Overview
11 DESCRIPTION Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action INMAZEB is an antiviral drug combination of three recombinant human IgG1κ monoclonal antibodies (atoltivimab, maftivimab, and odesivimab) that inhibit Orthoebolavirus zairense [ see Microbiology (12.4) ]. 12.2 Pharmacodynamics Atoltivimab, maftivimab, and odesivimab exposure-response relationships and the time course of pharmacodynamic response are unknown. 12.3 Pharmacokinetics No pharmacokinetic data are available in patients with Orthoebolavirus zairense infection. The pharmacokinetics of atoltivimab, maftivimab, and odesivimab in 18 healthy subjects 21 to 60 years of age are linear and dose-proportional over the range of 1 mg of atoltivimab, 1 mg of maftivimab, and 1 mg of odesivimab per kg to 50 mg of atoltivimab, 50 mg of maftivimab,...
Indications
- 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...
Common Doses
- 50 mg
- 16.67 mg
- 33.33 mg
- 500 mg
Dosage
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.
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 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.
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.