ISEMBYLD Solution for injection Ref.[116934] Active ingredients: Apitegromab

2.1 Recommended Dosage

The recommended dosage of ISEMBYLD is 10 mg/kg administered once every 4 weeks as an intravenous infusion over approximately 60 minutes to 120 minutes at an infusion rate no greater than 150 mL/hour.

ISEMBYLD must be diluted prior to administration [see Dosage and Administration (2.3)].

Doses of ISEMBYLD of 20 mg/kg administered once every 4 weeks were also assessed in Study 1; however, this dosage is not recommended as it did not demonstrate additional efficacy [see Clinical Studies (14)].

2.2 Recommendations Regarding Missed Dose

If a planned dose is missed, it is recommended to administer ISEMBYLD as soon as possible and then restart the dosing schedule 4 weeks after the missed dose is administered [see Dosage and Administration (2.1)].

Alternatively, if a planned dose is missed, dosing may be resumed on the next scheduled dose to maintain the original dosing schedule.

2.3 Preparation Instructions

ISEMBYLD must be diluted in 0.9% Sodium Chloride Injection to a final concentration of 5 mg/mL prior to intravenous infusion. The diluted solution for infusion must be prepared by a healthcare professional using aseptic technique as follows:

1. Calculate the required dose (mg) of ISEMBYLD to be administered based on the patient's weight and on the recommended dosage of 10 mg/kg. Determine the volume (mL) of ISEMBYLD needed and the correct number of vials to supply the calculated dose.

2. Remove ISEMBYLD vials from the refrigerator and allow vials to warm to room temperature while remaining in the carton until time of use. Do not use external heat sources to warm ISEMBYLD vials because heat may damage the product. Do not shake.

3. Visually inspect each vial of ISEMBYLD. ISEMBYLD is a clear to moderately opalescent, colorless to slightly yellow solution that is free from visible particulates. Do not use if the solution in the vial is discolored or particulate matter is present.

4. Withdraw the required volume of ISEMBYLD from each vial using a sterile syringe and transfer to an infusion bag that is di(2-ethylhexyl)phthalate (DEHP)-free.

5. Dilute ISEMBYLD to a final concentration of 5 mg/mL by adding the appropriate amount of 0.9% Sodium Chloride Injection to the infusion bag.

6. Gently invert the bag to mix the solution. Do not shake. Do not mix or dilute with other drugs.

7. Discard any unused ISEMBYLD remaining in the vial(s).

8. The diluted solution should be administered immediately after preparation. If not used immediately, store the infusion bag, protected from light, either at room temperature (20°C to 25°C [68°F to 77°F]) or in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 4 hours (including preparation and infusion time). Do not freeze.

2.4 Administration Instructions

1. If necessary, remove the diluted ISEMBYLD solution from the refrigerator and allow the diluted solution to warm to room temperature. Do not use external heat sources to warm ISEMBYLD diluted solution because heat may damage the product.

2. Visually inspect the diluted ISEMBYLD solution for particles or discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if it is discolored, opaque, or foreign particles are seen.

3. Use a dedicated line with an infusion set containing a 0.2 or 0.22 micron low protein binding polyethersulfone (PES) in-line infusion filter. Use infusion sets and lines that are di(2-ethylhexyl)phthalate (DEHP)-free.

4. Infuse the diluted solution of ISEMBYLD intravenously over approximately 60 minutes to 120 minutes at an infusion rate no greater than 150 mL/hour.

5. After completion of the infusion, flush the infusion line with 0.9% Sodium Chloride Injection to ensure that all the ISEMBYLD has been administered

Store ISEMBYLD vials in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Discard unused portion.

For storage of the diluted infusion solution, see Dosage and Administration (2.3).