TIONS AND USAGE
1.1 Hodgkin Lymphoma
1.2 Systemic Anaplastic Large Cell Lymphoma
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Dose Modification
2.3 Instructions for Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
5.2 Infusion Reactions
5.3 Neutropenia
5.4 Tumor Lysis Syndrome
5.5 Stevens-Johnson Syndrome
5.6 Progressive Multifocal Leukoencephalopathy
5.7 Use in Pregnancy
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on ADCETRIS
7.2 Effect of ADCETRIS on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
14 CLINICAL STUDIES
14.1 Hodgkin Lymphoma
14.2 Systemic Anaplastic Large Cell Lymphoma
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
16.3 Special Handling
17 PATIENT COUNSELING INFORMATION
PACKAGE LABEL
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with ADCETRIS.
1.1 Hodgkin Lymphoma
ADCETRIS (brentuximab vedotin) is indicated for treatment of patients with 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.
1.2 Systemic Anaplastic Large Cell Lymphoma
ADCETRIS is indicated for treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30minutes every 3 weeks.
Do not administer as an intravenous push or bolus.
Continue treatment until a maximum of 16 cycles, disease progression or unacceptable toxicity.
2.2 De Modification
Peripheral Neuropathy: Peripheral neuropathy should be managed using a combination of dose delay and reduction to 1.2 mg/kg. For new or worsening Grade 2 or 3 neuropathy, dosing should be held until neuropathy improves to Grade 1 or baseline and then restarted at 1.2mg/kg. For Grade 4 peripheral neuropathy, ADCETRIS should be discontinued.
Neutropenia: Neutropenia should be managed by dose delays and reductions. The dose of ADCETRIS should be held for Grade 3 or 4 neutropenia until resolution to baseline or Grade 2 or lower. Growth factor support should be considered for subsequent cycles in patients who experience Grade 3 or 4 neutropenia. In patients with recurrent Grade 4 neutropenia despite the use of growth factors, discontinuation or dose reduction of ADCETRIS to1.2 mg/kg may be considered.
2.3 Instructions for Preparation and Administration
Procedures for proper handling and dispos |
