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Komzifti
ziftomenib
Black Box Warnings .
Differentiation Syndrome
incl. fatal or life-threatening cases, occurred in 26% of patients; reduce WBC to <25,000 before tx start; signs/symptoms incl. fever, joint pain, hypotension, hypoxia, dyspnea, rapid wt gain, peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, or rashes; if suspected, initiate corticosteroids and hemodynamic monitoring for minimum of 3 days and until symptoms resolved
Adult Dosing .
Dosage forms: CAP: 200 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
NPM1-mutated AML, relapsed or refractory
- [600 mg PO qd for at least 6mo]
- Info: for patients w/ no alternative tx options; give 1h before or 2h after meal; do not open/crush/chew cap
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; 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
- WBC >25,000
- electrolyte abnormalities, uncorrected
- QTc >480 msec
- avoid: breastfeeding during tx and x2wk after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: long QT syndrome, congenital
- caution: CHF
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
Drug Interactions .
Overview
ziftomenib
- CYP3A4 substrate
- CYP3A4 inhibitor, weak
- gastric pH sensitive
- immunomodulatory effects
- prolongs QT interval (known)
- content coming soon
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- cisapride
- dengue vaccine, live
- domperidone
- dronedarone
- eliglustat
- influenza nasal vaccine, live
- levoketoconazole
- measles/mumps/rubella vaccine, live
- pimozide
- rotavirus vaccine, live
- smallpox vaccine, live
- thioridazine
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adagrasib
- alprazolam
- aluminum hydroxide
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- azithromycin
- bedaquiline
- bosentan
- butalbital
- cabozantinib
- calcium carbonate
- carbamazepine
- cenobamate
- ceritinib
- chloroquine
- cimetidine
- citalopram
- clarithromycin
- clofazimine
- codeine
- colchicine
- crizotinib
- dabrafenib
- degarelix
- desflurane
- desipramine
- dexlansoprazole
- dexmedetomidine
- dexmedetomidine injection
- disopyramide
- dofetilide
- donepezil
- dordaviprone
- droperidol
- efavirenz
- encorafenib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- esomeprazole
- etravirine
- famotidine
- fexinidazole
- flecainide
- fluorouracil
- fluoxetine
- foscarnet
- fosfomycin injection
- fosphenytoin
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibutilide
- iloperidone
- inotuzumab ozogamicin
- isoflurane
- ivabradine
- ivosidenib
- lansoprazole
- lefamulin
- leuprolide
- levofloxacin
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- macimorelin
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- mavacamten
- meperidine
- methadone
- mifepristone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- moxifloxacin
- nafcillin
- nilotinib
- nizatidine
- oliceridine
- omeprazole
- ondansetron
- osimertinib
- oxaliplatin
- oxycodone
- ozanimod
- pacritinib
- paliperidone
- palonosetron
- panobinostat
- pantoprazole
- pasireotide
- pazopanib
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pitolisant
- ponesimod
- pralsetinib
- primidone
- procainamide
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- rabeprazole
- rabies vaccine
- repotrectinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- romidepsin
- rucaparib
- sertraline
- sevoflurane
- simvastatin
- siponimod
- sodium bicarbonate
- sodium citrate
- sodium zirconium cyclosilicate
- solifenacin
- sorafenib
- sotalol
- sotorasib
- St. John's wort
- taletrectinib
- telavancin
- tetrabenazine
- toremifene
- tramadol
- trazodone
- triclabendazole
- trifluridine
- triptorelin
- vandetanib
- vemurafenib
- vonoprazan
- ziprasidone
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- albuterol
- albuterol inhaled
- alfentanil
- alfuzosin
- amisulpride
- amitriptyline
- anthrax vaccine
- aprepitant
- arformoterol inhaled
- asciminib
- atazanavir
- avacopan
- avanafil
- avapritinib
- berotralstat
- brigatinib
- buprenorphine
- capivasertib
- chikungunya vaccine
- chloramphenicol
- chlorpromazine
- ciprofloxacin
- clomipramine
- clozapine
- cobicistat
- conivaptan
- COVID-19 vaccine
- cyclosporine
- danazol
- darunavir
- dasatinib
- deutetrabenazine
- diltiazem
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- docetaxel
- duvelisib
- ebola vaccine, live
- escitalopram
- etrasimod
- everolimus
- fedratinib
- felodipine
- fentanyl
- finerenone
- fingolimod
- flibanserin
- fluconazole
- formoterol inhaled
- fosamprenavir
- fostemsavir
- gemtuzumab ozogamicin
- gepirone
- granisetron
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- ibrutinib
- idelalisib
- imatinib
- influenza H5N1 vaccine
- influenza vaccine
- isavuconazonium
- itraconazole
- ixabepilone
- Japanese encephalitis vaccine
- ketoconazole
- lapatinib
- lemborexant
- lenacapavir
- lenvatinib
- letermovir
- levalbuterol inhaled
- lomitapide
- loperamide
- lovastatin
- lumateperone
- lurasidone
- lurbinectedin
- mavorixafor
- mefloquine
- meningococcal vaccine
- metronidazole
- midazolam
- midostaurin
- mirtazapine
- nefazodone
- nelfinavir
- netupitant
- nifedipine
- nimodipine
- nirogacestat
- nisoldipine
- ofloxacin
- olodaterol inhaled
- osilodrostat
- pemigatinib
- pneumococcal vaccine
- poliovirus vaccine
- posaconazole
- primaquine
- promethazine
- ranolazine
- red yeast rice
- relugolix
- respiratory syncytial virus vaccine
- rilzabrutinib
- ritonavir
- sacituzumab govitecan
- salmeterol inhaled
- sebetralstat
- selpercatinib
- selumetinib
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sufentanil
- sunitinib
- tacrolimus
- tadalafil
- tazemetostat
- temsirolimus
- terbutaline
- tick-borne encephalitis vaccine
- tipranavir
- tolterodine
- tolvaptan
- triazolam
- tucatinib
- typhoid vaccine
- ubrogepant
- valbenazine
- vardenafil
- venetoclax
- venlafaxine
- verapamil
- vilanterol inhaled
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- voriconazole
- warfarin
- zanubrutinib
Caution Advised
- armodafinil
- belzutifan
- bexarotene
- cariprazine
- clobazam
- cobimetinib
- cyclophosphamide
- danshen
- daridorexant
- darolutamide
- dexamethasone
- dicloxacillin
- dihydroergotamine
- echinacea
- elafibranor
- elagolix
- elinzanetant
- enasidenib
- eplerenone
- ergotamine
- eslicarbazepine acetate
- felbamate
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- meropenem
- methylergonovine
- nevirapine
- odevixibat
- olutasidenib
- omaveloxolone
- oxcarbazepine
- palovarotene
- perampanel
- pioglitazone
- prednisone
- roflumilast
- roflumilast topical
- rufinamide
- sarilumab
- sirolimus topical
- stiripentol
- sunvozertinib
- suzetrigine
- tecovirimat
- telotristat ethyl
- tocilizumab
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- vorasidenib
Adverse Reactions .
Serious Reactions
- differentiation syndrome
- hypotension
- hypoxia
- dyspnea
- pleural effusion
- pericardial effusion
- pulmonary infiltrates
- acute kidney injury
- QT prolongation
- infection
- febrile neutropenia
- hemorrhage
Common Reactions
- infection
- hemorrhage
- diarrhea
- nausea
- fatigue
- edema
- musculoskeletal pain
- differentiation syndrome
- pruritus
- febrile neutropenia
- ALT or AST incr.
- renal impairment
- leukocytosis
- QT prolongation
- HTN
- hypoxia
- potassium decr.
- albumin decr.
- sodium decr.
- Cr incr.
- alk phos incr.
- bilirubin incr.
- potassium incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test before tx start; CBC w/ diff, chemistry profile at baseline; ECG at baseline, then at least qwk x4wk, then at least qmo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, incl. embryo-fetal death, malformations, and decr. fetal wt based on animal data at 0.3x systemic exposure 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 patients of childbearing potential and during tx and x3mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x2wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: 3A substrate
Excretion: feces 86% (73% unchanged), urine 0.5% (0.03% unchanged); Half-life: 93.6h
Subclass: Menin Inhibitors
Mechanism of Action
inhibits menin-KMT2A binding interaction, inducing differentiation of leukemic cells
Formulary .
No Formulary Selected
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