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Adcetris Dosage

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

Medically reviewed by Drugs.com. Last updated on Nov 26, 2018.

Recommended Dosage

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

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

2.2 Recommended Prophylactic Medications

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

Dose Modification

Table 3: Dose Modifications for Peripheral Neuropathy or Neutropenia
Recommended ADCETRIS Dose from Table 1* Monotherapy or Combination Therapy Severity Dose Modification
* 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 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

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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