Jakavi

Jakavi

ruxolitinib

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ruxolitinib phosphate
Indications/Uses
Disease-related splenomegaly or symptoms in adults w/ primary myelofibrosis (MF) (chronic idiopathic MF), post polycythaemia vera (PV) MF or post essential thrombocythaemia MF. PV in adults who are resistant to or intolerant of hydroxyurea. Acute or chronic graft versus host disease (GvHD) in patients ≥12 yr who have inadequate response to corticosteroids or other systemic therapies.
Dosage/Direction for Use
MF Recommended starting dose: Platelet count >200,000/mm3 20 mg bd, 100,000 to 200,000/mm3 15 mg bd, 75,000 to <100,000/mm3 10 mg bd, 50,000 to <75,000/mm3 5 mg bd. Hepatic & severe renal Reduce dose by approx 50% to be administered bd. ESRD 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 haemodialysis. PV Recommended starting dose: 10 mg bd. Dose reduction should be considered if Hb decreases <12 g/dL & is recommended if it decreases <10 g/dL. Hepatic & severe renal impairment 5 mg bd. ESRD 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. MF & PV May increase doses by max of 5 mg bd, up to max dose of 25 mg bd, if efficacy is considered insufficient & blood counts are adequate. Do not increase starting dose w/in the 1st 4 wk of treatment & thereafter no more frequently than at 2-wk intervals. Acute & chronic GvHD Recommended starting dose: 10 mg bd. Patient w/ thrombocytopenia, neutropenia, or elevated total bilirubin after standard supportive therapy including growth-factors, anti-infective therapies & transfusions; liver involvement & increase of total bilirubin to >3x ULN 1 dose level reduction step is recommended (10 mg bd to 5 mg bd or 5 mg bd to 5 mg once daily). Severe renal impairment 5 mg 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 CBC, including WBC differential count, prior to initiation of therapy & monitor as clinically indicated. Discontinue use in MF patients w/ platelet count <50,000/mm3 or ANC <500/mm3. Risk of developing serious bacterial, mycobacterial, fungal, viral & other opportunistic infections. Screen patient for active & latent TB, & HBV prior to treatment. Seek treatment in early 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 is recommended for patients who are at increased risk for skin cancer. Increases in lipid parameters including total cholesterol, HDL-C, LDL-C, & triglycerides. Lipid monitoring & treatment of dyslipidaemia is recommended. Risk of withdrawal effects. Gradual dose tapering may be considered. Concomitant use w/ strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 & CYP2C9 enzymes (eg, fluconazole); cytoreductive therapies. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment. MF & PV: Childn & adolescents ≤18 yr. GvHD: Paed patient <12 yr.
Adverse Reactions
Anaemia, thrombocytopenia, neutropenia; increased ALT & AST. MF: Bruising, other bleeding (including epistaxis, post-procedural haemorrhage, haematuria), dizziness; hypertriglyceridaemia. PV: Wt gain, dizziness, headache; hypercholesterolaemia. Acute GvHD: Cytomegalovirus infection, sepsis, UTI; hypercholesterolaemia. Chronic GvHD: HTN, headache, UTI; hypercholesterolaemia.
Drug Interactions
Increased Cmax & AUC 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 AUC 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-gp 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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