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Safety Information

JAKAVI® Basic Succinct Statement

Important note: Before prescribing, consult full prescribing information.

Presentation: Tablets containing 5 mg, 10 mg, 15 mg, and 20 mg ruxolitinib.

Indications: Treatment of patients with myelofibrosis (MF), including primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis. Treatment of patients with polycythaemia vera (PV) who are resistant to or intolerant of hydroxyurea.

Dosage and administration: • Perform blood cell count before initiating Jakavi therapy. Monitor complete blood counts every 2 to 4 weeks until optimal dose is reached. • Administration twice daily at the same time every day, with or without food. • Recommended starting dose for adults in MF: 15 mg (platelet count between 100,000 and 200,000/mm3) and 20 mg (platelet count >200,000/mm3) twice daily. • Recommended starting dose for adults in PV: 10 mg twice daily. • Maximum starting dose of 5 mg twice daily in patients with a platelet count <100,000/mm3, caution in this patient population. • Interrupt treatment if platelet counts <50,000/mm3 or ANC <500/mm3 (MF and PV patients) or Hg <8 g/dL (in PV patients). • In PV, dose reduction to be considered if Hg <12 g/dL and recommended if Hg <10 g/dL. • Dose adjustment may be required due to thrombocytopenia or when used with strong CYP3A4 inhibitors or dual moderate inhibitors of CYP2C9 and CYP3A4 enzymes (eg, fluconazole; avoid daily dose of fluconazole >200 mg). • 4 weeks after initiating therapy, dose may be increased at intervals of greater than 2 weeks to ensure adequate response. • Maximum dose is 25 mg twice daily. • Treatment to be continued as long as the benefits outweigh the risks for the patient. • Recommend to reduce the starting dose by approximately 50% in patients with renal impairment (Clcr <30 mL/min) or with hepatic impairment. Monitor patients diagnosed with renal or hepatic impairment and reduce the dose as appropriate. • No dosage adjustment required for elderly patients.

Contraindications: Hypersensitivity to ruxolitinib or to any of the excipients.

Warnings and precautions: • Decrease in blood cell count: Haematologic adverse reactions, including thrombocytopenia, anaemia, and neutropenia have been reported with Jakavi treatment. Complete blood counts monitoring recommended. Dose reduction or interruption may be required in patients developing thrombocytopenia, anaemia, and neutropenia. • Infections: Serious bacterial, mycobacterial, fungal, viral, and other opportunistic infections have occurred in patients treated with Jakavi. Patients should be assessed for the risk of developing serious infections. Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly. Jakavi therapy should not be started until active serious infections have resolved. Tuberculosis cases have been reported. Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations. Progressive multifocal leukencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. If PML suspected, suspend treatment and until PML is excluded. Hepatitis B viral load (HBV-DNA titre) increases have been reported in patients with chronic HBV infections. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. • Non-Melanoma Skin Cancer (NMSC): NMSC, including basal cell, squamous cell, and Merkel cell carcinoma, reported in Jakavi treated patients. Periodic skin examination recommended. • Lipid Abnormalities/Elevations: Increases in lipid parameters, including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides have been associated with Jakavi. Monitoring and treatment of dyslipidemia is recommended. • Hepatic and severe renal impairment: Due to increased Jakavi exposure, dose reduction is required.

Pregnancy, lactation, females and males of reproductive potential: • Pregnancy: Use in pregnancy not recommended. Avoid becoming pregnant during Jakavi therapy. • Breast-feeding: Women taking Jakavi should not breast-feed.

Adverse drug reactions:Very common (>10%): Urinary tract infections, anaemia, thrombocytopenia, neutropenia, hypercholesterolaemia, hypertriglyceridaemia, dizziness, headache, alanine aminotransferase increased, aspartate aminotransferase increased, bruising, weight gain. • Common (1 to 10%): Pneumonia, herpes zoster, flatulence, constipation, hypertension. • Uncommon: Tuberculosis.

Interactions: • Caution with CYP3A4 inhibitors or dual moderate inhibitors of CYP2C9 and CYP3A4 enzymes. Dose reduction recommended when co-administered with strong CYP3A4 inhibitors or dual moderate inhibitors of CYP2C9 and CYP3A4 enzymes. Avoid fluconazole daily doses >200 mg.

Packs and prices: Country specific.

Legal classification: Country specific.

References
BSS, dated May 2017