Miscellaneous immune disorders:
Indications for: REZUROCK
Chronic graft-versus-host disease (GVHD) after failure of ≥2 prior lines of systemic therapy.
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.
<12yrs: not established.
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).
Antagonized by strong CYP3A inducers (eg, rifampin), PPIs (eg, rabeprazole, omeprazole); increase dose (see Adult).
Infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased phosphate, decreased lymphocytes, increased GGT, hypertension; hepatotoxicity.
Generic Drug Availability: