Lecanemab

Switching Routes of Administration During the Starting Dosage Regimen or During the Maintenance Dosage Regimen During the starting dosage regimen and maintenance dosage regimen, the route of administration (intravenous with LEQEMBI vials or subcutaneous with LEQEMBI IQLIK) may be switched as described below. Thereafter follow the dosing schedule for the new route of administration.

Switching Routes of Administration During the Starting Dosage Regimen

To switch from the intravenous to subcutaneous route of administration, administer the first subcutaneous dose 1 week after the last intravenous dose.

To switch from the subcutaneous to the intravenous route of administration, administer the first intravenous dose a minimum of 2 weeks, but no more than 3 weeks, after the last subcutaneous dose. Switching Routes of Administration During the Maintenance Dosage Regimen

To switch from the intravenous to subcutaneous route of administration, administer the first subcutaneous dose 1 week after the last intravenous dose.

To switch from the subcutaneous to the intravenous route of administration, administer the first intravenous dose 1 week after the last subcutaneous dose. When switching the route of administration and simultaneously transitioning from the starting dosage regimen to the maintenance dosage regimen, see Table 2 .

Preparation and Administration of LEQEMBI for Intravenous Infusion Dilution Prior to intravenous administration, LEQEMBI must be diluted in 250 mL of 0.9% Sodium Chloride Injection, USP. Use aseptic technique when preparing the LEQEMBI diluted solution for intravenous infusion. Calculate the dose (mg), the total volume (mL) of LEQEMBI solution required, and the number of vials needed based on the patient’s actual body weight and the recommended dose of 10 mg/kg.

Each vial contains a LEQEMBI concentration of 100 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the LEQEMBI solution is clear to opalescent and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.

Remove the flip-off cap from the vial. Insert the sterile syringe needle into the vial through the center of the rubber stopper. Withdraw the required volume of LEQEMBI from the vial(s) and add to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. Each vial is for one-time use only. Discard any unused portion.

Gently invert the infusion bag containing the LEQEMBI diluted solution to mix completely. Do not shake. After dilution, immediate use is recommended [see Description] . If not administered immediately, store LEQEMBI refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours, or at room temperature up to 30°C (86°F) for up to 4 hours.

Do not freeze. Administration Visually inspect the LEQEMBI diluted solution for particles or discoloration prior to administration. Do not use if it is discolored, opaque, or foreign particles are seen. Prior to infusion, allow the LEQEMBI diluted solution to warm to room temperature. Infuse the entire volume of the LEQEMBI diluted solution intravenously over approximately one hour through an intravenous line containing a terminal low-protein binding 0.2 micron in-line filter.

Flush infusion line to ensure all LEQEMBI is administered. Monitor for any signs or symptoms of an infusion-related reaction during the infusion and consider longer periods of observation if clinically indicated. The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated.

Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids [see Warnings and Precautions].

Preparation and Administration of LEQEMBI IQLIK for Subcutaneous Injection Initiate therapy with LEQEMBI IQLIK under the guidance and supervision of a healthcare provider. LEQEMBI IQLIK may be administered by a patient or caregiver after the healthcare provider provides direct guidance for at least 2 consecutive subcutaneous doses, and determines that administration of LEQEMBI IQLIK by the patient or caregiver is appropriate.

Selection for Administration by the Patient or Caregiver Base selection of patients and caregivers who are capable of administration of LEQEMBI IQLIK on: 1. The patient and/or caregiver’s ability to perform subcutaneous injections with the LEQEMBI IQLIK autoinjector with proper technique according to the prescribed dosing regimen. 2.

The patient and/or caregiver’s ability to recognize and manage symptoms of a hypersensitivity reaction, such as anaphylaxis. The healthcare provider should periodically re-assess the appropriateness of administration of LEQEMBI IQLIK by the patient or caregiver on an ongoing basis. Instruct patients and/or caregivers on the proper subcutaneous administration of LEQEMBI IQLIK.

Direct patients and/or caregivers to follow the directions provided in the Instructions for Use for additional details on administration [see Instructions for Use ]. Preparation and Administration

Before injection, remove LEQEMBI IQLIK from the refrigerator and leave at room temperature for 20 minutes. Do not use an external heat source to heat LEQEMBI IQLIK because heat may damage the product.

Do not shake LEQEMBI IQLIK.

Visually inspect LEQEMBI IQLIK for particles or discoloration prior to administration. The solution should be a clear to opalescent, colorless to pale yellow solution, and free of visible particles. Do not use LEQEMBI IQLIK if it is cloudy or there are visible particles.

Do not use LEQEMBI IQLIK if it looks damaged or has been dropped.

Sites for injection include the abdomen or upper thigh. The back of the upper arm can also be used as an injection site if healthcare provider or caregiver administers the injection.

Rotate injection sites and administer at least 1 inch from the previous injection.

Do not inject into moles, scars, bruises, tattoos or into areas where the skin is red, hard, tender or injured.

Do not inject into the 2-inch area around the navel.

Monitor for signs or symptoms of an injection reaction.

Missed Dose Intravenous Infusion If a starting dosage or maintenance dosage infusion is missed, administer the next dose as soon as possible. Subcutaneous Injection If a scheduled dose of the subcutaneous starting or maintenance dosing regimen is missed, administer LEQEMBI IQLIK as soon as possible, up to 6 days after the missed dose, and then administer the next dose on the regularly scheduled day.

Thereafter, resume the original dosing schedule.