Adcetris Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned as follows.
Special precautions for disposal and other handling: General precautions: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Proper aseptic technique throughout the handling of this medicinal product should be followed.
Instructions for reconstitution: Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/mL. Each vial contains a 10% overfill giving 55 mg of BRENTUXIMAB VEDOTIN (ADCETRIS) per vial and a total reconstituted volume of 11 mL.
1. Direct the stream toward the wall of the vial and not directly at the cake or powder.
2. Gently swirl the vial to aid dissolution. DO NOT SHAKE.
3. The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
4. The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration. In the event of either being observed, discard the medicinal product.
Preparation of infusion solution: The appropriate amount of reconstituted BRENTUXIMAB VEDOTIN (ADCETRIS) must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection in order to achieve a final concentration of 0.4-1.2 mg/mL BRENTUXIMAB VEDOTIN (ADCETRIS). The recommended diluent volume is 150 mL. The already reconstituted BRENTUXIMAB VEDOTIN (ADCETRIS) can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Gently invert the bag to mix the solution containing BRENTUXIMAB VEDOTIN (ADCETRIS). DO NOT SHAKE.
Any portion left in the vial, after withdrawal of the volume to be diluted, must be disposed of in accordance with local requirements.
Do not add other medicinal products to the prepared BRENTUXIMAB VEDOTIN (ADCETRIS) infusion solution or intravenous infusion set. The infusion line should be flushed following administration with sodium chloride 9 mg/mL (0.9%) solution for injection, 5% dextrose for injection, or Lactated Ringer's for injection.
Following dilution, infuse the BRENTUXIMAB VEDOTIN (ADCETRIS) solution immediately at the recommended infusion rate.
Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Determining dosage amount: Calculation to determine the total BRENTUXIMAB VEDOTIN (ADCETRIS) dose (mL) to be further diluted (see Dosage & Administration): See equation.

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Note: If patient's weight is more than 100 kg, the dose calculation should use 100 kg. The maximal recommended dose is 180 mg.
Calculation to determine the total number of BRENTUXIMAB VEDOTIN (ADCETRIS) vials needed: See equation and Table 20.

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Click on icon to see table/diagram/image

Disposal: BRENTUXIMAB VEDOTIN (ADCETRIS) is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.