Inmazeb

INMAZEB- atoltivimab, maftivimab and odesivimab injection, solution
Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

INMAZEB is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration (2.2), and Clinical Studies (14)].

Limitations of Use

The efficacy of INMAZEB has not been established for other species of the Ebolavirus and Marburgvirus genera.

Zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use INMAZEB.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

INMAZEB is a combination of three human monoclonal antibodies co-formulated in a 1:1:1 ratio of atoltivimab, maftivimab, and odesivimab. The recommended dosage of INMAZEB is 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg diluted and administered as a single intravenous infusion [see Dosage and Administration (2.2)].

2.2 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 2500 mg of atoltivimab, 2500 mg of maftivimab, and 2500 mg of odesivimab.
  • Determine the number of vials needed based on the calculated dose in volume (mL). Refer to Table 1 to determine the calculated dose based on volume (mL) of INMAZEB per patient’s weight (kg). Multiple INMAZEB vials may be needed. Each vial contains 14.5 mL of INMAZEB solution. For example, for a 50 kg patient, the volume of INMAZEB needed is 150 mL (11 vials).
  • 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 1). The total volume of the infusion solution to be administered is based on the patient’s body weight and is specified in Table 1.
    Select a diluent solution infusion bag of appropriate fill volume based on the patient’s body weight (see Table 1). 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, 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.
Table 1: INMAZEB Infusion Volumes and Times by Body Weight
Body Weight (kg) Volume of INMAZEB per kg of Body Weight * Total Infusion Volume After Dilution (mL) Infusion Time
*
The dose is 50 mg of atolivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg of body weight (a volume of 3 mL/kg).
The recommended infusion volume ensures the final concentration of the diluted solution is 9.5 mg/mL to 23.7 mg/mL. 5% Dextrose Injection, USP is recommended for neonates.
0.5 to less than 1 3 mL per kg of body weight 7 4 hours
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 2.
  • Do not freeze the diluted solution.
  • Discard any unused medicinal product or waste material.
Table 2: Diluted INMAZEB Solution Storage Conditions
Diluent Used to Prepare Solution for Infusion Diluted INMAZEB Solution Storage Conditions
0.9% Sodium Chloride Injection, USP Store at room temperature up to 25°C (77°F) for no more than 8 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours.
5% Dextrose Injection, USP or Lactated Ringer’s Injection, USP Store at room temperature up to 25°C (77°F) for no more than 4 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 4 hours.

Administration

  • INMAZEB must be administered by a healthcare provider.
  • Allow the diluted infusion solution to come to room temperature prior to administration.
  • 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 1). It is important to follow the infusion time outlined in Table 1 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 (5.1)].
  • 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.

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