Inmazeb (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection is a clear to slightly opalescent and colorless to pale yellow solution. It is supplied in a carton containing one single dose vial of:
- 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) (NDC 61755-018-01)
- 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab per 14.5 mL (33.33 mg/33.33 mg/33.33 mg per mL) (NDC 61755-019-01)
Prior to dilution
Store INMAZEB vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
After dilution
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 according to Table 9 below. Do not freeze the diluted solution [see Dosage and Administration (2.2)].
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 | 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 24 hours. |
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. |
17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions Including Infusion-Associated Events
Inform patients that hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with INMAZEB and to immediately report if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.1) ].
Lactation
Instruct patients with Zaire ebolavirus infection not to breastfeed because of the risk of passing Zaire ebolavirus to the baby [see Use in Specific Populations (8.2)].
Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
U.S. License No. 1760
INMAZEB is a registered trademark owned by Regeneron Pharmaceuticals, Inc.
©2022 Regeneron Pharmaceuticals, Inc. All rights reserved.
Revised: May 2022
PRINCIPAL DISPLAY PANEL — 14.5 mL Vial Carton — 61755-018
NDC 61755-018-01
Rx only
Inmazeb®
(atoltivimab, maftivimab,
and odesivimab – ebgn)
Injection
241.7 mg / 241.7 mg / 241.7 mg per 14.5 mL (16.67 mg / 16.67 mg / 16.67 mg per mL)
For Intravenous Infusion after Dilution
Single-Dose Vial
Discard unused portion.
Do not use vial if seal is broken or missing.
One 14.5 mL Vial
PRINCIPAL DISPLAY PANEL — 14.5 mL Vial Carton — 61755-019
NDC 61755-019-01
Rx only
Inmazeb®
(atoltivimab, maftivimab,
and odesivimab – ebgn)
Injection
483.3 mg / 483.3 mg / 483.3 mg per 14.5 mL (33.33 mg / 33.33 mg / 33.33 mg per mL)
For Intravenous Infusion after Dilution
Single-Dose Vial
Discard unused portion.
Do not use vial if seal is broken or missing.
One 14.5 mL Vial
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INMAZEB atoltivimab, maftivimab, and odesivimab-ebgn injection, solution | |||||||||||||||||
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Labeler — Regeneron Pharmaceuticals, Inc. (194873139) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Regeneron Pharmaceuticals, Inc. | 945589711 | API MANUFACTURE (61755-018), ANALYSIS (61755-018), ANALYSIS (61755-019) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Regeneron Ireland Designated Activity Company | 986063166 | ANALYSIS (61755-018), ANALYSIS (61755-019), API MANUFACTURE (61755-019) |
Revised: 12/2022 Regeneron Pharmaceuticals, Inc.
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