Brentuximab Vedotin (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- ADCETRIS
Boxed Warning
JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9), Adverse Reactions (6.1)].
Contraindications
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation) [see Adverse Reactions (6.1)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Peripheral Neuropathy [see Warnings and Precautions (5.1)] •Anaphylaxis and Infusion Reactions [see Warnings and Precautions (5.2)] •Hematologic Toxicities [see Warnings and Precautions (5.3)] •Serious Infections and Opportunistic Infections [see Warnings and Precautions (5.4)] •Tumor Lysis Syndrome [see Warnings and Precautions (5.5)] oIncreased Toxicity in the Presence of Severe Renal Impairment [see Warnings and Precautions (5.6)] •Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment [see Warnings and Precautions (5.7)] •Hepatotoxicity [see Warnings and Precautions (5.8)] •Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.9)] •Pulmonary Toxicity [see Warnings and Precautions (5.10)] •Serious Dermatologic Reactions [see Warnings and Precautions (5.11)] •Gastrointestinal Complications [see Warnings and Precautions (5.12)] •Hyperglycemia [see Warnings and Precautions (5.13)]
Mechanism of Action
CD30 is a member of the tumor necrosis factor receptor family and is expressed on the surface of sALCL cells and on Hodgkin Reed-Sternberg (HRS) cells in cHL. CD30 is variably expressed in other T-cell lymphomas. Expression of CD30 on healthy tissue and cells is limited. In vitro data suggest that signaling through CD30-CD30L binding may affect cell survival and proliferation. Brentuximab vedotin is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against CD30. The small molecule, MMAE, is a microtubule-disrupting agent. MMAE is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of ADCETRIS is due to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC‑CD30 complex, and the release of MMAE via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic death of the cells. Additionally, in vitro data provide evidence for antibody-dependent cellular phagocytosis (ADCP).
Overdosage
There is no known antidote for overdosage of ADCETRIS. In case of overdosage, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered.