Rezurock Generic Name & Formulations
Legal Class
Rx
General Description
Belumosudil 200mg; tabs.
Pharmacological Class
Kinase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Rezurock Indications
Indications
Chronic graft-versus-host disease (GVHD) after failure of ≥2 prior lines of systemic therapy.
Rezurock Dosage and Administration
Adult
Swallow whole. Take with food at the same time each day. 200mg once daily until progression of chronic GVHD that requires new systemic therapy. Concomitant strong CYP3A inducers, PPIs: increase to 200mg twice daily.
Children
<12yrs: not established.
Rezurock Contraindications
Not Applicable
Rezurock Boxed Warnings
Not Applicable
Rezurock Warnings/Precautions
Warnings/Precautions
Monitor LFTs (total bilirubin, AST, ALT) at least monthly. Discontinue permanently if Grade 4 AST/ALT (>20×ULN), Grade ≥3 bilirubin (>3×ULN), or other Grade 4 adverse reactions occur. Withhold if Grade 3 AST/ALT (5–20×ULN), Grade 2 bilirubin (1.5–3×ULN), or other Grade 3 adverse reactions occur until recovery to Grade 0–1; then resume treatment. Pre-existing severe renal or hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for ≥1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Rezurock Pharmacokinetics
See Literature
Rezurock Interactions
Interactions
Antagonized by strong CYP3A inducers (eg, rifampin), PPIs (eg, rabeprazole, omeprazole); increase dose (see Adult).
Rezurock Adverse Reactions
Adverse Reactions
Infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased phosphate, decreased lymphocytes, increased GGT, hypertension; hepatotoxicity.
Rezurock Clinical Trials
See Literature
Rezurock Note
Not Applicable
Rezurock Patient Counseling
See Literature
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