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Adcetris Dosage

Generic name: Brentuximab Vedotin 50mg in 10.5mL
Dosage form: injection, powder, lyophilized, for solution

Medically reviewed on December 14, 2017.

Recommended Dosage

The recommended ADCETRIS dosage is provided in Table 1.

The recommended dose for patients with renal or hepatic impairment is provided in Table 2.

For dosing instructions of combination agents administered with ADCETRIS, see Clinical Studies (14.1) 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*
Administration Frequency and Duration
Previously Untreated Stage III or IV Classical Hodgkin Lymphoma 1.2 mg/kg up to a maximum of 120 mg in combination with chemotherapy Intravenous infusion over 30 minutes Administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity
Classical Hodgkin Lymphoma Consolidation 1.8 mg/kg up to a maximum of 180 mg Intravenous infusion over 30 minutes 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
Relapsed Classical Hodgkin Lymphoma 1.8 mg/kg up to a maximum of 180 mg Intravenous infusion over 30 minutes Administer every 3 weeks until disease progression or unacceptable toxicity
Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-expressing Mycosis Fungoides 1.8 mg/kg up to a maximum of 180 mg Intravenous infusion 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 up to a maximum of 180 mg Intravenous infusion over 30 minutes Administer every 3 weeks until disease progression or unacceptable toxicity
Table 2: Recommended Dose for Patients with Renal or Hepatic Impairment
* The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg
CrCL: creatinine clearance
Recommended Dose from Table 1 Degree of Impairment Recommended Dose
Renal Impairment
1.2 mg/kg up to a maximum of 120 mg* every 2 weeks Normal

Mild (CrCL greater than
50–80 mL/min)

Moderate (CrCL 30–50 mL/min)
1.2 mg/kg up to a maximum of 120 mg* every 2 weeks
Severe (CrCL less than 30 mL/min) Avoid use [see Warnings and Precautions (5.6)]
1.8 mg/kg up to a maximum of 180 mg* every 3 weeks Normal

Mild (CrCL greater than
50–80 mL/min)

Moderate (CrCL 30–50 mL/min)
1.8 mg/kg up to a maximum of 180 mg* every 3 weeks
Severe (CrCL less than 30 mL/min) Avoid use [see Warnings and Precautions (5.6)]
Hepatic Impairment
1.2 mg/kg up to a maximum of 120 mg* every 2 weeks Normal 1.2 mg/kg up to a maximum of 120 mg* every 2 weeks
Mild (Child-Pugh A) 0.9 mg/kg up to a maximum of 90 mg* every 2 weeks
Moderate (Child-Pugh B)

Severe (Child-Pugh C)
Avoid use [see Warnings and Precautions (5.7)]
1.8 mg/kg up to a maximum of 180 mg* every 3 weeks Normal 1.8 mg/kg up to a maximum of 180 mg* every 3 weeks
Mild (Child-Pugh A) 1.2 mg/kg up to a maximum of 120 mg* every 3 weeks
Moderate (Child-Pugh B)

Severe (Child-Pugh C)
Avoid use [see Warnings and Precautions (5.7)]

Recommended Prophylactic Medications

In patients with previously untreated Stage III or IV cHL who are treated with ADCETRIS + AVD, administer G-CSF beginning with Cycle 1.

Dose Modification

Table 3: Dose Modifications for Peripheral Neuropathy or Neutropenia
Recommended dose from Table 1 Severity Dose Modification
Events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
* The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg
Peripheral Neuropathy
1.2 mg/kg up to a maximum of 120 mg* every 2 weeks 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 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
Neutropenia
1.2 mg/kg up to a maximum of 120 mg* every 2 weeks 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 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

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 anticancer 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.
  • 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 2–8°C (36–46°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 a minimum volume of 100 mL of 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection 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 2–8°C (36–46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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