Remibrutinib
RHAPSIDO
What it isAn oral covalent BTK inhibitor for chronic spontaneous urticaria and symptomatic dermographism 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.
Remibrutinib prescription history
Animated chart of estimated U.S. prescriptions per year, Tyrosine kinase inhibitors (2001–2026). Remibrutinib enters in 2025 (estimated).
FDA-approved for
- chronic spontaneous urticaria (2025)
- symptomatic dermographism (2026)
Principal riskBleeding
Classes and tags
Clinical profile
Legacy pregnancy categoryN/A (post-2015 labeling)
Defining liabilityBleeding and perioperative interruption
FDA label
Read the full label on DailyMed ↗
NO BOXED WARNINGS
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic spontaneous urticaria (symptomatic despite H1 antihistamine treatment) | Adults | 25 mg BID | 25 mg BID | 25 mg BID |
| Symptomatic dermographism (symptomatic despite H1 antihistamine treatment) | Adults | 25 mg BID | 25 mg BID | 25 mg BID |
Renal No clinically significant PK difference in mild–severe impairment (eGFR 15-89); no adjustment stated
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 for 3 to 7 days pre- and post-surgery depending on surgery type and bleeding risk
Available strengths
- tab 25 mg
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%)
- Symptomatic dermographism trial (RemIND): safety consistent with CSU
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
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 25 mg | tab | 60 BID | — | $4,347.73 | not offered |
Open Remibrutinib in the interactive console ↗
Self-check
- Remibrutinib: Does it require routine laboratory monitoring?
No. - Remibrutinib: What should happen around surgery?
Interrupt treatment.