregnancy/Lactation section

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.

Info Sheet Name:

niraparib (patient)

Info Sheet Introduction:

• For treating certain types of cancers such as ovarian, fallopian tube, or peritoneal cancer.

Info Sheet Date: Friday, October 27, 2023 Info Sheet body:

Medication Information Sheet

niraparib (nye-RAP-a-rib)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Zejula

Appearance:

tablet or capsule

What is this medication for?

For treating certain types of cancers such as ovarian, fallopian tube, or peritoneal cancer.

What should I do before I have this medication?

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

high blood pressure or heart problems
liver or kidney problems or
any allergies

This drug contains a small amount of lactose. If you cannot have lactose, talk to your health care team.

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.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this medication may affect your sexual health.
Symptoms of menopause such as hot flashes if this applies to you.
How this medication may affect your ability to have a baby, if this applies to you.

This medication can 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 of pregnancy happening, 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.
Do not breastfeed while on this medication and for 1 month after the last dose.

How is this medication given?

This medication is usually taken once a day by mouth. You may need to take more than 1 capsule to get the right dose. Talk to your health care team about how and when to take your medication.
Swallow whole with a glass of water, with or without food.
Do not crush or open the capsules.
If you miss a dose, skip this and take your next dose as you normally do. Do not take an extra dose to make up for the missed dose.
If you vomit (throw up) after taking your medication, talk to your health care team about what to do.
If you take too much of your 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.

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 medications 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.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?
- This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment 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.
What should I do if I 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.

What to DO while on this medication:

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 protect your skin from the sun. Wear a long sleeved shirt, long pants and a hat. Apply sunscreen with UVA and UVB protection and an SPF of at least 30. Your skin may be more sensitive to the sun and you could develop a bad sunburn or rash more easily.

What NOT to DO while on this medication:

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

How should I safely store this medication?

Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.
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.
How to safely touch oral anti-cancer medications

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 oral 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 medication?

The following table lists side effects that you may have when getting niraparib. 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 niraparib.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
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.
Anemia (low red blood cells) 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.
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

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
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
Headache; Mild joint, muscle pain or cramps What to look for? Mild headache New pain in your muscles or joints, muscle cramps, or feeling achy. 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
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

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Trouble Sleeping Your medications may cause trouble sleeping. It may get better once your body gets used to the medication or when your treatment ends. What to look for? You may find it hard to fall asleep or stay asleep. How well you sleep may change over your treatment. For example, you may have several nights of poor sleep followed by a night of better sleep. You may wake up too early or not feel well-rested after a night's sleep. You may feel tired or sleepy during the day. What to do? Talk to your health care team if it does not improve or if it is severe	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
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
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
High blood pressure What to look for? There are usually no signs of high blood pressure. Rarely, you may have headaches, shortness of breath or nosebleeds. What to do? Check your blood pressure regularly. Your doctor may prescribe medication to treat high blood pressure. If you have a severe headache get emergency help right away as it may be a sign your blood pressure is too high.	Talk to your health care team if it does not improve or if it is severe
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. 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)
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
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
Kidney problems Your health care team may check your kidney function regularly with a blood test. What to look for? Swelling in your hands, ankles, feet or other areas of your body. Weight gain that is not normal for you. Pain in your lower back. Muscle twitches and cramps or itchiness that won't go away. Nausea (feeling like you need to throw up) and vomiting. Changes in urination (peeing) such as less urine than usual. What to do? If you have any of these signs, talk to your health care team or go to your closest emergency department	Get emergency help right away
Hot flashes (feeling or wave of warmth) What to look for? A hot flash feels like a sudden warmth in your upper body and face. It can happen quickly and with no warning. Your face may get flushed (turn red) and you may sweat more. Hot flashes can cause you to have trouble sleeping What to do? To help prevent hot flashes : Avoid triggers such as spicy food, alcohol and caffeine (tea, coffee, and soft drinks), Exercise regularly. Ask your health care team what exercises are appropriate for you before you start any new exercise. Quitting smoking may also help. If you have hot flashes : To keep cool, dress in light, cotton clothing or in layers that you can easily remove. Use a fan Drink plenty of water or other liquids (at least 6 to 8 cups) unless your health care team has told you to drink more or less. Lay a towel on top of your bed sheet before you sleep so you can change it easily if you sweat at night. Hot flashes may improve over time. Talk to your health care team if they bother you.	Talk to your health care team if it does not improve or if it is severe
Fast or pounding heartbeat What to look for? You may have a fast, pounding or fluttering heartbeat. What to do? Talk to your health care team if it does not improve or if it is severe	Talk to your health care team if it does not improve or if it is severe

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

seeing or hearing things that are not really there, confusion or memory problems and thinking
itchiness, rash, swollen lips, face or tongue, chest and throat tightness
severe belly pain, bloating or feeling of fullness and severe constipation
severe headache, fainting, seizures, or vision loss

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:______________________________________________

Other Notes:

____________________________________________________________________________

October 2023 Modified Appearance section

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

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):

niraparib patient.pdf Info Sheet (French):

niraparib pour le patient.pdf Monograph:

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

niraparib - For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to clinical criteria

Phonetic Spelling:

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Cancer Type: Gynecologic Ovary Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Wednesday, March 5, 2025 Universal Date: 2025-03-05 00:00:00 AddThis: Title URL: niraparib Drug Display Status: Active Revision Summary:
Drug Monograph: Updated Pregnancy/Lactation section