Jakavi Tablet

Ruxolitinib is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Myelofibrosis Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. Polycythemia Vera Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. Acute Graft-Versus-Host Disease Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older. Chronic Graft-Versus-Host Disease Ruxolitinib is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Thrombocytopenia, Anemia, and Neutropenia: Manage by dose reduction or interruption, or transfusion. Risk of Infection: Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with Ruxolitinib. Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with Ruxolitinib. Risk of Non-Melanoma Skin Cancer: Perform periodic skin examinations. Lipid Elevations: Assess lipid levels 8 to 12 weeks from start of therapy and treat as needed. Major Adverse Cardiovascular Events (MACE): Monitor for development of MACE. Thrombosis: Evaluate and treat symptoms of thrombosis promptly. Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers. Thrombocytopenia, Anemia, and Neutropenia Treatment with Ruxolitinib can cause thrombocytopenia, anemia, and neutropenia. Manage thrombocytopenia by reducing the dose or temporarily interrupting Ruxolitinib. Platelet transfusions may be necessary. Patients developing anemia may require blood transfusions and/or dose modifications of Ruxolitinib. Severe neutropenia (ANC less than 0.5 × 10 9 /L) was generally reversible by withholding Ruxolitinib until recovery. Perform a pre-treatment CBC and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Risk of Infection Serious bacterial, mycobacterial, fungal, and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines. Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia Risk of Infection Symptom Exacerbation Following Interruption or Discontinuation of Treatment Non-Melanoma Skin Cancer Lipid Elevations Major Adverse Cardiovascular Events (MACE) Thrombosis Secondary Malignancies In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infections. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Ruxolitinib has been established from adequate and well-controlled studies of Ruxolitinib in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease. Below is a display of the adverse reactions of Ruxolitinib in these adequate and well-controlled studies. Myelofibrosis The safety of Ruxolitinib was assessed in 617 patients in 6 clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with MF in 2 Phase 3 studies. In these 2 Phase 3 studies, patients had a median duration of exposure to Ruxolitinib of 9.5 months (range: 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months. One hundred and eleven patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.