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Hernexeos
zongertinib
Adult Dosing .
Dosage forms: TAB: 60 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
HER2-mutant nonsquamous non-small cell lung CA, unresectable or metastatic
- [<90 kg]
- Dose: 120 mg PO qd; Info: for patients w/ previously treated dz w/ HER2 tyrosine kinase domain activating mutations; do not cut/crush/chew tab
- [>90 kg]
- Dose: 180 mg PO qd; Info: for patients w/ previously treated dz w/ HER2 tyrosine kinase domain activating mutations; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x 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 x2wk after D/C
- caution: patients of childbearing potential
Drug Interactions .
Overview
zongertinib
HER2 kinase inhibitor
- CYP3A4 substrate
- BCRP inhibitor
- cardiotoxic effects
- immunosuppressive effects
Avoid/Use Alternative
- adenovirus vaccine, live
- alpelisib
- apalutamide
- butalbital
- carbamazepine
- chikungunya vaccine, live
- cholera vaccine, live
- cladribine oral
- dengue vaccine, live
- encorafenib
- enzalutamide
- epirubicin
- fosphenytoin
- idarubicin
- influenza nasal vaccine, live
- ivosidenib
- lumacaftor/ivacaftor
- measles/mumps/rubella vaccine, live
- mitotane
- pazopanib
- pentobarbital
- phenobarbital
- phenytoin
- primidone
- rabies vaccine
- rifabutin
- rifampin
- rotavirus vaccine, live
- smallpox vaccine, live
- St. John's wort
- topotecan
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Monitor/Modify Tx
- adalimumab
- ado-trastuzumab emtansine
- aldesleukin
- alogliptin
- anagrelide
- anthrax vaccine
- asciminib
- atorvastatin
- 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
- entrectinib
- etanercept
- fam-trastuzumab deruxtecan
- fluorouracil
- fluvastatin
- 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
- irinotecan
- itraconazole
- Japanese encephalitis vaccine
- lapatinib
- lenvatinib
- linagliptin
- margetuximab
- mavacamten
- meningococcal vaccine
- methotrexate
- mirdametinib
- mitoxantrone
- mobocertinib
- osimertinib
- peginterferon beta 1a
- pertuzumab
- pioglitazone
- pitavastatin
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- pravastatin
- propafenone
- respiratory syncytial virus vaccine
- riociguat
- ripretinib
- ropeginterferon alfa-2b
- rosiglitazone
- rosuvastatin
- saxagliptin
- selumetinib
- simvastatin
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- sunitinib
- talazoparib
- tenofovir alafenamide
- tenofovir disoproxil
- tick-borne encephalitis vaccine
- tivozanib
- trabectedin
- trametinib
- trastuzumab
- typhoid vaccine
- ubrogepant
- vandetanib
- zanidatamab
- zenocutuzumab
Caution Advised
- bosentan
- cenobamate
- efavirenz
- etravirine
- fexinidazole
- glecaprevir
- lopinavir/ritonavir
- lorlatinib
- mitapivat
- modafinil
- nafcillin
- pacritinib
- pexidartinib
- pibrentasvir
- repotrectinib
- rifapentine
- seladelpar
- sotorasib
- sulfasalazine
Adverse Reactions .
Serious Reactions
- hepatotoxicity, severe or life-threatening
- LV dysfxn, severe
- interstitial lung dz, severe or life-threatening
- pneumonitis, severe or life-threatening
Common Reactions
- diarrhea
- rash
- hepatotoxicity
- fatigue
- nausea
- cough
- musculoskeletal pain
- URI
- nail disorder
- vomiting
- dyspnea
- LVEF decr.
- lymphocytes decr.
- ALT or AST incr.
- Hgb decr.
- lipase incr.
- bilirubin incr.
- triglycerides incr.
- aPTT incr.
- calcium decr.
- amylase incr.
- Plt decr.
- sodium decr.
- CK incr.
- albumin decr.
- cholesterol incr.
- alk phos incr.
- magnesium decr.
- potassium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LFTs at baseline, q2wk x12wk, then qmo or more frequently if ALT or AST elevation; LVEF at baseline, then regularly during tx; s/sx interstitial lung dz
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity and decr. fetal wt based on animal data at 19x 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 x2wk after D/C in patients of childbearing potential
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: liver; CYP450: 3A4, 3A5 substrate; UGT: 1A4 substrate
Excretion: feces 93% (31% unchanged), urine 1.3% (0.2% unchanged); Half-life: 12h
Subclass: HER2 Antagonists ; Kinase Inhibitors, HER2 Inhibitors
Mechanism of Action
inhibits HER2 phosphorylation and its downstream signaling, leading to inhibition of cell proliferation in tumor cells harboring HER2 tyrosine kinase domain activating mutations
Formulary .
No Formulary Selected
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