Generic Name and Formulations:
Brentuximab vedotin 50mg/vial; pwd for IV infusion after reconstitution; preservative-free.

Company:
Seattle Genetics, Inc.

Indications for ADCETRIS:
Treatment of Hodgkin lymphoma (HL) 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. Treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Adult Dose for ADCETRIS:
Give by IV infusion over 30 minutes. 1.8mg/kg every 3 weeks (if >100kg, calculate dose based on wt. of 100kg); continue until a max of 16 cycles, disease progression or unacceptable toxicity. Peripheral neuropathy: if Grade 2/3: withhold until resolve to ≤Grade 1, then restart with 1.2mg/kg; if Grade 4: discontinue therapy. Neutropenia: Grade 3/4: withhold until resolve to ≤Grade 2; may consider growth factor support; recurrent Grade 4: discontinue or consider reducing dose to 1.2mg/kg.

Children's Dose for ADCETRIS:
Not established.

Pharmacological Class:
CD30-directed antibody-drug conjugate.

Contraindications:
Concomitant bleomycin.

Warnings/Precautions:
Risk of JC virus infection. Monitor for progressive multifocal leukoencephalopathy (PML); withhold dose if suspected and discontinue if confirmed. Monitor for neuropathy and delay, change, or discontinue dose accordingly. Monitor for infusion-related reactions; permanently discontinue and treat if anaphylaxis occurs. Monitor CBCs prior to each dose and frequently for Grade 3 or 4 neutropenia; if develops, delay, reduce or discontinue dose. Increased risk of tumor lysis syndrome in rapidly proliferating tumor/high tumor burden patients; monitor closely. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.

Interactions:
See Contraindications. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); monitor. Antagonized by potent CYP3A4 inducers (eg, rifampin).

Adverse Reactions:
Neutropenia, peripheral sensory neuropathy, fatigue, GI upset, anemia, upper respiratory tract infection, pyrexia, rash, thrombocytopenia, cough; infusion reactions, Stevens-Johnson syndrome (discontinue if occurs), PML (may be fatal).

How Supplied:
Single-use vial—1

Adcetris Prescribing Information Updated
Seattle Genetics announced that it has updated the prescribing information for Adcetris (brentuximab vedotin injection) to include a boxed warning, a new contraindication, and discussion of progressive multifocal leukoencephalopathy in the warnings. The revised labeling now includes:
•A boxed warning related to the risk that JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving Adcetris
•A discussion in the PML warning and precaution provision regarding other possible contributing factors to PML such as other prior therapies and underlying disease, symptoms to be aware of and suggested methodologies for diagnosis of PML
•A contraindication warning of the concomitant use of Adcetris and bleomycin due to pulmonary toxicity
Adcetris is a CD30-directed antibody-drug conjugate indicated for the treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two p