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Adcetris Dosage

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.

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.

Table 1: Recommended ADCETRIS Dosage
  Recommended Starting Dosage
Normal renal and hepatic function 1.8 mg/kg up to 180 mg
Renal impairment
       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)]
Hepatic impairment
       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)]

Dose Modification

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

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-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.

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.
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