Jakavi

Jakavi

ruxolitinib

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ruxolitinib phosphate
Indications/Uses
Disease related splenomegaly or symptoms in adult w/ primary myelofibrosis (chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Polycythaemia vera in adult patients resistant to or intolerant of hydroxyurea.
Dosage/Direction for Use
Starting dose should not be increased w/in the 1st 4 wk of treatment & thereafter no more frequently than at 2-wk intervals. Max: 25 mg bd. Myelofibrosis Platelet count >200,000/mm3 Recommended starting dose 20 mg bd. Platelet count between 100,000/mm3 & 200,000/mm3 Recommended starting dose 15 mg bd. Platelet count between 50,000/mm3 & <100,000/mm3 Max recommended starting dose 5 mg bd. Titrate cautiously. Severe renal & hepatic impairment Reduce dose by approx 50% to be administered bd. End-stage renal disease on haemodialysis Single dose of 15-20 mg or 2 doses of 10 mg given 12 hr apart, to be administered post-dialysis & only on the day of haemodialyis. Polycythaemia vera Recommended starting dose 10 mg bd. Severe renal impairment Recommended starting dose 5 mg bd. End-stage renal disease on haemodialysis Single dose of 10 mg or 2 doses of 5 mg given 12 hr apart, to be administered post-dialysis & only on the day of haemodialysis. Hepatic impairment Reduce dose by approx 50% to be administered bd.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Pregnancy & lactation.
Special Precautions
Risk of haematological adverse drug reactions, including thrombocytopenia, anaemia, & neutropenia. Perform complete blood cell count, including WBC differential count, prior to initiation of therapy & monitor as clinically indicated. Risk of developing serious bacterial, mycobacterial, fungal & viral infections. Seek treatment as early as possible in case of signs & symptoms of herpes zoster. Reports of progressive multifocal leukoencephalopathy; non-melanoma skin cancers, including basal cell, squamous cell, & Merkel cell carcinoma. Periodic skin exam for patients who are at increased risk for skin cancer. Associated w/ increases in lipid parameters including total cholesterol, HDL cholesterol, LDL cholesterol, & triglycerides. Lipid monitoring & treatment of dyslipidaemia is recommended. Risk of withdrawal effects. Concomitant use w/ strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 & CYP2C9 enzymes (eg, fluconazole); cytoreductive therapies or haematopoietic growth factors. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Renal & hepatic impairment. Childn up to 18 yr.
Adverse Reactions
Anaemia, thrombocytopenia; dizziness; increased AST & ALT, hypercholesterolaemia. Myelofibrosis: Neutropenia, bruising, headache. Polycythaemia vera: Constipation, HTN.
Drug Interactions
Increased conc w/ strong CYP3A4 inhibitors eg, but not limited to 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, but not limited to ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine. Decreased conc w/ CYP3A4 inducers eg, but not limited to avasimibe, carbamazepine, phenobarb, phenytoin, rifabutin, rifampin (rifampicin), St. John's wort. Increased systemic exposure of substrates of P-glycoprotein or other transporters (eg, dabigatran etexilate, ciclosporin, rosuvastatin & potentially 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.
Presentation/Packing
Form
Jakavi tab 5 mg
Packing/Price
56's
Form
Jakavi tab 15 mg
Packing/Price
56's
Form
Jakavi tab 20 mg
Packing/Price
56's
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