Ruxolitinib Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Myeloproliferative Disorders

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.

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