TEVIMBRA tislelizumab-jsgr 10 mg/mL Injection, Solution, Concentrate
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Tislelizumab-jsgr injection is used to treat a certain type of esophageal cancer (cancer of the tube that connects your throat to your stomach) and a certain type of gastric cancer (cancer of the stomach). Tislelizumab-jsgr is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the growth of cancer cells.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with tislelizumab-jsgr — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.42 mg / 1 mL
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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2.54 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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0.2 mg / 1 mL
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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5.93 mg / 1 mL
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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65.04 mg / 1 mL
UNII B8WCK70T7I
Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9329 | $58.169 / J9329 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tevimbra 10 mg/mLthis 72579-0121-01 | BeOne | 1 vial | — | — | FDA listed | — |
| Tevimbra 10 mg/mL 72579-0125-00 | BeOne | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 13, 2036 |
Is there a biosimilar for TEVIMBRA 100 MG/10 ML VIAL?
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Can a biosimilar launch before the last patent expires?
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📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72579-0121-01 You're viewing this | 1 VIAL, GLASS in 1 CARTON (72579-121-01) / 10 mL in 1 VIAL, GLASS | 2024-03-14 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).
( 1.2 ) Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy in adults for the first line treatment of HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. ( 1.3 )
1.1Esophageal Cancer First-Line Treatment of Esophageal Squamous Cell Carcinoma TEVIMBRA, in combination with platinum-containing chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). Previously Treated Esophageal Squamous Cell Carcinoma TEVIMBRA, as a single agent, is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
1.2Gastric Cancer TEVIMBRA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).
1.3Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma TEVIMBRA, in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma as detected by an FDA-authorized test [see Dosage and Administration (2.1) ].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended Dosage: Esophageal Cancer 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with platinum-containing chemotherapy for first-line treatment of unresectable or metastatic ESCC. ( 2.2 ) 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks as a single agent for treatment of unresectable or metastatic ESCC. ( 2.2 ) Gastric Cancer 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with platinum and fluoropyrimidine-based chemotherapy.
( 2.2 ) Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with zanidatamab-hrii and fluoropyrimidine- and platinum- containing chemotherapy. ( 2.2 )
2.1Patient Selection Select patients for the first-line treatment of unresectable or metastatic esophageal squamous cell carcinoma based on the presence of PD-L1 in tumor specimens [see Clinical Studies (14.1) ]. An FDA-authorized companion diagnostic for the detection of PD-L1 in patients with unresectable or metastatic esophageal squamous cell carcinoma is not available. Select patients for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) based on the presence of PD-L1 in tumor specimens [see Clinical Studies (14.2) ] .
An FDA-authorized companion diagnostic for the detection of PD-L1 in patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) is not available. Select patients for the first-line treatment of HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma based on HER2-positive status from tumor specimens, as detected by an FDA-authorized test [see Clinical Studies (14) ]. Information on FDA-authorized tests for HER2 protein expression in gastric, gastroesophageal junction, or esophageal adenocarcinoma at: http://www.fda.gov/CompanionDiagnostics
2.2Recommended Dosage The recommended dosages of TEVIMBRA administered intravenously as a single agent or in combination with other therapeutic agents are presented in Table 1. Table 1: Recommended Dosages for TEVIMBRA as a Single Agent or in Combination with Other Therapeutic Agents Indication Recommended Dosage of TEVIMBRA Duration/Timing of Treatment Esophageal Squamous Cell Carcinoma OR First-Line HER2-Negative Gastric Cancer OR First-Line HER2-Positive Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma 150 mg every 2 weeks OR 200 mg every 3 weeks OR 300 mg every 4 weeks OR 400 mg every 6 weeks Until disease progression or unacceptable toxicity.
Refer to the respective Prescribing Information for each therapeutic agent administered in combination with TEVIMBRA for the recommended dosage information, including premedication requirements, as appropriate.
2.3Dosage Modifications for Adverse Reactions No dose reduction of TEVIMBRA is recommended. In general, withhold TEVIMBRA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TEVIMBRA for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids [see Warnings and Precautions (5.1) ] .
Dosage modifications for TEVIMBRA for adverse reactions that require management different from these general guidelines are summarized in Table 2 . Refer to the respective Prescribing Information of each of the individual therapeutic agents used in combination with TEVIMBRA for dosage modification recommendations. Table 2: Recommended Dosage Modifications for Adverse Reactions A…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/10 mL (10 mg/mL) and 150 mg/15 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial. Injection: 100 mg/10 mL (10 mg/mL) and 150 mg/15 mL (10 mg/mL) solution in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions : ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
Withhold or permanently discontinue TEVIMBRA based on the severity of reaction. Infusion-Related Reactions : Slow the rate of infusion, interrupt, or permanently discontinue based on severity of infusion reaction. ( 5.2 ) Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) : Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 )
5.1Severe and Fatal Immune-Mediated Adverse Reactions TEVIMBRA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under WARNINGS AND PRECAUTIONS may not include all possible severe and fatal immune-mediated reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.
Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue TEVIMBRA depending on severity [see Dosage and Administration (2.2) ] .
In general, if TEVIMBRA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids.
Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis TEVIMBRA can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
Immune-mediated pneumonitis occurred in 4.7% (113/2390) of patients receiving TEVIMBRA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (1.4%), and Grade 2 (1.9%) adverse reac…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the label: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥20%), including laboratory abnormalities, were: TEVIMBRA in combination with platinum-containing chemotherapy: decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased aspartate aminotransferase (AST), decreased potassium, increased serum creatinine, decreased calcium, increased alanine aminotransferase (ALT), diarrhea, stomatitis, and vomiting.
( 6.1 ) TEVIMBRA as a single agent: increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough. ( 6.1 ) TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count, decreased neutrophil count, increased AST, diarrhea, abdominal pain, increased ALT, decreased white blood cell count, decreased weight, and pyrexia.
( 6.1 ) TEVIMBRA in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy: diarrhea, nausea, anemia, decreased appetite, vomiting, hypokalemia, fatigue, rash, decreased neutrophil count, decreased platelet count, peripheral neuropathy, infusion-related reaction, and increased aspartate aminotransferase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in WARNINGS AND PRECAUTIONS reflect exposure to TEVIMBRA as a single agent in 2390 patients enrolled in three randomized open-label, active-controlled studies (BGB-A317-301, RATIONALE-302, BGB-A317-303) and six open-label, single-arm studies (BGB-A317-209, BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB-A317_Study_001), which enrolled 307 patients with esophageal squamous cell carcinoma and 2083 patients with advanced or recurrent tumors.
TEVIMBRA was administered at a dose of 200 mg intravenously once every 3 weeks, except in study BGB-A317_Study_001 where patients also received other dosage regimens. Among the 2390 patients, 38% were exposed for longer than 6 months, and 23% were exposed for longer than 12 months. First-line Treatment of Unresectable or Metastatic Esophageal Carcinoma (ESCC) The safety of TEVIMBRA in combination with chemotherapy was evaluated in RATIONALE-306, a randomized, placebo-controlled, multicenter, double-blind trial in patients with unresectable, advanced, or metastatic ESCC [see Clinical Studies (14.1) ] .
Patients were randomized (1:1) to receive either TEVIMBRA 200 mg by intravenous infusion over 30-60 minutes every 3 weeks or placebo plus a chemotherapy doublet regimen. The chemotherapy doublet regimens consisted of: Platinum (cisplatin [60 to 80 mg/m 2 IV, on Day 1] or oxaliplatin [130 mg/m 2 IV, on Day 1]) and a fluoropyrimidine (5-FU [750 to 800 mg/m 2 IV, on Day 1 to 5] or capecitabine [1000 mg/m 2 orally twice daily, on Day 1 to 14]) or Platinum (cisplatin [60 to 80 mg/m 2 IV, on Day 1 or 2] or oxaliplatin [130 mg/m 2 IV, on Day 1 or 2]) and (paclitaxel 175 mg/m 2 IV, on Day 1) Patients were treated until disease progression or unacceptable toxicity.
The median duration of exposure was 6.4 months (range: 0.1 to 38.3 months) in TEVIMBRA-treated patients. Serious a…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on its mechanism of action, TEVIMBRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TEVIMBRA in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data ) .
Human IgG4 immunoglobulins (IgG4) are known to cross the placental barrier; therefore, tislelizumab-jsgr has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Animal reproduction studies have not been conducted with TEVIMBRA to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering TEVIMBRA during pregnancy include increased rates of abortion or stillbirth.
As reported in the literature, there were no malformations related to the blockade of PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to tislelizumab-jsgr may increase the risk of developing immune-mediated disorders or altering the normal immune response.
8.2Lactation Risk Summary There is no information regarding the presence of tislelizumab-jsgr in human milk, or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose of TEVIMBRA.
8.3Females and Males of Reproductive Potential TEVIMBRA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating TEVIMBRA [see Use in Specific Populations (8.1) ] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TEVIMBRA and for 4 months after the last dose of TEVIMBRA.
8.4Pediatric Use The safety and effectiveness of TEVIMBRA have not been established in pediatric patients.
8.5Geriatric Use TEVIMBRA as a Single Agent Of the 255 patients who were treated with TEVIMBRA for previously treated unresectable or metastatic ESCC in the clinical study RATIONALE-302, 98 (38%) were 65 years and older and 13 (5%) were 75 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients. TEVIMBRA in Combination with Chemotherapy Of the 324 patients who were treated with TEVIMBRA and platinum-containing chemotherapy as first-line treatment for unresectable advanced or metastatic ESCC in the clinical study RATIONALE-306, 149 (46%) were 65 years and older and 13 (4%) were 75 years and older.
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. Of the 498 patients who were treated with TEVIMBRA in combination with platinum-containing chemotherapy for G/GEJ adenocarcinoma in the clinical study RATIONALE-305, 161 (32%) were 65 years and older, and 28 (6%) were 75 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
TEVIMBRA in Combination with Zanidatamab-hrii and Chemotherapy Of the 30…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, TEVIMBRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TEVIMBRA in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data ) .
Human IgG4 immunoglobulins (IgG4) are known to cross the placental barrier; therefore, tislelizumab-jsgr has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Animal reproduction studies have not been conducted with TEVIMBRA to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering TEVIMBRA during pregnancy include increased rates of abortion or stillbirth.
As reported in the literature, there were no malformations related to the blockade of PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to tislelizumab-jsgr may increase the risk of developing immune-mediated disorders or altering the normal immune response.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TEVIMBRA have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use TEVIMBRA as a Single Agent Of the 255 patients who were treated with TEVIMBRA for previously treated unresectable or metastatic ESCC in the clinical study RATIONALE-302, 98 (38%) were 65 years and older and 13 (5%) were 75 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients. TEVIMBRA in Combination with Chemotherapy Of the 324 patients who were treated with TEVIMBRA and platinum-containing chemotherapy as first-line treatment for unresectable advanced or metastatic ESCC in the clinical study RATIONALE-306, 149 (46%) were 65 years and older and 13 (4%) were 75 years and older.
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. Of the 498 patients who were treated with TEVIMBRA in combination with platinum-containing chemotherapy for G/GEJ adenocarcinoma in the clinical study RATIONALE-305, 161 (32%) were 65 years and older, and 28 (6%) were 75 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
TEVIMBRA in Combination with Zanidatamab-hrii and Chemotherapy Of the 302 patients who received TEVIMBRA in combination with zanidatamab-hrii and chemotherapy for GEA, there were 139 (46%) patients 65 years of age and older, 106 (35%) were 65 to 74 years old, and 33 (11%) were 75 years and older. There was a higher incidence of Grade ≥3 adverse reactions observed in patients 65 years of age and older (87%) as compared to younger patients (80%). The incidence of Grade 3 or 4 diarrhea was higher in patients 65 years and older (32%) compared to patients younger than 65 years (20%).
There was an increased incidence of fatal adverse reactions in patients 65 years and older (4.4%), including acute kidney injury (N=2), cardiac failure, dehydration, hypovolemic shock and intestinal obstruction (all N=1), compared to younger patients (0.6%), including diarrhea (N=1).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Tislelizumab-jsgr binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Tislelizumab-jsgr decreased tumor growth in xenograft models and a human PD-1 transgenic mouse model.
12.2Pharmacodynamics The tislelizumab-jsgr exposure-response relationship for efficacy and safety and time course of pharmacodynamic response has not been fully characterized.
12.3Pharmacokinetics Pharmacokinetic parameters are presented as geometric mean (% CV) unless otherwise specified. The peak concentration (C max ) and area under the plasma concentration versus time curve (AUC) of tislelizumab-jsgr increased dose proportionally in the dose range of 0.5 (0.2 times the approved recommended dosage in a 70 kg patient) to 10 mg/kg (3.5 times the approved recommended dosage in a 70 kg patient). The steady-state AUC tau of tislelizumab-jsgr is 1,283 mcg/mL∙day (28.7%) and the C max is 110 mcg/mL (22.2%) following the approved recommended dosage.
Steady-state concentration of tislelizumab-jsgr is reached after 12 weeks of repeated dosing with an every 3-week regimen and the systemic accumulation was 2.14-fold. Distribution The tislelizumab-jsgr steady-state total volume of distribution is
6.42L (32.6%). Elimination The tislelizumab-jsgr total clearance is 0.153 L/day (29.5%) and the terminal half-life (t ½ ) is 24 days (31%). Specific Populations No clinically significant differences in the pharmacokinetics of tislelizumab-jsgr were observed based on age (range: 18 to 90 years), weight (range: 32 to 130 kg), race (White, Asian, or Black), mild to moderate renal impairment (CLcr ≥30 mL/min, estimated by Cockcroft-Gault), mild to moderate hepatic impairment (total bilirubin ≤3 times ULN and any AST, estimated by NCI criteria).
The effect of severe hepatic impairment (total bilirubin >3 times ULN and any AST), severe renal impairment (CLcr 15-29 mL/min), or end-stage renal disease (CLcr <15 mL/min) on the pharmacokinetics of tislelizumab-jsgr is unknown.
12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of tislelizumab-jsgr products. In patients who received tislelizumab-jsgr in RATIONALE-306 for up to 26 months, the incidence of anti-tislelizumab antibodies was 22% (66/300).
Among the anti-tislelizumab antibody-positive patients, the incidence of neutralizing antibodies was 1.5% (1/66). In patients who received tislelizumab-jsgr in RATIONALE-302 for up to 22 months, the incidence of anti-tislelizumab antibodies was 14.5% (32/221). Among the anti-tislelizumab antibody-positive patients, the incidence of neutralizing antibodies was 3.1% (1/32).
In patients who received tislelizumab-jsgr in RATIONALE-305 throughout the treatment period and in the ADA analysis set, the incidence of anti-tislelizumab antibodies was 22.7% (108/475). Among the anti-tislelizumab antibody-positive patients, the incidence of neutralizing antibodies was 5.6% (6/108). There was no significant effect of anti-drug antibodies on the pharmacokinetics of tislelizumab-jsgr.
The effect of anti-drug antibodies on pharmacodynamics, safety, or effectiveness of tislelizumab-jsgr has not been fully characterized.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Tislelizumab-jsgr binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Tislelizumab-jsgr decreased tumor growth in xenograft models and a human PD-1 transgenic mouse model.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TEVIMBRA injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied in a carton containing one single-dose vial, available as follows: Strength NDC 100 mg/10 mL (10 mg/mL) 72579-121-01 150 mg/15 mL (10 mg/mL) 72579-125-00 Storage 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.
📦 Storage and Handling ▾
Storage 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.
📋 Description ▾
11 DESCRIPTION Tislelizumab-jsgr is a programmed death receptor-1 (PD-1)–blocking antibody. Tislelizumab-jsgr is an Fc-engineered humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 147 kDa. Tislelizumab-jsgr is produced in recombinant Chinese hamster ovary (CHO) cells.
TEVIMBRA (tislelizumab-jsgr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use, supplied in single-dose vials. Each mL of TEVIMBRA solution contains tislelizumab-jsgr monoclonal antibody (10 mg), citric acid monohydrate (0.42 mg), histidine (1.72 mg), L-histidine hydrochloride monohydrate (0.82 mg), polysorbate 20 (0.2 mg), sodium citrate (5.93 mg), trehalose (65.04 mg), and Water for Injection, USP. The pH is 6.5.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of TEVIMBRA. These reactions may include: Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1) ] .
Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, or severe abdominal pain [see Warnings and Precautions (5.1) ] . Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of the abdomen, or easy bruising or bleeding [see Warnings and Precautions (5.1) ] . Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, thyroiditis, or Type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] .
Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis [see Warnings and Precautions (5.1) ] . Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS, TEN, or DRESS [see Warnings and Precautions (5.1) ] . Other Immune-Mediated Adverse Reactions: Advise patients that immune-mediated adverse reactions can occur and may involve any organ system, and to contact their healthcare provider immediately for any new or worsening signs or symptoms [see Warnings and Precautions (5.1) ] .
Advise patients of the risk of solid organ transplant rejection and other transplant (including corneal graft) rejection and to contact their healthcare provider immediately for signs or symptoms of organ transplant rejection [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.2) ] . Complications of Allogeneic Hematopoietic Stem Cell Transplantation Complications Advise patients of potential risk of post-allogeneic hematopoietic stem cell transplantation complications (HSCT) [see Warnings and Precautions (5.3) ].
Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ]. Advise females of reproductive potential to use effective contraception during treatment with TEVIMBRA and for 4 months after the last dose [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ]. Lactation Advise women not to breastfeed during treatment with TEVIMBRA and for 4 months after the last dose [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
Medication Guide TEVIMBRA ® (teh-vim-brah) (tislelizumab-jsgr) injection This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 8/2026 What is the most important information I should know about TEVIMBRA?
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 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 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. What is TEVIMBRA? TEVIMBRA is a prescription medicine used to treat a…