Pronunciation:

zen-oh-kue-TOOZ-ue-mab - zbco

Brand Names:

• Bizengri

Dosage Forms:

• Solution

Warnings:

Exposure to zenocutuzumab-zbco during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Zenocutuzumab

Uses of This Medicine:

Zenocutuzumab-zbco injection is used to treat non-small cell lung cancer (NSCLC) and pancreatic cancer that have a neuregulin 1 (NRG1) gene fusion in patients whose cancer has spread or cannot be removed by surgery and who have previously received treatment. Your doctor will test for the presence of the NRG1 gene.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of zenocutuzumab-zbco injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zenocutuzumab-zbco injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Heart disease, history of or
• Interstitial lung disease or
• Pneumonitis (lung disease) or—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. The medicine must be given slowly, so the IV will have to stay in place for at least 4 hours. The injection is usually given once every 2 weeks.

This medicine comes with patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor may also give you other medicines (eg, allergy medicine, fever medicine, steroids) before starting treatment with this medicine to help prevent unwanted side effects from the injection.

You may be monitored for at least 1 hour after the infusion for any unwanted effects.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving the medicine and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 2 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause infusion-related reactions and serious allergic reactions, including anaphylaxis, which can be life threatening and require immediate medical attention. Check with your doctor right away if you have blurred vision, chest tightness, confusion, cough, difficulty swallowing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, facial swelling, fever or chills, headache, nausea or vomiting, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, sweating, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have chest pain or tightness, confusion, cough, dizziness, fast heartbeat, fever, trouble breathing, or unusual tiredness or weakness. These may be symptoms of serious lung problems (eg, interstitial lung disease or pneumonitis).

This medicine may cause heart problems. Your doctor may test your heart before and during treatment. Contact your doctor right away if you have chest pain, increased coughing, trouble breathing, rapid weight gain, or swelling in your ankles or legs.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

chills

cough

coughing up blood

diarrhea

dizziness

fever

flushing

headache

increased menstrual flow or vaginal bleeding

loss of taste and smell

muscle or body pain

nausea and vomiting

nosebleeds

paralysis

prolonged bleeding from cuts

rapid weight gain

red or dark brown urine

stuffy or runny nose

tingling of hands or feet

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Decreased urine output

dilated neck veins

general feeling of discomfort or illness

irregular heartbeat

swelling of face, fingers, feet, or lower legs

thickening of bronchial secretions

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

dry skin

lack or loss of strength

muscle or bone pain

stomach pain

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.