Resources for
IMAAVY™ treatment

There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is a pregnancy safety study for IMAAVY. If IMAAVY is administered during pregnancy, or if a patient becomes pregnant while receiving IMAAVY, healthcare providers should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com

IMAAVY is administered as an intravenous infusion lasting at least 15 minutes every 2 weeks (following an initial starting dose administered over at least 30 minutes).¹

Please see Dosing and Administration Guide for more details.

The most common adverse reactions (≥10% of patients) for patients taking IMAAVY were respiratory tract infections (18%), peripheral edema (12%), and muscle spasms (12%). Rates of serious adverse events in both arms were similar (9% for IMAAVY, 14% for placebo).^1,2

Please read the Important Safety Information located at the bottom of the screen and the Medication Guide to learn more about these and other risks for IMAAVY.

IMAAVY is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.¹

A fully human design may help to minimize immune reactions by resembling natural human proteins. It has a lower risk of eliciting neutralizing antidrug antibodies vs a nonhuman mAb.³

In the phase 3 pivotal study, the pharmacological effect of IMAAVY was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for anti-AChR and anti-MuSK autoantibodies who were treated with IMAAVY, there was a reduction in anti-AChR and anti-MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.¹

IMAAVY does not impact IgG production; it reduces circulating IgG by binding FcRn and preventing IgG recycling. In the phase 3 pivotal study, the pharmacological effect of IMAAVY was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for anti-AChR and anti-MuSK autoantibodies who were treated with IMAAVY, there was a reduction in anti-AChR and anti-MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.¹

IMAAVY binds to FcRn with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH levels, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG.⁴

IMAAVY demonstrated a reduction only in immunoglobulin G (IgG).¹