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Prescribing Information

Jakafi™ (ruxolitinib) tablets for oral administration

Full Prescribing Information

Jakafi™ (ruxolitinib)
The First and Only Medication to Treat Intermediate or High-Risk Myelofibrosis

Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis.

About Jakafi

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Access & Support

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INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required
The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
Patients with platelet counts <200 X 109/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered
Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered
Neutropenia (ANC <0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi
Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly
A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy
There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus
Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

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RUX-1057a 05/12