Ruxolitinib Dosage

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Myeloproliferative Disorders

Platelet count greater than 200 x 10(9)/L: 20 mg orally twice daily.
Platelet count 100 x 10(9)/L to 200 x 10(9)/L: 15 mg orally twice daily.

Renal Dose Adjustments

CrCl 15 to 59 ml/min and a platelet count between 100 x 10(9)/L and 150 x 10(9)/L: Starting dose: 10 mg orally twice daily.

CrCl 15 to 59 ml/min and a platelet count less than 100 x 10(9)/L, not on dialysis: Not recommended.

Liver Dose Adjustments

Any degree of hepatic impairment and a platelet count between 100 x 10(9)/L and 150 x 10(9)/L: Starting dose: 10 mg orally twice daily.
Platelet count below 100 x 10(9)/L: Not recommended.

Dose Adjustments

If efficacy is considered insufficient and platelet and neutrophil counts are adequate, doses may be increased in 5 mg twice daily increments to a maximum of 25 mg twice daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every 2 weeks. Discontinue treatment after 6 months if there is no spleen size reduction or symptom improvement since initiation of therapy.

Consider dose increases in patients who meet all of the following conditions:
Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50%, or a 35% reduction in spleen volume as measured by CT or MRI; platelet count greater than 125 x 10(9)/L at 4 weeks and platelet count never below 100 x 10(9)/L; ANC levels greater than 0.75 x 10 (9)/L.

If thrombocytopenia occurs, the following dose adjustments are recommended:

If the dose at the time of the platelet decline is 25 mg twice daily: platelet count 100 x 10(9)/L to less than 125 x 10(9)/L: decrease dose to 20 mg twice daily; platelet count 75 x 10(9)/L to less than 100 x 10(9)/L: decrease dose to 10 mg twice daily; platelet count 50 x 10(9)/L to less than 75 x 10(9)/L: decrease dose to 5 mg twice daily.

If the dose at the time of the platelet decline is 20 mg twice daily: platelet count 100 x 10(9)/L to less than 125 x 10(9)/L: decrease dose to 15 mg twice daily; platelet count 75 x 10(9)/L to less than 100 x 10(9)/L: decrease dose to 10 mg twice daily; platelet count 50 x 10 (9)/L to less than 75 x 10(9)/L: decrease dose to 5 mg twice daily.

If the dose at the time of the platelet decline is 15 mg twice daily: platelet count 100 x 10(9)/L to less than 125 x 10(9)/L: no change; platelet count 75 x 10(9)/L to less than 100 x 10(9)/L: decrease dose to 10 mg twice daily; platelet count 50 x 10(9)/L to less than 75 x 10(9)/L: decrease dose to 5 mg twice daily.

If the dose at the time of the platelet decline is 10 mg twice daily: platelet count 75 x 10 (9)/L to less than 125 x 10(9)/L: no change; platelet count 50 x 10(9)/L to less than 75 x 10(9)/L: decrease dose to 5 mg twice daily.

If the dose at the time of the platelet decline is 5 mg twice daily: platelet count 50 x 10(9)/L to less than 125 x 10(9)/L: no change.

Interrupt treatment for platelet counts less than 50 x 10(9)/L.

After recovery of platelet counts above this level, it is recommended to restart ruxolitinib at a dose at least 5 mg twice daily below the dose at interruption. Dosing may be restarted or increased to the following maximum doses after interruption:

Current platelet count 125 x 10(9)/L or greater: 20 mg twice daily
Current platelet count 100 x 10(9)/L to less than 125 x 10(9)/L: 15 mg twice daily
Current platelet count 75 x 10(9)/L to less than 100 x 10(9)/L: 10 mg twice daily for at least 2 weeks; if stable, may increase to 15 mg twice daily.
Current platelet count 50 x 10(9)/L to less than 75 x 10(9)/L: 5 mg twice daily for at least 2 weeks; if stable, may increase to 10 mg twice daily.

When ruxolitinib is administered with strong CYP450 3A4 inhibitors, the recommended starting dose is 10 mg twice daily for patients with a platelet count greater than or equal to 100 x 10(9)/L. Concurrent use of Ruxolitinib with strong CYP450 3A4 inhibitors should be avoided in patients with platelet counts less than 100 x 10(9)/L.

When discontinuing ruxolitinib therapy for reasons other than thrombocytopenia, gradual tapering of the dose of ruxolitinib may be considered, for example by 5 mg twice daily each week.

Precautions

A complete blood count (CBC) and platelet count is recommended prior to initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated, with dosing adjusted as required.

Thrombocytopenia was generally reversible and was usually managed by dose reduction or interruption of ruxolitinib therapy. If clinically indicated, platelet transfusions may be administered.

Patients developing anemia may require blood transfusions. Dose modifications of ruxolitinib for patients developing anemia may also be considered.
Reversal of neutropenia was generally accomplished by temporarily withholding ruxolitinib.

All patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Do not initiate ruxolitinib in patients with active serious infections until they have resolved. Physicians should carefully observe patients receiving ruxolitinib for signs and symptoms of infection and initiate appropriate treatment promptly.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Platelet count greater than 200 x 10(9)/L: 20 mg initially and following each dialysis session.
Platelet count between 100 and 200 x 10(9)/L: 15 mg initially and following each dialysis session.

Hide
(web1)