Enfortumab Vedotin: package leaflet
For patients
Package leaflet, verbatim
Package leaflet: Padcev 20 mg powder for concentrate for solution for infusion
1. Follow procedures for proper handling and disposal of anticancer medicinal products.
2. Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
3. Calculate the recommended dose based on the patient’s weight to determine the number and
strength (20 mg or 30 mg) of vials needed.
4. Reconstitute each vial as follows and, if possible, direct the stream of sterile water for injection
along the walls of the vial and not directly onto the lyophilized powder:
a.
20 mg vial: Add 2.3 mL of sterile water for injection, resulting in 10 mg/mL enfortumab vedotin.
b.
30 mg vial: Add 3.3 mL of sterile water for injection, resulting in 10 mg/mL enfortumab vedotin.
5. Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted
vial(s) to settle for at least 1 minute until the bubbles are gone. Do not shake the vial. Do not expose to direct sunlight.
6. Visually inspect the solution for particulate matter and discolouration. The reconstituted solution
should be clear to slightly opalescent, colourless to light yellow and free of visible particles.
Discard any vial with visible particles or discolouration.
Dilution in infusion bag
7.
Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag.
8.
Dilute enfortumab vedotin with either dextrose 50 mg/mL (5%), sodium chloride 9 mg/mL (0.9%) or Lactated Ringer’s solution for injection. The infusion bag size should allow enough solvent to achieve a final concentration of 0.3 mg/mL to 4 mg/mL enfortumab vedotin.
Diluted dosing solution of enfortumab vedotin is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), ethylvinyl acetate, polyolefin such as polypropylene (PP), or IV bottles comprised of polyethylene (PE), polyethylene terephthalate glycol-modified, and infusion sets composed of PVC with either plasticizer (bis(2-ethylhexyl) phthalate (DEHP) or tris(2-ethylhexyl) trimellitate (TOTM)), PE and with filter membranes (pore size: 0.2-1.2 μm) composed of polyethersulfone, polyvinylidene difluoride or mixed cellulose esters.
9.
Mix diluted solution by gentle inversion. Do not shake the bag. Do not expose to direct sunlight.
10.
Visually inspect the infusion bag for any particulate matter or discolouration prior to use. The reconstituted solution should be clear to slightly opalescent, colourless to light yellow and free of visible particles. Do not use the infusion bag if particulate matter or discolouration is observed.
11.
Discard any unused portion left in the single-dose vials.
Administration
12.
Administer the infusion over 30 minutes through an intravenous line. Do not administer as an intravenous push or bolus.
No incompatibilities have been observed with closed system transfer device composed of acrylonitrile butadiene styrene (ABS), acrylic, activated charcoal, ethylene propylene diene monomer, methacrylate ABS, polycarbonate, polyisoprene, polyoxymethylene, PP, silicone, stainless steel, thermoplastic elastomer for reconstituted solution.
13.
Do not co-administer other medicinal products through the same infusion line.
14.
In-line filters or syringe filters (the pore size: 0.2-1.2 μm, recommended materials:
polyethersulfone, polyvinylidene difluoride, mixed cellulose esters) are recommended to be used during administration.
Disposal
Padcev is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.