What Is Rhapsido and Why Does It Matter?
The FDA approved Rhapsido (remibrutinib) for adults with a condition called symptomatic dermographism. People with this condition get severe itchiness and raised hives when their skin is rubbed, scratched, or pressed upon. Rhapsido can be prescribed when common allergy medicines, called H1 antihistamines, do not stop the symptoms.
Rhapsido is a prescription pill that works inside your immune cells. It blocks a specific protein called Bruton's tyrosine kinase, or BTK. By blocking this protein, the drug stops your body from releasing histamine and other natural chemicals that cause skin swelling, redness, and itching.
Why Was It Approved?
The FDA approval was based on a clinical trial that included 115 adults with symptomatic dermographism whose symptoms were not controlled by H1 antihistamines. Researchers split the patients into two groups. One group took Rhapsido, and the other group took a dummy pill called a placebo.
At 12 weeks, twice as many people taking Rhapsido had their hives completely clear up compared to those taking the placebo (29.3% versus 14%). People taking Rhapsido also felt relief from itching as early as two weeks into treatment.
The safety of Rhapsido in this study was similar to what was seen in earlier trials for chronic hives. The most common side effects reported by patients were nasal congestion, runny nose, sore throat, bleeding, headache, nausea, and stomach pain.
What Do I Need to Know?
Rhapsido comes as a tablet that you swallow whole with water twice a day. You can take it with or without food. Do not crush, chew, or split the tablets.
Before starting Rhapsido, tell your healthcare provider about all of your medical conditions. This medication can increase your risk of bleeding, so let your healthcare provider know if you take blood thinners or if you have a planned surgery. Your healthcare provider may ask you to stop taking Rhapsido for three to seven days before and after a medical procedure.
You should not receive live or live-attenuated vaccines while taking Rhapsido. In addition, Rhapsido is not recommended for people with liver problems, and it can interact with certain other prescription medicines or supplements.
Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. They can help you decide on the safest plan for you and your baby while managing your symptoms.