Jakavi Dosage/Direction for Use

Monitoring instructions: Blood cell counts: a blood cell count must be performed before initiating therapy with ruxolitinib (Jakavi).
Complete blood counts should be monitored every 2 to 4 weeks until doses are stabilized, and then as clinically indicated (see Precautions).
Starting dose: The recommended starting dose of ruxolitinib (Jakavi) in Myelofibrosis is 15 mg given orally twice daily for patients with a platelet count between 100,000 and 200,000/mm³ and 20 mg twice daily for patients with a platelet count of >200,000/mm³.
The recommended starting dose of ruxolitinib (Jakavi) in Polycythemia vera is 10 mg given orally twice daily.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm³ and 100,000/mm³. The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
Dose modifications: Doses may be titrated based on safety and efficacy. Treatment should be interrupted for platelet counts less than 50,000/mm³ or absolute neutrophil counts less than 500/mm³.
In polycythemia vera, treatment should also be interrupted when hemoglobin is below 8 g/dL.
After recovery of blood counts above these levels, dosing may be restarted at 5 mg twice daily and gradually increased based on careful monitoring of blood cell counts.
Dose reductions should be considered if the platelet counts decrease below 100,000/mm³ with the goal of avoiding dose interruptions for thrombocytopenia. In polycythemia vera, dose reduction should also be considered if hemoglobin decreases below 12 g/dL and is recommended if hemoglobin decreases below 10 g/dL.
If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals.
Administration instruction: The maximum dose of ruxolitinib (Jakavi) is 25 mg twice daily.
If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Treatment may be continued as long as the benefit: risk remains positive.
Dose adjustment with concomitant strong CYP3A4 Inhibitors or fluconazole: When ruxolitinib (Jakavi) is administered with strong CYP3A4 inhibitors or dual moderate inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole), the total daily dose of ruxolitinib (Jakavi) should be reduced by approximately 50% either by decreasing the twice daily dose or by decreasing the frequency of dosing to the corresponding once daily dose when twice daily dosing is not practical. Avoid the concomitant use of ruxolitinib (Jakavi) with fluconazole doses of greater than 200 mg daily (see Interactions).
More frequent monitoring of hematology parameters and clinical signs and symptoms of ruxolitinib (Jakavi) related adverse reactions is recommended upon initiation of a strong CYP3A4 inhibitor or dual moderate inhibitors of CYP2C9 and CYP3A4 enzymes.
Special populations: Renal impairment: In patients with severe renal impairment (creatinine clearance (Clcr) less than 30 mL/min) the recommended starting dose based on platelet count for MF patients should be reduced by approximately 50%. The recommended starting dose for PV patients with severe renal impairment is 5 mg twice daily. Patients diagnosed with severe renal impairment while receiving ruxolitinib (Jakavi) should be carefully monitored and may need to have their doses reduced to avoid adverse drug reactions.
There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on dialysis.
Available data in this population suggest that, MF patients on dialysis, should be started on an initial single dose of 15 mg or 20 mg based on platelet counts with subsequent single doses only after each dialysis session, and with careful monitoring of safety and efficacy.
The recommended starting dose for PV patients with ESRD on hemodialysis is a single dose of 10 mg, to be administered post-dialysis and only on the day of hemodialysis and with careful monitoring of safety and efficacy (see Pharmacology under Actions).
Hepatic impairment: In patients with any hepatic impairment the recommended starting dose based on platelet count should be reduced by approximately 50%. Patients diagnosed with hepatic impairment while receiving ruxolitinib (Jakavi) should be carefully monitored and may need to have their dose reduced to avoid adverse drug reactions.
Pediatrics: Safety and efficacy of ruxolitinib (Jakavi) in pediatric patients have not been established.
Geriatrics: No additional dose adjustments are recommended for elderly patients.
Method of administration: Ruxolitinib (Jakavi) is dosed orally and can be administered with or without food.