Remibrutinib
RHAPSIDO
What it isAn oral covalent BTK inhibitor for chronic spontaneous urticaria not controlled by antihistamines.
Why this oneIt is an oral alternative to injectable biologics and requires no routine laboratory monitoring.
What limits itBleeding changes prescribing; interrupt around surgery and weigh antithrombotics. Avoid strong or moderate CYP3A4 inhibitors or inducers.
FDA-approved for
- chronic spontaneous urticaria (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic spontaneous urticaria (symptomatic despite H1 antihistamine treatment) | Adults | 25 mg BID | 25 mg BID | 25 mg BID |
Renal Undefined
Hepatic Avoid use in mild, moderate, or severe hepatic impairment (Child-Pugh A, B, and C) — exposure increased
Instructions
- Swallow tablet whole with water; do not split, crush, or chew
- With or without food
- Missed dose(s): skip; take next dose at regular time; do not double up
- Interrupt treatment for 3-7 days pre- and post-surgery depending on surgery type and bleeding risk
Cautions
- Risk of bleeding (mucocutaneous bleeding 9% vs 2% placebo): monitor for signs/symptoms; interrupt if bleeding occurs and around surgery/invasive procedures; concomitant antithrombotics may further increase risk — weigh benefits/risks
- Avoid live or live-attenuated vaccines during treatment (no data)
Adverse reactions
- Nasopharyngitis (11%)
- Bleeding (9%; most commonly petechiae 4%, contusion 2%; no severe bleeding events)
- Headache (7%)
- Nausea (3%)
- Abdominal pain (3%)
Pregnancy Insufficient human data; rabbit external malformations at exposures 141x MRHD; pregnancy exposure registry available (Novartis 1-888-669-6682)
Lactation No data in human or animal milk; weigh benefits of breastfeeding against maternal need and potential infant risk
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Remibrutinib ballicule
