What Is Rhapsido, and Why Does It Matter?
Rhapsido (remibrutinib) is a new oral medicine approved to treat adults with chronic spontaneous urticaria (CSU). CSU is a long-term skin condition that causes itchy hives or swelling without a clear cause. It can last for weeks, months, or even years and may affect your sleep, work, and emotional well-being.
Rhapsido works by blocking a protein in your body called Bruton's tyrosine kinase (BTK). This protein helps trigger the release of histamine and other chemicals that cause hives and swelling. By stopping this process, Rhapsido may help reduce your symptoms.
This approval is important because Rhapsido is the first BTK blocker approved for CSU and the only one available as a pill. Until now, if antihistamines didn't work, you likely had to use injectable treatments. Having a pill option may make treatment easier and more comfortable for many people.
Why Was It Approved?
Rhapsido was approved because it helped reduce itching and hives in people with CSU who didn't get enough relief from antihistamines. In studies, people who took Rhapsido showed a significant reduction in hives and itching, compared with those who took a placebo. Some people started feeling better within two weeks. By week 12, about half had their symptoms under control, and around one-third had no hives or itching at all.
The most common side effects were mild and included a stuffy nose, sore throat, bleeding, headaches, nausea, and stomach pain. Bleeding, such as easy bruising or small red spots on the skin, happened more often in people taking Rhapsido than in those taking a placebo. But no serious bleeding was reported.
The studies included adults who had CSU symptoms for at least six weeks even after they used antihistamines. People with liver problems were not part of the studies, and the medicine is not recommended if you have liver issues.
What Do I Need to Know?
You take Rhapsido as a 25 mg tablet twice a day, with or without food. Swallow the tablet whole – don't split, crush, or chew it. If you miss a dose, just skip it and take your next dose at the usual time. Don't take two doses at once.
You shouldn't take Rhapsido if you have liver problems. Also, your health care provider may ask you to stop taking it a few days before and after surgery because of a higher risk of bleeding. If you take blood thinners or plan to get a vaccine – especially a live vaccine – talk to your health care provider first, as these may not be safe to use with Rhapsido.