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Labeling: • Hypersensitivity Reactions Including Infusion-Associated Events [See Warnings and Precautions (5.1)]

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Labeling: • Hypersensitivity Reactions Including Infusion-Associated Events [See Warnings and Precautions (5.1)] ___________________ ___________________ HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use None. (4) INMAZEB safely and effectively. See full prescribing information for _______________ _______________ INMAZEB. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Infusion-Associated Events: INMAZEB™ (atoltivimab, maftivimab, and odesivimab-ebgn) injection, Hypersensitivity reactions including infusion-associated events have been for intravenous use reported during and post-infusion with INMAZEB. These may include acute, Initial U.S. Approval: 2020 life-threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue __________________ _________________ INDICATIONS AND USAGE the administration of INMAZEB immediately and administer appropriate INMAZEB is a combination of Zaire ebolavirus glycoprotein-directed human emergency care. (5.1) monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated ___________________ ___________________ for the treatment of infection caused by Zaire ebolavirus in adult and pediatric ADVERSE REACTIONS patients, including neonates born to a mother who is RT-PCR positive for The most common adverse events (incidence ≥20%) were pyrexia, chills, Zaire ebolavirus infection. (1) tachycardia, tachypnea, and vomiting. (6.1) Limitation of Use • The efficacy of INMAZEB has not been established for other species of the To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at Ebolavirus and Marburgvirus genera. 1-844-734-6643 or FDA AT 1-800-FDA-1088 or www.fda.gov/medwatch. • Zaire ebolavirus can change over time, and factors such as emergence of ___________________ ____________________ resistance, or changes in viral virulence could diminish the clinical benefit DRUG INTERACTIONS of antiviral drugs. Consider available information on drug susceptibility Interaction with live vaccine indicated for prevention of Zaire ebolavirus patterns for circulating Zaire ebolavirus strains when deciding whether to infection: No vaccine interaction studies have been performed. INMAZEB use INMAZEB. may reduce the efficacy of the live vaccine. The interval between live _______________ ______________ vaccination following initiation of INMAZEB therapy should be in DOSAGE AND ADMINISTRATION accordance with current vaccination guidelines. (7.1) 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 USE IN SPECIFIC POPULATIONS single intravenous infusion. (2.1) Lactation: Patients infected with Zaire ebolavirus should be instructed not to Refer to the Full Prescribing Information for information on preparation and breastfeed due to the potential for Zaire ebolavirus transmission. (8.2) administration. (2.2) ______________ _____________ See 17 for PATIENT COUNSELING INFORMATION DOSAGE FORMS AND STRENGTHS Injection: 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of Revised: 10/2020 odesivimab per 14.5 mL (16.67 mg/16.67 mg/16.67 mg per mL) in a single- dose vial. (3) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.4 Pediatric Use 2 DOSAGE AND ADMINISTRATION 8.5 Geriatric Use 2.1 Recommended Dosage 11 DESCRIPTION 2.2 Preparation and Administration 12 CLINICAL PHARMACOLOGY 3 DOSAGE FORMS AND STRENGTHS 12.1 Mechanism of Action 4 CONTRAINDICATIONS 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Hypersensitivity Reactions Including Infusion-Associated 12.4 Microbiology Events 13 NONCLINICAL TOXICOLOGY 6 ADVERSE REACTIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 6.1 Clinical Trials Experience 14 CLINICAL STUDIES 6.2 Immunogenicity 16 HOW SUPPLIED/STORAGE AND HANDLING 7 DRUG INTERACTIONS 17 PATIENT COUNSELING INFORMATION 7.1 Vaccine Interactions 8 USE IN SPECIFIC POPULATIONS *Sections or subsections omitted from the full prescribing information 8.1 Pregnancy are not listed. 8.2 Lactation Reference ID: 4685619 FULL PRESCRIBING INFORMATION 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 Reference ID: 4685619 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 Total Infusion Infusion Time kg of Body Weighta Volume After Dilution (mL)b 0.5 to less than 1 7 4 hours 1 to 1.9 15 2 to 3.9 25 3 hours 4 to 7 50 8 to 15 3 mL per kg of body weight 100 16 to 38 250 39 to 79 500 2 hours 80 to 149 1,000 150 and above 2,000 4 hours a 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). b 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. • 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. Reference ID: 4685619 Diluent Used to Prepare Solution for Infusion Diluted INMAZEB Solution Storage Conditions 5% Dextrose Injection, USP or Lactated Ringer’s Store at room temperature up to 25°C (77°F) for no Injection, USP 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. 3 DOSAGE FORMS AND STRENGTHS INMAZEB is a clear to slightly opalescent and colorless to pale yellow solution available as: Injection: 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab per 14.5 mL (16.67 mg/16.67 mg/16.67 mg per mL) in a single-dose vial.
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