Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
NIRP
Palliative
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
For the treatment of newly diagnosed or recurrent high grade epithelial, ovarian, fallopian tube or primary peritoneal cancer as maintenance in patients with good performance status, who have achieved complete or partial radiological response
(Refer to EAP for full funding criteria)
niraparib
Exceptional Access Program
(niraparib - For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to clinical criteria)
(EAP Website)
To start within 12 weeks of completing chemotherapy.†
Patients <77 kg or with a platelet count <150 x 109/L:*
| niraparib | 200 mg | PO | Daily |
|
|
|||
| niraparib | 300 mg | PO | Daily |
*based on pCODR, Berek et al
† Disease progression should be excluded before starting niraparib, if > 8 weeks have elapsed from last chemotherapy treatment.
CONTINUOUS TREATMENT
Maintenance for recurrent disease: Until disease progression or unacceptable toxicity
First-line maintenance: Funding will be considered until disease progression or toxicity, OR up to a maximum of 3 years if there is no evidence of disease recurrence
Moderate – Consider prophylaxis daily
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Doses should be modified according to the protocol by which the patient is being treated.
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.
Dosage with toxicity
| Dose Level | Niraparib Dose (mg/day) | |
| 0 | 200 | 300 |
| -1 | 100 | 200 |
| -2 | Discontinue | 100 |
| -3 | 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 ↓. |
| 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 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.
Hepatic Impairment
|
Hepatic Impairment |
Bilirubin |
|
AST |
Niraparib Dose |
|
Mild |
≤1.5xULN |
and |
any |
No dose adjustment required |
|
≤ULN |
and |
>ULN |
||
|
Moderate |
>1.5 to 3 xULN |
and |
any |
↓ 1 dose level |
|
Moderate or Severe |
>3xULN |
and |
any |
Has not been studied |
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.
Refer to niraparib drug monograph(s) for additional details of adverse effects
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to niraparib drug monograph(s) for additional details
No formal drug interaction studies have been performed with niraparib.
Refer to niraparib drug monograph(s) for additional details
Administration
-
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.
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.
Pregnancy/Lactation
-
This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
-
Breastfeeding is contraindicated during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
-
Fertility Effects: Documented in male animals
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
-
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
Suggested Clinical Monitoring
-
Liver function tests; Baseline and as clinically indicated
-
Renal function tests; Baseline and as clinically indicated
back to top
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.
Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med 2016;375:2154-64.DOI: 10.1056/NEJMoa1611310
Niraparib drug monograph, Ontario Health (Cancer Care Ontario).
pCODR expert review committee: final recommendation. Niraparib (recurrent ovarian cancer), September 2020.
October 2023 Modified Drug administration and Other warnings/precautions sections
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. 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, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
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.