KISUNLA Solution for injection Ref.[110679] Active ingredients: Donanemab

2.1 Patient Selection

Confirm the presence of amyloid beta pathology prior to initiating treatment [see Clinical Pharmacology (12.1)].

2.2 Dosing Instructions

The recommended dosage of KISUNLA is 700 mg every four weeks for three doses, then 1400 mg every four weeks (see Table 1). KISUNLA is administered every four weeks as an intravenous infusion over approximately 30 minutes. KISUNLA must be diluted prior to administration (see Table 4).

Table 1. Dosing Schedule:

Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging. In Study 1, dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET imaging [see Clinical Studies (14)].

If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

2.3 Monitoring and Dosing Interruption for Amyloid Related Imaging Abnormalities

KISUNLA can cause amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H) [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Monitoring for ARIA

Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with KISUNLA. Obtain an MRI prior to the 2^nd, 3^rd, 4^th, and 7^th infusions. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.

Recommendations for Dosing Interruptions in Patients with ARIA

ARIA-E:

The recommendations for dosing interruptions for patients with ARIA-E are provided in Table 2.

Table 2. Dosing Recommendations for Patients With ARIA-E:

^a Mild: discomfort noticed, but no disruption of normal daily activity.
Moderate: discomfort sufficient to reduce or affect normal daily activity.
Severe: incapacitating, with inability to work or to perform normal daily activity.
^b Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification. Resumption of dosing should be guided by clinical judgment.

ARIA-H:

The recommendations for dosing interruptions for patients with ARIA-H are provided in Table 3.

Table 3. Dosing Recommendations for Patients With ARIA-H:

^a Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
^b Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Use clinical judgment when considering whether to continue treatment or permanently discontinue KISUNLA.

In patients who develop intracerebral hemorrhage greater than 1 cm in diameter during treatment with KISUNLA, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Resumption of dosing should be guided by clinical judgment.

2.4 Dilution Instructions

• Prior to administration, KISUNLA must be diluted with 0.9% sodium chloride injection (see Table 4).
• Use aseptic technique when preparing the diluted KISUNLA solution for intravenous infusion.
• Allow KISUNLA to equilibrate to room temperature before preparation.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. KISUNLA solution is clear to opalescent, colorless to slightly yellow to slightly brown. Do not use if particulate matter or discolorations are present.
• Withdraw required volume of KISUNLA and mix with 0.9% sodium chloride injection, to the recommended total volume for a final concentration of 4 mg/mL to 10 mg/mL (see Table 4). Use only 0.9% sodium chloride injection for dilution.

Table 4. Preparation and Reconstitution of KISUNLA:

^a final concentration of 4 mg/mL to 10 mg/mL
^b 2 vials of KISUNLA
^c 4 vials of KISUNLA

• Each vial is for one-time use only. Discard any unused portion left in the vial.
• Gently invert the diluted KISUNLA solution to mix completely. Do not shake.
• After dilution, immediate use is recommended [see Description (11)]. If the diluted KISUNLA solution is not administered immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.
• Do not freeze the diluted KISUNLA solution.
• Storage times include the duration of infusion.

2.5 Administration Instructions

• Visually inspect the diluted KISUNLA solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
• Prior to infusion, if the diluted solution has been stored under refrigeration, allow the diluted KISUNLA solution to warm to room temperature.
• Administer the entire diluted solution intravenously over approximately 30 minutes.
• Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction [see Warnings and Precautions (5.2)].
• Flush the line only with 0.9% sodium chloride injection at the end of the infusion per access specific line maintenance protocol.
• Observe the patient post-infusion for a minimum of 30 minutes to evaluate for infusion reactions and hypersensitivity reactions [see Warnings and Precautions (5.2)].

Unopened Vial:

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Keep the vial in the outer carton to protect from light.
• Do not freeze or shake.
• If refrigeration is not available, may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days.

Diluted Solution:

For storage of the diluted infusion solution see Dosage and Administration (2.4).