Side Effects
It's important to watch for side effects
You know your body best.
Paying attention to how you feel helps your healthcare team recognize and manage side effects early.
Be sure to:
- Communicate any side effects to your healthcare provider
- Write down any side effects you feel in a treatment journal
- Talk to your friends and family about side effects
- Reach out to support groups
The most common side effects associated with TEVIMBRA + zanidatamab-hrii + chemotherapy are:
- diarrhea
- nausea
- decreased red blood cell count (anemia)
- decreased appetite
- vomiting
- decreased potassium in your blood
- tiredness
- rash
- decreased white blood cell count
- decreased platelet count
- numbness, pain, tingling, or burning in your hands or feet
- infusion reactions
- increase in certain liver blood tests
Possible side effects that may occur
Call your doctor if you experience any of the following:
Lung problems
- New or worsening cough
- Shortness of breath
- Chest pain
Intestinal problems
- Diarrhea (loose stools) or more bowel movements than usual
- Stools that are black, tarry, sticky, or have blood or mucus
- Severe stomach-area (abdomen) pain or tenderness
Liver problems
- Yellowing of your skin or the whites of your eyes
- Severe nausea or vomiting
- Pain on the right side of your stomach area (abdomen)
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
Hormone gland problems
- Headaches that will not go away or unusual headaches
- Eye sensitivity to light
- Eye problems
- Rapid heartbeat
- Increased sweating
- Extreme tiredness
- Weight gain or weight loss
- Feeling more hungry or thirsty than usual
- Urinating more often than usual
- Hair loss
- Feeling cold
- Constipation
- Your voice gets deeper
- Dizziness or fainting
- Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- Decrease in your amount of urine
- Blood in your urine
- Swelling in your ankles
- Loss of appetite
Skin problems
- Rash
- Itching
- Skin blistering or peeling
- Painful sores or ulcers in your mouth or in your nose, throat, or genital area
- Fever or flu-like symptoms
- Swollen lymph nodes
Immune system problems in other organs
- Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Reactions during or shortly after the infusion that can sometimes be severe or life-threatening
- Chills or shaking
- Itching or rash
- Flushing
- Shortness of breath or wheezing
- Dizziness
- Feeling like passing out
- Fever
- Back or neck pain
Lung problems
- New or worsening cough
- Shortness of breath
- Chest pain
Intestinal problems
- Diarrhea (loose stools) or more bowel movements than usual
- Stools that are black, tarry, sticky, or have blood or mucus
- Severe stomach-area (abdomen) pain or tenderness
Liver problems
- Yellowing of your skin or the whites of your eyes
- Severe nausea or vomiting
- Pain on the right side of your stomach area (abdomen)
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
Hormone gland problems
- Headaches that will not go away or unusual headaches
- Eye sensitivity to light
- Eye problems
- Rapid heartbeat
- Increased sweating
- Extreme tiredness
- Weight gain or weight loss
- Feeling more hungry or thirsty than usual
- Urinating more often than usual
- Hair loss
- Feeling cold
- Constipation
- Your voice gets deeper
- Dizziness or fainting
- Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- Decrease in your amount of urine
- Blood in your urine
- Swelling in your ankles
- Loss of appetite
Skin problems
- Rash
- Itching
- Skin blistering or peeling
- Painful sores or ulcers in your mouth or in your nose, throat, or genital area
- Fever or flu-like symptoms
- Swollen lymph nodes
Immune system problems in other organs
- Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Reactions during or shortly after the infusion that can sometimes be severe or life-threatening
- Chills or shaking
- Itching or rash
- Flushing
- Shortness of breath or wheezing
- Dizziness
- Feeling like passing out
- Fever
- Back or neck pain
How do I prepare for treatment?
TEVIMBRA is a prescription medicine used to treat adults with:
- Cancer of the tube that connects your throat to your stomach (esophageal cancer).
- TEVIMBRA may be used in combination with chemotherapy that contains platinum as your first treatment when your esophageal cancer:
- is a type called squamous cell carcinoma, and
- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- your tumor tests positive for “PD-L1.”
- TEVIMBRA may be used alone when your esophageal cancer:
- is a type called squamous cell carcinoma, and
- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- you have had previous treatment that did not include a PD-(L)1 inhibitor medicine.
- TEVIMBRA may be used in combination with chemotherapy that contains platinum as your first treatment when your esophageal cancer:
- Cancer of the stomach (gastric cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer).
- TEVIMBRA may be used in combination with chemotherapy that contains platinum and fluoropyrimidine as your first treatment when your gastric or gastroesophageal
junction cancer:- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- your tumor tests positive for “PD-L1.”
- TEVIMBRA may be used in combination with chemotherapy that contains platinum and fluoropyrimidine as your first treatment when your gastric or gastroesophageal
- Cancer of the stomach (gastric cancer), or cancer where the esophagus joins the stomach (gastroesophageal junction cancer), or of the tube that connects your throat to your
stomach (esophageal cancer).- TEVIMBRA may be used in combination with zanidatamab and chemotherapy that contains platinum and fluoropyrimidine as your first treatment when your gastric,
gastroesophageal, or esophageal adenocarcinoma:- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- is human epidermal growth factor receptor 2 (HER2)-positive.
- TEVIMBRA may be used in combination with zanidatamab and chemotherapy that contains platinum and fluoropyrimidine as your first treatment when your gastric,
It is not known if TEVIMBRA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
TEVIMBRA works with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
What signs and symptoms of immune system problems can happen with TEVIMBRA?
Contact your healthcare provider right away if you develop any new or worsening symptoms including:
- Lung problems: New or worsening cough, shortness of breath, and chest pain.
- Intestinal problems: Diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area pain or tenderness.
- Liver problems: Yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area; dark urine; and bleeding or bruising more easily than normal.
- Hormone gland problems: Headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; voice gets deeper; dizziness or fainting; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
- Kidney problems: Decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
- Skin problems: Rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; and swollen lymph nodes.
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with TEVIMBRA. Contact your healthcare provider right away if you have any new or worsening signs or symptoms which may include chest pain, irregular heartbeat, shortness of breath, swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs; double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight; persistent or severe muscle pain or weakness, muscle cramps; low red blood cells, bruising.
What problems can occur during infusion?
Infusion reactions can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, or back or neck pain.
What if I have a transplanted organ or tissue; or bone marrow transplant?
Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had. There may be complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells. These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with TEVIMBRA. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with TEVIMBRA. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines, or may delay or completely stop treatment with TEVIMBRA if you have severe side effects.
Before receiving TEVIMBRA, tell your healthcare provider about all of your medical conditions, including if you have immune system problems; received an organ or tissue transplant; received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic); received radiation treatment to your chest area; or a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome; or are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Can I take TEVIMBRA while pregnant or breastfeeding?
TEVIMBRA can harm your unborn baby. If you are a female who can become pregnant, your healthcare provider will do a pregnancy test before you start treatment with TEVIMBRA. Use effective birth control during treatment and for 4 months after your last dose. Do not breastfeed during treatment and for 4 months after your last dose. Talk to your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TEVIMBRA.
The most common side effects of TEVIMBRA in combination with zanidatamab-hrii and chemotherapy include diarrhea; nausea; decreased red blood cell count (anemia); decreased appetite; vomiting; decreased potassium in your blood; tiredness; rash; decreased white blood cell count; decreased platelet count; numbness, pain, tingling, or burning in your hands or feet; infusion reactions; and increase in certain liver blood tests.
The most common side effects of TEVIMBRA when used in combination with chemotherapy include decreased white blood cell count; decreased salt (sodium) in your blood; increased glucose in your blood; decreased red blood cell count (anemia); tiredness; decreased appetite; increase in certain liver blood tests; decreased potassium in your blood; increase in certain kidney blood tests; decreased calcium in your blood; diarrhea; mouth sores; and vomiting.
The most common side effects of TEVIMBRA in combination with chemotherapy include nausea; tiredness; decreased appetite; decreased red blood cell count (anemia); numbness, pain, tingling, or burning in your hands or feet; vomiting; decreased platelet count; decreased white blood cell count; increase in certain liver blood tests; diarrhea; stomach-area (abdominal) pain; decreased weight; and fever.
These are not all the possible side effects of TEVIMBRA. Contact your healthcare provider for medical advice about side effects. You may report side effects to BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What is TEVIMBRA?
TEVIMBRA is a prescription medicine used to treat adults with:
- cancer of the stomach (gastric cancer), or cancer where the esophagus joins the stomach (gastroesophageal junction cancer), or of the tube that connects your throat to your stomach (esophageal cancer).
- TEVIMBRA may be used in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy as your first treatment when your gastric, gastroesophageal, or esophageal adenocarcinoma:
- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- is human epidermal growth factor receptor 2 (HER2)-positive (IHC 3+ or IHC 2+/ISH+).
You should also refer to the Medication Guide that comes with zanidatamab-hrii.
- TEVIMBRA may be used in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy as your first treatment when your gastric, gastroesophageal, or esophageal adenocarcinoma:
- cancer of the tube that connects your throat to your stomach (esophageal cancer).
- TEVIMBRA may be used in combination with platinum-containing chemotherapy as your first treatment when your esophageal cancer:
- is a type called squamous cell carcinoma, and
- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- your tumor tests positive for “PD-L1.”
- TEVIMBRA may be used in combination with platinum-containing chemotherapy as your first treatment when your esophageal cancer:
- cancer of the stomach (gastric cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer).
- TEVIMBRA may be used in combination with fluoropyrimidine- and platinum-containing chemotherapy as your first treatment when your gastric or gastroesophageal junction cancer:
- cannot be removed with surgery or has spread to other parts of the body (metastatic), and
- your tumor tests positive for “PD-L1.”
- TEVIMBRA may be used in combination with fluoropyrimidine- and platinum-containing chemotherapy as your first treatment when your gastric or gastroesophageal junction cancer:
It is not known if TEVIMBRA is safe and effective in children.