For US Patients
Prescribing Information
IMAAVY® (nipocalimab-aahu)

Additional
resources

For patients prescribed
IMAAVY and their
caregivers:

IMAAVY withMe Savings Program Web Flashcard

Download the IMAAVY withMe Savings Program Web Flashcard

Learn about the IMAAVY withMe Savings Program and how it can help eligible patients save on out-of-pocket treatment costs.

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IMAAVY withMe Affordability Brochure

Download the IMAAVY withMe Affordability Brochure

Read about how IMAAVY withMe can help you find cost support options, regardless of your insurance type.

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IMAAVY withMe Caregiver's Guide to Self-Care

Download the IMAAVY withMe Caregiver’s Guide to Self Care

Follow these tips to help you care for yourself so that you can be a better caregiver for someone else.

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The support and resources provided by IMAAVY withMe are not intended to provide medical advice, replace a treatment plan you receive from your doctor or nurse, or serve as a reason for you to start or stay on treatment.

Find an infusion center

Use this tool to look up infusion centers near you that may carry IMAAVY. This can help you and your healthcare provider plan for where you’ll receive your IMAAVY infusions.

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Commonly asked questions about wAIHA

Your immune system protects you from invaders, like germs. Think of it as a bodyguard. But with wAIHA, the bodyguard gets confused. It starts creating harmful IgG antibodies, or attackers, that attach to your red blood cells.

The harmful IgG antibodies mistakenly identify and tag your red blood cells as the bad guys. This tells the bodyguards—your immune system—to destroy the red blood cells.

FcRn is a protein found naturally inside your cells. Its normal job is to keep IgG antibodies circulating in your bloodstream longer.

FcRn does not distinguish between helpful and harmful IgG antibodies. It keeps them in circulation longer, including the ones that are attacking your red blood cells. This contributes to the continued destruction of red blood cells.

Symptoms can vary but some people with wAIHA experience fatigue, weakness, dizziness, pale skin, shortness of breath, or heart palpitations.

IMAAVY is the first and only FDA-approved treatment for wAIHA in adults and children 12 years and older who are currently or were previously treated with corticosteroids. Before IMAAVY was approved, there was no medicine that was FDA approved for this condition. Talk to your healthcare provider about whether IMAAVY may be right for you.

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Commonly asked questions about IMAAVY

You may be eligible for IMAAVY if you are 12 years and older and have warm autoimmune hemolytic anemia (wAIHA) and are currently or have previously been treated with corticosteroids. Talk to your healthcare provider to find out if IMAAVY is the right choice for you.*

*It is not known if IMAAVY is safe and effective in children under 12 years.

IMAAVY reduces IgG antibodies, including harmful IgG antibodies that attach to red blood cells, by binding and blocking FcRn.

Based on research from laboratory and/or clinical studies. The clinical significance of these findings is unknown.

If you miss a scheduled IMAAVY infusion, you should receive your next dose as soon as possible.

In the clinical study, patients were allowed to continue their usual wAIHA medicines. This included steroids (90% for IMAAVY and 87% for placebo), immunosuppressants (24% for IMAAVY and 26% for placebo), or both (18% for IMAAVY and 21% for placebo). Talk to your healthcare provider about your specific situation. They will help determine the right medication plan for you.

IMAAVY will be given to you by your healthcare provider through intravenous (IV) infusion (through a needle placed into your vein).

  • You will receive a starting dose of IMAAVY infusion lasting at least 30 minutes. Four weeks later you will receive your next dose of IMAAVY infusion lasting at least 15 minutes. Your following doses will be given every four weeks
  • Your healthcare provider should monitor you for reactions to IMAAVY during the infusion and for 30 minutes after each infusion. If you have a reaction during your IMAAVY infusion, your healthcare provider may infuse IMAAVY more slowly, or give you medicine before your infusion, or stop your infusion if your reaction is severe

IMAAVY may cause serious side effects, including:

  • Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you get any of the following symptoms of infection:
    • fever
    • chills
    • shivering
    • cough
    • sore throat
    • fever blisters
    • burning when you urinate
    • trouble breathing
  • Allergic (hypersensitivity) reactions. Allergic reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:
    • swelling of your face, lips, mouth, tongue, or throat
    • trouble swallowing or breathing
    • hives
    • itchy rash
    • chest pain or tightness
  • Infusion-related reactions. Tell your healthcare provider right away if you get any of the following symptoms during or a few days after your infusion of IMAAVY:
    • headache
    • rash
    • nausea
    • fatigue
    • dizziness
    • chills
    • flu-like symptoms
    • redness of skin

The most common side effects in people with wAIHA treated with IMAAVY include:

  • swelling in your hands, ankles, or feet (peripheral edema)
  • diarrhea
  • fever (pyrexia)

These are not all of the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Terms and definitions

A-H
I-Z

Antibody: A protein made by your immune system to help fight infections. In wAIHA, a specific type of antibody (called an IgG autoantibody) mistakenly attacks your own red blood cells.

Autoimmune disease: Refers to a category of conditions in which the immune system mistakenly attacks the body’s own organs or tissues. wAIHA is an autoimmune disease.

FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue Scale: A questionnaire used to assess a patient's level of fatigue, including self-reported tiredness, weakness, and difficulty performing usual activities due to fatigue. Patients are asked to report their experiences during the previous 7 days.

FcRn (neonatal Fc receptor): A protein found naturally inside your cells. FcRn does not distinguish between helpful and harmful IgG antibodies and helps keep both circulating in the body longer.

Fatigue: Fatigue is extreme tiredness that can interfere with your usual activities.

Harmful IgG antibodies: Also known as IgG autoantibodies, which, in wAIHA, the immune system incorrectly makes to attack the body’s own red blood cells.

Hemoglobin: A protein inside red blood cells. Its main job is to carry oxygen from the lungs to the rest of the body. When wAIHA destroys red blood cells, hemoglobin levels drop and the body gets less oxygen.

IgG (Immunoglobulin G): A type of antibody that normally protects you from viruses and bacteria. In wAIHA, a harmful form called an IgG autoantibody mistakenly attacks red blood cells.

Infusion-related reaction: A side effect that can happen when medicine enters the body through an IV infusion.

Intravenous (IV) infusion: A process that delivers fluids or medication directly to the bloodstream through a vein. IMAAVY is given as an IV infusion by your healthcare provider or trained infusion specialist.

Nipocalimab-aahu: The generic name for IMAAVY. IMAAVY® (nipocalimab-aahu) is the first and only FDA-approved treatment ​for wAIHA in adults and children 12 years and older currently or previously treated with corticosteroids.

Placebo: In a clinical study, this is the group that does not receive the medicine that is being tested.

Red blood cells (RBCs): Cells in the blood that carry oxygen from the lungs to the rest of the body. In wAIHA, the immune system destroys red blood cells, leading to anemia and symptoms like fatigue.

Spleen: An organ that breaks down old or damaged red blood cells. In wAIHA, the spleen destroys red blood cells that have been tagged by harmful IgG antibodies.

Warm autoimmune hemolytic anemia (wAIHA): wAIHA is an autoimmune disease in which your immune system attacks your red blood cells.

Community resources

Gain insights and tips for living with wAIHA.

wAIHA Warriors logo

Warm Autoimmune Hemolytic Anemia Warriors (wAIHA Warriors)

A charitable organization that can provide you and your loved ones with a community of people living with wAIHA through education, events, research, and advocacy.

Visit wAIHA Warriors website
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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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