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Ziihera (zanidatamab-hrii)
zanidatamab
Black Box Warnings .
Embryo-Fetal Toxicity
exposure during pregnancy or w/in 4mo prior to conception can result in embryo-fetal harm, including oligohydramnios; advise patients of risks and need for effective contraception
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = zanidatamab-hrii
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing including toxicity-related dose adjustments
HER2-positive biliary tract CA, unresectable or metastatic
- [20 mg/kg/dose IV q2wk]
- Info: for patients w/ IHC3+ disease who have received prior tx
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x4mo after D/C
- caution: patients of childbearing potential
Drug Interactions .
Overview
zanidatamab
HER2-directed antibody
- cardiotoxic effects
- immunomodulatory effects
Avoid/Use Alternative
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- epirubicin
- idarubicin
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rabies vaccine
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Monitor/Modify Tx
- adalimumab
- ado-trastuzumab emtansine
- aficamten
- aldesleukin
- alogliptin
- anagrelide
- anthrax vaccine
- asciminib
- avelumab
- axitinib
- bevacizumab
- bezlotoxumab
- binimetinib
- bortezomib
- bosutinib
- capecitabine
- carfilzomib
- certolizumab pegol
- chikungunya vaccine
- cilostazol
- clozapine
- cobimetinib
- COVID-19 vaccine
- cyclophosphamide
- dabrafenib
- daunorubicin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- doxorubicin
- dronedarone
- ebola vaccine, live
- encorafenib
- entrectinib
- etanercept
- fam-trastuzumab deruxtecan
- fluorouracil
- golimumab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- ibrutinib
- ifosfamide
- imatinib
- infliximab
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- itraconazole
- Japanese encephalitis vaccine
- lapatinib
- lenvatinib
- linagliptin
- margetuximab
- mavacamten
- meningococcal vaccine
- mirdametinib
- mitoxantrone
- mobocertinib
- osimertinib
- pazopanib
- peginterferon beta 1a
- pertuzumab
- pioglitazone
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- propafenone
- respiratory syncytial virus vaccine
- ripretinib
- ropeginterferon alfa-2b
- rosiglitazone
- saxagliptin
- selumetinib
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- sunitinib
- tick-borne encephalitis vaccine
- tivozanib
- trabectedin
- trametinib
- trastuzumab
- typhoid vaccine
- vandetanib
- zenocutuzumab
- zongertinib
Adverse Reactions .
Serious Reactions
- left ventricular dysfunction
- infusion reaction
- diarrhea
- gastric obstruction
- biliary obstruction
- biliary tract infection
- sepsis
- pneumonia
- pneumonitis
Common Reactions
- diarrhea
- infusion reaction
- abdominal pain
- fatigue
- rash
- nausea
- appetite decr.
- vomiting
- Hgb decr.
- LDH incr.
- albumin decr.
- ALT or AST incr.
- lymphocytes decr.
- alk phos incr.
- sodium decr.
- potassium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; cardiac assessment including LVEF prior to tx start, then regularly during tx; signs/symptoms of infusion reaction during infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available, though risk of fetal harm, including oligohydramnios and oligohydramnios sequence, based on limited human data w/ HER2-directed antibody 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 x4mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for zanidatamab: catabolism; CYP450: unknown
Excretion: for zanidatamab: unknown; Half-life: 21 days
Subclass: HER2 Antagonists ; Immunotherapy, HER2 Inhibitors
Mechanism of Action
for zanidatamab: binds to two extracellular HER2 domains, resulting in HER2 internalization, downregulation, and tumor growth inhibition, inducing cell death via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis
Formulary .
No Formulary Selected
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