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.
ABIRNIRPPRED
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 metastatic castration-resistant prostate cancer (mCRPC) in patients with a BRCA mutation
Refer to EAP criteria for funding details.
niraparib / abiraterone
Exceptional Access Program
(niraparib / abiraterone - For the treatment of metastatic castration resistant prostate cancer in patients with a BRCA mutation)
(EAP Website)
prednisone
ODB - General Benefit
(prednisone)
(ODB Formulary
)
Patients should continue to receive a GnRH agonist unless they have had prior bilateral orchiectomy.
|
niraparib / abiraterone * | 200 mg / 1000 mg | PO | Daily |
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*Administered as 2 tablets, each containing 100 mg of niraparib and 500 mg of abiraterone acetate. |
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| prednisone | 10 mg | PO | Daily |
Moderate – Consider prophylaxis daily
- 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.
Other Supportive Care:
- Control hypertension and correct hypokalemia before treatment.
- Consider maintaining the patient’s potassium level at ≥ 4 mM in patients who develop hypokalemia.
- Patients should be counselled to avoid sun exposure when possible while on treatment.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Note: Niraparib/abiraterone tablets are available in two strengths. Use correct tablet strength for respective dose modifications.
Table 1 - Dose Levels:
| Dose Level |
Niraparib/abiraterone Dose (mg Daily) (for Hematologic Toxicity) |
Niraparib/abiraterone Dose (mg Daily) (for Hepatotoxicity) |
| 0 | 200/1000 (2 tablets of 100/500 each) |
200/1000 (2 tablets of 100/500 each) |
| -1 | 100/1000 (2 tablets of 50/500 each) |
100/500 |
| -2 | Discontinue | Discontinue |
Table 2 - Dose Modifications for Anemia:
| Toxicity | Action |
| Hgb 100 g/L to LLN | Consider monitoring blood counts weekly. |
|
Hgb 80 to <100 g/L |
Monitor blood counts at least weekly for 28 days if Hgb ≥ 100 g/L at baseline. |
| Hgb < 80 g/L; transfusion indicated |
First occurrence:
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Second occurrence:
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|
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Third occurrence:
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*Do not restart until Hgb ≥ 80 g/L, platelets ≥ 75 x 109 /L, ANC ≥ 1.5 x 109 /L, and recovery of non-hematologic toxicity (see table 4).
Table 3 - Dose Modifications for Thrombocytopenia or Neutropenia:
| Toxicity | Toxicity | Action | |
| Platelets 75 x 109/L to <LLN | and | ANC 1.5 x 109/L to <LLN | Consider monitoring blood counts weekly. |
| Platelets 50 to <75 x 109/L | or | ANC 1 to <1.5 x 109/L |
Monitor blood counts at least weekly. Consider holding* combination niraparib / abiraterone and switching to AAP until recovery. After recovery, resume combination niraparib / abiraterone at same dose. Monitor blood counts at least weekly for 28 days after restart. |
| Platelets <50 x 109/L | or | ANC <1 x 109/L |
First occurrence:
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Second occurrence:
|
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Third occurrence:
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*Do not restart until Hgb ≥ 80 g/L, platelets ≥ 75 x 109 /L, ANC ≥ 1.5 x 109 /L, and recovery of non-hematologic toxicity (see table 4).
**If platelet transfusion or G-CSF required, restart at 1 dose level ↓ after recovery.
Table 4 - Dose Modifications for Non-Hematologic Toxicities:
| Toxicity | Grade/ Severity | Action* |
| Hepatotoxicity |
ALT or AST > 5 x ULN or Total bilirubin > 3 x ULN |
Hold combination niraparib / abiraterone and closely monitor LFTs . Resume at 1 dose level ↓ if LFTs return to baseline. Monitor LFTs at a minimum of every two weeks for three months and monthly thereafter. |
| ALT or AST > 20 x ULN | Discontinue. | |
| ALT > 3 x ULN and total bilirubin > 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation | ||
| PRES, MDS/AML, or Hypertensive Crisis |
Any | Discontinue. |
| Other | Grade ≥ 3 |
Hold combination niraparib / abiraterone if toxicity cannot be definitively attributed to either niraparib or abiraterone acetate alone. Initiate AAP after recovery to Grade 1 or baseline; then switch to combination niraparib / abiraterone acetate ≥ 7 days of starting AAP (if recovery is maintained). If dose was previously reduced, discontinue if no resolution > 28 days. |
*Do not restart until Hgb ≥ 80 g/L, platelets ≥ 75 x 109/L, ANC ≥ 1.5 x 109/L, and recovery of non-hematologic toxicity.
Hepatic Impairment
The pivotal trial excluded patients with moderate and severe hepatic impairment, baseline hepatitis or significant abnormalities of liver function tests.
| Hepatic Impairment | Niraparib / Abiraterone Acetate Dose |
|
Mild |
No dose adjustment required |
|
Moderate or Severe |
Do not use |
Renal Impairment
| Creatinine Clearance (mL/min) | Niraparib/ Abiraterone Dose |
| ≥30 | No dose adjustment required |
| <30 | No data |
Dosage in the Elderly
No dose adjustment is necessary for elderly patients aged ≥ 65 years. No overall differences in safety and efficacy of niraparib and abiraterone acetate combination therapy were observed between these patients and younger patients. Higher exposure (~25%) of niraparib and abiraterone acetate has been observed in patients aged 75-90 years compared to patients aged 45-65 years. Consider close monitoring of individuals aged ≥ 75 years.
Refer to niraparib / abiraterone, prednisone 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 |
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|
|
|
Refer to niraparib / abiraterone, prednisone drug monograph(s) for additional details.
- Avoid concomitant use with strong CYP3A4 inducers due to potential for decreased abiraterone efficacy
- Avoid spironolactone as it may bind and activate the wild-type androgen receptor and stimulate disease progression.
- Avoid use with radium-223 dichloride due to increased risk of fractures and mortality.
- Monitor for substate toxicity when used with CYP2D6, CYP2C8, MATE-1 and MATE-2 substrates with narrow therapeutic indices; consider dose reduction for CYP2D6 substrates.
- Use with caution in patients with diabetes as isolated cases of hypoglycemia have been reported post marketing, particularly in patients receiving concomitant therapy with pioglitazone or repaglinide. Monitor blood glucose levels in these patients.
- Use caution and monitor for myopathy and rhabdomyolysis when using niraparib-abiraterone with drugs that may increase the risk of myopathy (e.g. statins).
Refer to niraparib / abiraterone, prednisone drug monograph(s) for additional details.
Administration
- Administer each dose on an empty stomach, at least 1 hour before or 2 hours after food.
- Tablets should be swallowed whole with water. Do not break, crush, or chew tablets.
- If a dose is missed, the missed dose should be taken as soon as possible on the same day. Then, administer the next dose at the usual time on the next day. Do not give extra tablets to make up for the missed dose.
- Store at room temperature (15-30°C) in original container.
Contraindications
- Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/ Precautions
- Niraparib / abiraterone acetate contains lactose and should not be used in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
- The pivotal trial excluded patients with certain medical conditions including uncontrolled hypertension, clinically significant heart disease (e.g., myocardial infarction, thrombotic events within the past 6 months, severe or unstable angina, LVEF < 50%), or a history of adrenal dysfunction.
- Use with caution in patients with a history of cardiovascular disease. Cardiac function should be optimized before and during treatment of patients with a significant risk for congestive heart failure (e.g., a history of cardiac failure, or cardiac events such as ischemic heart disease).
- Niraparib / abiraterone acetate can cause hypokalemia and fluid retention due to mineralocorticoid excess from CYP17 inhibition. Use with caution in patients whose underlying medical conditions (e.g. QT prolongation) may be affected by these effects.
- Use with caution in patients concomitantly treated with medications known to reduce platelet counts due to the risk of thrombocytopenia.
- Caution is advised if patients need to be withdrawn from prednisone. Monitoring for adrenal insufficiency should occur.
- Adrenal insufficiency has been reported in patients taking abiraterone and prednisone. Increased corticosteroid dosage may be required before, during and after a stressful situation.
- Severe infections, including fatal outcomes, occurred more frequently in patients treated with niraparib / abiraterone. Severe infections may occur with or without neutropenia and/or leukopenia.
- Caution with driving or using machinery as dizziness may occur with treatment.
Pregnancy/ Lactation
- Niraparib / abiraterone acetate is only indicated in patients with prostate cancer. 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.
- Niraparib / abiraterone acetate is only indicated in patients with prostate cancer. There are no data on the presence of niraparib/abiraterone metabolites in human milk, or on the effects of the breastfed child or milk production.
- Fertility effects: Probable
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
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CBC; Baseline, weekly for the first month, then bi-weekly for 2 months, then monthly for the first year, then every other month thereafter. (Weekly monitoring for the second month maybe warranted based on individual laboratory values)
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Liver function tests; Baseline, every 2 weeks for 3 months, then monthly for the first year, then every other month thereafter
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Serum potassium; Baseline, monthly for the first year, then every other month thereafter
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Blood pressure and heart rate; Baseline, at least weekly for 2 months, then monthly for the first year, then every other month thereafter (More frequent monitoring may be required in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension)
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Fluid retention (weight gain, peripheral edema); Baseline, every 2 weeks for 3 months, then monthly thereafter
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Adrenal insufficiency; As clinically indicated when prednisone is withdrawn, or during periods of infection/stress
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Mineralocorticoid excess; As clinically indicated if patient continues on abiraterone after stopping prednisone
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Blood glucose levels; Baseline and as clinically indicated (especially in patients with diabetes)
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Clinical toxicity assessment for anemia, bleeding, infection, fatigue, hypersensitivity, secondary malignancy, venous thromboembolism, GI, cardiac, musculoskeletal, neurologic, or respiratory effects; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Symptoms of congestive heart failure; Baseline, every 2 weeks for 3 months, then monthly thereafter
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CADTH reimbursement recommendation. Niraparib-abiraterone (Akeega). February 2024.
Chi KN, Sandhu S, Smith MR, et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol 2023 Sep;34(9):772-82.
Niraparib / Abiraterone drug monograph, Ontario Health (Cancer Care Ontario).
June 2025 Updated to full regimen monograph
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.
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