Brand Name
Bizengri
Generic Name
Zenocutuzumab
View Brand Information FDA approval date: December 04, 2024
Form: Injection
What is Bizengri (Zenocutuzumab)?
BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy.
Approved To Treat
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Brand Information
BIZENGRI (Zenocutuzumab)
WARNING: EMBRYO-FETAL TOXICITY
Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions (
1DOSAGE FORMS AND STRENGTHS
Injection: 375 mg/18.75 mL (20 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infusion-Related Reactions/Hypersensitivity/Anaphylaxis [
- Interstitial Lung Disease/Pneumonitis
- Left Ventricular Dysfunction [
- Embryo-Fetal Toxicity [
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to BIZENGRI as a single agent at 750 mg administered intravenously every 2 weeks until disease progression or unacceptable toxicity in 175 patients with
4DESCRIPTION
Zenocutuzumab-zbco is a low-fucose humanized full-length immunoglobulin G1 (IgG1) bispecific HER2- and HER3-directed antibody. It has a molecular weight of approximately 146 kDa and is produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
BIZENGRI is a sterile, clear to slightly opalescent, colorless to slightly yellow, preservative-free injection for intravenous infusion in single-dose vials. The pH is 6.0. Each BIZENGRI vial contains 375 mg/18.75 mL zenocutuzumab-zbco at a concentration of 20 mg/mL. Each vial also contains the following inactive ingredients: histidine (34.9 mg), L-histidine hydrochloride monohydrate (51.1 mg), polysorbate 20 (3.7 mg), trehalose (1412 mg), and water for injection.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).