Prescription medicine
Tremelimumab Brand names: Imjudo
Tremelimumab (Imjudo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tremelimumab FDA label on DailyMed (effective August 31, 2026); every tremelimumab 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 usageIMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:
in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
Forms and strengths
- 25 mg/1.25ml
- 300 mg/15ml
Injection (solution).
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
- 4,216 through July 30, 2026
What is tremelimumab used for?
From the label: indications and usageIMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:
in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 )
in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. […]
Conditions named in the indications of tremelimumab's FDA labels, with every medicine labeled for each:
From other tremelimumab labelsLung cancer: Cancer (NSCLC) IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or …
FDA pharmacologic class: CTLA-4-directed Blocking Antibody.
Source: FDA drug label (IMJUDO), AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 6690679c-be2f-4588-a2e4-89fff74dd6be), via openFDA; the full label on DailyMed
What does the patient leaflet for tremelimumab 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 IMJUDO?IMJUDO is a medicine that may treat certain cancers by working with your immune system. IMJUDO in combination with durvalumab 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 signs or symptoms, including: Lung problems. • cough • shortness of breath • chest pain Intestinal problems. • diarrhea (loose stools) or more frequent bowel movements than usual • stools that are black, tarry, sticky, or have blood or mucus • severe stomach-area (abdomen) pain or tenderness Liver problems. […] These are not all of the signs and symptoms of immune system problems that can happen with IMJUDO. […]
Source: FDA drug label (IMJUDO), AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 6690679c-be2f-4588-a2e4-89fff74dd6be), via openFDA; the full label on DailyMed
Is there a generic for tremelimumab (Imjudo)?
No generic tremelimumab 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 tremelimumab label say about other medicines?
The tremelimumab label names 3 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Durvalumab | warnings and precautions | In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. |
| Prednisone | warnings and precautions | In general, if combination of IMJUDO and durvalumab requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
| Propylthiouracil | warnings and precautions | All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. |
Source: FDA drug label (IMJUDO), AstraZeneca Pharmaceuticals LP, effective August 31, 2026 (SPL set 6690679c-be2f-4588-a2e4-89fff74dd6be), via openFDA; the full label on DailyMed
What do FAERS reports show for tremelimumab?
The FDA Adverse Event Reporting System holds 4,216 reports that list tremelimumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,203 are coded as a death and 2,043 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tremelimumab?
16 other medicines are given the same way (intravenous) and in the same FDA class as tremelimumab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as tremelimumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tremelimumab
- 16 medicines for the same use
- Other ctla-4-directed blocking antibodys
- the pharmacologic class, with prices and generics
- Tremelimumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other