Indications for JAKAFI:

Treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.

Adult Dose for JAKAFI:

Doses may be given by NG tube if unable to swallow tabs. Platelets >200X10⁹/L: initially 20mg twice daily. Platelets 100–200X10⁹/L: initially 15mg twice daily. Platelets 50–<100X10⁹/L: initially 5mg twice daily. May increase doses by 5mg twice daily to a max of 25mg twice daily; do not increase during the first 4wks of therapy and not more frequently than every 2wks. Discontinue treatment after 6mos if no reduction in spleen size or symptom improvement. Interrupt treatment if platelets <50X10⁹/L. May restart after recovery of platelets (see full labeling for max allowable restarting doses). Consider dose reductions if platelets decrease but remain ≥50X10⁹/L (see full labeling). Dose modifications for patients starting treatment with platelets 50–<100X10⁹/L: see full labeling. Concomitant strong CYP3A4 inhibitors: initially 10mg twice daily if platelets ≥100X10⁹/L; if platelets <100X10⁹/L: avoid. Moderate or severe renal impairment (CrCl 15–59mL/min) and platelets between 100–150X10⁹/L: initially 10mg twice daily. ESRD (CrCl <15mL/min) on dialysis with platelets between 100–200X10⁹/L: 15mg after dialysis session; if with platelets >200X10⁹/L: 20mg after dialysis session. ESRD not requiring dialysis, moderate or severe renal impairment with platelets <100X10⁹/L: avoid. Hepatic impairment with platelets between 100–150X10⁹/L: initially 10mg twice daily; if platelets <100X10⁹/L: avoid.

Children's Dose for JAKAFI:

Not established.

Pharmacological Class:

Kinase inhibitor.

Warnings/Precautions:

Monitor for thrombocytopenia, anemia, neutropenia; withhold or reduce dose if occur. Obtain CBC and platelets before initiating therapy, every 2–4 weeks until doses are stabilized, and then as clinically indicated. Risk of serious bacterial, mycobacterial, fungal, and viral infections; eva luate and treat if signs/symptoms occur. Confirm resolution of active infections before starting. Renal or hepatic impairment. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) and mild or moderate CYP3A4 inhibitors (eg, erythromycin). Antagonized by CYP3A4 inducers (eg, rifampin).

Adverse Reactions:

Thrombocytopenia, anemia, neutropenia, bruising, dizziness, headache, UTIs, weight gain, flatulence, progressive multifocal leukoencephalopathy (discontinue if occurs), herpes zoster.

How Supplied:

Tabs—60