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What is BIZENGRI?

BIZENGRI is a prescription medicine used to treat adults with non–small cell lung cancer (NSCLC) or adenocarcinoma that:

Has spread to other parts of the body (metastatic) or cannot be removed by surgery (advanced unresectable or metastatic)

Has a certain abnormal neuregulin 1 (NRG1) gene fusion

Whose disease has worsened while on or after prior cancer treatment

BIZENGRI was approved through a faster FDA review process that looked at the percentage of patients whose tumors shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of BIZENGRI for these uses. It is not known if BIZENGRI is safe and effective in children.

BIZENGRI is not chemotherapy

It is an antibody that decreases the signal that causes the cells to grow.

Learn about dosing and possible side effects of BIZENGRI

Explore the PTx Assist program for information about access and coverage

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BIZENGRI?

BIZENGRI may cause serious side effects, including:

Infusion-related, allergic and anaphylactic reactions. BIZENGRI may cause serious infusion-related and allergic reactions that can be life-threatening. Infusion-related reactions are also common during BIZENGRI treatment. Before each BIZENGRI infusion, your healthcare provider will give you medicines to help reduce your chance of getting infusion-related reactions. Your healthcare provider will monitor you for signs and symptoms during your infusion and for at least 1 hour after your first infusion and as needed. Tell your healthcare provider right away if you develop any of the following symptoms during or after your BIZENGRI infusion:
- chills or shaking
- nausea, vomiting, or diarrhea
- fever
- cough
- sudden swelling of your face, tongue, throat, or troubled swallowing
- throat tightness or discomfort
- itching or rash
- shortness of breath or wheezing
- chest discomfort
- feeling light-headed
- dizziness
- back or neck pain
- feeling of numbness or tingling
Lung problems. BIZENGRI may cause serious lung problems that may be life-threatening. If you develop lung problems, your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems, including:
- trouble breathing
- shortness of breath
- cough
- fever
Heart problems that may affect your heart’s ability to pump blood. BIZENGRI may cause serious and life-threatening heart problems that may lead to death. Your healthcare provider will check your heart function before you start treatment with BIZENGRI and as needed during your treatment. Tell your healthcare provider right away if you develop any new or worsening symptoms of heart problems, including:
- shortness of breath
- coughing
- tiredness
- swelling of your feet, ankles or legs
- irregular heartbeat
- sudden weight gain
- dizziness or feeling light-headed
- loss of consciousness

Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BIZENGRI.

Before receiving BIZENGRI, tell your healthcare provider about all your medical conditions, including if you:

have lung or breathing problems other than your lung cancer.
have or have had any heart problems.
are breastfeeding or plan to breastfeed. It is not known if BIZENGRI passes into your breast milk. Do not breastfeed during treatment and for 2 months after your last dose of BIZENGRI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

What are the possible side effects of BIZENGRI?

BIZENGRI may cause serious side effects, including:

See “What is the most important information I should know about BIZENGRI?”

The most common side effects of BIZENGRI include:

diarrhea
muscle or bone pain
tiredness
nausea
shortness of breath
rash
constipation
vomiting
stomach-area (abdominal) pain
swelling of your breast, face, ankles or legs

The most common severe abnormal blood test results with BIZENGRI include:

increased blood levels of liver enzymes and bilirubin
decreased red blood cell counts and platelet counts
decreased blood level of sodium, magnesium, and phosphate
increase in the time that it takes your blood to clot

These are not all of the possible side effects of BIZENGRI.

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

Please see full Prescribing Information, including BOXED WARNING.

What is BIZENGRI?

BIZENGRI is a prescription medicine used to treat adults who have:

lung cancer called non-small cell lung cancer (NSCLC):
- that has a neuregulin 1 (NRG1) gene fusion and cannot be removed by surgery or has spread to other parts of the body (advanced unresectable or metastatic), and
- whose disease has worsened on or after prior cancer treatment.
pancreatic cancer called pancreatic adenocarcinoma:
- that has a neuregulin 1 (NRG1) gene fusion and cannot be removed by surgery or has spread to other parts of the body (advanced unresectable or metastatic), and
- whose disease has worsened on or after prior cancer treatment.

It is not known if BIZENGRI is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING.

Contact Us

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