RHAPSIDO

Following administration of remibrutinib 25 mg twice daily, the mean (standard deviation) C max is 57 (27) ng/mL and AUC last is 193 (136) ng*h/mL at steady state. Remibrutinib C max and AUC increase in a dose-proportional manner between 0.4 to 4 times the recommended dosage. Following administration of multiple doses of 25 mg twice daily, C max increases 1.6-fold and AUC 0-4 increases 2.7-fold. No clinically significant differences in remibrutinib pharmacokinetics were observed between healthy ...

The efficacy of RHAPSIDO for chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment was evaluated in two identical, 52-week, multi-center, randomized, double-blind, placebo-controlled clinical trials (REMIX-1 [NCT05030311] and REMIX-2 [NCT05032157]). REMIX-1 and REMIX-2 enrolled a total of 925 adult patients, diagnosed with CSU inadequately controlled despite treatment with H1 antihistamines, as defined by the presence of itch and hives for ≥6 consecutive weeks. All patients were required to have a weekly urticaria activity score (UAS7) ...

The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction (ADR) rates observed in the clinical trials of a drug cannot be directly compared to rates in th...

None. None. ( 4 )

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 RHA...

7 DRUG 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 ) Antithrombot...