Tevimbra
Pronunciation: TEV-im-bra
Generic name: tislelizumab-jsgr
Dosage form: injection for intravenous infusion
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
What is Tevimbra?
Tevimbra is used to treat adults with certain types of esophageal squamous cell carcinoma (ESCC), gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma that has spread (metastasized) or cannot be surgically removed.
Tevimbra's mechanism of action involves targeting and blocking PD-1, a protein found on T cells (an important cell of the immune system) that normally acts as a checkpoint to prevent T-cells from attacking healthy cells. Cancer cells can exploit this checkpoint by producing signals (PD-L1) that bind to PD-1, effectively telling T cells not to attack them. By blocking PD-1, Tevimbra prevents cancer cells from using this evasion tactic. This allows T cells to recognize and attack cancer cells more effectively.
Tevimbra (generic name tislelizumab-jsgr) is an immunotherapy treatment that belongs to the drug class called checkpoint inhibitors. Tevimbra may also be called a PD-1 inhibitor.
Tevimbra first gained FDA approval on March 13, 2024.
Tevimbra uses
Tevimbra is used to treat adults with:
- esophageal cancer
- as first-line treatment in combination with platinum chemotherapy for unresectable or metastatic ESCC whose tumors express PD-L1 (≥1)
- as a single-agent in unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
- gastric cancer
- as first-line treatment in combination with platinum and fluoropyrimidine-based chemotherapy for unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).
It is not known if Tevimbra is safe and effective in children.
Tevimbra side effects
The most common side effects of Tevimbra when used alone are:
- increased blood sugar levels
- decreased albumin in the blood
- muscle and bone pain
- decreased red and white blood cells
- increases in certain liver blood
- weight loss
- decreased weight
- decreased salt (sodium) levels in the blood
- fatigue and tiredness.
The most common side effects of Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy include:
- nausea
- vomiting
- diarrhea
- fatigue and tiredness
- decreased platelet counts
- decreased red and white blood cells
- stomach-area (abdominal) pain
- decreased appetite
- decreased white blood cell counts
- weight loss
- fever
- increases in certain liver blood tests
- numbness, pain, tingling, or burning in your hands or feet.
Serious side effects and warnings
Tevimbra can cause the following serious side effects.
Immune system problems. 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 if you develop any 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
- dark urine (tea colored)
- severe nausea or vomiting
- bleeding or bruising more easily than normal
- pain on the right side of your stomach area (abdomen).
- Hormone gland problems
- headaches that will not go away or unusual headaches
- urinating more often than usual
- hair loss
- eye sensitivity to light
- eye problems
- rapid heartbeat
- increased sweating
- extreme tiredness
- weight gain or weight loss
- feeling cold
- constipation
- your voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as decreased
- sex drive, irritability, or forgetfulness
- feeling more hungry or thirsty than usual.
- Kidney problems
- decrease in your amount of urine
- swelling in your ankles
- blood in your urine
- 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, dizziness, itching or rash, feeling like passing out, flushing, fever,shortness of breath or wheezing, 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 or tissue 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.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
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 the FDA at 1-800-FDA-1088.
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Before taking
To make sure Tevimbra is safe for you, tell your healthcare provider 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
- are breastfeeding or plan to breastfeed.
Pregnancy
Tevimbra may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving Tevimbra and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.
Breastfeeding
It is not known if Tevimbra passes into your breast milk. Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
How is Tevimbra administered?
Your healthcare provider will give you Tevimbra into your vein through an intravenous (IV) line.
- The first infusion is usually administered over 60 minutes.
- If well tolerated, the next infusion can be given over 30 minutes.
Tevimbra is usually given 1 time every 3 weeks.
- Your healthcare provider will decide how many treatments you need.
- Your healthcare provider will do blood tests to check you for certain side effects.
Tevimbra dosing information
The recommended adult dose of Tevimbra is 200 mg as an IV infusion every 3 weeks.
What happens if I miss a dose?
If you miss any appointment, call your healthcare provider as soon as possible to reschedule your appointment.
What should I avoid while receiving Tevimbra?
Follow your doctor's instructions about restricting food, beverages, or activity.
What other drugs will affect Tevimbra?
Other drugs may interact with Tevimbra, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Storage
Your healthcare provider will store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze. Do not shake.
Tevimbra ingredients
Active: tislelizumab-jsgr
Inactive ingredients: citric acid monohydrate, histidine, L-histidine hydrochloride monohydrate, polysorbate 20,
sodium citrate, Sterile Water for Injection, and trehalose.
Available as a 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.
Who makes Tevimbra?
Tevimbra is made by BeiGene USA, Inc, a biopharmaceutical company with its U.S. headquarters located in Cambridge, Massachusetts. The company is the U.S. subsidiary of BeiGene, Ltd., which was founded in 2010 in Beijing, China.
Tevimbra 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 Tevimbra.
Tevimbra (tislelizumab-jsgr) - BeiGene USA, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
References
More about Tevimbra (tislelizumab)
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- Drug class: anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.