Concise Prescribing Info
Ruxolitinib phosphate
Disease-related splenomegaly or symptoms in adults w/ primary myelofibrosis (chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Polycythaemia vera in adults resistant to or intolerant of hydroxyurea.
Dosage/Direction for Use
Max: 25 mg bd. Myelofibrosis Starting dose: Platelet count >200,000/mm3 20 mg bd, 100,000/mm3 - 200,000/mm3 15 mg bd, 75,000/mm3 - <100,000/mm3 10 mg bd, 50,000/mm3 - <75,000/mm3 5 mg bd. Hepatic & severe renal impairment Reduce dose by approx 50% to be administered bd. ESRD on haemodialysis Initially 15-20 mg single dose or 2 doses of 10 mg given 12 hr apart administered post-dialysis & only on haemodialysis day. Polycythaemia vera Initially 10 mg bd. Severe renal impairment Initially 5 mg bd. ESRD on haemodialysis Initially 10 mg single dose or 2 doses of 5 mg given 12 hr apart administered post-dialysis & only on haemodialysis day. Hepatic impairment Reduce dose by approx 50% to be administered bd.
May be taken with or without food.
Hypersensitivity. Pregnancy & lactation.
Special Precautions
Discontinue use in patients w/ platelet count <50,000/mm3 or absolute neutrophil count <500/mm3. Risk of developing serious bacterial, mycobacterial, fungal, viral & other opportunistic infections. Myelosuppression; herpes zoster; progressive multifocal leukoencephalopathy; non-melanoma skin cancer including basal, squamous & Merkel cell carcinoma. Screen patients for active & latent TB & HBV prior to treatment. Perform complete blood cell count including WBC differential count prior to initiation of therapy & monitor every 2-4 wk & then as clinically indicated. Monitor lipid parameters eg, total, HDL-, LDL-cholesterol & triglycerides. Concomitant use w/ strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 & CYP2C9 eg, fluconazole; cytoreductive therapies. Avoid abrupt discontinuation. Not to be used in galactose intolerance, total lactase deficiency, glucose-galactose malabsorption. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment. Not to be used during lactation. Childn & adolescents up to 18 yr.
Adverse Reactions
UTI, herpes zoster, pneumonia; anaemia, thrombocytopenia, pancytopenia; bleeding eg, intracranial, GI & other bleeding, bruising; hypercholesterolaemia, hypertriglyceridaemia, wt gain; dizziness, headache; elevated lipase, constipation, flatulence; raised ALT & AST; HTN. Neutropenia.
Drug Interactions
Increased Cmax & AUC w/ CYP3A4 inhibitors eg, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole; dual CYP2C9 & CYP3A4 inhibitor eg, fluconazole; mild or moderate CYP3A4 inhibitors eg, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine. Decreased AUC w/ potent CYP3A4 inducers eg, avasimibe, carbamazepine, phenobarb, phenytoin, rifabutin, rifampin (rifampicin), St. John's wort (Hypericum perforatum). Increased systemic exposure of P-gp & BCRP transporters eg, dabigatran etexilate, ciclosporin, rosuvastatin, digoxin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EJ01 - ruxolitinib ; Belongs to the class of Janus-associated kinase (JAK) inhibitors. Used in the treatment of cancer.
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