Zenocutuzumab
Generic name: zenocutuzumab
Brand name: Bizengri
Dosage form: intravenous solution (zbco 20 mg/mL)
Drug class: Miscellaneous bispecific antibodies
What is zenocutuzumab?
Zenocutuzumab is used in adults to treat certain types of lung and pancreatic cancer that cannot be removed with surgery or has spread to other parts of the body (metastatic).
Zenocutuzumab is given after other treatments did not work or stopped working.
Your doctor will make sure you have the correct tumor type to be treated with zenocutuzumab.
Zenocutuzumab may also be used for purposes not listed in this medication guide.
Zenocutuzumab side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some serious side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Zenocutuzumab may cause serious side effects. Call your doctor at once if you have:
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feeling light-headed, loss of consciousness;
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new or worsening breathing problems--trouble breathing, shortness of breath, cough, fever; or
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new or worsening heart problems--swelling, rapid weight gain, feeling short of breath, cough, tiredness, irregular heartbeats.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects of zenocutuzumab may include:
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nausea, vomiting, diarrhea, constipation, stomach pain;
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swelling in your breast, face, ankles or legs;
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tiredness, muscle or bone pain;
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skin rash;
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abnormal liver function tests;
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low red blood cell and platelet counts;
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low sodium, magnesium, and phosphate levels; or
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abnormal blood clotting tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
Do not use if you are pregnant. Use effective birth control.
Before taking this medicine
Tell your doctor if you have or have ever had:
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lung or breathing problems (other than lung cancer); or
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heart problems such as congestive heart failure.
May harm an unborn baby. Do not use if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using zenocutuzumab and for at least 2 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using zenocutuzumab, and for at least 2 months after your last dose.
How is zenocutuzumab given?
Your doctor will perform tests to make sure zenocutuzumab is the right treatment for you.
Zenocutuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.
Zenocutuzumab is usually given once every 2 weeks. Your doctor will determine how long to treat you with this medicine.
You will be watched during and after your infusion to make sure you do not have an allergic reaction or serious side effects.
You may need frequent medical tests and your cancer treatments may be delayed based on the results.
You may need medical tests to check your heart function before and during treatment with zenocutuzumab.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Zenocutuzumab dosing information
Usual Adult Dose for Non-Small Cell Lung Cancer:
750 mg as an IV infusion every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
-Select patients for treatment based on the presence of a neuregulin 1 (NRG1) gene fusion in tumor specimens.
-These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval may be contingent upon verification of clinical benefits in confirmatory trials.
Uses:
-Advanced unresectable or metastatic NRG1 fusion-positive non-small cell lung cancer with disease progression on or after prior systemic therapy
-Advanced unresectable or metastatic NRG1 fusion-positive pancreatic adenocarcinoma with disease progression on or after prior systemic therapy
Usual Adult Dose for Pancreatic Cancer:
750 mg as an IV infusion every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
-Select patients for treatment based on the presence of a neuregulin 1 (NRG1) gene fusion in tumor specimens.
-These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval may be contingent upon verification of clinical benefits in confirmatory trials.
Uses:
-Advanced unresectable or metastatic NRG1 fusion-positive non-small cell lung cancer with disease progression on or after prior systemic therapy
-Advanced unresectable or metastatic NRG1 fusion-positive pancreatic adenocarcinoma with disease progression on or after prior systemic therapy
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your zenocutuzumab injection.
What happens if I overdose?
In a medical setting an overdose would be treated quickly.
What should I avoid while receiving zenocutuzumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect zenocutuzumab?
Tell your doctor about all other cancer treatments you are receiving.
Other drugs may affect zenocutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Zenocutuzumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for zenocutuzumab.
Bizengri (zenocutuzumab-zbco) - Merus NV
Formulation type | Strength |
---|---|
Single-Dose Vial | 375 mg/18.75 mL (20 mg/mL) |
View Bizengri information in detail.
More about zenocutuzumab
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: miscellaneous bispecific antibodies
- Breastfeeding
- En español
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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