# Ruxolitinib ```text DRUG INFORMATION ADULT - Myelofibrosis ( 2.2 ) The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count: • Greater than 200 × 10 9 /L: JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily. • 100 x 10 9 /L to 200 x 10 9 /L: JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily. • 50 x 10 9 /L to less than 100 x 10 9 /L: JAKAFI 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - Polycythemia Vera ( 2.3 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - Acute Graft-Versus-Host Disease ( 2.4 ) The starting dose of JAKAFI is 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 CHILD - Myelofibrosis The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of MF in pediatric patients have not been established. Polycythemia Vera The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of PV in pediatric patients have not been established. Acute Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of steroid-refractory aGVHD has been established for treatment of pediatric patients 12 years and older. Source: US FDA label for ruxolitinib (JAKAFI), section 'pediatric use', retrieved 2026-08-29 - Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below. Myelofibrosis ( 2.2 ) The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count: • Greater than 200 × 10 9 /L: JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily. • 100 x 10 9 /L to 200 x 10 9 /L: JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily. Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - When administered starting at postnatal Day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures (eg, bone mineral content, peripheral quantitative computed tomography, and x-ray analysis) occurred at doses ≥ 5 mg/kg/day. Source: US FDA label for ruxolitinib (JAKAFI), section 'pediatric use', retrieved 2026-08-29 RENAL IMPAIRMENT - Starting dose for patients with cGVHD: Fluconazole doses of less than or equal to 200 mg JAKAFI 5 mg twice daily JAKAFI XR 11 mg once daily Other CYP3A4 inhibitors Monitor blood counts more frequently for toxicity and modify the JAKAFI/JAKAFI XR dosage for adverse reactions if they occur [see Dosage and Administration ( 2.4 , 2.5 )] . Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - Avoid use of JAKAFI/JAKAFI XR in patients with ESRD (CLcr less than 15 mL/min) not requiring dialysis [see Use in Specific Populations ( 8.6 )] . Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - Renal Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 HEPATIC IMPAIRMENT - Starting dose for patients with cGVHD: Fluconazole doses of less than or equal to 200 mg JAKAFI 5 mg twice daily JAKAFI XR 11 mg once daily Other CYP3A4 inhibitors Monitor blood counts more frequently for toxicity and modify the JAKAFI/JAKAFI XR dosage for adverse reactions if they occur [see Dosage and Administration ( 2.4 , 2.5 )] . Source: US FDA label for ruxolitinib (JAKAFI), section 'dosage and administration', retrieved 2026-08-29 - ( 2.7 , 8.6 ) Hepatic Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 - Modify JAKAFI/JAKAFI XR dosage as recommended [see Dosage and Administration ( 2.7 )]. 8.7 Hepatic Impairment Exposure of ruxolitinib increased with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment [see Clinical Pharmacology ( 12.3 )]. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 PREGNANCY - Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data) . Source: US FDA label for ruxolitinib (JAKAFI), section 'pregnancy', retrieved 2026-08-29 - There are no studies with the use of JAKAFI/JAKAFI XR in pregnant women to inform drug-associated risks. Source: US FDA label for ruxolitinib (JAKAFI), section 'pregnancy', retrieved 2026-08-29 - The background risk of major birth defects and miscarriage for the indicated populations is unknown. Source: US FDA label for ruxolitinib (JAKAFI), section 'pregnancy', retrieved 2026-08-29 BREASTFEEDING - ( 2.7 , 8.7 ) Lactation: Advise not to breastfeed. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 - In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 - There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth, and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). 8.2 Lactation Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast-fed child, or the effects on milk production. Source: US FDA label for ruxolitinib (JAKAFI), section 'use in specific populations', retrieved 2026-08-29 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)