Generic name: Brentuximab Vedotin 50mg in 10.5mL
Dosage form: injection, powder, lyophilized, for solution
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2.1 Dosage Recommendations
Administer ADCETRIS as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. See Table 1 for the recommended starting dosage.
|Recommended Starting Dosage|
|Normal renal and hepatic function||1.8 mg/kg up to 180 mg|
| Mild (creatinine clearance >50–80 mL/min)
or moderate (creatinine clearance 30–50 mL/min)
|1.8 mg/kg up to 180 mg|
|Severe (creatinine clearance less than 30 mL/min)||Avoid use
[see Warnings and Precautions (5.6)]
|Mild (Child-Pugh A)||1.2 mg/kg up to 120 mg|
|Moderate (Child-Pugh B) or severe (Child-Pugh C)||Avoid use
[see Warnings and Precautions (5.7)]
Peripheral Neuropathy: For new or worsening Grade 2 or 3 neuropathy, dosing should be held until neuropathy improves to Grade 1 or baseline and then restarted at 1.2 mg/kg. For Grade 4 peripheral neuropathy, ADCETRIS should be discontinued.
Neutropenia: The dose of ADCETRIS should be held for Grade 3 or 4 neutropenia until resolution to baseline or Grade 2 or lower. Consider G-CSF prophylaxis for subsequent cycles in patients who experience Grade 3 or 4 neutropenia in the previous cycle. In patients with recurrent Grade 4 neutropenia despite the use of G-CSF prophylaxis, consider discontinuation or dose reduction of ADCETRIS to1.2 mg/kg.
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.