REMIBRUTINIB Drug Interactions: What You Need to Know

INTERACTIONS Strong or Moderate CYP3A4 Inhibitors: Avoid concomitant use with RHAPSIDO. ( 7.1 ) Strong or Moderate CYP3A4 Inducers: Avoid concomitant use with RHAPSIDO. ( 7.1 ) P-gp Substrates: Exposure increases where minimal concentration changes may lead to serious adverse reactions: Monitor more frequently for adverse reactions when used concomitantly with RHAPSIDO. ( 7.2 )

Antithrombotic

Agents: Consider the risks and benefits of concomitant use of antithrombotic agents with RHAPSIDO. ( 7.2 )

7.1 Effect of Other Drugs on RHAPSIDO Strong or Moderate CYP3A4 Inhibitors Avoid use of RHAPSIDO with strong or moderate CYP3A4 inhibitors. Remibrutinib is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inhibitor increases remibrutinib exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3)]</span> , which may increase the risk of RHAPSIDO adverse reactions. Strong or Moderate CYP3A4 Inducers Avoid use of RHAPSIDO with strong or moderate CYP3A4 inducers. Remibrutinib is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inducer decreases remibrutinib exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3)]</span> , which may decrease the efficacy of RHAPSIDO.

7.2 Effect of RHAPSIDO on Other Drugs P-gp Substrates Monitor more frequently for adverse reactions when using RHAPSIDO with P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin). Remibrutinib is a P-gp inhibitor. Remibrutinib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to P-gp substrates <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3)]</span> .

Antithrombotic Agents

Consider the risks and benefits of concomitant administration of antithrombotic agents with RHAPSIDO [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Adverse Reactions (6.1)] . 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.

None. None. ( 4 )

AND PRECAUTIONS Risk of Bleeding: Monitor for signs and symptoms of bleeding. Interrupt treatment with RHAPSIDO if bleeding is observed or pre- and post-surgery. Concomitant use of antithrombotic agents with RHAPSIDO may further increase risk of bleeding. ( 5.1 )

Live Attenuated

Vaccines: Avoid live or live-attenuated vaccines in patients receiving RHAPSIDO. ( 5.2 )

5.1 Risk of Bleeding In placebo-controlled studies in patients with CSU, mucocutaneous-related bleeding occurred in 9% of patients who received RHAPSIDO <span class="opacity-50 text-xs">[see Adverse Reactions (6.1)]</span> . 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 <span class="opacity-50 text-xs">[see Dosage and Administration (2.2)]</span> . Use of antithrombotic agents concomitantly with RHAPSIDO may further increase the risk of bleeding <span class="opacity-50 text-xs">[see Drug Interactions (7.2)]</span> . Consider the benefits and risks of antithrombotic agents when used concomitantly with RHAPSIDO. Monitor for signs and symptoms of bleeding.

5.2 Live Attenuated Vaccines No data are available on the effects of live or live-attenuated vaccines in patients receiving RHAPSIDO. The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO.