Référentiel des médicaments
Zanidatamab
Zanidatamab is a medicine in the class oncology. It is used for biliary tract cancers.
- Classe médicamenteuse: Oncology
- Indications: biliary tract cancers
Dernière mise à jour Sources: US FDA label, EMA SmPC
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L'essentiel
- Classe médicamenteuse
- Oncology
- Code ATC
- L01FD07
- Formes courantes
- injection
- Dosages courants
- 50 mg/ml
- Interactions connues
- 1 (Modérée: 1)
- Noms commerciaux
- 2
- Pays et marchés
- 2
Indications
Mécanisme d'action
Bispecific HER2-directed antibody binding extracellular domains 2 and 4 of HER2, causing clustering, internalization and receptor reduction; induces CDC, ADCC and ADCP, leading to tumor growth inhibition and cell death.
Posologie adulte habituelle (résumé de la notice)
GEA, patients <70 kg: 1,800 mg IV every 3 weeks or 1,200 mg every 2 weeks with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr; until disease progression or unacceptable toxicity
Grossesse et allaitement
- Grossesse
- Unsafe Can cause fetal harm; not recommended during pregnancy. HER2-directed antibodies have caused oligohydramnios, pulmonary hypoplasia, skeletal abnormalities and neonatal death.
- Allaitement
- Unknown No data on presence in human milk or effects on infant. Weigh benefits of breastfeeding against clinical need; consider half-life of about 24 days and 4-month washout.
Effets indésirables signalés
- Diarrhea
- Nausea
- Decreased appetite
- Vomiting
- Hypokalemia
- Fatigue
Mises en garde encadrées
- With fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr, can cause severe diarrhea, including life-threatening and fatal cases. Use antidiarrheal prophylaxis in the first cycle; interrupt, reduce dose or discontinue based on severity. Exposure during pregnancy can cause embryo-fetal harm; advise of risk and need for effective contraception.
Précautions particulières
- Severe, life-threatening and fatal diarrhea can occur despite loperamide prophylaxis; higher risk with tislelizumab and in patients aged 65 years or older.
- Left ventricular dysfunction: assess LVEF before starting and at regular intervals; safety not established with baseline LVEF below 50%.
- Infusion-related reactions: premedicate, monitor, slow or stop infusion; permanently discontinue for recurrent severe or life-threatening IRRs.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (1)
- Fluorouracil + Zanidatamab Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
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Questions fréquentes
What is Zanidatamab used for?
Zanidatamab is a medicine in the class oncology. It is used for Biliary tract cancers, Gastric cancer.
What side effects have been reported with Zanidatamab?
Diarrhea, Nausea, Decreased appetite, Vomiting, Hypokalemia, Fatigue. Serious warning: With fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab-jsgr, can cause severe diarrhea, including life-threatening and fatal cases.
Can Zanidatamab be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Can cause fetal harm; not recommended during pregnancy. HER2-directed antibodies have caused oligohydramnios, pulmonary hypoplasia, skeletal abnormalities and neonatal death. Breastfeeding: Unknown. No data on presence in human milk or effects on infant. Weigh benefits of breastfeeding against clinical need; consider half-life of about 24 days and 4-month washout.
What does Zanidatamab interact with?
MediHelp lists 1 known interactions for Zanidatamab. Moderate: 1. The most serious include Fluorouracil.
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