Remibrutinib

Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes.

• 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.

• None. None.contraindicated

Recommended dosage is 25 mg orally twice daily with or without food. ( 2.1 ) Swallow tablets whole. Do not split, crush, or chew RHAPSIDO. ( 2.1 ) Interrupt RHAPSIDO for 3 to 7 days pre- and post-surgery. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage is 25 mg taken orally twice daily with or without food. Swallow RHAPSIDO tablet whole with water. Do not split, crush, or chew RHAPSIDO. Missed Dose(s) If a dose or doses of RHAPSIDO is missed, skip the missed dose, and take the next dose at its regularly scheduled time. Do not take an extra dose(s) of RHAPSIDO to make up for a missed dose(s). 2.2 Temporary Interruption of RHAPSIDO for Surgery Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding [see Warnings and Precautions (5.1), Adverse Reactions (6.1) and Drug Interactions (7.2)] .

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 [see Adverse Reactions (6.1)] . 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 [see Dosage and Administration (2.2)] . Use of antithrombotic agents concomitantly with RHAPSIDO may further increase the risk of bleeding [see Drug Interactions (7.2)] . 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.

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 the clinical trials of another drug and may not reflect the rates observed in practice. The safety of RHAPSIDO was based on a pooled safety population from two identical clinical trials of 52 weeks duration, REMIX-1 and REMIX-2 [see Clinical Studies (14)] . The pooled safety population consisted of 912 adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and who received RHAPSIDO 25 mg orally twice daily (N=606) or placebo (N=306) for 24 weeks during the double-blind, controlled treatment period of the trial. Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than the placebo group from the pooled safety population (REMIX-1 and REMIX-2) during the 24-week blinded, placebo-controlled treatment period are shown in Table 1.

Mild, Moderate, or Severe Hepatic Impairment: Avoid use of RHAPSIDO. ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy. Pregnant women exposed to RHAPSIDO and healthcare providers are encouraged to contact Novartis Pharmaceuticals Corporation at 1-888-669-6682. Risk Summary Available data on the use of RHAPSIDO during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of remibrutinib to pregnant rabbits during organogenesis at exposures 141-times the human exposure at the maximum recommended human dose (MRHD) of 25 mg twice daily based on area under the curve (AUC) resulted in adverse developmental outcomes including external malformations. No adverse developmental effects were observed with oral administration of remibrutinib to pregnant rats during organogenesis at exposures up to 126-times the human exposure at the MRHD (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

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.

Consider contacting the poison help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

• Sep 30, 2025NDANDA218436Novartis

1. 1Petechiae9417%
2. 2Urticaria8215%
3. 3Contusion6011%
4. 4Drug Ineffective5610.0%
5. 5Pruritus447.8%
6. 6Headache386.8%
7. 7Condition Aggravated315.5%
8. 8Chronic Spontaneous Urticaria305.3%
9. 9Nausea264.6%
10. 10Angioedema213.7%
11. 11Cough203.6%
12. 12Treatment Failure193.4%
13. 13Heavy Menstrual Bleeding183.2%
14. 14Drug Intolerance173.0%
15. 15Off Label Use173.0%

The 10 most recently updated of 32 ClinicalTrials.gov registrations naming Remibrutinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
  Completed · Phase 2 · Interventional · 76 enrolled · Novartis Pharmaceuticals
  NCT05432388updated 2026-06-12
• Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
  Not yet recruiting · Observational · 470 enrolled · Novartis Pharmaceuticals
  NCT07642557updated 2026-06-11
• A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
  Active not recruiting · Phase 3 · Interventional · 362 enrolled · Novartis Pharmaceuticals
  NCT05976243updated 2026-06-08
• A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
  Active not recruiting · Phase 3 · Interventional · 565 enrolled · Novartis Pharmaceuticals
  NCT06840392updated 2026-06-05
• 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
  Recruiting · Phase 3 · Interventional · 100 enrolled · Novartis Pharmaceuticals
  NCT05677451updated 2026-06-05
• A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
  Recruiting · Phase 3 · Interventional · 400 enrolled · Novartis Pharmaceuticals
  NCT06868212updated 2026-06-05
• Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
  Recruiting · Phase 2 · Interventional · 44 enrolled · Novartis Pharmaceuticals
  NCT06865651updated 2026-06-03
• Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
  Active not recruiting · Phase 3 · Interventional · 470 enrolled · Novartis Pharmaceuticals
  NCT06042478updated 2026-06-03
• A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
  Recruiting · Phase 3 · Interventional · 180 enrolled · Novartis Pharmaceuticals
  NCT06744920updated 2026-06-01
• A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
  Recruiting · Phase 3 · Interventional · 1,275 enrolled · Novartis Pharmaceuticals
  NCT07225504updated 2026-06-01

Frequently asked questions

How does Remibrutinib work?

Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes.

What is Remibrutinib used for?

According to FDA labeling, Remibrutinib carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Remibrutinib?

Remibrutinib is classified as Selective immunosuppressants, Kinase Inhibitor, Bruton's Tyrosine Kinase Inhibitors, P-Glycoprotein Inhibitors, Decreased Histamine Release.

What are the brand names for Remibrutinib?

Remibrutinib is marketed under brand names including Rhapsido.

What are the contraindications for Remibrutinib?

Remibrutinib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.