Important Safety Information
TEVIMBRA is a medicine that may treat certain cancers by working with your immune system. TEVIMBRA 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.
Call or see your healthcare provider right away for new or worsening symptoms, including:
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
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. Call or see your healthcare provider right away for new or worsening 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
Infusion reactions that 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
- back or neck pain
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 transplant that you have had.
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). 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. Your healthcare provider may also need to 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:
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 TEVIMBRA?
TEVIMBRA may cause serious side effects. See “What is the most important information I should know about TEVIMBRA?”
The most common side effects of TEVIMBRA when used in combination with platinum-containing chemotherapy include:
decreased red blood cell count (anemia); decreased white blood cell count; tiredness; decreased appetite; nausea; constipation; decreased weight; diarrhea; numbness, pain, tingling, or burning in your hands or feet; decreased albumin in the blood; decreased salt (sodium) in your blood; vomiting; mouth sores; and decreased potassium in your blood.
The most common side effects of TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy include: nausea; tiredness; decreased appetite; decreased red blood cell count (anemia); numbness, pain, tingling or burning in your hands or feet; decreased platelet count; decreased white blood cell counts; increase in certain liver blood tests; stomach area (abdominal) pain; decreased weight; and fever.
The most common side effects of TEVIMBRA when used alone include: increased blood sugar, decreased red blood cell and white blood cell counts, decreased salt (sodium) in your blood, decreased albumin in the blood, increase in certain liver blood tests, tiredness; muscle and bone pain, decreased weight, and cough.
These are not all the possible side effects of TEVIMBRA. Talk to your health care provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
FDA-Approved Indications
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.
- 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.”
It is not known if TEVIMBRA is safe and effective in children.
Please read the accompanying Medication Guide for TEVIMBRA and discuss it with your doctor. The physician Prescribing Information also is available.
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