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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.

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:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. TEVIMBRA can harm your unborn baby.

  Females who are able to become pregnant:

  • Your healthcare provider will do a pregnancy test before you start treatment with TEVIMBRA.
  • You should use an effective method of birth control during your treatment and for 4 months after your last dose of TEVIMBRA. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TEVIMBRA.
• are breastfeeding or plan to breastfeed. It is not known if TEVIMBRA passes into your breast milk. Do not breastfeed during treatment with TEVIMBRA and for 4 months after your last dose of TEVIMBRA.

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 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.

Please read the accompanying Medication Guide for for TEVIMBRA and discuss it with your doctor. The physician Prescribing Information also is available.