Regulatory Affairs

RHAPSIDO^® (remibrutinib)
25 mg Film-coated tablets

National Succinct Statement (NSS)

Version 1.0

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May not be used, divulged, published or otherwise disclosed
without the consent of Novartis

Rhapsido^®

Important note: Before prescribing, consult full prescribing information: https://www.fda.gov/

Disclaimer: This link will contain the most updated product information approved by the reference country.

Presentation:

Film-coated tablets containing 25 mg of remibrutinib.

Indications:

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.

Dosage and administration: 

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).

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.

Contraindications: None 

Warnings and precautions: None

Pregnancy, lactation, females and males of reproductive potential

Pregnancy: The patient should be advised of a potential risk to the fetus if Rhapsido is used during pregnancy or if the patient becomes pregnant while taking remibrutinib. 

Lactation: The patient should be advised to not breast-feed during treatment and for one week after stopping Rhapsido. 

Females of reproductive potential: Sexually active females of reproductive potential should consider using effective contraception (methods that result in less than 1% pregnancy rates) during Rhapsido treatment and for at least 1 week after the last dose.

Adverse drug reactions: 

Upper respiratory tract infections, petechiae, contusion, ecchymosis, epistaxis, purpura, conjunctival bleeding, gingival bleeding

Interactions:

♦Caution is required with strong CYP3A4 inhibitors. ♦Avoid co-administration with strong or moderate CYP3A4 inducers. ♦Caution is required with P-gp and BCRP substrates with narrow therapeutic index. ♦Live or live-attenuated vaccines should not be co-administered.. ♦Consider benefits and risks of co-administration with antithrombotic agents.

Packs and prices: Country-specific.

Legal classification: Country-specific.

Leaflet revision date: September 2025. 

NSS version number: 1.0 

Leaflet presentation: R02.