Zanidatamab-Hrii Application Scope

Zanidatamab-hrii (Ziihera) is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.

Zanidatamab-Hrii Characteristics

Ingredients: Active ingredient: zanidatamab-hrii, a bispecific HER2-directed antibody.
Properties: Zanidatamab-hrii binds to two extracellular domains of the HER2 receptor, leading to receptor internalization and degradation. It induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP), resulting in tumor growth inhibition and cell death.
Packaging Specification: Supplied as a sterile, preservative-free, white lyophilized powder in a single-dose vial containing 300 mg of zanidatamab-hrii. Each carton contains two single-dose vials.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton until time of reconstitution. Do not freeze.
Expiry Date: Refer to the product label for the specific expiration date.
Executive Standard: Approved under the FDA’s Accelerated Approval Program.
Approval Number: National Drug Code (NDC): 68727-0950.
Date of Revision: November 2024.
Manufacturer: Jazz Pharmaceuticals Ireland Limited, Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Dublin, Ireland.

Guidelines for the Use of Zanidatamab-Hrii

Dosage and Administration:
- Patient Selection: Confirm HER2-positive (IHC 3+) status using an FDA-approved test.
- Premedication: Administer acetaminophen, an antihistamine (e.g., diphenhydramine), and a corticosteroid (e.g., hydrocortisone) 30 to 60 minutes prior to each infusion to reduce the risk of infusion-related reactions.
- Dosage: 20 mg/kg administered as an intravenous infusion once every 2 weeks until disease progression or unacceptable toxicity.
Adverse Reactions: Common adverse reactions (≥20%) include diarrhea, infusion-related reactions, abdominal pain, and fatigue.
Contraindications: None specified in the prescribing information.
Precautions:
- Embryo-Fetal Toxicity: Can cause embryo-fetal harm. Verify pregnancy status prior to initiation and advise effective contraception during treatment and for 4 months after the last dose.
- Left Ventricular Dysfunction: Assess left ventricular ejection fraction (LVEF) prior to initiation and at regular intervals during treatment. Withhold or discontinue based on severity.
- Infusion-Related Reactions: Monitor for signs and symptoms during infusion. Interrupt, slow, or discontinue infusion based on severity.
- Diarrhea: Manage with antidiarrheal treatment as clinically indicated. Withhold or discontinue based on severity.

Zanidatamab-Hrii Interactions

Drug Interactions: No specific drug interaction studies have been conducted. Consult the manufacturer’s labeling for detailed information.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.