Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Brentuximab vedotin
Drug ID BADD_D00291
Description Brentuximab vedotin, also known as Adcetris®, is an antibody-drug conjugate that combines an anti-CD30 antibody with the drug monomethyl auristatin E (MMAE). It is an anti-neoplastic agent used in the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin was initially approved in 2011. In January 2012, the drug label was revised with a boxed warning of a condition known as progressive multifocal leukoencephalopathy and death due to opportunistic JC virus infection post treatment [L1737]. 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 when it is compared to the previous standard of care. Importantly, removing the drug bleomycin, a highly toxic agent, was completely removed from the regimen. This demonstrates meaningful progress in treatment for patients affected by this disease [L1739].
Indications and Usage Seattle Genetics Announced FDA Approval of ADCETRIS® (Brentuximab Vedotin) in combination with chemotherapy for adults with previously untreated stage III or IV Classical Hodgkin Lymphoma in March 2018 [L1737, L1739]. Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates [FDA label], [L1737]. Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen [FDA label].
Marketing Status approved; investigational
ATC Code L01FX05
DrugBank ID DB08870
KEGG ID D09587
MeSH ID D000079963
PubChem ID Not Available
TTD Drug ID D03TIS
NDC Product Code 51144-050; 49187-0212; 69443-050; 78848-003
UNII 7XL5ISS668
Synonyms Brentuximab Vedotin | cAC10-vcMMAE | cAC10 vcMMAE | cAC10vcMMAE | Adcetris | CAC10-1006 | CAC10 1006 | CAC101006 | SGN-35 | SGN 35 | SGN35
Chemical Information
Molecular Formula Not Available
CAS Registry Number 914088-09-8
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dry skin23.03.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Headache17.14.01.001--
Insomnia19.02.01.002; 17.15.03.002--
Lymphadenopathy01.09.01.002--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neutropenia01.02.03.004--Not Available
Night sweats23.02.03.006; 08.01.03.031--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Peripheral motor neuropathy17.09.03.004--
Peripheral sensory neuropathy17.09.03.005--
Progressive multifocal leukoencephalopathy17.16.02.002; 11.05.05.001--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
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