Dose optimisation

The recommended starting dose for JAKAVI® in myelofibrosis is based on a patient’s platelet count at treatment initiation.¹

• 5 mg twice daily for patients with a platelet count between 50,000/mm³ and <75,000/mm³

• 10 mg twice daily for patients with a platelet count between 75,000/mm³ and <100,000/mm³

• 15 mg twice daily for patients with a platelet count between 100,000/mm³ and 200,000/mm³

• 20 mg twice daily for patients with a platelet count of >200,000/mm³

The recommended starting dose of JAKAVI® in polycythaemia vera (PV) is 10 mg given orally twice daily.¹ For more information about JAKAVI® in PV, click here.

Optimise your patients’ response to therapy with dose titration that’s based on efficacy and safety data¹

JAKAVI® treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with JAKAVI®.

For further information, please refer to the SmPC.

No specific dose adjustment is needed in patients with mild or moderate renal impairment.

In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the recommended starting dose based on platelet count for MF patients should be reduced by approximately 50% to be administered twice daily.

There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on haemodialysis. Pharmacokinetic/pharmacodynamic simulations based on available data in this population suggest that the starting dose for MF patients with ESRD on haemodialysis is a single dose of 15-20 mg or two doses of 10 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis. A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm³ and 200,000/mm³. A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of >200,000/mm³. Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session.

In MF patients with any hepatic impairment, the recommended starting dose based on platelet count should be reduced by approximately 50% to be administered twice daily. Subsequent doses should be adjusted based on careful monitoring of safety and efficacy.

If JAKAVI® is to be co-administered with strong CYP3A4 inhibitors in MF and PV patients or dual inhibitors of CYP3A4 and CYP2C9 enzymes (e.g., fluconazole), the unit dose of JAKAVI® should be reduced by approximately 50%, to be administered twice daily (for monitoring frequency, see sections 4.2 and 4.5 of the SmPC).¹

Treatment may continue as long as benefit-risk balance remains positive. After interruption or discontinuation of JAKAVI® dosing, symptoms of myelofibrosis may return over a period of approximately 1 week. Unless abrupt discontinuation is required, gradual tapering of the dose may be considered, although the utility of tapering is unproven. Refer to the full Summary of Product Characteristics for further management guidance.¹

Please refer to the SmPC for full dosing information before prescribing.

UK | November 2024 | FA-11210096