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AKEEGA is a brand name for Niraparib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PrAKEEGA® (niraparib and abiraterone acetate) is indicated with prednisone or prednisolone for: The treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations AKEEGA is a fixed-dose dual combination of niraparib and abiraterone acetate. Confirm presence of a BRCA mutation using a validated test prior to initiation of AKEEGA (see 14 CLINICAL TRIALS). 2 Recommended Dose and Dosage Adjustment The recommended dosage of AKEEGA is 200 mg niraparib and 1000 mg abiraterone acetate (two 100 mg/500 mg tablets), as a single daily dose that must be taken on an empty stomach at approximately the same time every day (see 4 DOSAGE AND ADMINISTRATION, Administration).
For dose reduction to 100 mg niraparib and 1000 mg abiraterone acetate, a low strength tablet (two 50 mg/ 500 mg tablets) is recommended (see 4 DOSAGE AND ADMINISTRATION, Dose Modification). If further dose reduction below 100 mg/day niraparib is required, discontinue AKEEGA.
Dosage of Prednisone or Prednisolone AKEEGA is used with 10 mg prednisone or prednisolone daily. Treatment Withdrawal Treatment should be continued until disease progression, unequivocal clinical progression, or unacceptable toxicity.
Dose Modification Hematologic Adverse Reactions The dose adjustment recommendations for anemia, thrombocytopenia and neutropenia are listed in Table 1 and in Table 2.
Table 1:
Dose Adjustment Recommendations for Anemia Grade 1 No change, consider weekly monitoring. Grade 2 At least weekly monitoring for 28 days, if baseline anemia was Grade ≤ 1. Grade ≥ 3 Withhold AKEEGA1 and switch to single agent abiraterone acetate plus prednisone (AAP).
Provide supportive management with monitoring at least weekly until recovered to Grade ≤ 2. Consider resuming AKEEGA at one dose-level reduction [two low strength (50 mg/500 mg) tablets] if anemia persists based on clinical judgment.
Second occurrence ≥ Grade 3 Withhold AKEEGA and switch to single agent AAP. Provide supportive management and monitor at least weekly until recovered to Grade ≤ 2. Further treatment with AKEEGA should restart at one dose-level reduction [two low strength (50 mg/500 mg) tablets].
Weekly monitoring is recommended for 28 days after resuming treatment with AKEEGA. If patient was already on a reduced dose [two low strength (50 mg/500 mg) tablets], consider treatment discontinuation. 0 Page 6 of 47 Protected B / Protégé B Third occurrence ≥ Grade 3 Consider discontinuing treatment with AKEEGA based on clinical judgment.
5%) in the placebo+AAP arm. For suspected MDS/AML or prolonged hematological toxicities that have not resolved with treatment interruption or dose reduction, the patient should be referred to a hematologist for further evaluation. If MDS and/or AML is confirmed, treatment with AKEEGA should be permanently discontinued.
0 Page 10 of 47 Protected B / Protégé B Cardiovascular AKEEGA should be used with caution in patients with a history of cardiovascular disease. , a history of cardiac failure, or cardiac events such as ischemic heart disease), cardiac failure should be treated, and cardiac function optimized.
Symptoms of congestive heart failure should be monitored every two weeks for three months, then monthly thereafter. The safety of AKEEGA in patients with clinically significant heart disease, as evidenced by myocardial infarction, arterial and venous thrombotic events in the past six months, severe or unstable angina, or NYHA Class II to IV heart failure or cardiac ejection fraction measurement of <50%, is unknown as these patients were excluded from the MAGNITUDE study.
Hypertension AKEEGA may cause hypertension. Pre-existing hypertension should be adequately controlled before starting AKEEGA treatment. Blood pressure should be monitored at least weekly for two months, monthly afterwards for the first year and every other month thereafter during treatment with AKEEGA.
2 Pharmacodynamics). Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions. Caution is required in treating patients whose underlying medical conditions might be compromised by hypokalemia.
QT prolongation has been observed in patients experiencing hypokalemia in association with AKEEGA treatment. Hypokalemia and fluid retention should be corrected and controlled. Fluid retention (weight gain, peripheral edema) should be monitored every two weeks for three months, then monthly thereafter and abnormalities corrected.
, Endocrine and Metabolism, Adrenocortical Insufficiency 03/2025 7 WARNINGS AND PRECAUTIONS, Infection 03/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics (<18 years of age)..................................................................................
2 Geriatrics (≥65 years of age) .................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Administration ....................................................................................................... 4 Missed Dose ..........................................................................................................
8 5 OVERDOSAGE............................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ...................................................................................
AKEEGA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 During AKEEGA treatment interruption, physician may consider giving abiraterone acetate and prednisone to maintain daily dose of abiraterone acetate (see abiraterone acetate product monograph). 1 Resume AKEEGA with recommendation of weekly monitoring for 28 days after restart.
First occurrence ≥ Grade 32 Withhold AKEEGA and switch to single agent AAP combination. 1 Then resume AKEEGA or, if warranted, at one dose-level reduction [two low strength (50 mg/500 mg) tablets]. Weekly monitoring of blood counts is recommended for 28 days after restarting dose.
Second occurrence ≥ Grade 3 Withhold AKEEGA and switch to single agent AAP combination. Monitor at least weekly until platelets and/or neutrophils recover to Grade 1. Further treatment with AKEEGA should restart at one dose-level reduction [two low strength (50 mg/500 mg) tablets].
Weekly monitoring is recommended for 28 days after resuming treatment with AKEEGA. If patient was already on a reduced dose [two low strength (50 mg/500 mg) tablets], consider treatment discontinuation. Third occurrence ≥ Grade 3 Permanently discontinue AKEEGA and switch to single agent AAP combination 1 During AKEEGA treatment interruption related to hematological toxicities, abiraterone acetate plus prednisone or prednisolone should be generally continued by the physician (see abiraterone acetate product monograph) 2 If patient requires platelet transfusion or has neutropenic fever or neutropenia requiring granulocyte-colony stimulating factor for Grade ≥3 AE deemed to be related to AKEEGA toxicity, interrupt study drug and restart at 1 dose-level reduction after resolution to Grade 1 or baseline.
If AKEEGA was previously dose-reduced for the same hematologic toxicity, discontinue AKEEGA Non-Hematologic Adverse Reactions For drug-related ≥Grade 3 toxicities, if the toxicity cannot be definitively attributed to either niraparib or abiraterone acetate only, then AKEEGA should be interrupted.
Treatment with AKEEGA must not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline. To resume treatment, initiate treatment with single AAP combination first. If there is continued resolution of the toxicity to baseline/Grade 1, then switch to treatment with AKEEGA at least 7 days after restarting AAP.
If a patient was on a reduced dose of AKEEGA (100mg/1000mg), AKEEGA must be discontinued for a Grade ≥ 3 treatment-related adverse reaction lasting more than 28 days. Permanently discontinue AKEEGA for treatment-related hypertensive crisis.
0 Page 7 of 47 Protected B / Protégé B Hepatotoxicity For patients who develop ≥Grade 3 hepatotoxicity (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above five times the upper limit of normal [ULN]), treatment with AKEEGA should be interrupted and liver function closely monitored.
Re-treatment may take place only after return of liver function tests to the patient’s baseline and at a reduced dose level of one regular strength AKEEGA tablet (equivalent to 100 mg niraparib and 500 mg abiraterone acetate). For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for […]
Venous Thromboembolic Events Venous thromboembolic events (VTE), including pulmonary embolism, have occurred in patients treated with AKEEGA (see 8 ADVERSE REACTIONS). Monitor patients for clinical signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.
Driving and Operating Machinery Patients who take AKEEGA may experience asthenia, fatigue, dizziness. AKEEGA may influence the ability to drive or use machines. Patients should use caution when driving or operating a vehicle or potentially dangerous machinery.
0 Page 11 of 47 Protected B / Protégé B prednisolone was administered to patients with pre-existing diabetes receiving pioglitazone or repaglinide (see
1 Special Populations.............................................................................................. 1 Pregnant Women ............................................................................................ 3 Pediatrics (<18 years of age) ............................................................................
4 Geriatrics (≥65 years of age) ............................................................................ 14 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview .................................................................................
2 Clinical Trial Adverse Reactions ........................................................................... 3 Less Common Clinical Trial Adverse Reactions .................................................... 0 Page 3 of 47 Protected B / Protégé B Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions .......................................................................... 19 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview .................................................................................
3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 23 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action........................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
25 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 28 PART II: SCIENTIFIC INFORMATION ........................................................................................
29 13 PHARMACEUTICAL INFORMATION ............................................................................. 29 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .................................................................................. 30 15 MICROBIOLOGY .........................................................................................................
37 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 37 PATIENT MEDICATION INFORMATION ...................................................................................
0 Page 4 of 47 Protected B / Protégé B PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PrAKEEGA® (niraparib and abiraterone acetate) is […]