Tislelizumab
Generic name: tislelizumab [ TIS-le-LIZ-ue-mab ]
Brand name: Tevimbra
Dosage form: intravenous solution (jsgr 10 mg/mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
What is tislelizumab?
Tislelizumab is used in adults to treat cancer of esophagus that has spread to other parts of the body (metastatic) or cannot be removed with surgery.
Your doctor will make sure you have correct tumor type to be treated with tislelizumab.
Tislelizumab may also be used for purposes not listed in this medication guide.
Tislelizumab side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Serious and sometimes fatal reactions may occur during treatment with tislelizumab or months after your last dose. Call your doctor right away if you have symptoms such as:
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symptoms of brain swelling--confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions).
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lung problems--new or worsening cough, chest pain, feeling short of breath;
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liver problems--right-sided upper stomach pain, tiredness, bruising or bleeding, dark urine, yellowing of your skin or eyes;
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signs of a hormonal disorder--frequent or unusual headaches, lack of energy, dizziness, fainting, mood or behavior changes, increased thirst or urination, feeling cold, weight gain, or weight loss;
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kidney problems--little or no urination, swelling in your feet or ankles, blood in your urine;
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(if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling;
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new or worsening skin rash, itching, or blistering;
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fever, swollen glands, body aches;
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chest pain, irregular heartbeats;
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severe muscle weakness, ongoing pain in your muscles or joints;
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numbness or tingling in your hands or feet; or
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vision problems, eye pain or redness.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects of tislelizumab may include:
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pain in your muscles, joints, or bones;
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weight loss;
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fever, cough, shortness of breath;
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nausea, vomiting, stomach pain, loss of appetite;
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hormonal problems;
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rash or itching; or
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headache, dizziness, tiredness.
This is not a complete list of side effects and others may occur. 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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Warnings
Tislelizumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have: a cough, shortness of breath, chest pain, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, bruising or bleeding, dark urine, yellowing of your skin or eyes, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, or weight gain or loss.
Before taking this medicine
Tell your doctor if you have ever had:
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an autoimmune disorder such as Crohn's disease, ulcerative colitis, lupus;
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an organ transplant, or a stem cell transplant from a donor;
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radiation treatment to the chest area; or
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a nerve-muscle disorder, such as myasthenia gravis, or Guillain-Barré syndrome.
You may need to have a negative pregnancy test before starting this treatment.
May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using tislelizumab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using tislelizumab, and for at least 4 months after your last dose.
How is tislelizumab given?
Tislelizumab is injected into a vein by a healthcare provider.
This medicine must be given slowly, and the infusion can take 30 to 60 minutes to complete.
Tislelizumab is usually given once every 3 weeks. Your doctor will determine how long to treat you with this medicine.
You may be given other medications to treat or prevent certain side effects.
You may need frequent medical tests and your cancer treatments may be delayed based on the results.
Tislelizumab dosing information
Usual Adult Dose for Esophageal Carcinoma:
200 mg every 3 weeks as an IV infusion
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
-Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.
Use: Unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your tislelizumab injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving tislelizumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect tislelizumab?
Other drugs may affect tislelizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Tislelizumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for tislelizumab.
Tevimbra (tislelizumab-jsgr) - BeiGene USA, Inc.
Formulation type | Strength |
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Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
View Tevimbra information in detail.
More about tislelizumab
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
- Breastfeeding
- En español
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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