BIZENGRI 20 mg/mL
Zenocutuzumab · INJECTION · Partner Therapeutics, Inc.
Bizengri (zenocutuzumab) is a prescription injection given intravenously that is used to treat certain types of cancer. It works by targeting specific proteins on cancer cells to help slow or stop their growth.
Key Facts
- Brand Name
- BIZENGRI
- Generic Name
- Zenocutuzumab
- NDC Code (Product)
71837-1000- Manufacturer
- Partner Therapeutics, Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761352
- Marketing Start
- 12/04/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Select patients for treatment with BIZENGRI based on the presence of an NRG1 gene fusion. ( 2.1 ) Evaluate left ventricular ejection fraction (LVEF) before initiating BIZENGRI. ( 2.2 ) The recommended dosage of BIZENGRI is 750 mg every 2 weeks until disease progression or unacceptable toxicity. ( 2.3 ) Administer premedications before each infusion to reduce the risk of infusion-related reactions. ( 2.4 ) Administer as an intravenous infusion, after dilution, over 4 hours. ( 2.7 ) 2.1 Patient Selection Select patients for treatment with BIZENGRI based on the presence of an NRG1 gene fusion in tumor specimens [see Clinical Studies (14.1 , 14.2 , 14.3) ] . An FDA-approved test for the detection of NRG1 gene fusions is not currently available. 2.2 Recommended Evaluation Before Initiating BIZENGRI Before initiating BIZENGRI, evaluate left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3) ]. 2.3 Recommended Dosage The recommended dosage of BIZENGRI is 750 mg as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity [see Dosage and Administration (2.7) ]. Administer premedications before each BIZENG…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-Related Reactions/Hypersensitivity/Anaphylaxis [ see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Left Ventricular Dysfunction [ see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [ see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 10%) in patients were diarrhea musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were increased GGT, decreased hemoglobin, decreased sodium, decreased platelets, increased AST, increased ALT, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased aPTT and increased bilirubin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Partner Therapeutics, Inc. at 1-888-479-5385 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed…
Frequently Asked Questions
What is BIZENGRI used for?
Bizengri (zenocutuzumab) is a prescription injection given intravenously that is used to treat certain types of cancer. It works by targeting specific proteins on cancer cells to help slow or stop their growth.
Is BIZENGRI a controlled substance?
BIZENGRI is not classified as a controlled substance by the DEA.
What is the generic name for BIZENGRI?
The generic name for BIZENGRI is Zenocutuzumab. There are no other listed brand versions of Zenocutuzumab.
What is the NDC code for BIZENGRI 20 mg/mL?
The NDC (National Drug Code) for BIZENGRI 20 mg/mL is 71837-1000, listed by Partner Therapeutics, Inc..
Other BIZENGRI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)