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Important Safety Information
Warnings and Precautions
- Risk of Bleeding: Mucocutaneous-related bleeding occurred in 9% of patients who received RHAPSIDO. Interrupt treatment with RHAPSIDO if bleeding is observed and resume if the benefit is expected to outweigh the risk. Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery or invasive procedures. Use of antithrombotic agents concomitantly with RHAPSIDO may further increase the risk of bleeding. Consider the benefits and risks of antithrombotic agents when used with RHAPSIDO. Monitor for signs and symptoms of bleeding
- The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO
Please see full Prescribing Information, including Patient Information.
Indications
RHAPSIDO® (remibrutinib) is indicated for the treatment of chronic spontaneous urticaria (CSU) or symptomatic dermographism (SD) in adult patients who remain symptomatic despite H1 antihistamine treatment.
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