Consider Jakafi^® (ruxolitinib) at the First Sign of Steroid-Refractory Acute GVHD

For adults and pediatric patients 12 years and older under

Program Summary: This promotional presentation, sponsored by lncyte Corporation, will review the unmet needs of adult and pediatric patients 12 years and older with steroid-refractory acute graft-versus-host
disease (GVHD), and use of Jakafi, a targeted JAK1/JAK2 inhibitor, for these patients Data from the REACH1 and REACH2 studies will be reviewed, along with important safety information, and dosing, for Jakafi

Indications and Usage
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

Program Objectives:

• • Review the unmet need of patients with steroid-refractory acute GVHD
  • Describe the definitions for inadequate response to steroids
  • Review the study design, efficacy results, and safety data from REACH1, an open-label, single-arm, phase 2 study
  • Review the study design, efficacy results, and safety data from REACH2, a randomized, open-label, phase 3 study of Jakafi vs control therapy
  • Review the Important Safety Information for Jakafi

Select Safety Information:

Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. In patients with cytopenias, consider dose reductions, temporarily interrupting Jakafi, or transfusions, as clinically indicated.

See the Important Safety Information below for related and other risks.

Please note this program is intended for healthcare professionals (HCPs) only. This program is sponsored by Incyte Corporation and not eligible for CE credits.

Consistent with PhRMA guidelines, spouses and other guests of an HCP are not permitted to attend. The cost of meals associated with this event may be disclosed consistent with applicable federal and state law disclosure requirements. State and federal laws and regulations may restrict state or federal employees from receiving meals. By attending this event, you confirm that you have obtained any necessary approvals from your employer. HCPs may be subject to state law restrictions regarding attendance. HCPs licensed in Vermont or employees/agents of Vermont HCPs may not attend this event. Minnesota law restricts Incyte from offering meals or other refreshments to certain HCPs who are licensed in Minnesota and have the ability to prescribe prescription drugs (eg physicians, physician assistants, nurse practitioners, advanced nurses). If you are licensed to prescribe in Minnesota, please identify yourself on this document and inform an Incyte representative prior to the start of the program.

Important Safety Information

• Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated
• Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary
• Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi
• Severe neutropenia (ANC <0.5 × 10⁹/L) was generally reversible by withholding Jakafi until recovery
• Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines
• Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination
• Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate
• Advise patients about early signs and symptoms of herpes zoster and to seek early treatment
• Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines
• When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation
• Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations
• Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia
• In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections and edema
• Dose modifications may be required when administering Jakafi with strong CYP3A4 inhibitors or fluconazole or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy
• 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 breastfeed during treatment and for 2 weeks after the final dose

Please click here for Full Prescribing Information for Jakafi.

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