Prescription medicine
Tislelizumab Brand names: Tevimbra
Tislelizumab (Tevimbra) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tislelizumab FDA label on DailyMed (effective August 31, 2026); every tislelizumab label on DailyMed.
Highlights of the record
FDA label of August 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTEVIMBRA 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).
Forms and strengths
- 10 mg/ml
Injection (solution) (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 177 through July 30, 2026
What is tislelizumab used for?
From the label: indications and usageTEVIMBRA 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. […]
FDA pharmacologic class: Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (TEVIMBRA), BeOne Medicines USA, Inc., effective August 31, 2026 (SPL set 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a), via openFDA; the full label on DailyMed
What does the patient leaflet for tislelizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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. […] 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. […]
Source: FDA drug label (TEVIMBRA), BeOne Medicines USA, Inc., effective August 31, 2026 (SPL set 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a), via openFDA; the full label on DailyMed
Is there a generic for tislelizumab (Tevimbra)?
No generic tislelizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tislelizumab label say about other medicines?
The tislelizumab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name tislelizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Prednisone | warnings and precautions | 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. |
Source: FDA drug label (TEVIMBRA), BeOne Medicines USA, Inc., effective August 31, 2026 (SPL set 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a), via openFDA; the full label on DailyMed
What do FAERS reports show for tislelizumab?
The FDA Adverse Event Reporting System holds 177 reports that list tislelizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 32 are coded as a death and 49 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Tislelizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other