Seattle Genetics, Inc.

Seattle Genetics, Inc. Drugs

• Divalproex Sodium
  

  ×

  Divalproex Sodium

  

  ---

  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.

  For classical HL post-auto-HSCT consolidation treatment, initiate ADCETRIS treatment within 4–6 weeks post-auto-HSCT or upon recovery from auto-HSCT. These patients should continue treatment until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

  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)]

  2.2 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 to 1.2 mg/kg.

  2.3 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.

  Close
  More Info