TEVIMBRA- tislelizumab injection, solution, concentrate
BEIGENE USA, INC.
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Medication Guide TEVIMBRA (teh-vim-brah) (tislelizumab-jsgr) injection |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: 3/2024 | ||
What is the most important information I should know about TEVIMBRA?
TEVIMBRA is a medicine that may treat a certain type of esophageal cancer 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 if you develop any new or worsening symptoms, including: Lung problems |
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Intestinal problems
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Hormone gland problems | |||
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Kidney problems | |||
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Skin problems | |||
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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:
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Rejection of a transplanted organ. 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. |
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What is TEVIMBRA?
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 alone when your esophageal cancer:
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Before receiving TEVIMBRA, tell your healthcare provider about all of your medical conditions, including if you:
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How will I receive TEVIMBRA?
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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 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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General information about the safe and effective use of TEVIMBRA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider or pharmacist for more information about TEVIMBRA that is written for health professionals. |
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What are the ingredients in TEVIMBRA?
Active ingredient: tislelizumab-jsgr Inactive ingredients: citric acid monohydrate, histidine, L-histidine hydrochloride monohydrate, polysorbate-20, sodium citrate, trehalose, and Water for Injection. Manufactured by: BeiGene USA, Inc. San Mateo, CA 94404 U.S. License No. 2232 TEVIMBRA® is a registered trademark owned by BeiGene, Ltd. © BeiGene, Ltd. 2024 For more information, call 1-833-969-2463 or go to www.TEVIMBRA.com |