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Zejula
niraparib
Adult Dosing .
Dosage forms: CAP: 100 mg; TAB: 100 mg, 200 mg, 300 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
ovarian CA, maintenance tx
- [first-line tx, <77 kg or Plt <150,000]
- Dose: 200 mg PO qd; Start: w/in 12wk of last platinum-based tx; Info: for platinum-sensitive advanced epithelial ovarian, fallopian tube, or primary peritoneal CA; do not open cap; do not cut/crush/chew tab
- [first-line tx, >77 kg and Plt >150,000]
- Dose: 300 mg PO qd; Start: w/in 12wk of last platinum-based tx; Info: for platinum-sensitive advanced epithelial ovarian, fallopian tube, or primary peritoneal CA; do not open cap; do not cut/crush/chew tab
- [recurrent dz]
- Dose: 300 mg PO qd; Start: w/in 8wk of last platinum-based tx; Info: for platinum-sensitive gBRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal CA; do not open cap; do not cut/crush/chew tab
homologous recombination deficiency-positive ovarian CA, advanced
- [indication withdrawn in US]
- Info: mfr has voluntarily withdrawn this indication in pts who have received 3 or more lines of chemo d/t potential survival detriment
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.5-3x ULN: start 200 mg qd; bilirubin >3x ULN: not defined
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
- avoid: breastfeeding during tx and x1mo after D/C
- caution: hypersensitivity to tartrazine (cap form)
- caution: pts of childbearing potential
- caution: cardiovascular dz
- caution: arrhythmia
- caution: HTN
Drug Interactions .
Overview
niraparib
PARP inhibitor
- MATE1 inhibitor
- MATE2-K inhibitor
- hypertensive effects
- myelosuppressive oncologic agent
Avoid/Use Alternative
- chloramphenicol
- cladribine oral
- deferiprone
- dexrazoxane
- dofetilide
- epinephrine inhaled
- fexinidazole
- furosemide
- ganciclovir
- midodrine
- palifermin
- penicillamine
- primaquine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- valganciclovir
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- albendazole
- albuterol
- albuterol inhaled
- alemtuzumab
- aliskiren
- allopurinol
- almotriptan
- amiloride
- amlodipine
- amphetamine
- angiotensin II
- anti-thymocyte globulin
- aprocitentan
- arformoterol inhaled
- armodafinil
- asciminib
- asenapine
- atenolol
- atidarsagene autotemcel
- atogepant
- atomoxetine
- atropine ophthalmic
- auranofin
- axitinib
- azathioprine
- azilsartan medoxomil
- balsalazide
- baricitinib
- benazepril
- benznidazole
- benzphetamine
- betamethasone
- betaxolol
- betibeglogene autotemcel
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brigatinib
- budesonide
- bumetanide
- bupropion
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- carvedilol
- celecoxib
- chlorothiazide
- chlorthalidone
- cidofovir
- clevidipine
- clonidine
- clozapine
- cocaine
- colchicine
- copanlisib
- corticotropin
- cortisone
- cyclophosphamide
- cyclosporine
- danazol
- dapsone
- darbepoetin alfa
- deferasirox
- deflazacort
- desmopressin
- desvenlafaxine
- deuruxolitinib
- dexamethasone
- dexmethylphenidate
- dextroamphetamine
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- dobutamine
- dopamine
- doxapram
- doxazosin
- dronabinol
- droxidopa
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- eletriptan
- elivaldogene autotemcel
- enalapril
- enalaprilat
- enzalutamide
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- everolimus
- exagamglogene autotemcel
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- filgrastim (G-CSF)
- fingolimod
- flucytosine
- fludrocortisone
- fluphenazine
- flurbiprofen
- formoterol inhaled
- foscarnet
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- galcanezumab
- givinostat
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- iloperidone
- indapamide
- indomethacin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irbesartan
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- leflunomide
- lenvatinib
- levalbuterol inhaled
- levomilnacipran
- licorice
- linezolid
- lisdexamfetamine
- lisinopril
- lonafarnib
- lorlatinib
- losartan
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- lumateperone
- luspatercept
- lymphocyte immune globulin, anti-thymocyte globulin
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- mercaptopurine
- mesalamine
- mesalamine rectal
- metformin
- methamphetamine
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- metoclopramide
- metolazone
- metoprolol
- milnacipran
- minoxidil
- mirabegron
- modafinil
- moexipril
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- nadolol
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nicardipine
- nifedipine
- nimodipine
- nisoldipine
- norepinephrine
- olmesartan medoxomil
- olodaterol inhaled
- olsalazine
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- pazopanib
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- perindopril
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- procainamide
- proguanil
- propranolol
- pseudoephedrine
- pyrimethamine
- quetiapine
- quinapril
- ramipril
- ramucirumab
- regorafenib
- ribavirin
- rifabutin
- rimegepant
- ripretinib
- rituximab
- rizatriptan
- ropinirole
- rotigotine transdermal
- ruxolitinib topical
- salmeterol inhaled
- salsalate
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selpercatinib
- siponimod
- sirolimus
- solriamfetol
- sorafenib
- spironolactone
- stiripentol
- succimer
- sulfasalazine
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tagraxofusp
- telmisartan
- teplizumab
- terazosin
- terbutaline
- teriflunomide
- testosterone
- thalidomide
- timolol
- tivozanib
- tocilizumab
- tofacitinib
- tolmetin
- torsemide
- trametinib
- trandolapril
- triamcinolone
- triamterene
- trimethoprim
- ubrogepant
- upadacitinib
- vadadustat
- valproic acid
- valsartan
- vamorolone
- vandetanib
- vasopressin
- venlafaxine
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- yohimbe
- zavegepant
- zidovudine
- ziv-aflibercept
- zolmitriptan
Caution Advised
- lamivudine
- memantine
- pramipexole
Adverse Reactions .
Serious Reactions
- AML
- myelodysplastic syndrome
- thrombocytopenia
- anemia
- neutropenia
- pancytopenia
- hypertensive crisis
- acute kidney injury
- hypersensitivity rxn
- anaphylaxis
- posterior reversible encephalopathy syndrome
- cognitive impairment
- hallucinations
- pneumonitis, non-infectious
- intestinal obstruction
- intestinal perforation
- photosensitivity
- pleural effusion
- cardiac arrest
Common Reactions
- nausea
- thrombocytopenia
- anemia
- fatigue
- constipation
- neutropenia
- vomiting
- headache
- insomnia
- leukopenia
- appetite decr.
- dyspnea
- HTN
- musculoskeletal pain
- dizziness
- cough
- ALT or AST elevated
- nasopharyngitis
- acute kidney injury
- rash
- mucositis
- dyspepsia
- back pain
- UTI
- anxiety
- palpitations
- xerostomia
- dysgeusia
- diarrhea
- alk phos incr.
- intestinal obstruction
- glucose incr.
- lymphocytes decr.
- Cr incr.
- magnesium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC w/ diff qwk x1mo, then qmo x11mo, then periodically; BP, HR at least qwk x2mo, then qmo x10mo, then periodically
Look/Sound-Alike Drug Names
niraparib confused with: neratinib; nilotinib
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity and embryo-fetal death based on animal data w/ other PARP inhibitors and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x6mo after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x1mo after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: hydrolysis primarily, glucuronidation; CYP450: none; UGT: substrate (enzymes not defined)
Excretion: urine 47.5% (11% unchanged), feces 38.8% (19% unchanged); Half-life: 36h
Subclass: PARP Inhibitors
Mechanism of Action
inhibits poly (ADP-ribose) polymerase (PARP) enzymes and increases PARP-DNA complex formation, resulting in DNA damage and cell death
Formulary .
No Formulary Selected
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