Prescription medicine
Brentuximab vedotin Brand names: Adcetris
Brentuximab vedotin (Adcetris) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the brentuximab vedotin FDA label on DailyMed (effective November 11, 2025, SEAGEN INC.); the BLA 125388 record on Drugs@FDA; every brentuximab vedotin label on DailyMed.
Highlights of the record
FDA label of November 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).
JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9), Adverse Reactions (6.1) ]. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning. JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS ( 5.9 , 6.1 ).
Used for
From the label: indications and usageADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:
Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ).
Forms and strengths
- 50 mg/10.5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 19, 2011 Adcetris, Seattle Genetics; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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
- 10,190 through July 30, 2026
What is brentuximab vedotin used for?
From the label: indications and usageADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:
Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ).
Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide ( 1.2 ).
Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation ( 1.3 ). […]
Conditions named in the indications of brentuximab vedotin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD30-directed Immunoconjugate.
Source: FDA drug label (ADCETRIS), BLA125388 (Seattle Genetics), as published by SEAGEN INC., effective November 11, 2025 (SPL set 3904f8dd-1aef-3490-e48f-bd55f32ed67f), via openFDA; the full label on DailyMed
Is there a generic for brentuximab vedotin (Adcetris)?
No generic brentuximab vedotin is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the brentuximab vedotin label say about other medicines?
The brentuximab vedotin label names 5 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 |
|---|---|---|
| Acetaminophen | warnings and precautions | Patients who have experienced a prior infusion-related reaction should be premedicated for subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid. |
| Bleomycin | contraindications | CONTRAINDICATIONS ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation) [see Adverse Reactions (6.1) ]. |
| Ketoconazole | drug interactions | Drugs on ADCETRIS CYP3A4 Inhibitors: Co-administration of ADCETRIS with ketoconazole, a potent CYP3A4 inhibitor, increased exposure to MMAE [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reaction. |
| Lenalidomide | warnings and precautions | In ECHELON-3 (Study 8), 27% of patients treated with ADCETRIS + lenalidomide + a rituximab product experienced peripheral neuropathy of any grade (by maximum grade, 14% Grade 1, 7% Grade 2, 5% Grade 3). |
| Rituximab | warnings and precautions | In ECHELON-3 (Study 8), 27% of patients treated with ADCETRIS + lenalidomide + a rituximab product experienced peripheral neuropathy of any grade (by maximum grade, 14% Grade 1, 7% Grade 2, 5% Grade 3). |
Source: FDA drug label (ADCETRIS), BLA125388 (Seattle Genetics), as published by SEAGEN INC., effective November 11, 2025 (SPL set 3904f8dd-1aef-3490-e48f-bd55f32ed67f), via openFDA; the full label on DailyMed
What do FAERS reports show for brentuximab vedotin?
The FDA Adverse Event Reporting System holds 10,190 reports that list brentuximab vedotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,938 are coded as a death and 3,848 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 brentuximab vedotin?
36 other medicines are given the same way (intravenous) and in the same FDA class as brentuximab vedotin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Brentuximab vedotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other