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1L HER2+ Advanced GEA 1L HER2- Advanced GC/GEJC 1L Advanced ESCC

Upper GI
Cancer Overview
Product Design
Efficacy
Safety
Safety
Safety
Safety
Dosing
- Dosing and Administration
- Dosing Modifications
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Prescribing Information
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Choose Indication

1L HER2+ Advanced GEA 1L HER2- Advanced GC/GEJC 1L Advanced ESCC

Upper GI
Cancer Overview
Product Design
Efficacy
Safety
Safety
Safety
Safety
Dosing
- Dosing and Administration
- Dosing Modifications
Resources

US Patients & Caregivers
myBeOneSupport^®
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IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Immune-Mediated Adverse Reactions (IMARs): TEVIMBRA can cause immune-mediated adverse reactions, which may be severe or fatal and can occur in any organ system or tissue.

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INDICATIONS

TEVIMBRA is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adults with:

IMPORTANT SAFETY INFORMATION

WARNINGS & PRECAUTIONS

Immune-Mediated Adverse Reactions (IMARs): TEVIMBRA can cause immune-mediated adverse reactions, which may be severe or fatal and can occur in any organ system or tissue. Early identification and management of IMARs are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. IMARs may occur at any time during or after treatment. Monitor for signs and symptoms of IMARs. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For suspected IMARs, initiate appropriate workup to exclude alternative etiologies. Withhold or permanently discontinue TEVIMBRA based on severity and administer systemic corticosteroids or other immunosuppressants as clinically indicated. The IMARs listed were observed in clinical studies of TEVIMBRA (n=2390) and may not include all possible severe and fatal IMARs.
- Pneumonitis: TEVIMBRA can cause immune-mediated pneumonitis, which can be fatal. Immune-mediated pneumonitis occurred in 4.7% of patients, including Grade 3-4 reactions in 1.7% and fatal events in 0.1%.
- Colitis: TEVIMBRA can cause immune-mediated colitis, which can be fatal. Immune-mediated colitis occurred in 0.8% of patients, including Grade 3 reactions in 0.3%.
- Hepatitis: TEVIMBRA can cause immune-mediated hepatitis, which can be fatal. Immune-mediated hepatitis occurred in 1.3% of patients, including Grade 3-4 reactions in 0.9%.
- Endocrinopathies: TEVIMBRA can cause immune-mediated endocrinopathies, including adrenal insufficiency, hypophysitis/hypopituitarism, thyroid disorders, and type 1 diabetes mellitus. Reported rates included adrenal insufficiency (0.5%; Grade 3-4: 0.24%), hypophysitis/hypopituitarism (0.3%; all Grade 2), thyroiditis (1.0%; Grade 2: 0.5%), hyperthyroidism (4.9%; Grade 3: 0.04%), hypothyroidism (12.5%; Grade 3-4: 0.08%), and diabetes mellitus (0.7%; Grade 3-4: 0.4%).
- Nephritis with Renal Dysfunction: TEVIMBRA can cause immune-mediated nephritis with renal dysfunction, which can be fatal. Immune-mediated nephritis with renal dysfunction occurred in 0.2% of patients, including Grade 3 reactions in 0.04%.
- Dermatologic Adverse Reactions: TEVIMBRA can cause immune-mediated rash or dermatitis, including severe cutaneous adverse reactions. Immune-mediated dermatologic adverse reactions occurred in 13% of patients, including Grade 3-4 reactions in 1.2%; Stevens-Johnson syndrome occurred in 0.04% of patients.
- Other Immune-Mediated Adverse Reactions: Other clinically significant immune-mediated adverse reactions occurred in <1% of patients and may involve cardiac/vascular, neurologic, ocular, gastrointestinal, musculoskeletal/connective tissue, endocrine, hematologic/immune systems (including solid organ transplant rejection), and myocarditis-myositis-myasthenia gravis (or myasthenia-like) overlap syndrome. Severe or fatal cases have been reported for some of these reactions.
Infusion-Related Reactions: TEVIMBRA can cause infusion-related reactions, which may be severe or life-threatening. Infusion-related reactions occurred in 4.7% of patients (Grade ≥3: 0.2%). Monitor patients during infusion; slow the infusion for Grade 1 reactions, interrupt the infusion for Grade 2, and permanently discontinue TEVIMBRA for Grade 3 or higher.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and serious complications, including graft-versus-host disease, have occurred in patients who receive allogeneic HSCT before or after treatment with PD-1/PD-L1 blockade. Complications may occur despite intervening therapy between treatment with PD-1/PD-L1 blockade and allogeneic HSCT. Monitor patients closely and intervene promptly.
Embryo-Fetal Toxicity: TEVIMBRA can cause fetal harm and potential fetal death as shown in animal studies. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status prior to initiation of TEVIMBRA. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including lab abnormalities were:

Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (Combination with zanidatamab-hrii and chemotherapy, 1L): diarrhea, nausea, anemia, decreased appetite, vomiting, hypokalemia, fatigue, rash, decreased neutrophil count, decreased platelet count, peripheral neuropathy, infusion-related reaction, and increased AST.
Esophageal Cancer (Combination with chemotherapy, 1L): decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased AST, decreased potassium, increased serum creatinine, decreased calcium, increased ALT, diarrhea, stomatitis, and vomiting.
Gastric Cancer (Combination with chemotherapy, 1L): 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.

SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment and for 4 months after the last dose.

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.

Please see full Prescribing Information.

INDICATIONS

TEVIMBRA is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adults with:

Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma: In combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Esophageal Cancer: In combination with platinum-containing chemotherapy for first-line treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (≥1).
Gastric Cancer: In combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).

Please see full Prescribing Information.

TEVIMBRA, BeOne Medicines, and myBeOneSupport are trademarks owned by BeOne Medicines I GmbH or its affiliates.
© BeOne Medicines I GmbH, 2026 All Rights Reserved. 0526-TEV-PRC-190 09/26

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