Important Safety Information

Warnings and Precautions<ul><li>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</li><li>The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO</li></ul>Adverse Reactions<ul><li>The most common adverse reactions (incidence ≥ 3%) were nasopharyngitis, bleeding, headache, nausea, and abdominal pain</li></ul>Drug Interactions<ul><li>Remibrutinib is a CYP3A4 substrate and a P-glycoprotein (P-gp) inhibitor</li><li>Avoid use of RHAPSIDO with strong or moderate CYP3A4 inhibitors. Concomitant use with a strong or moderate CYP3A4 inhibitor increases remibrutinib exposure, which may increase the risk of RHAPSIDO adverse reactions</li><li>Avoid use of RHAPSIDO with strong or moderate CYP3A4 inducers. Concomitant use with a strong or moderate CYP3A4 inducer decreases remibrutinib exposure, which may decrease the efficacy of RHAPSIDO</li><li>Monitor more frequently for adverse reactions when using RHAPSIDO with P-gp substrates where minimal concentration changes may lead to serious adverse reactions (eg, digoxin). Remibrutinib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to P-gp substrates</li><li>No data are available on concomitant use of RHAPSIDO with anticoagulants. The concomitant use of RHAPSIDO and anticoagulants was not allowed in clinical studies. Use of the antiplatelet agents, acetyl salicylic acid at doses up to 100 mg daily or clopidogrel up to 75 mg daily, was allowed in the RHAPSIDO clinical studies</li></ul>Use In Specific Populations<ul><li>There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy</li><li>Avoid use of RHAPSIDO in patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, and C). RHAPSIDO exposure is increased in these patients relative to patients with normal hepatic function</li></ul>Please see full<a href="https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf" target="_blank"> Prescribing Information</a>, including <a href="https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido_ppi.pdf" target="_blank">Patient Information</a>.

RHAPSIDO is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria.

Indication

Warnings and Precautions<ul><li>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</li><li>The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO</li></ul>Please see full<a href="https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf" target="_blank"> Prescribing Information</a>, including <a href="https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido_ppi.pdf" target="_blank">Patient Information</a>.

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