For adults and pediatric patients 12 years and older
Please note this program is intended for healthcare professiona ls (HCPs) only. This program is sponsored by lncyte 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 emp loyer. 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 lncyte from offering meals
or other refreshme nts to certain HCPs who are licensed in Minnesota and have the ability to prescribe prescription drugs (eg physicians, physician assistants, nurse
practitioners, advance d nurses). If you are licensed to prescribe in Minnesota, please ident ify yourself on this document and inform an lncyte 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 thrombocytopen ia 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 x 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 patientsreceiving 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
- Progress ive 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, myeloprol iferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotens ion, DIC, or multi-organ failure. If any of these occur after discontinuat ion 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 Merke l cell carcinoma have occurred. Perform periodic skin examinations
- Treatment with Jakafi has been associated with increases in total cholestero l, low-density lipoprotein cholesterol, and triglycerides. Assess lipid paramete rs 8-12
weeks after initiating Jakafi . Monitor and treat accordi ng to clinical guidelines for the management of hyperlipidemia
- In myelofibrosis and polycythemia vera, the most common nonhemato logic adverse reactions (incidence <1:5%) were bruising, dizziness, headache , and diarrhea.
In acute graft-versus-host disease, the most common nonhemato logic adverse reactions (incidence >50%) were infections and edema
- Dose modifi cations 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.
Jakafi and the Jakafi logo are registered trademarks of lncyte.
© 2020, lncyte Corporation. MAT-JAK-02420 08/20