Adcetris

Adcetris Caution For Usage

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Caution For Usage
Special precautions for disposal and other handling: General precautions: Procedures for proper handling and disposal of anticancer medicines 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 ADCETRIS per vial and a total reconstituted volume of 11mL.
Direct the stream toward the wall of the vial and not directly at the cake or powder.
Gently swirl the vial to aid dissolution. DO NOT SHAKE.
The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration. In the event of either being observed, discard the medicinal product.
ADCETRIS contains no bacteriostatic preservative.
Preparation of infusion solution: The appropriate amount of reconstituted ADCETRIS must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection in order to achieve a final concentration of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 ADCETRIS. The recommended diluent volume is 150 ml. The already reconstituted 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 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 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 ADCETRIS solution immediately at the recommended infusion rate.
If not used immediately, the reconstituted solution may be stored at 2 - 8°C (Do not freeze) for no more than 24 hours.
Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Determining dosage amount: Calculation to determine the total ADCETRIS dose (ml) to be further diluted (see Dosage & Administration): (See Equation 1.)

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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 ADCETRIS vials needed: (See Equation 2 and Table 18.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Disposal: ADCETRIS is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.
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