Inmazeb 483.3 mg/14.5mL
atoltivimab, maftivimab, and odesivimab-ebgn · INJECTION, SOLUTION · Regeneron Pharmaceuticals, Inc.
Inmazeb is a injection, solution containing atoltivimab, maftivimab, and odesivimab-ebgn at 483.3 mg/14.5mL, taken intravenous. Manufactured by Regeneron Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Inmazeb
- Generic Name
- atoltivimab, maftivimab, and odesivimab-ebgn
- NDC Code (Product)
61755-019- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Strength
- 483.3 mg/14.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761169
- Marketing Start
- 07/29/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) , and Clinical Studies (14) ] . INMAZEB is a combination of Orthoebolavirus zairense glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection. ( 1 ) Limitation of Use The efficacy of INMAZEB has not been established for other species of the Orthoebolavirus and Orthomarburgvirus genera . Orthoebolavirus zairense 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 Orthoebolavirus zairense strains when deciding whether to use INMAZEB. Limitations of Use The efficacy of INMAZEB has not been establ…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. ( 2.1 ) Refer to the Full Prescribing Information for information on preparation and administration. ( 2.2 ) 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. INMAZEB is available as two different strength presentations, containing either 16.67 mg of each antibody per mL or 33.33 mg of each antibody per mL [see Dosage Forms and Strengths (3) ] . 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 as shown in Table 1 [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 sl…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Interaction with live vaccine indicated for prevention of Orthoebolavirus zairense infection: No vaccine interaction studies have been performed. INMAZEB may reduce the efficacy of the live vaccine. The interval between live vaccination following initiation of INMAZEB therapy should be in accordance with current vaccination guidelines. ( 7.1 ) 7.1 Vaccine Interactions No vaccine-therapeutic interaction studies have been performed in human subjects using INMAZEB. However, because of the potential for INMAZEB to inhibit replication of a live vaccine virus indicated for prevention of Orthoebolavirus zairense infection and possibly reduce the efficacy of the vaccine, avoid the concurrent administration of a live vaccine during treatment with INMAZEB. The interval between live vaccination following initiation of INMAZEB therapy should be in accordance with current vaccination guidelines. The efficacy of INMAZEB among subjects who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM clinical trial was similar to subjects who did not receive a vaccine.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions (5.1) ] The most common adverse events (incidence ≥20%) were pyrexia, chills, tachycardia, tachypnea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-734-6643 or www.regeneron.com/contact or FDA AT 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates may not reflect the rates observed in practice. Overall, 382 adult and pediatric subjects with Orthoebolavirus zairense infection received INMAZEB in one clinical trial (the PALM trial) and as part of an expanded access program conducted in the Democratic Republic of Congo during a Orthoebolavirus zairense outbreak in 2018-2019. In the PALM trial, the safety of INMAZEB was evaluated in a multi-center, open-label, randomized controlled trial, in which 154 subjects (115 adult subjects and 39 pediatric subjects) received INMAZEB [50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg o…
Frequently Asked Questions
What is Inmazeb used for?
Inmazeb contains atoltivimab, maftivimab, and odesivimab-ebgn. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Inmazeb a controlled substance?
Inmazeb is not classified as a controlled substance by the DEA.
What is the generic name for Inmazeb?
The generic name for Inmazeb is atoltivimab, maftivimab, and odesivimab-ebgn. There are no other listed brand versions of atoltivimab, maftivimab, and odesivimab-ebgn.
What is the NDC code for Inmazeb 483.3 mg/14.5mL?
The NDC (National Drug Code) for Inmazeb 483.3 mg/14.5mL is 61755-019, listed by Regeneron Pharmaceuticals, Inc..
Other Inmazeb Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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