INDICATIONS AND USAGE（适应症）

Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine.

Classical Hodgkin lymphoma (cHL) consolidation

ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.

Relapsed classical Hodgkin lymphoma (cHL)

ADCETRIS is indicated for the treatment of adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with chemotherapy

ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.

Relapsed systemic anaplastic large cell lymphoma (sALCL)

ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.

Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)

ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy.

DOSAGE（服用剂量）

The recommended ADCETRIS dosage is provided as follows. Administer ADCETRIS as a 30-minute intravenous infusion.

1.2 mg/kg up to a maximum of 120 mg in combination with chemotherapy for Previously Untreated Stage III or IV Classical Hodgkin Lymphoma. Administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity.

1.8 mg/kg up to a maximum of 180 mg for Classical Hodgkin Lymphoma Consolidation, initiate ADCETRIS treatment within 4–6 weeks post-auto-HSCT or upon recovery from auto-HSCT. Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

1.8 mg/kg up to a maximum of 180 mg for Relapsed Classical Hodgkin Lymphoma. Administer every 3 weeks until disease progression or unacceptable toxicity.

1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy for Previously Untreated Systemic ALCL or Other CD30-expressing Peripheral T-Cell Lymphomas. Administer every 3 weeks with each cycle of chemotherapy for 6 to 8 doses.

1.8 mg/kg up to a maximum of 180 mg for Relapsed Systemic ALCL. Administer every 3 weeks until disease progression or unacceptable toxicity.

1.8 mg/kg up to a maximum of 180 mg for Relapsed Primary Cutaneous ALCL or CD30-expressing Mycosis Fungoides. Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Peripheral Neuropathy

Anaphylaxis and Infusion Reactions

Hematologic Toxicities

Serious Infections and Opportunistic Infections

Tumor Lysis Syndrome

Increased Toxicity in the Presence of Severe Renal Impairment

Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment

Hepatotoxicity

Progressive Multifocal Leukoencephalopathy

Pulmonary Toxicity

Serious Dermatologic Reactions  

Gastrointestinal Complications

Hyperglycemia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/3904f8dd-1aef-3490-e48f-bd55f32ed67f/spl-doc?hl=Adcetris

Adcetrisinformation