ADCETRIS® Highlights

(brentuximab vedotin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADCETRIS safely and effectively. See full prescribing information for ADCETRIS.

ADCETRIS (brentuximab vedotin) for injection, for intravenous use
Initial U.S. approval: 2011

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

See full prescribing information for complete boxed warning.

JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS (5.9, 6.1).

RECENT MAJOR CHANGES

Indications and Usage (1.2)

11/2022

Dosage and Administration (2.1, 2.2, 2.3, 2.4)

11/2022

Warnings and Precautions (5.1)

6/2023

INDICATIONS AND USAGE

ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:

•
Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine (1.1).
•
Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (1.2).
•
Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation (1.3).
•
Adult patients with classical Hodgkin lymphoma (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 (1.4).
•
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (1.5).
•
Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen (1.6).
•
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (1.7).

DOSAGE AND ADMINISTRATION

•
Administer only as an intravenous infusion over 30 minutes (2.1).
•
The recommended dosage as monotherapy for adult patients is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks (2.1).
•
The recommended dosage in combination with chemotherapy for adult patients with previously untreated Stage III or IV cHL is 1.2 mg/kg up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses (2.1).
•
The recommended dosage in combination with chemotherapy for pediatric patients 2 years and older with previously untreated high risk cHL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses (2.1)
•
The recommended dosage in combination with chemotherapy for adult patients with previously untreated PTCL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for 6 to 8 doses (2.1).
•
Avoid use in patients with severe renal impairment (2.2)
•
Reduce dose in patients with mild hepatic impairment; avoid use in patients with moderate or severe hepatic impairment (2.3).

DOSAGE FORMS AND STRENGTHS

For injection: 50 mg lyophilized powder in a single-dose vial (3).

CONTRAINDICATIONS

Concomitant use with bleomycin due to pulmonary toxicity (4).

WARNINGS AND PRECAUTIONS

•
Peripheral neuropathy: Monitor patients for neuropathy and institute dose modifications accordingly (5.1).
•
Anaphylaxis and infusion reactions: If an infusion reaction occurs, interrupt the infusion. If anaphylaxis occurs, immediately discontinue the infusion (5.2).
•
Hematologic toxicities: Monitor complete blood counts. Monitor for signs of infection. Manage using dose delays and growth factor support (5.3).
•
Serious infections and opportunistic infections: Closely monitor patients for the emergence of bacterial, fungal or viral infections (5.4).
•
Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor or high tumor burden (5.5).
•
Hepatotoxicity: Monitor liver enzymes and bilirubin (5.8).
•
Pulmonary toxicity: Monitor patients for new or worsening symptoms (5.10).
•
Serious dermatologic reactions: Discontinue if Stevens-Johnson syndrome or toxic epidermal necrolysis occurs (5.11).
•
Gastrointestinal complications: Monitor patients for new or worsening symptoms (5.12).
•
Hyperglycemia: Monitor patients for new or worsening hyperglycemia. Manage with anti-hyperglycemic medications as clinically indicated (5.13).
•
Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception (5.14, 8.1, 8.3).

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-473-2436 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE) (7.1).

USE IN SPECIFIC POPULATIONS

•
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased (6, 7, 8.6, 8.7).
•
Lactation: Advise women not to breastfeed (8.2).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADCETRIS safely and effectively. See full prescribing information for ADCETRIS.

ADCETRIS (brentuximab vedotin) for injection, for intravenous use
Initial U.S. approval: 2011

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

See full prescribing information for complete boxed warning.

JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS (5.9, 6.1).

RECENT MAJOR CHANGES

Indications and Usage (1.2)

11/2022

Dosage and Administration (2.1, 2.2, 2.3, 2.4)

11/2022

Warnings and Precautions (5.1)

6/2023

INDICATIONS AND USAGE

ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:

•
Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine (1.1).
•
Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (1.2).
•
Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation (1.3).
•
Adult patients with classical Hodgkin lymphoma (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 (1.4).
•
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (1.5).
•
Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen (1.6).
•
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (1.7).

DOSAGE AND ADMINISTRATION

•
Administer only as an intravenous infusion over 30 minutes (2.1).
•
The recommended dosage as monotherapy for adult patients is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks (2.1).
•
The recommended dosage in combination with chemotherapy for adult patients with previously untreated Stage III or IV cHL is 1.2 mg/kg up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses (2.1).
•
The recommended dosage in combination with chemotherapy for pediatric patients 2 years and older with previously untreated high risk cHL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses (2.1)
•
The recommended dosage in combination with chemotherapy for adult patients with previously untreated PTCL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for 6 to 8 doses (2.1).
•
Avoid use in patients with severe renal impairment (2.2)
•
Reduce dose in patients with mild hepatic impairment; avoid use in patients with moderate or severe hepatic impairment (2.3).

DOSAGE FORMS AND STRENGTHS

For injection: 50 mg lyophilized powder in a single-dose vial (3).

CONTRAINDICATIONS

Concomitant use with bleomycin due to pulmonary toxicity (4).

WARNINGS AND PRECAUTIONS

•
Peripheral neuropathy: Monitor patients for neuropathy and institute dose modifications accordingly (5.1).
•
Anaphylaxis and infusion reactions: If an infusion reaction occurs, interrupt the infusion. If anaphylaxis occurs, immediately discontinue the infusion (5.2).
•
Hematologic toxicities: Monitor complete blood counts. Monitor for signs of infection. Manage using dose delays and growth factor support (5.3).
•
Serious infections and opportunistic infections: Closely monitor patients for the emergence of bacterial, fungal or viral infections (5.4).
•
Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor or high tumor burden (5.5).
•
Hepatotoxicity: Monitor liver enzymes and bilirubin (5.8).
•
Pulmonary toxicity: Monitor patients for new or worsening symptoms (5.10).
•
Serious dermatologic reactions: Discontinue if Stevens-Johnson syndrome or toxic epidermal necrolysis occurs (5.11).
•
Gastrointestinal complications: Monitor patients for new or worsening symptoms (5.12).
•
Hyperglycemia: Monitor patients for new or worsening hyperglycemia. Manage with anti-hyperglycemic medications as clinically indicated (5.13).
•
Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception (5.14, 8.1, 8.3).

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-473-2436 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE) (7.1).

USE IN SPECIFIC POPULATIONS

•
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased (6, 7, 8.6, 8.7).
•
Lactation: Advise women not to breastfeed (8.2).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2023
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