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)].

Table 9: 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 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 -- 61755-018
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 14.5 mL Vial Carton -- 61755-019
(click image for full-size original)
INMAZEB atoltivimab, maftivimab, and odesivimab-ebgn injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61755-018
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
atoltivimab (atoltivimab) atoltivimab 241.7 mg in 14.5 mL
maftivimab (maftivimab) maftivimab 241.7 mg in 14.5 mL
odesivimab (odesivimab) odesivimab 241.7 mg in 14.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
Polysorbate 80
Sucrose
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61755-018-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (61755-018-00)
1 NDC:61755-018-00 14.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (61755-018-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761169 10/14/2020
INMAZEB atoltivimab, maftivimab, and odesivimab-ebgn injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61755-019
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
atoltivimab (atoltivimab) atoltivimab 483.3 mg in 14.5 mL
maftivimab (maftivimab) maftivimab 483.3 mg in 14.5 mL
odesivimab (odesivimab) odesivimab 483.3 mg in 14.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
Polysorbate 80
Sucrose
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61755-019-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (61755-019-00)
1 NDC:61755-019-00 14.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (61755-019-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761169 07/29/2021
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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