ADCETRIS® Dosage and Administration

(brentuximab vedotin)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended ADCETRIS dosage is provided in Table 1. Administer ADCETRIS as a 30-minute intravenous infusion.

For recommended dosage for patients with renal or hepatic impairment, see Dosage and Administration (2.2 and 2.3).

For dosing instructions of combination agents administered with ADCETRIS, see Clinical Studies (14.1 and 14.2) and the manufacturer’s prescribing information.

Table 1: Recommended ADCETRIS Dosage
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.

Indication

Recommended Dose*

Frequency and Duration

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma

1.2 mg/kg up to a maximum of 120 mg in combination with chemotherapy

Administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Pediatric patients with previously untreated high risk classical Hodgkin lymphoma

1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy

Administer every 3 weeks with each cycle of chemotherapy for a maximum of 5 doses

Adult patients with classical Hodgkin lymphoma consolidation

1.8 mg/kg up to a maximum of 180 mg

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

Adult patients with relapsed classical Hodgkin lymphoma

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until disease progression or unacceptable toxicity

Adult patients with previously untreated systemic ALCL or other CD30-expressing peripheral T-cell lymphomas

1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy

Administer every 3 weeks with each cycle of chemotherapy for 6 to 8 doses

Adult patients with relapsed Systemic ALCL

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until disease progression or unacceptable toxicity

Adult patients with relapsed primary cutaneous ALCL or CD30-expressing mycosis fungoides

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

2.2 Recommended Dosage in Patients with Renal Impairment

No dosage adjustment is required for mild renal impairment (CrCL greater than 50‑80 mL/min) and moderate renal impairment (CrCL 30-50 mL/min).

Avoid use in patients with severe (CrCL less than 30 mL/min) renal impairment [see Warnings and Precautions (5.6)].

2.3 Recommended Dosage in Patients with Hepatic Impairment

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma

Reduce the dosage of ADCETRIS to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

All other indications

Reduce the dosage of ADCETRIS to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

2.4 Recommended Prophylactic Medications

In adult patients with previously untreated Stage III or IV cHL who are treated with ADCETRIS + doxorubicin, vinblastine, and dacarbazine (AVD), administer G‑CSF beginning with Cycle 1.

In pediatric patients with previously untreated high risk cHL who are treated with ADCETRIS + doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC), administer G-CSF beginning with Cycle 1.

In adult patients with previously untreated PTCL who are treated with ADCETRIS + cyclophosphamide, doxorubicin, and prednisone (CHP), administer G-CSF beginning with Cycle 1.

2.5 Dosage Modifications for Adverse Reactions

Table 2: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Adult Patients
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg

Recommended ADCETRIS Dosage from Table 1*

Monotherapy
or
Combination Therapy

Severity

Dosage Modification

Peripheral Neuropathy

1.2 mg/kg up to a maximum of 120 mg every 2 weeks

In combination with chemotherapy

Grade 2

Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks

Grade 3

Hold ADCETRIS dosing until improvement to Grade 2 or lower

Restart at 0.9 mg/kg up to a maximum of 90 mg every 2 weeks

Consider modifying the dose of other neurotoxic chemotherapy agents

Grade 4

Discontinue dosing

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

As monotherapy

New or
worsening
Grade 2 or 3

Hold dosing until improvement to baseline or Grade 1

Restart at 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Grade 4

Discontinue dosing

In combination with chemotherapy

Grade 2

Sensory neuropathy: Continue treatment at same dose

Motor neuropathy: Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Grade 3

Sensory neuropathy: Reduce dose to 1.2 mg/kg, up to a maximum of 120 mg every 3 weeks

Motor neuropathy: Discontinue dosing

Grade 4

Discontinue dosing

Neutropenia

1.2 mg/kg up to a maximum of 120 mg every 2 weeks

In combination with chemotherapy

Grade 3 or 4

Administer G‑CSF prophylaxis for subsequent cycles for patients not receiving primary G‑CSF prophylaxis

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

In combination with chemotherapy

Grade 3 or 4

Administer G-CSF prophylaxis in subsequent cycles for patients not receiving primary G-CSF

1.8 mg/kg up to a maximum of 180 mg* every 3 weeks

As monotherapy

Grade 3 or 4

Hold dosing until improvement to baseline or Grade 2 or lower

Consider G-CSF prophylaxis for subsequent cycles

Recurrent Grade 4 despite G‑CSF prophylaxis

Consider discontinuation or dose reduction to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Table 3: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Pediatric Patients
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.
†
Peripheral neuropathy was assessed using the Balis scale.

Recommended ADCETRIS Dosage from Table 1*

Severity

Dosage Modification

Peripheral Neuropathy†

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

Grade 2†

Reduce dose of vincristine per prescribing information

Continue dosing with ADCETRIS

If neuropathy improves to Grade ≤1 by day 8 of next cycle, then resume vincristine at full dose

Grade 3†

Discontinue vincristine

First Occurrence:

Hold ADCETRIS dosing until improvement to ≤ Grade 2 then restart at 1.2 mg/kg up to a maximum of 120 mg

Second Occurrence:

Hold until improvement to ≤ Grade 2 then restart at 0.8 mg/kg up to a maximum of 80 mg

Third Occurrence:

Discontinue ADCETRIS

Grade 4†

Discontinue ADCETRIS and vincristine

Neutropenia

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

Grade 3 or 4

Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks in patients who are unable to start a cycle > 5 weeks after the start of the previous cycle (> 2-week delay) due to neutropenia

2.6 Instructions for Preparation and Administration

Administration

•
Administer ADCETRIS as an intravenous infusion only.
•
Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.

Reconstitution

•
Follow procedures for proper handling and disposal of hazardous drugs [see References (15)].
•
Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
•
Determine the number of 50 mg vials needed based on the patient’s weight and the prescribed dose [see Dosage and Administration (2.1)].
•
Reconstitute each 50 mg vial of ADCETRIS with 10.5 mL of Sterile Water for Injection, USP, to yield a single-dose solution containing 5 mg/mL brentuximab vedotin.
•
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.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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 2° to 8°C (36° to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.
•
Discard any unused portion left in the vial.

Dilution

•
Calculate the required volume of 5 mg/mL reconstituted ADCETRIS solution needed.
•
Withdraw this amount from the vial and immediately add it to an infusion bag containing 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP or Lactated Ringer's Injection, USP to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin.
•
Gently invert the bag to mix the solution.
•
Following dilution, infuse the ADCETRIS solution immediately. If not used immediately, store the solution at 2° to 8°C (36° to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended ADCETRIS dosage is provided in Table 1. Administer ADCETRIS as a 30-minute intravenous infusion.

For recommended dosage for patients with renal or hepatic impairment, see Dosage and Administration (2.2 and 2.3).

For dosing instructions of combination agents administered with ADCETRIS, see Clinical Studies (14.1 and 14.2) and the manufacturer’s prescribing information.

Table 1: Recommended ADCETRIS Dosage
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.

Indication

Recommended Dose*

Frequency and Duration

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma

1.2 mg/kg up to a maximum of 120 mg in combination with chemotherapy

Administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Pediatric patients with previously untreated high risk classical Hodgkin lymphoma

1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy

Administer every 3 weeks with each cycle of chemotherapy for a maximum of 5 doses

Adult patients with classical Hodgkin lymphoma consolidation

1.8 mg/kg up to a maximum of 180 mg

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

Adult patients with relapsed classical Hodgkin lymphoma

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until disease progression or unacceptable toxicity

Adult patients with previously untreated systemic ALCL or other CD30-expressing peripheral T-cell lymphomas

1.8 mg/kg up to a maximum of 180 mg in combination with chemotherapy

Administer every 3 weeks with each cycle of chemotherapy for 6 to 8 doses

Adult patients with relapsed Systemic ALCL

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until disease progression or unacceptable toxicity

Adult patients with relapsed primary cutaneous ALCL or CD30-expressing mycosis fungoides

1.8 mg/kg up to a maximum of 180 mg

Administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

2.2 Recommended Dosage in Patients with Renal Impairment

No dosage adjustment is required for mild renal impairment (CrCL greater than 50‑80 mL/min) and moderate renal impairment (CrCL 30-50 mL/min).

Avoid use in patients with severe (CrCL less than 30 mL/min) renal impairment [see Warnings and Precautions (5.6)].

2.3 Recommended Dosage in Patients with Hepatic Impairment

Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma

Reduce the dosage of ADCETRIS to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

All other indications

Reduce the dosage of ADCETRIS to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks for patients with mild hepatic impairment (Child-Pugh A).

Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.7)].

2.4 Recommended Prophylactic Medications

In adult patients with previously untreated Stage III or IV cHL who are treated with ADCETRIS + doxorubicin, vinblastine, and dacarbazine (AVD), administer G‑CSF beginning with Cycle 1.

In pediatric patients with previously untreated high risk cHL who are treated with ADCETRIS + doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC), administer G-CSF beginning with Cycle 1.

In adult patients with previously untreated PTCL who are treated with ADCETRIS + cyclophosphamide, doxorubicin, and prednisone (CHP), administer G-CSF beginning with Cycle 1.

2.5 Dosage Modifications for Adverse Reactions

Table 2: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Adult Patients
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg

Recommended ADCETRIS Dosage from Table 1*

Monotherapy
or
Combination Therapy

Severity

Dosage Modification

Peripheral Neuropathy

1.2 mg/kg up to a maximum of 120 mg every 2 weeks

In combination with chemotherapy

Grade 2

Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks

Grade 3

Hold ADCETRIS dosing until improvement to Grade 2 or lower

Restart at 0.9 mg/kg up to a maximum of 90 mg every 2 weeks

Consider modifying the dose of other neurotoxic chemotherapy agents

Grade 4

Discontinue dosing

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

As monotherapy

New or
worsening
Grade 2 or 3

Hold dosing until improvement to baseline or Grade 1

Restart at 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Grade 4

Discontinue dosing

In combination with chemotherapy

Grade 2

Sensory neuropathy: Continue treatment at same dose

Motor neuropathy: Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Grade 3

Sensory neuropathy: Reduce dose to 1.2 mg/kg, up to a maximum of 120 mg every 3 weeks

Motor neuropathy: Discontinue dosing

Grade 4

Discontinue dosing

Neutropenia

1.2 mg/kg up to a maximum of 120 mg every 2 weeks

In combination with chemotherapy

Grade 3 or 4

Administer G‑CSF prophylaxis for subsequent cycles for patients not receiving primary G‑CSF prophylaxis

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

In combination with chemotherapy

Grade 3 or 4

Administer G-CSF prophylaxis in subsequent cycles for patients not receiving primary G-CSF

1.8 mg/kg up to a maximum of 180 mg* every 3 weeks

As monotherapy

Grade 3 or 4

Hold dosing until improvement to baseline or Grade 2 or lower

Consider G-CSF prophylaxis for subsequent cycles

Recurrent Grade 4 despite G‑CSF prophylaxis

Consider discontinuation or dose reduction to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks

Table 3: Dosage Modifications for Peripheral Neuropathy or Neutropenia in Pediatric Patients
*
The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.
†
Peripheral neuropathy was assessed using the Balis scale.

Recommended ADCETRIS Dosage from Table 1*

Severity

Dosage Modification

Peripheral Neuropathy†

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

Grade 2†

Reduce dose of vincristine per prescribing information

Continue dosing with ADCETRIS

If neuropathy improves to Grade ≤1 by day 8 of next cycle, then resume vincristine at full dose

Grade 3†

Discontinue vincristine

First Occurrence:

Hold ADCETRIS dosing until improvement to ≤ Grade 2 then restart at 1.2 mg/kg up to a maximum of 120 mg

Second Occurrence:

Hold until improvement to ≤ Grade 2 then restart at 0.8 mg/kg up to a maximum of 80 mg

Third Occurrence:

Discontinue ADCETRIS

Grade 4†

Discontinue ADCETRIS and vincristine

Neutropenia

1.8 mg/kg up to a maximum of 180 mg every 3 weeks

Grade 3 or 4

Reduce dose to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks in patients who are unable to start a cycle > 5 weeks after the start of the previous cycle (> 2-week delay) due to neutropenia

2.6 Instructions for Preparation and Administration

Administration

•
Administer ADCETRIS as an intravenous infusion only.
•
Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.

Reconstitution

•
Follow procedures for proper handling and disposal of hazardous drugs [see References (15)].
•
Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
•
Determine the number of 50 mg vials needed based on the patient’s weight and the prescribed dose [see Dosage and Administration (2.1)].
•
Reconstitute each 50 mg vial of ADCETRIS with 10.5 mL of Sterile Water for Injection, USP, to yield a single-dose solution containing 5 mg/mL brentuximab vedotin.
•
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.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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 2° to 8°C (36° to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.
•
Discard any unused portion left in the vial.

Dilution

•
Calculate the required volume of 5 mg/mL reconstituted ADCETRIS solution needed.
•
Withdraw this amount from the vial and immediately add it to an infusion bag containing 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP or Lactated Ringer's Injection, USP to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin.
•
Gently invert the bag to mix the solution.
•
Following dilution, infuse the ADCETRIS solution immediately. If not used immediately, store the solution at 2° to 8°C (36° to 46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.
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