al of anticancer drugs should be considered. Several guidelines on this subject have been published[see References (15)].
Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
Reconstitution
Calculate the dose (mg) and number of vials of ADCETRIS required. The dose for patients with a weight of >100 kg should be calculated for 100 kg. 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 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, or 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 and withdraw this amount from the vials. The dose for patients with a weight of >100 kg should be calculated for 100 kg. Immediately add the reconstituted solution to an infusion bag containing a minimum volume of 100 mL to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin. ADCETRIS can be diluted into 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection. Gently invert the bag to mix the solution. ADCETRIS contains no bacteriostatic preservatives. Following dilution, infuse the ADCETRIS solution immediately, or store the solution at 2-8˚C (36-46˚F) and use within 24 hours of reconstitution. DO NOT FREEZE.
Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.
3 DOSAGE FORMS AND STRENGTHS
ADCETRIS (brentuximab vedotin) for Injection single-use vial containing 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
ADCETRIS treatment causes a peripheral neuropathy that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced peripheral neuropathy is cumulative. In the HL and sALCL clinical trials, 54% of patients experienced any grade of neuropathy. Of these patients, 49% had complete resolution, 31% had partial improvement, and 20% had no improvement. Of the patients who reported neuropathy, 51% had residual neuropathy at the time of their last eva luation. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require a delay, change in dose, or discontinuation of ADCETRIS [see Dose Modification (2.2) ].
5.2 Infusion Reactions
Infusion-related reactions, including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an infusion-related reaction occurs, the infusion should be interrupted and appropriate medical management instituted. Patient |
