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Akeega is a brand name for Niraparib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Akeega is indicated with prednisone or prednisolone: in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic). for the treatment of adult patients with metastatic…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Akeega plus prednisone or prednisolone should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. 1). 1). 3 Posology The recommended starting dose of Akeega is 200 mg/1 000 mg (two 100 mg niraparib/500 mg abiraterone acetate tablets), as a single daily dose at approximately the same time every day (see “Method of administration” below).
The 50 mg/500 mg tablet is available for dose reduction. Medical castration with a gonadotropin-releasing hormone (GnRH) analogue should be continued during treatment in patients not surgically castrated. Dosage of prednisone or prednisolone Akeega is used with prednisone or prednisolone 5 mg daily for mHSPC.
Akeega is used with prednisone or prednisolone 10 mg daily for mCRPC. Duration of treatment Patients should be treated until disease progression or unacceptable toxicity. Missed dose If a dose of either Akeega, prednisone or prednisolone is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.
Extra tablets must not be taken to make up for the missed dose. 4). Treatment with Akeega should not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline. Haematological adverse reactions For patients who develop a ≥ Grade 3 or intolerable haematological toxicity, dosing with Akeega should be interrupted rather than discontinued and supportive management considered.
Akeega should be permanently discontinued if haematological toxicity has not returned to acceptable levels within 28 days of the dose interruption period. The dose adjustment recommendations for thrombocytopenia and neutropenia are listed in Table 1.
1 Resume Akeega with recommendation of weekly monitoring for 28 days after restarting dose. 1 Then resume Akeega or, if warranted, use two lower strength tablets (50 mg/500 mg). Weekly monitoring of blood counts is recommended for 28 days after restarting dose or starting the lower strength dose (two 50 mg/500 mg tablets).
When starting the lower strength dose, please refer to “Recommended monitoring” below for further information regarding liver function. Second occurrence ≥ grade 3 Withhold Akeega and monitor at least weekly until platelets and/or neutrophils recover to Grade 1.
8. For Grade ≥ 3 anaemia, Akeega should be interrupted and supportive management provided until recovered to Grade ≤ 2. Dose reduction (two 50 mg/500 mg tablets) should be considered if anaemia persists based on clinical judgment. The dose adjustment recommendations for anaemia are listed in Table 2.
Table 2:
Dose adjustment recommendations for anaemia Grade 1 No change, consider weekly monitoring. Grade 2 At least weekly monitoring for 28 days, if baseline anaemia was Grade ≤ 1. Grade ≥ 3 Withhold Akeega1 and provide supportive management with monitoring at least weekly until recovered to Grade ≤ 2.
Dose reduction [two lower strength tablets (50 mg/500 mg)] should be considered if anaemia persists based on clinical judgment. When starting the lower strength dose, please refer to “Recommended monitoring” below for further information regarding liver function.
Second occurrence ≥ Grade 3 Withhold Akeega, provide supportive management and monitor at least weekly until recovered to Grade ≤ 2. Further treatment should restart with two lower strength tablets (50 mg/500 mg). Weekly monitoring is recommended for 28 days after resuming treatment with lower strength Akeega.
When starting the lower strength dose, please refer to “Recommended monitoring” below for further information regarding liver function. If patient was already on lower strength Akeega tablet (50 mg/500 mg), consider treatment discontinuation.
Third occurrence ≥ Grade 3 Consider discontinuing treatment with Akeega based on clinical judgment. 1 During Akeega treatment interruption, abiraterone acetate and prednisone or prednisolone may be considered by the physician and given to maintain daily dose of abiraterone acetate (see abiraterone acetate prescribing information).
2). 2). Based on individual laboratory values, weekly monitoring for the second month may be warranted. If a patient develops severe persistent haematological toxicity including pancytopenia that does not resolve within 28 days following interruption, Akeega should be discontinued.
8). 2). Hypertension Akeega may cause hypertension and pre-existing hypertension should be adequately controlled before starting Akeega treatment. Blood pressure should be monitored at least weekly for two months, monitored monthly afterwards for the first year and every other month thereafter during treatment with Akeega.
1). Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions. , those with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment).
QT prolongation has been observed in patients experiencing hypokalaemia in association with Akeega treatment. Hypokalaemia and fluid retention should be corrected and controlled. , a history of cardiac failure, or cardiac events such as ischaemic heart disease), cardiac failure should be treated and cardiac function optimised.
Fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure should be monitored every two weeks for three months, then monthly thereafter and abnormalities corrected. Akeega should be used with caution in patients with a history of cardiovascular disease.
Management of cardiac risk factors (including hypertension, dyslipidaemia, and diabetes) should be optimised in patients receiving Akeega and these patients should be monitored for signs and symptoms of cardiac disease. Abiraterone acetate, a component of Akeega, increases mineralocorticoid levels and carries a risk for cardiovascular events.
1. 6). 2)]. Akeega plus prednisone or prednisolone is contraindicated in combination with Ra-223 treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Further treatment should restart with two lower strength tablets (50 mg/500 mg). Weekly monitoring is recommended for 28 days after resuming treatment with lower strength Akeega. When starting the lower strength dose (two 4 50 mg/500 mg tablets), please refer to “Recommended monitoring” below for further information regarding liver function.
If patient was already on lower strength Akeega tablet (50 mg/500 mg), consider treatment discontinuation. Third occurrence ≥ grade 3 Permanently discontinue treatment. 1 During Akeega treatment interruption, abiraterone acetate and prednisone or prednisolone may be considered by the physician and given to maintain daily dose of abiraterone acetate (see abiraterone acetate prescribing information).
Further dosing with Akeega may be resumed only when toxicity due to thrombocytopenia and neutropenia is improved to Grade 1 or resolved to baseline. Treatment may resume at a lower strength of Akeega 50 mg/500 mg (2 tablets). 8. For Grade ≥ 3 anaemia, Akeega should be interrupted and supportive management provided until recovered to Grade ≤ 2.
Dose reduction (two 50 mg/500 mg tablets) should be considered if anaemia persists based on clinical judgment. The dose adjustment recommendations for anaemia are listed in Table 2.
Table 2:
Dose adjustment recommendations for anaemia Grade 1 No change, consider weekly monitoring. Grade 2 At least weekly monitoring for 28 days, if baseline anaemia was Grade ≤ 1. Grade ≥ 3 Withhold Akeega1 and provide supportive management with monitoring at least weekly until recovered to Grade ≤ 2.
Dose reduction [two lower strength tablets (50 mg/500 mg)] should be considered if anaemia persists based on clinical judgment. When starting the lower strength dose, please refer to “Recommended monitoring” below for further information regarding liver function.
Second occurrence ≥ Grade 3 Withhold Akeega, provide supportive management and monitor at least weekly until recovered to Grade ≤ 2. Further treatment should restart with two lower strength tablets (50 mg/500 mg). Weekly monitoring is recommended for 28 days after resuming treatment with lower strength Akeega.
When starting the lower strength dose, please refer to “Recommended monitoring” below for further information regarding liver function. If patient was already on lower strength Akeega tablet (50 mg/500 mg), consider treatment discontinuation.
Third occurrence ≥ Grade 3 Consider discontinuing treatment with Akeega based on clinical judgment. 1 During Akeega treatment interruption, abiraterone acetate and prednisone or prednisolone may be considered by the physician and given to maintain daily dose of abiraterone acetate (see abiraterone acetate prescribing information).
Hepatotoxicity For patients who develop […]
4). 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/500 mg abiraterone acetate). For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for three months and monthly thereafter.
If hepatotoxicity recurs at the reduced dose of 100 mg/500 mg daily (1 tablet), treatment with Akeega should be discontinued. 5 If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) while on Akeega, treatment should be permanently discontinued.
4). 4). Serum aminotransferases and total bilirubin should be measured prior to starting treatment, every two weeks for the first three months of treatment and monthly thereafter for the first year and then every other month for the duration of treatment.
2), before resuming regular monitoring. 4). Blood pressure monitoring should occur weekly for the first two months, monthly for the first year and then every other month for the duration of treatment. 0 mM. 2). Hepatic impairment No dose adjustment is necessary for patients with pre-existing mild hepatic impairment (Child-Pugh Class A).
There are no data on the clinical safety and efficacy of multiple doses of Akeega when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). No dose adjustment can be predicted. 2). 2). Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment, although close monitoring of safety events should be conducted with moderate renal impairment due to the potential for increased niraparib exposure.
There are no data on the use of Akeega in patients with severe renal impairment or end stage renal disease undergoing haemodialysis. 2). Paediatric population There is no relevant use of Akeega in the paediatric population. Method of administration Akeega is for oral use.
The tablets must be taken as a single dose, once daily. 2). For optimal absorption, Akeega tablets must be […]
Mineralocorticoid excess may cause hypertension, hypokalaemia, and fluid retention. Previous ADT exposure as well as advanced age are additional risks for cardiovascular morbidity and mortality. The AMPLITUDE and MAGNITUDE studies excluded patients with clinically significant heart disease as evidenced by myocardial infarction, arterial and venous thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class II to IV heart failure or cardiac ejection fraction measurement of < 50%.
Patients with a history of cardiac failure should be clinically optimised and appropriate management of symptoms instituted. If there is a clinically significant decrease in cardiac function, discontinuation of Akeega should be considered.
Infections In both the AMPLITUDE and MAGNITUDE studies, severe infections including COVID-19 infections with fatal outcome occurred more frequently in patients treated with Akeega. Patients should be monitored for signs and symptoms of infection.
Severe infections may occur in absence of neutropenia and/or leukopenia. Pulmonary embolism (PE) In both the AMPLITUDE and MAGNITUDE studies, cases of PE were reported in patients treated with Akeega with a higher frequency compared to control.
Patients with a prior history of PE or venous thrombosis may be more at risk of a further occurrence. Patients should be monitored for clinical signs and symptoms of PE. If clinical features of PE occur, patients should be evaluated promptly, followed by appropriate treatment.
Posterior reversible encephalopathy syndrome (PRES) PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). There have been reports of PRES in patients receiving 300 mg niraparib (a component of Akeega) as a monotherapy in the ovarian cancer population.
In both the AMPLITUDE and MAGNITUDE studies, among prostate cancer patients treated with 200 mg of niraparib, there were no PRES cases reported. In case of PRES, treatment with Akeega should be permanently discontinued and appropriate medical management should be instituted.
Hepatotoxicity and hepatic impairment Hepatotoxicity had been recognised as an important identified risk for abiraterone acetate, a component of Akeega. The mechanism for hepatotoxicity of abiraterone acetate is not fully […]