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Ziihera (zanidatamab-hrii)
zanidatamab
Black Box Warnings .
Embryo-Fetal Toxicity
exposure during pregnancy or within 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 with 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
Monitor/Modify Tx
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 with 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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