CSU, also known as chronic hives with no known external triggers, is a condition characterized by the spontaneous appearance of wheals, angioedema, or both for >6 weeks. Allergy testing is not required for diagnosis. CSU differs from other urticaria subtypes.¹

Learn more about the Unmet Needs in CSU

CSU symptoms may include hives, itch, and angioedema.¹

The pathogenesis of CSU has not been fully elucidated; however, it is believed to be primarily a mast cell–driven disease. CSU may be mediated by IgE and IgG inflammatory pathways.^1,2

No. Angioedema associated with CSU is typically non–life-threatening. It typically resolves without emergency intervention.³

The pathogenesis of CSU has not been fully elucidated; however, it is believed to be primarily a mast cell–driven disease.⁴

RHAPSIDO offers a unique approach to CSU. By inhibiting Bruton's tyrosine kinase (BTK) in mast cells, RHAPSIDO blocks both IgE and IgG pathways, stopping mast cell degranulation and the release of histamine and proinflammatory mediators.^4-6

Explore the MOA

Adult patients with CSU who remain symptomatic despite H1 antihistamines.⁴

To see what characteristics patients may have, visit Patient Profiles

The International (EAACI) Guideline suggests RHAPSIDO as a next-step treatment option after 2 to 4 weeks on antihistamines if CSU symptoms remain inadequately controlled with antihistamines alone.¹

RHAPSIDO is administered orally twice daily with or without food.⁴

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No. Lab monitoring is not required with RHAPSIDO.⁴

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No. RHAPSIDO is an oral Bruton's tyrosine kinase (BTK) inhibitor, not a steroid.^4,7

No. RHAPSIDO is an oral tablet.⁴

No. RHAPSIDO is an oral Bruton's tyrosine kinase (BTK) inhibitor, not an antihistamine.^4,7

Yes. RHAPSIDO was studied concomitantly with antihistamines in the REMIX trials.²

See the full Study Design

RHAPSIDO is indicated for the treatment of CSU in adult patients who remain symptomatic despite H1 antihistamine treatment. RHAPSIDO is not indicated for other forms of urticaria.⁴

RHAPSIDO was approved by the FDA on September 30, 2025, after completing the largest phase 3 clinical trial program for an oral CSU treatment with over 900 adult patients with moderate to severe CSU.^2,4,8-11,*

In REMIX-2, RHAPSIDO (n=297) significantly reduced HSS7 and ISS7 vs placebo (n=153) at week 12 (LS mean CFB in HSS7; –10.47 vs –6.00: P<.001; LS mean CFB in ISS7;  –8.95 vs  –5.72; P<.001).^† Similar results were observed in REMIX-1.^4,12

^*Based on completed trails for CSU as of September 2025.⁴

^†Multiple imputation techniques were implemented for missing data.⁴

See full Efficacy results and Study Design 

In REMIX-1 and REMIX-2, the co-primary end points evaluated absolute change from baseline in HSS7 and ISS7 at week 12.⁴

In REMIX-2, RHAPSIDO (n=297) significantly reduced HSS7 and ISS7 vs placebo (n=153) at week 12 (LS mean CFB in HSS7; –10.47 vs –6.00: P<.001; LS mean CFB in ISS7;  –8.95 vs  –5.72; P<.001).* Similar results were observed in REMIX-1.^4,12

 A secondary end point evaluated the proportion of patients achieving UAS7 ≤6 at week 2.⁴

In REMIX-2, 30% (n=89) of patients achieved well-controlled CSU (UAS ≤6) with RHAPSIDO vs 5.9% (n=9) on placebo at week 2 (P<.001).^4,12,*

See Efficacy results

*Multiple imputation techniques were implemented for missing data.⁴

The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea, and abdominal pain.⁴

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In the REMIX trials, 9% of patients experienced bleeding events which were mucocutaneous-related.⁴ 

• Bleeding occurred in 9% of patients treated with RHAPSIDO compared to 2% in the placebo group during the 24-week controlled treatment period. The most common bleeding events were petechiae (4%) and contusion (2%) in patients treated with RHAPSIDO⁴

• Patients could have experienced more than 1 type of bleeding event. 78% of patients had 1 unique mucocutaneous bleeding event, 20% had 2 events, and 2% had 3 events. None had >3 unique mucocutaneous bleeding event types^13,14

• Mucocutaneous bleeding refers to superficial bleeding localized to skin and mucosal surfaces and may include cutaneous, nasal, ocular, oral, genitourinary or gastrointestinal bleeding^15,16

  
  See more Safety ↗ information

The safety and efficacy of RHAPSIDO in pediatric patients have not been established.⁴

RHAPSIDO is indicated for the treatment of CSU in adult patients who remain symptomatic despite H1 antihistamine treatment. RHAPSIDO is not indicated for other forms of urticaria.⁴

LIMITATIONS: No conclusions or comparisons can be drawn since post hoc or prespecified exploratory analyses were performed at week 1 and weeks 12 and 24, respectively. These analyses were not adjusted for multiplicity. Data after week 24 should be interpreted with caution due to the open-label design and absence of a control group. Week 52 data is a prespecified exploratory analysis and no statistical tests were done.^2,12

Available data on the use of RHAPSIDO during pregnancy were insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.⁴

If a patient becomes pregnant while taking RHAPSIDO, register them in the pregnancy exposure registry for RHAPSIDO by calling 
1-888-669-6682. The purpose of this registry is to collect information about the safety of RHAPSIDO during pregnancy.

No data are available regarding the presence of RHAPSIDO in breast milk, its effects on the breastfed child, or on milk production.⁴

Patients can receive non-live vaccines (eg, annual flu vaccine), but use of live or live-attenuated vaccines should be avoided.⁴

See the full Prescribing Information

Patients with cirrhosis (ie, Child-Pugh hepatic impairment Class A, B, and C) should avoid use of RHAPSIDO, as exposure is increased.^4,12

See the full Prescribing Information

Yes. Avoid use of RHAPSIDO with strong or moderate CYP3A4 inhibitors. RHAPSIDO is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inhibitor increases RHAPSIDO exposure, which may increase the risk of RHAPSIDO adverse reactions.⁴

Avoid use of RHAPSIDO with strong or moderate CYP3A4 inducers. RHAPSIDO is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inducer decreases RHAPSIDO exposure, which may decrease the efficacy of RHAPSIDO.⁴

See the full Prescribing Information

You get your patients started on RHAPSIDO by:

• Submitting the Start Form electronically via https://www.covermymeds.health/ ↗

• Faxing the Start Form to the Novartis Patient Support Center (866-433-2300)

• Sending a prescription to any Specialty Pharmacy

Novartis has contracted with select specialty pharmacies that may be able to provide you and your patient with additional services.

Access the Start Form here

Yes. Novartis Patient Support is a program designed to help your eligible patients start, stay, and save on RHAPSIDO. This program helps patients navigate the insurance process, including benefits verification and support with the prior authorization and appeals processes.

Learn more about Novartis Patient Support

Novartis offers 2 financial support programs for eligible patients with private insurance: a $0 Co-Pay Plus Offer and a Bridge Program that provides up to 12 months of RHAPSIDO at no cost.*

$0 Co-Pay Plus Offer
Reduces out-of-pocket co-pay costs for eligible patients with private insurance and a valid RHAPSIDO prescription.

Bridge Program
Eligible patients whose insurance coverage is delayed or denied can receive up to 12 months of free RHAPSIDO while health plan coverage is being pursued.

To qualify for either program, patients must have:

• Private insurance

• A valid prescription for RHAPSIDO

• Meet additional program terms

Once coverage status is confirmed, Novartis will help connect your patient to the appropriate financial support offering.

For financial support, visit Novartis Patient Support or call 87-RHAPSIDO (877-427-7436)

*Limitations apply. Subject to annual co-pay benefit limit. Not valid under Medicare, Medicaid, or any other federal or state health insurance program. Patients with private insurance and a prior authorization requirement or an initial denial of coverage may receive up to 12 months of free product while coverage is pursued. Novartis reserves the right to rescind, revoke, or amend this program without notice. Additional limitations may apply. See complete Terms & Conditions at rhapsido.com.