Usual Adult Dose for Hodgkin's Disease

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 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

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:

• The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
• In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

• For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
• For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
• For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
• For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Usual Adult Dose for Mycosis Fungoides

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 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

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:

• The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
• In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

• For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
• For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
• For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
• For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Usual Adult Dose for Lymphoma

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 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

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:

• The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
• In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

• For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
• For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
• For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
• For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Renal Dose Adjustments

CrCl 30 mL/min or greater: Initial: No adjustment recommended.
CrCl less than 30 mL/min: Not recommended.

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh A):

• If the recommended dose is 1.2 mg/kg (maximum 120 mg) IV over 30 minutes every 2 weeks, reduce the dose to 0.9 mg/kg (maximum 90 mg) IV over 30 minutes every 2 weeks; the dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg
• If the recommended dose is 1.8 mg/kg (maximum 180 mg) IV over 30 minutes every 3 weeks, reduce the dose to 1.2 mg/kg (maximum 120 mg) IV over 30 minutes every 3 weeks; the dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg

Dose Adjustments

Peripheral Neuropathy/Neutropenia:
GRADE 3 OR 4:

• If the recommended dose is 1.2 mg/kg (maximum 120 mg) IV over 30 minutes every 2 weeks, administer G-CSF prophylaxis for subsequent cycles for patients not receiving primary G-CSF prophylaxis.
• If the recommended dose is 1.8 mg/kg (maximum 180 mg) IV over 30 minutes every 3 weeks, hold dosing until improvement to baseline or Grade 2 or lower and consider G-CSF prophylaxis for subsequent cycles; for recurrent Grade 4 despite G-CSF prophylaxis consider discontinuing therapy or reduce the dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks.

Precautions

US BLACK BOX WARNING:
Progressive Multifocal Leukoencephalopathy (PML): John Cunningham virus (JCV) infection resulting in PML and death has been reported with this drug. First onset of symptoms occurred at various times from initiation of therapy, with some cases occurring within 3 months of initial exposure. In addition to therapy with this drug, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
• Proper procedures for handling and disposal of anticancer drugs should be followed.

• Use appropriate aseptic technique for reconstitution and preparation.
• Determine the number of 50 mg vials needed based on patient weight and the prescribed dose.
• Reconstitute each 50-mg vial with 10.5 mL of Sterile Water for Injection, to yield a single-dose solution containing 5 mg/mL.
• Direct the stream toward the wall of vial and not directly at the cake or powder.
• Gently swirl the vial to aid dissolution. DO NOT SHAKE.
• Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution should be clear to slightly opalescent, colorless, and free of visible particulates.
• Following reconstitution, dilute immediately into an infusion bag; if not diluted immediately, store the solution at 2C to 8C (36F to 46F) and use within 24 hours. DO NOT FREEZE.
• Discard any unused portion left in the vial.