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Brand Name :
N/A
Synonyms :
zongertinib
Class :
Anti-HER2, Antineoplastics
Brand Name :
N/A
Synonyms :
zongertinib
Class :
Anti-HER2, Antineoplastics
ADULT DOSING
Dosage Forms & Strengths
Tablet
60 mg
For body weight <90 kg, it is recommended to take 120 mg orally in a day
For body weight ≥90 kg, it is recommended to take 180 mg orally in a day
Maintain therapy until the disease progresses or toxicity becomes unacceptable
PEDIATRIC DOSING
Dosage Forms & Strengths
Safety and efficacy are not established
GERIATRIC DOSING
Refer to adult dosing
Action
Zongertinib selectively inhibits mutant EGFR tyrosine kinase activity, including common activating mutations and resistant mutations like T790M.
By blocking the ATP-binding site of the EGFR tyrosine kinase domain, it prevents phosphorylation and downstream signaling that promotes cancer cell proliferation and survival.
Frequency not defined
Rash
Diarrhea
Black Box Warning
None
Contraindication/Caution:
Contraindication:
Known hypersensitivity to zongertinib or any of its components.
Pregnancy and breastfeeding: Should be avoided as safety has not been established.
Caution:
Liver impairment
Interstitial lung disease (ILD) / Pneumonitis
QT prolongation
Drug interactions
Renal impairment
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
Irreversible tyrosine kinase inhibitor (TKI) that selectively targets human epidermal growth factor receptor 2 (HER2) with ERBB2 gene alterations, while sparing epidermal growth factor receptors (EGFR).
Pharmacokinetics:
Absorption
Zongertinib is rapidly absorbed and exhibits high absolute bioavailability, with a mean of 76.2%.
Distribution
Metabolism
The primary metabolic pathway of zongertinib is oxidation, with glucuronidation and glutathione conjugation playing lesser roles.
Elimination and excretion
Zongertinib is mainly eliminated through fecal excretion, with only a small portion excreted via the kidneys.
Administration:
OralAdministration
Can be taken with or without food.
Swallow tablets whole with water; do not split, crush, or chew.
If you miss a dose:
If less than or equal to 12 hours have passed, take the missed dose.
If more than 12 hours have passed, skip the missed dose and take the next dose at the usual scheduled time.
Patient information leaflet
Generic Name: zongertinib
Why do we use zongertinib?
Primarily used to treat non-small cell lung cancer (NSCLC) with specific EGFR mutations,
Sensitizing mutations (e.g., exon 19 deletions, L858R)
Resistance mutations (especially T790M) that cause resistance to earlier EGFR inhibitors.
Used in patients who have progressed on or are intolerant to first- and second-generation EGFR tyrosine kinase inhibitors.
Investigational use in clinical trials for other EGFR-mutated solid tumors may be ongoing.
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