Generic name: Brentuximab Vedotin 50mg in 10.5mL
Dosage form: injection, powder, lyophilized, for solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The recommended ADCETRIS dosage is provided in Table 1.
The recommended dose for patients with renal or hepatic impairment is provided in Table 2.
|Administration||Frequency and Duration|
|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|
|CrCL: creatinine clearance|
|Impairment||Degree of Impairment||Recommended Dose|
Mild (CrCL greater than
Moderate (CrCL 30–50 mL/min)
|1.8 mg/kg up to a maximum of 180 mg*|
|Severe (CrCL less than 30 mL/min)||Avoid use [see Warnings and Precautions (5.6)]|
|Hepatic||Normal||1.8 mg/kg up to a maximum of 180 mg*|
|Mild (Child-Pugh A)||1.2 mg/kg up to a maximum of 120 mg*|
|Moderate (Child-Pugh B)
Severe (Child-Pugh C)
|Avoid use [see Warnings and Precautions (5.7)]|
|Events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|
|Peripheral Neuropathy||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*
|Grade 4||Dosing should be discontinued|
|Neutropenia||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*|
Instructions for Preparation and Administration
- Administer ADCETRIS as an intravenous infusion only.
- Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.
- 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-use 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.
- 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.
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- Drug class: CD30 monoclonal antibodies