Instructions for zenidatumab for injection (zanidatamab-hrii) - Ziihera

1. Common name:Zanidatamab

Product name:Ziihera

Other names: Zenidatuzumab for injection (transliteration)

2. Indications:

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

3. Usage and dosage:

1. Patient selection: Patients with unresectable or metastatic biliary tract cancer are selected for treatment based on HER2-positive (IHC 3+) tumor specimens detected by FDA-approved tests.

2. Premedication: Premedicate all patients 30 to 60 minutes before each use of zenidatuzumab for injection to reduce the risk of infusion-related reactions. Take acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as hydrocortisone).

3. Recommended dose: The recommended dose of zenidatuzumab for injection is 20 mg/kg, which should be infused intravenously every 2 weeks until disease progression or unacceptable toxicity occurs. If a scheduled dose of zenidatuzumab for injection is delayed or missed, give the dose as soon as possible; do not wait until the next scheduled dose. Adjust the dosing schedule to maintain an interval of 2 weeks between doses.

4. Dose adjustment: Based on individual safety and tolerability, it is recommended to adjust the dose of zenidatuzumab for injection. The recommended dose for adverse reactions is reduced to 15 mg/kg; patients who cannot tolerate 15 mg/kg should permanently stop using this drug.

4. Adverse reactions:

In clinical studies of zenidatuzumab for injection, the most common adverse reactions were diarrhea, infusion-related reactions, abdominal pain and fatigue; serious adverse reactions may include biliary obstruction, biliary infection, sepsis, pneumonia, diarrhea, gastric obstruction and fatigue; laboratory abnormalities may include decreased hemoglobin, lymphopenia, increased lactate dehydrogenase, decreased albumin, increased aspartate aminotransferase, increased alanine aminotransferase, increased alkaline phosphatase, decreased sodium, decreased potassium content, etc.

5. Supply and storage:

Zenidatuzumab for injection is a sterile, preservative-free, white, lyophilized powder in single-dose vials. Each single-dose vial contains 300 mg of zanidatamab-hrii. Store in original carton in refrigerator at 2°C to 8°C (36°F to 46°F) until reconstituted. Do not freeze.

6. Special groups:

1. Women: According to its mechanism of action, zenidatuzumab for injection can cause harm to the fetus when used by pregnant women. Use of this medicine during pregnancy may cause embryo-fetal damage. Advise females of childbearing potential to use effective contraception during treatment and for 4 months after the last dose.

7. Mechanism of action:

The main ingredient in zenidatumab for injectionzanidatamab-hrii is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii to HER2 results in internalization, resulting in the reduction of the receptor on the tumor cell surface. zanidatamab-hrii induces complement-dependent cellular cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms lead to tumor growth inhibition and cell death in vitro and in vivo.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae5d9425-fae5-4541-a158-150998343348##