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Rhapsido
remibrutinib
Adult Dosing .
Dosage forms: TAB: 25 mg
chronic spontaneous urticaria
- [25 mg PO bid]
- Info: depending on bleeding risk, hold tx x3-7 days before and after surgery or invasive procedure; do not cut/crush/chew tab
dermographism, symptomatic
- [25 mg PO bid]
- Info: depending on bleeding risk, hold tx x3-7 days before and after surgery or invasive procedure; do not cut/crush/chew tab
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment
- avoid: tx x3-7 days before and after surgery or procedure
- caution: bleeding risk
Drug Interactions .
Overview
remibrutinib
kinase inhibitor
- CYP3A4 substrate
- P-gp inhibitor, weak
- antiplatelet/anticoagulant effects
- immunomodulatory effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- bleeding
Common Reactions
- nasopharyngitis
- bleeding
- headache
- nausea
- abdominal pain
Safety/Monitoring .
Monitoring Parameters
signs/symptoms of bleeding
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; possible risk of teratogenicity, including fetal external malformations, based on animal data at 141x MRHD; no known risk of fetal harm based on animal data at up to 126x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Pregnancy Exposure Registry at 1-888-669-6682
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for remibrutinib: liver primarily; CYP450: 3A4 substrate
Excretion: for remibrutinib: feces 70% (none unchanged), urine 30% (2.9% unchanged); Half-life: 1-2h
Subclass: Kinase Inhibitors, BTK Inhibitors ; Pruritus/Urticaria, Systemic Nonsteroidal Agents
Mechanism of Action
for remibrutinib: inhibits Bruton tyrosine kinase (BTK), blocking mast cell and basophil degranulation, preventing release of histamine and other pro-inflammatory mediators
Formulary .
No Formulary Selected
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