JAKAVI
RUXOLITINIB · by NOVARTIS
Composition
Tab 5 mg/15 mg/20 mg: Ruxolitinib (as phosphate) 5 mg/15 mg/20 mg.
Indications & Dosage
Treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, postpolycythaemia veramyelofibrosis, or post-essential thrombocythaemia myelofibrosis: Adults: Platelets count 50000-100000/mm3: 5 mg twice daily; 100000-200000/mm3: 15 mg twice daily; >200000/ mm3: 20 mg twice daily. Increase according to response and blood counts; starting dose may be increased after 4 wk by max 5 mg twice daily at >2-wk intervals. Max dose 25 mgtwice daily. Discontinue if no response after 6 mth, or if 40% increase in baseline spleen length without sustained symptom improvement. Children: Not recommended.
Contraindications
Active serious infections, Platelets <50000/mm3, ANC <500/mm3.
Precautions
Avoid abrupt withdrawal, Platelets <100000/ mm3. Perform FBC, including white cell differential, before starting treatment, every 2-4 weeks until dose stabilized (every 1-2 weeks for first 6 weeks in hepatic impairment) and as necessary thereafter, hepatic or severe renal impairment, baseline haemoglobin<10g/dl. Monitor for infections and treat promptly; warn patient of symptoms of herpes zoster. Monitor for new or worsening neurological symptoms suggestive of progressive multifocal leukoencephalopathy; discontinue if suspected. Ensure effective contraception in women of childbearing potential.
Interactions
Carbamazepine, phenobarbital, phenytoin, rife-mycin, CYP3A4 inducers, Protease inhibitors, macrolides, azole antifungals and other CYP3A4 inhibitors, Fluconazole and other dual inhibitors of CYP3A4 or P-gp, Cytoreductive therapies, haematopoietic growth factors
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Dizziness, flatulence, headache, hypercholesterolaemia, weight gain, alopecia, bone-marrow suppression, hyperuricaemia, nausea, oral mucositis, progressive multifocal leucoencephalopathy, thromboembolism, tumourlysis syndrome, vomiting, Tuberculosis (rare), Urinary tract infection, herpes zoster, anae-mia, thrombocytopenia, neutropenia, hy-percholesterolaemia