Brentuximab vedotin 50mg powder for solution for infusion vials
Requires a prescription from a doctor or prescriber
Brentuximab vedotin, also known as Adcetris®, is an antibody-drug conjugate that combines an anti-CD30 antibody with the drug monomethyl auristatin E (MMAE).
Safety information for pregnancy and breastfeeding
Pregnancy
MMAE was found to be genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism.
Breastfeeding
MMAE was found to be genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
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Yellow Card reports
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Suspected adverse reactions reported for Brentuximab vedotin
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Brentuximab vedotin
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Adcetris 50mg powder for concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(10)
Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma (TA524)
Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma (TA577)
Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma (TA641)
Brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma (TA478)
Brentuximab vedotin in combination for untreated stage 3 or 4 CD30-positive Hodgkin lymphoma (TA1059)
Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma after stem cell transplant or at least 2 previous therapies (TA772)
Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over (TA967)
Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma (TA462)
Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma (TA540)
Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome (TA754)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & safety information
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 8 · Randomised trials: 9 · 2010–2026
Showing the 50 most relevant studies, sorted by most relevant.
Steven M. Horwitz, Owen A. O’Connor, Barbara Pro, et al.
The Lancet, 2018
- Brentuximab Vedotin
- Antineoplastic Agents
- Antineoplastic Combined Chemotherapy Protocols
H. Miles Prince, Youn H. Kim, Sarah McCue Horwitz, et al.
The Lancet, 2017
- Quality of Life
- Lymphoma, T-Cell, Cutaneous
- Brentuximab Vedotin
Steven M. Horwitz, Owen A. O’Connor, Barbara Pro, et al.
Annals of Oncology, 2021
- Lymphoma, T-Cell, Peripheral
- Ki-1 Antigen
- Brentuximab Vedotin
Craig H. Moskowitz, Auayporn Nademanee, Tamás Masszi, et al.
The Lancet, 2015
- Brentuximab Vedotin
- Antineoplastic Agents
- Hodgkin Disease
David J. Straus, Monika Długosz‐Danecka, Joseph M. Connors, et al.
The Lancet Haematology, 2021
- Progression-Free Survival
- Brentuximab Vedotin
- Antineoplastic Combined Chemotherapy Protocols
Garrett K. Berger, Ali McBride, Stephanie Lawson, et al.
Critical Reviews in Oncology/Hematology, 2016
- Brentuximab Vedotin
- Antineoplastic Agents
- Lymphoma, Non-Hodgkin
Dennis A. Eichenauer, Annette Plütschow, Stefanie Kreissl, et al.
The Lancet Oncology, 2017
- Brentuximab Vedotin
- Antineoplastic Combined Chemotherapy Protocols
- Bleomycin
Sureda A, Pavlovsky A, Haidar D, et al.
2025
- Hodgkin Disease
- Hematopoietic Stem Cell Transplantation
- Transplantation, Autologous
Brentuximab vedotin (BV) as post-autologous stem cell transplantation (ASCT) consolidation was shown to reduce the relapse risk among high-risk patients with relapsed/refractory Hodgkin lymphoma (RRHL) in the clinical trial setting. This systematic review and meta-analysis characterizes real-world evidence (RWE) on the effectiveness and safety of BV as post-ASCT consolidation in 1504 adult and pediatric patients with RRHL from 23 studies across 17 countries. A random-effects model yielded pooled progression-free survival (PFS) and overall survival rates (OS); PFS: 2-year, 74.2%; 5-year, 65.8%; OS: 2-year, 95.8%; 5-year, 91.9%. The most common any-grade adverse events were neuropathy (34.2%) and neutropenia (20.2%). Despite heterogeneity in populations and outcomes, this analysis utilizing real-world data corroborates the efficacy and safety of BV as post-ASCT consolidation in RRHL reported in the experimental arm of the Phase III AETHERA trial. The favorable PFS results in cases exposed to BV prior to ASCT indicate the value of BV in controlling Hodgkin lymphoma (HL) in the salvage setting. Continued research is essential to refine BV treatment strategies amid the evolving treatment landscape.
Abstract licence: CC BY
Arabloo J, Azari S, Gorji HA, et al.
2023
- Hodgkin Disease
- Hematopoietic Stem Cell Transplantation
- Dacarbazine
Yang Y, Liu SR, Wang L, et al.
2025
BackgroundBrentuximab vedotin (BV), an anti-CD30 antibody-drug conjugate, has established efficacy in relapsed/refractory Hodgkin lymphoma (HL), yet its role as frontline therapy for newly diagnosed classical HL requires systematic evaluation.MethodsWe conducted a meta-analysis of randomized controlled trials (RCTs) compared BV-based versus conventional non-BV-containing regimens (namely, classical chemotherapeutic regimens) in previously untreated classical HL patients, assessing progression-free survival (PFS), PET metabolic responses (interim PET-2 negativity and end-of-treatment complete response), and safety profiles (grade ≥3 adverse events [AEs], including febrile neutropenia, peripheral neuropathy, and secondary malignancies).ResultsPooled data from four RCTs (N = 3591 patients) demonstrated significant PFS improvement with BV-based regimens (HR: 0.58, 95% CI: 0.44 to 0.77, P P = 0.286), end-of-treatment complete metabolic response rates were significantly higher (RR: 1.03, 95% CI: 1.00 to 1.06, P = 0.024). Safety analyses revealed comparable incidences of grade ≥3 AEs between groups (RR: 1.05, 95% CI: 0.80 to 1.37, P = 0.739), with no increased risk of peripheral neuropathy or secondary malignancies.ConclusionsOur meta-analysis demonstrates that incorporation of BV into frontline therapy for classical HL provides significant PFS benefits and improved end-of-treatment metabolic responses, with manageable toxicity. These findings support BV-based regimens as a promising frontline therapeutic strategy in classical HL, though extended follow-up is required to evaluate long-term survival outcomes.
Abstract licence: CC BY
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
4-6 days
Mechanism
Brentuximab vedotin is composed of 3 parts: a chimeric human-murine IgG1 that se…
Food interactions
2 warnings
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
21 days
Half-life
4-6 days
[L39789]
Protein binding
68–82%
[L39789]
Volume of distribution
Metabolism
Elimination
1.8 mg/k
Clearance
1.2 mg/k
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The U.S. Food and Drug Administration approved Adcetris in March 2018 to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.[L1737]
Adcetris has also been previously approved by the FDA to treat Hodgkin's lymphoma after relapse, Hodgkin's lymphoma after stem cell transplantation when a patient has a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after the failure of other treatment regimens, and primary cutaneous ALCL after failure of other treatment regimens.[L1737]
Lymphoma is a malignancy that begins in the lymphatic system, which helps to combat infection and disease. Lymphoma may begin anywhere in the body and can spread to nearby lymph nodes. The two main types of lymphoma are Hodgkin lymphoma (also called Hodgkin disease) and non-Hodgkin lymphoma. Most individuals with Hodgkin's lymphoma have the classical type. In this type of lymphoma, large, abnormal lymphocytes (a type of white blood cell) are found in the lymph nodes called Reed-Sternberg cells. With early diagnosis and intervention, patients with Hodgkin lymphoma normally experience long-term remission.[L1737]
The ECHELON-1 study results demonstrated superior efficacy of the drug combined with a chemotherapy regimen compared to the previous standard of care. Importantly, bleomycin - a highly toxic agent - was completely removed from the regimen. This demonstrates meaningful progress in treatment for patients affected by this disease.[L1739]
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Brentuximab vedotin is additionally indicated in the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL), or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with [cyclophosphamide], doxorubicin, and [prednisone].
It may also be used as monotherapy in sALCL after therapeutic failure of a least one prior multi-agent chemotherapy regimen.
[L39789]
Brentuximab vedotin is also indicated in the treatment of primary cutaneous large anaplastic large cell lymphoma, or CD30-expressing mycosis fungoides, who have received prior systemic therapy.
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Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1229 interactions
[L39789]
Progressive multifocal leukoencephalopathy (PML) follows infection by the JC virus (which is not related to Creutzfeldt-Jakob disease). Symptoms of this condition begin insidiously and usually worsen progressively. The symptoms vary depending on which region of the brain is infected. In about two out of three patients, mental function deteriorates rapidly, leading to dementia.
Speaking and walking may become increasingly difficult. Vision may be impaired, and total blindness may occur. Rarely, headaches and seizures can occur, mainly in immunocompromised patients.
The most serious sequela of this condition is death.
[L1743]
Common adverse effects of Adcetris may include: neutropenia, anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and fever. In one trial, neutropenia occurred in 91 percent of patients treated with Adcetris plus chemotherapy, which was associated with a 19 percent rate of febrile neutropenia (neutropenia and fever).
[L1737]
Preventive treatment with G-CSF, a growth factor for the bone marrow to produce white blood cells, is recommended with Adcetris plus chemotherapy for the first-line treatment of Stage III or IV cHL.
[L1737]
Adcetris has a boxed warning that emphasizes the risk of John Cunningham virus infection leading to progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection that may be lethal.
Serious risks of Adcetris include peripheral neuropathy; severe allergic (anaphylaxis) or infusion-site reactions; damage to the blood, lungs and liver (hematologic, pulmonary and hepato-toxicities); severe/opportunistic infections; metabolic abnormalities (tumor lysis syndrome); dermatologic reactions and gastrointestinal complications. Adcetris may cause harm to the fetus and newborn baby; women should be warned of the potential risk to the fetus and to use effective contraception, and to avoid breastfeeding while taking Adcetris.
[L1737]
MMAE was found to be genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism.
This effect is consistent with the pharmacological effect of MMAE as a microtubule-disrupting drug. Fertility studies with Brentuximab vedotin or MMAE have not been conducted. Despite this, results of repeat-dose toxicity studies in rats suggest the potential for Brentuximab vedotin to have a negative effect on male reproductive function and fertility. In a 4-week repeated-dose toxicity study in rats with weekly dosing at 0.5, 5 or 10 mg/kg brentuximab vedotin, seminiferous tubule degeneration, Sertoli cell vacuolation, reduced spermatogenesis, and aspermia were observed.
[L1737]
Effects in animals were seen mostly at 5 and 10 mg/kg doses of brentuximab vedotin. These dosages are approximately 3 and 6-fold the human recommended dose of 1.8 mg/kg, respectively, based on individual body weight.
[L39789]
The antibody component of this drug is a chimeric IgG1 directed against CD30. The small molecule, MMAE, is a microtubule-disrupting particle. MMAE is covalently attached to the antibody by a linker. Data suggest that the anticancer activity of Adcertris is due to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex, and the subsequent release of MMAE by proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, inducing cell cycle arrest and apoptotis of the malignant cells [FDA label].
Hodgkin lymphoma (HL) is characterized by malignant Reed-Sternberg cells which express CD30, a marker of large cell lymphoma.[A32159] Until March 2018, USA National Comprehensive Cancer Network guidelines for patients with advanced HL (stage III/IV disease) recommend treatment with adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD), or escalated bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) as first-line regimens.[L1740]
ABVD appears to be as effective, with fewer side effects, as escalated BEACOPP. Escalated BEACOPP leads to a greater progression-free survival but no difference in overall survival. Recent progress in technology has enabled a new shift to cancer therapy targeting specific molecules. Brentuximab vedotin, a CD30-directed antibody conjugate, selectively targets malignant HL cells.[A32158]
The effect of Brentuximab vedotin (1.8 mg/kg) on the QTc interval was studied in an open-label, single-group study in 46 patients diagnosed with CD30-expressing hematologic malignancies. Ingestion of brentuximab vedotin did not prolong the mean cardiac QTc interval >10 ms from baseline levels. Smaller increases in the mean QTc interval (<10 ms) cannot be ruled out because this study did not include a placebo arm and a positive control arm.[L39789]
How the body processes this drug — absorption, distribution, metabolism, and elimination
The AUC of MMAE was measured to be approximately 2.2-fold higher in patients with hepatic impairment in comparison with patients with normal hepatic function.
[L39789]
[L39789]
[L39789]
[L39789]
[L39789]
[L39789]
[L39789]
It is recommended to avoid use in patients with severe renal impairment (CrCl <30mL/min).
[L1742]
Proteins and enzymes this drug interacts with in the body
PMID:8391931
May play a role in the regulation of cellular growth and transformation of activated lymphoblasts. Regulates gene expression through activation of NF-kappa-B PMID:8999898
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:12960149 PMID:15205344 PMID:15899824 PMID:22306008
Specifically present in limbal stem cells, where it plays a key role in corneal development and repair (By similarity)
ATC L01FX05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Brentuximab vedotin
Additional database identifiers
Drugs Product Database (DPD)
21796
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11923
GenAtlas
TNFRSF8
GeneCards
TNFRSF8
GenBank Gene Database
AY498860
Guide to Pharmacology
1877
UniProt Accession
TNR8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:46
GenAtlas
ABCB5
GeneCards
ABCB5
GenBank Gene Database
AY090613
UniProt Accession
ABCB5_HUMAN
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q422324), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.