Inmazeb 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.

6.1 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-

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 of odesivimab per kg (3 mL/kg)] intravenously as a single infusion and 168 subjects received an investigational control [see Clinical Studies (14) ] .

All subjects received optimized standard of care treatment.

During the same outbreak, INMAZEB [50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg (3 mL/kg)] was given to 228 subjects (190 adult subjects and 38 pediatric subjects) in the expanded access program.

The safety data described below is derived from the PALM trial.

Table 4 summarizes adverse events that were reported during INMAZEB infusion.

The evaluation of adverse events in subjects who received INMAZEB may have been confounded by the signs and symptoms of the underlying Orthoebolavirus zairense infection.