Kisunla Dosage/Direction for Use

Treatment should be initiated by a physician experienced in the diagnosis and treatment of Alzheimer's disease. KISUNLA should be administered under the supervision of a multidisciplinary team trained in detection, monitoring and management of ARIA and experienced in detecting and managing infusion related reactions.
KISUNLA is single use only. Use in one patient on one occasion only. It contains no antimicrobial preservative.
Dosing information: The recommended dose of donanemab is 350 mg for the first dose, 700 mg for the second dose, 1050 mg for the third dose (350/700/1050 mg), followed by 1400 mg every 4 weeks (see Table 2). Treatment should be maintained until amyloid plaques are cleared, as confirmed using a validated method, up to a maximum of 18 months. Treatment should be continued for up to 18 months if monitoring of amyloid plaque clearance with a validated method is not possible.
The benefit-risk of treatment should be reassessed at regular intervals on an individual basis and if the patient progresses to moderate Alzheimer's disease.
KISUNLA must be diluted and is administered as an intravenous infusion over approximately 30 minutes every four weeks.

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Monitoring and dosing interruption for amyloid related imaging abnormalities: A recent (within 6 months) baseline brain magnetic resonance imaging (MRI) should be available prior to initiating treatment. An MRI should be performed prior to the second dose (one month), prior to the third dose (two months), prior to the fourth dose (usually three months) and prior to the seventh dose (usually six months) (see Precautions).
The recommendations for dosing interruptions for patients with amyloid-related imaging abnormalities-oedema/effusions (ARIA-E) and amyloid-related imaging abnormalities haemorrhage/hemosiderin deposition (ARIA-H) are provided in Table 3. (See Table 3.)

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In case of asymptomatic mild ARIA, consider dose suspension based on radiological features of ARIA, number of ARIA episodes and clinical condition. In case of asymptomatic moderate or severe ARIA and symptomatic ARIA, suspend dose until MRI demonstrates radiographic resolution (ARIA-E) or stabilisation (ARIA-H) and symptoms, if present, resolve. Consider a follow-up MRI to assess for resolution (ARIA-E) or stabilisation (ARIA-H) 2 to 4 months after initial identification. Resumption of dosing or permanent discontinuation after ARIA-E resolution and ARIA-H stabilisation should be guided by clinical judgment including re-evaluation of risk factors (see Precautions). Standard supportive treatment, including corticosteroids may be considered in case of ARIA-E.
KISUNLA should be permanently discontinued after serious ARIA-E, serious ARIA-H or intracerebral haemorrhage greater than 1 cm (see Contraindications).
Radiographic Severity: The radiographic severity of ARIA associated with donanemab was classified by the criteria shown in Table 4. (See Table 4.)

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Dilution instruction: Prior to administration, KISUNLA must be diluted with 0.9% sodium chloride injection.
Use aseptic technique when preparing the KISUNLA diluted solution for intravenous infusion.
Allow KISUNLA to equilibrate to room temperature for approximately 30 minutes before preparation.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. KISUNLA solution is clear to opalescent, colourless to slightly yellow to slightly brown and free of visible particles. If particulate matter or discolourations are identified, discard the vial.
Withdraw required volume of KISUNLA using an appropriately sized needle and transfer to the infusion bag.
The concentrate should be diluted only in infusion bags containing sodium chloride 9 mg/mL (0.9%).
The final concentration after dilution is approximately 4 mg/mL to 10 mg/mL (see Table 5).

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Gently invert the KISUNLA diluted solution to mix completely. Do not shake or freeze dosing solution.
Each vial is for one time use only. Use in one patient on one occasion only. Contains no antimicrobial preservative. Discard any unused portion left in the vial.
After dilution, immediate use is recommended. If the KISUNLA diluted solution is not administered immediately, store refrigerated at 2°C to 8°C for up to 72 hours or at room temperature (20°C to 25°C) for up to 12 hours.
Storage times include the duration of infusion.
Administration: KISUNLA, solution for infusion should be prepared and administered by a qualified healthcare professional using aseptic technique to ensure the sterility of the prepared solution: Visually inspect the KISUNLA diluted solution for particles or discolouration prior to administration. Do not use if it is discoloured, or opaque or foreign particles are seen.
Prior to infusion, if the diluted solution has been stored under refrigeration, allow the KISUNLA diluted solution to warm to room temperature.
The intravenous administration set (infusion line) should be connected to the prepared intravenous bag and the line should be primed.
Administer the entire diluted solution intravenously over a period of at least 30 minutes.
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction (see Precautions).
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.
Observe the patient post-infusion for a minimum of 30 minutes.
Missed Dose: If an infusion is missed, the missed dose should be administered at the next possible occasion. Then, resume the recommended dosing regimen every 4 weeks at the same dose as soon as possible.
Paediatric population: There is no relevant use of KISUNLA in the paediatric population for the treatment of Alzheimer's disease.