Ruxolitinib

eMC (Jakavi 10mg Tablets). Treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. A complete blood count including white cell differential must be performed before starting, then every 2 to 4 weeks until doses are stabilised, then as clinically indicated. TITRATION (MF and PV): if efficacy is insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily up to the maximum of 25 mg twice daily; the starting dose should not be increased within the first four weeks and thereafter no more frequently than at 2-week intervals. INTERRUPTION: discontinue for platelet counts less than 50,000/mm3 or absolute neutrophil counts less than 500/mm3; in PV also interrupt when haemoglobin is below 8 g/dl. After recovery above these levels, dosing may restart at 5 mg twice daily and be increased gradually with careful monitoring. THROMBOCYTOPENIA DOSE REDUCTION (new dose by current dose): platelets 100,000 to <125,000/mm3 — 25 mg bd becomes 20 mg bd, 20 mg bd becomes 15 mg bd, others unchanged; platelets 75,000 to <100,000/mm3 — 25, 20 and 15 mg bd all become 10 mg bd, others unchanged; platelets 50,000 to <75,000/mm3 — 25, 20, 15 and 10 mg bd all become 5 mg bd; platelets less than 50,000/mm3 — hold at all dose levels. In PV, dose reduction should also be considered if haemoglobin falls below 12 g/dl and is recommended if it falls below 10 g/dl. GvHD: one dose-level reduction step is recommended (10 mg twice daily to 5 mg twice daily, or 5 mg twice daily to 5 mg once daily); if 5 mg once daily is not tolerated, interrupt treatment. Detailed GvHD reductions are specified for platelets <20,000/mm3 and <15,000/mm3, ANC 500 to <750/mm3 and <500/mm3, and for total bilirubin elevation with and without liver GvHD. PAEDIATRIC GvHD (recorded here because these are age-band and body-surface-area doses, not per-kg, so paedDose is null): 6 years to less than 12 years — 5 mg orally twice daily; 2 years to less than 6 years — 4 mg/m2 orally twice daily. These GvHD starting doses can be given using either the tablet (patients aged 6 years and above who can swallow tablets) or the oral solution (patients under 12 years). Clinician to verify any paediatric use against a children's formulary. SOURCE NOTE: the US label in the fetched bundle was OPZELURA (ruxolitinib topical cream) — a different formulation and route — and was NOT used for this oral haematology page.