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Imaavy (nipocalimab-aahu) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating warm autoimmune hemolytic anemia (wAIHA) in adults and children ages 12 years and older.
Imaavy is a type of biologic medicine called a neonatal Fc receptor (FcRn) blocker. It works by binding to a protein called FcRn, which lowers levels of immunoglobulin G (IgG), a type of antibody, in the blood. In wAIHA, this helps reduce harmful antibodies that attack red blood cells.
Doctors prescribe Imaavy when a person age 12 or older has wAIHA and is currently using or has previously used corticosteroids.
Imaavy is given through an intravenous (IV) infusion by a healthcare professional. Treatment starts with an initial dose, followed by another dose four weeks later and every four weeks after that.
The recommended starting dose of Imaavy for wAIHA is 30 milligrams per kilogram of body weight, given by IV infusion over at least 30 minutes. Four weeks after the first dose, the recommended dose is 30 milligrams per kilogram by IV infusion over at least 15 minutes. Treatment continues every four weeks thereafter. The dose is based on the person’s current body weight and is calculated before infusions.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Imaavy for wAIHA in adults and children ages 12 years and older, the most common side effects occurred in over 10 percent of people. They include:
Imaavy can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
If you experience serious side effects, you can report them to the FDA online or by calling 1-800-FDA-1088. You can also contact the drug's manufacturer.
Janssen Biotech, Inc, the manufacturer of Imaavy, offers the IMAAVY withMe Savings Program. Eligible people with commercial insurance may pay as little as $0 per infusion.
To learn more, visit the IMAAVY withMe Savings Program website or call 888-750-8733.
Before starting Imaavy, your doctor will check whether you need age-appropriate vaccines. Because Imaavy can temporarily lower IgG levels, live vaccines are not recommended during treatment.
Tell your doctor if you have any allergies to nipocalimab-aahu or any ingredients in Imaavy. Do not take Imaavy if you have had a serious allergic reaction to nipocalimab-aahu or any of its ingredients.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements.
Before receiving Imaavy, tell your healthcare provider about all of your medical conditions, including if you:
If you are pregnant, planning to become pregnant, or breastfeeding while taking Imaavy, talk with your doctor about the risks and benefits.
There is a pregnancy safety study for Imaavy. If Imaavy is given during pregnancy or you become pregnant while receiving Imaavy, your healthcare provider should report Imaavy exposure by contacting Janssen at 800-526-7736.
Imaavy is also FDA-approved to treat generalized myasthenia gravis in adults and children ages 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
These answers are fact-checked by our editorial staff.
How effective is Imaavy?
In a 24-week study of adults with wAIHA, about 24 percent of people taking Imaavy had a lasting improvement in hemoglobin levels, compared with about 8 percent taking a placebo (a treatment with no active medicine). A lasting response meant hemoglobin levels reached at least 10 grams per deciliter and increased by at least 2 grams per deciliter from the start of the study. These levels had to be maintained across at least three visits over at least 28 days, with the response starting by week 16, without needing rescue treatment. By week 24, fatigue scores also improved more with Imaavy than with the placebo.
Should I take Imaavy for warm autoimmune hemolytic anemia if I have an infection?
If you have an active infection, treatment is delayed until the infection has resolved. During treatment, your healthcare provider monitors for signs and symptoms of infection. If a serious infection happens, appropriate treatment is given, and Imaavy may be withheld until the infection has resolved.
What should I do if I miss a dose of Imaavy for warm autoimmune hemolytic anemia?
If you miss a scheduled infusion, the dose should be given as soon as possible. After that, treatment should continue every 4 weeks.
On myAIHAteam, people share their experiences with autoimmune hemolytic anemia, get advice, and find support from others who understand.
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