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Akeega
niraparib/ abiraterone acetate
Adult Dosing .
Dosage forms: TAB: 50 mg/500 mg, 100 mg/500 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
BRCA-mutated prostate CA, metastatic
- [castration-sensitive disease]
- Dose: 200 mg/1000 mg PO qd; Info: use with prednisone 5 mg PO daily; also use with GnRH analog in patients without bilateral orchiectomy; give at least 1h before or 2h after meals; do not cut/crush/chew tab
- [castration-resistant disease]
- Dose: 200 mg/1000 mg PO qd; Info: use with prednisone 10 mg PO daily; also use with GnRH analog in patients without bilateral orchiectomy; give at least 1h before or 2h after meals; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class B or C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- incomplete hematologic toxicity recovery after prior chemo use
- HTN, uncontrolled
- hypokalemia
- hepatic impairment, Child-Pugh Class B-C
- avoid: handling drug (pregnant or potentially pregnant individuals)
- avoid: Ra-223 use during and for at least 5 days after D/C
- caution: CrCl <30
- caution: cardiovascular disease
- caution: heart failure
- caution: MI, recent
- caution: ventricular arrhythmia
- caution: adrenal insufficiency
- caution: hypoglycemia risk
Drug Interactions .
Overview
abiraterone acetate
antiandrogen
- CYP3A4 substrate
- CYP2C8 inhibitor, weak
- CYP2D6 inhibitor, moderate
- hypertensive effects
- hypokalemia
- rhabdomyolysis
niraparib
PARP inhibitor
- MATE1 inhibitor
- MATE2-K inhibitor
- hypertensive effects
- myelosuppressive oncologic agent
Contraindicated
- eliglustat
- thioridazine
Avoid/Use Alternative
- amphetamine
- apalutamide
- arsenic trioxide
- butalbital
- carbamazepine
- chloramphenicol
- cladribine oral
- codeine
- deferiprone
- dexrazoxane
- dextroamphetamine
- dihydrocodeine
- dofetilide
- doxorubicin
- encorafenib
- enzalutamide
- epinephrine inhaled
- fexinidazole
- fosphenytoin
- furosemide
- ganciclovir
- ivosidenib
- lisdexamfetamine
- lumacaftor/ivacaftor
- methadone
- midodrine
- mitotane
- oliceridine
- palifermin
- penicillamine
- pentobarbital
- phenobarbital
- phenytoin
- pimozide
- pirfenidone
- primaquine
- primidone
- propafenone
- radium Ra 223 dichloride
- red yeast rice
- rifabutin
- rifampin
- ropeginterferon alfa-2b
- spironolactone
- St. John's wort
- tamsulosin
- tramadol
- valganciclovir
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- acetazolamide
- albendazole
- albuterol
- albuterol inhaled
- alemtuzumab
- aliskiren
- allopurinol
- almotriptan
- aloe
- amiloride
- amiodarone
- amlodipine
- amphotericin
- angiotensin II
- anti-thymocyte globulin
- aprocitentan
- arformoterol inhaled
- aripiprazole oral
- armodafinil
- asciminib
- asparaginase
- atenolol
- atidarsagene autotemcel
- atogepant
- atomoxetine
- atorvastatin
- atropine ophthalmic
- auranofin
- axitinib
- azathioprine
- azilsartan medoxomil
- balsalazide
- baricitinib
- benazepril
- benznidazole
- benzphetamine
- betamethasone
- betaxolol
- betibeglogene autotemcel
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- bosentan
- brexpiprazole
- brigatinib
- budesonide
- bumetanide
- bupropion
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- carvedilol
- celecoxib
- cenobamate
- cetuximab
- chlorothiazide
- chlorthalidone
- cidofovir
- cisplatin
- clevidipine
- clonidine
- clozapine
- cocaine
- colchicine
- copanlisib
- copper histidinate
- corticotropin
- cortisone
- crizotinib
- cyclophosphamide
- cyclosporine
- dabrafenib
- danazol
- dapsone
- darbepoetin alfa
- decitabine
- deferasirox
- deflazacort
- desipramine
- desmopressin
- desvenlafaxine
- deuruxolitinib
- deutetrabenazine
- dexamethasone
- dexmethylphenidate
- dichlorphenamide
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- digoxin
- dihydroergotamine
- diltiazem
- dinutuximab
- dobutamine
- dopamine
- doxapram
- doxazosin
- dronabinol
- droxidopa
- efavirenz
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- eletriptan
- elivaldogene autotemcel
- emapalumab
- enalapril
- enalaprilat
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- etravirine
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- filgrastim (G-CSF)
- fingolimod
- flecainide
- flucytosine
- fludrocortisone
- fluphenazine
- flurbiprofen
- fluvastatin
- formoterol inhaled
- foscarnet
- fosfomycin injection
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- galcanezumab
- givinostat
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- iloperidone
- imipramine
- indapamide
- indomethacin
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irbesartan
- isoproterenol
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- leflunomide
- lenalidomide
- lenvatinib
- levalbuterol inhaled
- levomilnacipran
- licorice
- linezolid
- lisinopril
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- losartan
- lovastatin
- lovotibeglogene autotemcel
- luspatercept
- lymphocyte immune globulin, anti-thymocyte globulin
- magnesium citrate
- magnesium salicylate
- mannitol
- mavacamten
- meclofenamate
- mefenamic acid
- meloxicam
- mercaptopurine
- mesalamine
- mesalamine rectal
- metformin
- methamphetamine
- methazolamide
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- mifepristone
- milnacipran
- milsaperidone
- minoxidil
- mirabegron
- mitapivat
- modafinil
- moexipril
- motixafortide
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- nadolol
- nafcillin
- naproxen
- naratriptan
- naxitamab
- nebivolol
- necitumumab
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- nortriptyline
- obinutuzumab
- olmesartan medoxomil
- olodaterol inhaled
- olsalazine
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- paclitaxel
- pacritinib
- pamidronate
- panitumumab
- pazopanib
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- perindopril
- perphenazine
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- pioglitazone
- piroxicam
- pitavastatin
- pitolisant
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- ponesimod
- posaconazole
- pralsetinib
- pravastatin
- prazosin
- prednisolone
- prednisone
- procainamide
- proguanil
- propranolol
- pseudoephedrine
- pyrimethamine
- quetiapine
- quinapril
- ramipril
- ramucirumab
- regorafenib
- repaglinide
- repotrectinib
- ribavirin
- rifapentine
- rimegepant
- ripretinib
- rituximab
- rizatriptan
- ropinirole
- rosiglitazone
- rosuvastatin
- rotigotine transdermal
- ruxolitinib topical
- sacituzumab govitecan
- salmeterol inhaled
- salsalate
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selinexor
- selpercatinib
- simvastatin
- siponimod
- sirolimus
- sirolimus albumin-bound
- sodium benzoate
- sodium phenylacetate
- sodium phenylbutyrate
- sodium polystyrene sulfonate
- sodium thiosulfate
- solriamfetol
- sorafenib
- sotorasib
- stiripentol
- succimer
- sulfasalazine
- sulfate bowel prep
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tafasitamab
- tagraxofusp
- telmisartan
- teplizumab
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrabenazine
- thalidomide
- timolol
- tivozanib
- tocilizumab
- tofacitinib
- tolmetin
- topiramate
- torsemide
- trametinib
- trandolapril
- triamcinolone
- triamterene
- trimethoprim
- ubrogepant
- upadacitinib
- vadadustat
- valproic acid
- valsartan
- vamorolone
- vancomycin
- vandetanib
- vasopressin
- venlafaxine
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- yohimbe
- zavegepant
- zidovudine
- ziv-aflibercept
- zolmitriptan
- zonisamide
Caution Advised
- lamivudine
- memantine
- pramipexole
- tamoxifen
- vortioxetine
Adverse Reactions .
Serious Reactions
- AML
- myelodysplastic syndrome
- anemia
- thrombocytopenia
- neutropenia
- infection, serious
- hemorrhage
- fluid retention, severe
- hypokalemia
- QT prolongation
- torsades de pointes
- arrhythmia
- stroke
- pulmonary embolism
- DVT
- HTN
- hypertensive crisis
- cardiopulmonary arrest
- cardiac failure
- ischemic heart disease
- hepatotoxicity
- hepatitis, fulminant
- hepatic failure, acute
- acute kidney injury
- adrenal insufficiency
- fractures (in combo with radium Ra 223 dichloride)
- mortality incr. (in combo with radium Ra 223 dichloride)
- posterior reversible encephalopathy syndrome
- rhabdomyolysis
Common Reactions
- musculoskeletal pain
- fatigue
- constipation
- HTN
- nausea
- edema
- dyspnea
- appetite decr.
- vomiting
- dizziness
- infection
- abdominal pain
- hemorrhage
- headache
- cough
- insomnia
- weight loss
- arrhythmia
- hot flashes
- diarrhea
- cardiac failure
- ischemic heart disease
- fever
- rash
- stroke
- pulmonary embolism
- DVT
- acute kidney injury
- ALT or AST incr.
- Hgb decr.
- lymphocytes decr.
- Plt decr.
- alk phos incr.
- neutrophils decr.
- Cr incr.
- potassium incr.
- potassium decr.
- bilirubin incr.
Safety/Monitoring .
Monitoring Parameters
CBC with diff at baseline, qwk x1mo, then q2wk x2mo, then qmo x9mo, then q2mo and as clinically indicated; BP, K at baseline, then at least qwk x2mo, then qmo; LFTs at baseline, then q2wk x3mo, then qmo; signs/symptoms of edema at least qwk x2mo, then qmo; adrenal function; glucose during and after tx if diabetes
Pregnancy/Lactation .
Pregnancy
Clinical Summary
while not indicated in female patients, pregnant individuals should avoid handling drug because of potential absorption through skin; risk of fetal harm based on animal data
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x4mo after D/C in male patients
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: for niraparib: hydrolysis primarily, glucuronidation; CYP450: none; UGT: substrate (enzymes not defined); for abiraterone acetate: liver; CYP450: 3A4 substrate
Excretion: for niraparib: urine 47.5% (11% unchanged), feces 38.8% (19% unchanged); Half-life: 36h; for abiraterone acetate: feces 88% (55% unchanged), urine 5%; Half-life: 12h
Subclass: Hormonal Oncologics, Antiandrogens ; PARP Inhibitors
Mechanism of Action
for niraparib: inhibits poly (ADP-ribose) polymerase (PARP) enzymes and increases PARP-DNA complex formation, resulting in DNA damage and cell death; for abiraterone acetate: prodrug converted to abiraterone, which inhibits 17 alpha-hydroxylase/C17,20-lyase (CYP17) to block androgen biosynthesis, leading to decr. androgen-sensitive tumor growth (androgen biosynthesis inhibitor)
Formulary .
No Formulary Selected
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