Intermediate- or High-Risk Myelofibrosis: For adults, the initial dosage is based on baseline platelet counts: 20 mg twice daily for platelets >200,000/mm³; 15 mg twice daily for 100,000–200,000/mm³; and 5 mg twice daily for 50,000–<100,000/mm³ Polycythemia Vera: For adults with an inadequate response or intolerance to hydroxyurea, the starting dose is 10 mg twice daily Acute Graft-Versus-Host Disease (GVHD): For adults and pediatric patients ≥12 years with corticosteroid-refractory disease, the initial dose is 5 mg twice daily, which can be increased to 10 mg twice daily after 3 days if blood counts remain stable Chronic Graft-Versus-Host Disease (GVHD): For adults and pediatric patients ≥12 years, the initial dose is 10 mg twice daily. (Note: Dosages for all indications require individualized titration based on efficacy and hematologic toxicities

Contraindication: Delay treatment with Jakavi (Ruxolitinib) if there is an active serious infection until the infection is resolved Precaution: Hematologic Toxicity: Jakavi (Ruxolitinib) can cause severe thrombocytopenia, anemia, and neutropenia Infections: Patients are at an increased risk of serious bacterial, mycobacterial, fungal, and viral infections. Reactivation of hepatitis B, herpes simplex/zoster, and occurrences of progressive multifocal leukoencephalopathy (PML) have been reported. Patients should be evaluated for tuberculosis and hepatitis B prior to therapy Cardiovascular & Thromboembolic Events: Increased risk of major adverse cardiovascular events (MACE) and severe thromboembolic events (deep-vein thrombosis, pulmonary embolism). The benefits should be weighed against risks, particularly in smokers or those with cardiovascular risk factors Withdrawal Symptoms: Abrupt discontinuation can lead to a rapid return of disease symptoms, worsening of cytopenias, and a potentially fatal septic shock-like syndrome. Gradual tapering is highly recommended Malignancies: Nonmelanoma skin cancers and lymphomas have been reported; periodic dermatologic exams are recommended Metabolic Effects: Treatment can cause elevations in total cholesterol, LDL-cholesterol, and triglycerides Pregnancy: Jakavi (Ruxolitinib) should be avoided during pregnancy due to evidence of fetal toxicity and decreased fetal weight in animal studies. Effective contraception must be used during treatment. Breastfeeding: It is unknown if Jakavi (Ruxolitinib) is excreted in human milk, but it is present in animal milk. Because of the potential for adverse reactions in the infant, breastfeeding should be discontinued during treatment and for at least 2 weeks after the final dose Renal/Hepatic Impairment: Hepatic Impairment: Jakavi (Ruxolitinib) clearance is reduced in hepatic impairment. The starting dose should generally be reduced by 50% or adjusted downward depending on the specific condition and the patient's baseline platelet count Renal Impairment: Dose reductions are recommended for patients with moderate to severe renal impairment (creatinine clearance 15–59 mL/min) and those with end-stage renal disease (ESRD) on dialysis. For ESRD patients on hemodialysis, the drug should be administered only after the dialysis session on scheduled dialysis days

Jakavi is a medicine that contains the active substance ruxolitinib. Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis. Take as directed by a specialist.

Common/Very Common: Anemia, thrombocytopenia, neutropenia, bruising, dizziness, headache, weight gain, flatulence, abdominal pain, diarrhea, constipation, fatigue, pruritus, cough, dyspnea, edema, arthralgia, hemorrhage, and hypertension. Uncommon/Rare: Hepatitis B reactivation, cardiac death, myocardial infarction, progressive multifocal leukoencephalopathy (PML), secondary malignancies, and severe thromboembolism.

Store at room temperature (20–25°C), with excursions permitted between 15–30°C

Monitoring Requirements: Complete blood counts (CBC) must be monitored before initiation, every 2 to 4 weeks until the dose is stabilized, and then as clinically indicated. Blood lipid concentrations should be checked 8 to 12 weeks after starting therapy. Patient Instructions: Patients should be warned never to abruptly alter or stop their dosage without consulting a physician, as symptoms of their condition will likely return rapidly