For US Patients
Prescribing Information
IMAAVY® (nipocalimab-aahu)
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For patients 12 years of age and older with warm autoimmune hemolytic anemia (wAIHA) currently or previously treated with corticosteroids

NOW APPROVED!

IMAAVY® (nipocalimab-aahu) is the first and only FDA-approved treatment for patients 12 years and older with wAIHA currently or previously treated with corticosteroids.

Why choose IMAAVY?

IMAAVY
is the first & only FDA-approved treatment for

wAIHA

For adults and children 12 years and older with wAIHA currently or previously treated with corticosteroids

IMAAVY
was proven to increase

hemoglobin
levels in a 24-week clinical study

24% of patients receiving IMAAVY compared with 8% of patients receiving

placebo
had improved hemoglobin levels* without the need for additional treatment†

Individual results may vary. Talk to your healthcare provider to see if IMAAVY is right for you.

IMAAVY
is dosed once every
4 weeks

Received through an

intravenous (IV) infusion
‡

IMAAVY
has a proven safety profile

The most common side effects reported in people with wAIHA taking IMAAVY were swelling in the hands, ankles, or feet; diarrhea; and fever

FDA=Food and Drug Administration.
*Improved hemoglobin levels were defined as hemoglobin levels ≥10 g/dL and an increase of ≥2 g/dL from the start of the study, without the need for additional treatment. These goals had to be met ≥3 times in a row over ≥28 days, starting by Week 16 of the clinical study. In this study, 38 patients received IMAAVY every 4 weeks, and 39 patients received placebo.
†No additional treatment means no rescue treatment (extra treatment) was given by a healthcare provider based on
worsening signs and symptoms of wAIHA.
‡An IV infusion is given by a healthcare provider through a needle placed into your vein.
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Get personalized support tailored
to your unique needs

Once you and your healthcare provider have decided that IMAAVY is right for you, IMAAVY withMe is here for you and your loved ones with free personalized support when and where you may need it.

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