donanemab: package leaflet
For patients
Package leaflet, verbatim
Package leaflet: Kisunla 350 mg concentrate for solution for infusion
1. Prepare the solution for infusion using aseptic technique to ensure the sterility of the prepared
solution.
2. Allow donanemab to equilibrate to room temperature for approximately 30 minutes before
preparation.
3. Inspect the content of the vial. The concentrate should be clear, colourless to slightly yellow to
slightly brown and free of visible particles. Otherwise, it should be discarded.
4. Withdraw required volume of donanemab using an appropriately sized needle and transfer to the
infusion bag.
- For 350 mg of donanemab: 20 mL
- For 700 mg of donanemab: 40 mL
- For 1 050 mg of donanemab: 60 mL
- For 1 400 mg of donanemab: 80 mL
The concentrate should be diluted only in infusion bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection. The final concentration after dilution is approximately 4 mg/mL to approximately 10 mg/mL. Use only sodium chloride 9 mg/mL (0.9 %) solution for injection for dilution.
5. Gently invert the infusion bag to mix.
Administration of the diluted solution
6. The intravenous administration set (infusion line) should be connected to the prepared intravenous
bag and the line should be primed. The infusion should be administered for at least 30 minutes.
7. At the end of the infusion, to ensure a full dose is administered, the infusion line should be flushed with sodium chloride 9 mg/mL (0.9 %) solution for injection. The flush should be administered at the same rate as used for Kisunla administration. The time required to flush Kisunla solution from the infusion line is in addition to the minimum 30 minutes infusion time.
8. Observe the patient post-infusion for a minimum of 30 minutes.
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.