It is for people who are taking or have taken steroid medicines for their condition.
Warm autoimmune hemolytic anemia is a rare disorder in which the body’s immune system makes harmful proteins called antibodies. These antibodies attack and break down healthy red blood cells. When red blood cells are destroyed too quickly, it causes low blood counts, also known as anemia. Patients with this condition often feel very weak and extremely tired. Imaavy works by lowering the level of these bad antibodies in the blood. This helps stop the body from destroying its own red blood cells.
Why Was Imaavy Approved?
The FDA approved Imaavy based on a study called the ENERGY trial. The main part of the study included 77 adults who were divided into two groups. One group received Imaavy infusions, while the other group received dummy treatments called placebos. Researchers looked at how many patients were able to raise their blood levels and keep them steady without needing extra emergency treatments. In the study, about 24% of people treated with this medicine reached a healthy and stable blood level. In contrast, only about 8% of people in the placebo group met this goal. Those who received Imaavy also reported feeling less tired compared to those who took the placebo. During the study, the most common side effects reported were swelling in the hands, ankles, or feet, as well as diarrhea and fever.
What Do I Need to Know About Imaavy?
Imaavy is given as an intravenous (IV) infusion into a vein by a healthcare provider. After the first treatment, patients return for another infusion a few weeks later and then continue receiving infusions on a regular schedule. A healthcare provider will watch you during each infusion and for 30 minutes after it finishes to check for any sudden reactions. Because Imaavy lowers antibody levels, it can make it easier for you to get infections. You should tell your healthcare provider if you have an active infection or if you get a fever, chills, a cough, or trouble breathing. You should also avoid getting live vaccines while being treated with this medicine. Common side effects include swelling in your feet or ankles, loose stools, and a fever. Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if this medicine can harm a fetus, but the medicine can pass into breast milk. Make sure your healthcare provider knows about all other medicines, vitamins, and supplements you take before starting treatment.
