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Ruxolitinib Dosage

Medically reviewed on May 23, 2016.

Applies to the following strengths: 5 mg; 10 mg; 15 mg; 20 mg; 25 mg

Usual Adult Dose for Myeloproliferative Disorder

Initial Dose:
-Platelets greater than 200 x 10(9)/L: 20 mg orally twice a day
-Platelets 100 to 200 x 10(9)/L: 15 mg orally twice a day
-Platelets 50 to less than 100 x 10(9)/L: 5 mg orally twice a day

Maximum dose:
-Starting platelets 100 x 10(9)/L or greater: 25 mg twice a day
-Starting platelets 50 to less than 100 x 10(9)/L: 10 mg twice a day

Duration of therapy: 6 months if no spleen reduction or symptom improvement

Comments:
-Doses may be titrated based on safety and efficacy.
-If efficacy is considered insufficient and platelet and neutrophil counts are adequate, doses may be increased by a maximum of 5 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.

Uses: Intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis

Renal Dose Adjustments

Moderate renal impairment (CrCl 30-59 mL/min):
-Platelets 100 to 150 x 10(9)/L: Initial dose: 10 mg twice a day
-Platelets less than 100 x 10(9)/L: Not recommended
Severe renal impairment (CrCl 15-29 mL/min):
-Platelets 100 to 150 x 10(9)/L: Initial dose: 10 mg twice a day
-Platelets less than 100 x 10(9)/L: Not recommended
End-stage renal disease (CrCl less than 15 mL/min) not on dialysis: Not recommended

Liver Dose Adjustments

Hepatic impairment:
-Platelets 100 to 150 x 10(9)/L: Initial dose: 10 mg twice a day
-Platelets less than 100 x 10(9)/L: Not recommended

Dose Adjustments

For patients with pre-treatment platelets 50 to less than 100 x 10(9)/L, consult the most current therapeutic guidelines and/or the manufacturer product information for dosing recommendations.

Platelets:
Platelet decline at 25 mg twice a day:
-100 to less than 125 x 10(9)/L: 20 mg twice a day
-75 to less than 100 x 10(9)/L: 10 mg twice a day
-50 to less than 75 x 10(9)/L: 5 mg twice a day
-Less than 50 x 10(9)/L: Hold

Platelet decline at 20 mg twice a day:
-100 to less than 125 x 10(9)/L: 15 mg twice a day
-75 to less than 100 x 10(9)/L: 10 mg twice a day
-50 to less than 75 x 10(9)/L: 5 mg twice a day
-Less than 50 x 10(9)/L: Hold

Platelet decline at 15 mg twice a day:
-100 to less than 125 x 10(9)/L: no change
-75 to less than 100 x 10(9)/L: 10 mg twice a day
-50 to less than 75 x 10(9)/L: 5 mg twice a day
-Less than 50 x 10(9)/L: Hold

Platelet decline at 10 mg twice a day:
-75 x 10 (9)/L to less than 125 x 10(9)/L: no change
-50 x 10(9)/L to less than 75 x 10(9)/L: 5 mg twice a day
-Less than 50 x 10(9)/L: Hold

Platelet decline at 5 mg twice a day:
-50 to less than 125 x 10(9)/L: no change
-Less than 50 x 10(9)/L: Hold

Initial restarting doses after interruption:
-At least 5 mg twice a day below the dose at interruption

Maximum restarting doses after interruption:
-Current platelets 125 x 10(9)/L or greater: 20 mg twice a day
-Current platelets 100 to less than 125 x 10(9)/L: 15 mg twice a day
-Current platelets 75 to less than 100 x 10(9)/L: 10 mg twice a day for at least 2 weeks; if stable, may increase to 15 mg twice a day
-Current platelets 50 to less than 75 x 10(9)/L: 5 mg twice a day for at least 2 weeks; if stable, may increase to 10 mg twice a day

Neutrophils:
Absolute neutrophil count (ANC) less than 0.5 x 10(9)/L:
-Interrupt treatment
-After recovery to 0.75 x 10(9)/L or greater, restart at the higher of 5 mg once a day or 5 mg twice a day below the largest dose in the week prior to interruption.

Bleeding:
Bleeding requiring intervention:
-Interrupt treatment
-If the underlying cause has been controlled, consider resuming at prior dose; if the underlying cause persists, consider resuming at a lower dose.

Therapeutic Response:
General:
-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.
-Discontinue treatment after 6 months if there is no spleen size reduction or symptom improvement since initiation of therapy.

Drug Interactions:
Dose Modifications for Use with Strong CYP450 3A4 Inhibitors:
Initial dose:
-Platelets 100 x 10(9)/L or greater: 10 mg twice a day
-Platelets 50 to less than 100 x 10(9)/L: 5 mg once a day
Maintenance dose:
-At 10 mg twice a day or more: 50% reduction
-At 5 mg twice a day: 5 mg once a day
-At 5 mg once a day: Avoid inhibitor or interrupt ruxolitinib for duration of inhibitor use

Other:
When discontinuing therapy for reasons other than thrombocytopenia or neutropenia, gradual tapering of the dose may be considered (e.g., by 5 mg twice a day each week).

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:
-Platelets greater than 200 x 10(9)/L: Initial dose: 20 mg once after a dialysis session; subsequent doses should be administered on dialysis days following each dialysis session
-Platelets 100 to 200 x 10(9)/L: Initial dose: 15 mg once after a dialysis session; subsequent doses should be administered on dialysis days following each dialysis session

Peritoneal Dialysis: Data not available

Other Comments

Administration advice:
-May be administered without regard to meals.
-For a missed dose, the patient should not take an additional dose, but should take the next usual scheduled dose.

Reconstitution/preparation techniques:
-May be administered through a nasogastric tube (manufacturer product information should be consulted).

Monitoring:
-Full blood cell counts, prior to initiating therapy and every 2 to 4 weeks until doses are stabilized, then as clinically warranted

Patient advice:
-Ruxolitinib may cause dizziness. Patients should avoid driving or operating machinery if they report dizziness.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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