Atoltivimab, maftivimab, and odesivimab

Preparation and Administration INMAZEB must be prepared and administered under the supervision of a healthcare provider. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. INMAZEB should be clear to slightly opalescent, colorless to pale yellow solution that is free from visible particulates.

Discard the vial if the solution is cloudy, discolored or contains particulate matter. Preparation for Intravenous Infusion The recommended dosage is based on 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg. For example, a patient weighing 50 kg the recommended dosage is 2,500 mg of atoltivimab, 2,500 mg of maftivimab, and 2,500 mg of odesivimab.

Determine the number of vials needed based on the calculated dose in volume (mL). – The number of vials needed depends on the INMAZEB strength used. Refer to Table 1 for the corresponding volume per kg needed to withdraw from each available strength presentation to prepare dose. – Multiple INMAZEB vials may be needed. Each vial contains 14.5 mL of INMAZEB solution, regardless of the strength presentation.

For example, for a 50 kg patient, the volume of INMAZEB needed is 150 mL (11 vials) if using the 16.67 mg/16.67 mg/16.67 mg per mL solution or 75 mL (6 vials) if using the 33.33 mg/33.33 mg/33.33 mg per mL solution. [See table below.] Withdraw 1.5 mL of solution per kg to prepare the dose Do not shake the vial. Prior to intravenous infusion, INMAZEB must be further diluted in an intravenous PVC infusion bag containing either 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, or Lactated Ringer's Injection, USP.

For neonates, the INMAZEB solution should be diluted in 5% Dextrose Injection, USP (see Table 2 ). The total volume of the infusion solution to be administered is based on the patient's body weight and is specified in Table 2 . Select a diluent solution infusion bag of appropriate fill volume based on the patient's body weight (see Table 2 ).

Withdraw and discard from the bag a volume of diluent solution equal to the calculated dose in volume (mL) of INMAZEB. Then add the calculated volume of INMAZEB to the bag. For example: – When using the 16.67 mg/16.67 mg/16.67 mg per mL solution for a 50 kg patient, withdraw and discard 150 mL of diluent from a 500 mL infusion bag.

Then add 150 mL of INMAZEB to obtain a total infusion volume of 500 mL. – When using the 33.33 mg/33.33 mg/33.33 mg per mL solution for a 50 kg patient, withdraw and discard 75 mL of diluent from a 500 mL infusion bag. Then add 75 mL of INMAZEB to obtain a total infusion volume of 500 mL. [See table below.] 1 to 1.9 15 2 to 3.9 25 3 hours 4 to 7 50 8 to 15 100 16 to 38 250 2 hours 39 to 79 500 80 to 149 1,000 150 and above 2,000 4 hours Mix the diluted solution by gentle inversion.

Do not shake. INMAZEB does not contain preservatives. It is always recommended to administer intravenous medication immediately after preparation when possible. Store the diluted INMAZEB solution as specified in Table 3 . Do not freeze the diluted solution. Discard any unused medicinal product or waste material. [See table below.] Administration INMAZEB must be administered by a healthcare provider.

Allow the diluted infusion solution to come to room temperature prior to administration. INMAZEB diluted with 5% Dextrose Injection, USP can be infused at temperatures up to 35°C (95°F). When the temperature is higher than 25°C (77°F), administer the diluted INMAZEB with 5% Dextrose Injection, USP immediately after completion of dose preparation.

Administer the diluted infusion solution intravenously through an intravenous line containing a sterile, in-line or add-on 0.2-micron filter. The infusion rate is based on the patient's body weight and prepared infusion volume. Select an appropriate infusion rate for the diluted infusion solution (see Table 2 ). It is important to follow the infusion time outlined in Table 2 based on the patient's weight.

The rate of infusion of INMAZEB may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events [see Warnings and Precautions ] . Do not mix other medications with INMAZEB. Compatibility studies of INMAZEB have not been performed when co-administering other drugs simultaneously through the same infusion line.