JAKAFI- ruxolitinib tablet
1. INDICATIONS AND USAGE
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
1.2 Polycythemia Vera
Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
1.3 Acute Graft-Versus-Host Disease
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
1.4 Chronic Graft-Versus-Host Disease
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
2. DOSAGE AND ADMINISTRATION
2.1 Monitoring to Assess Safety
Prior to Jakafi treatment:
- Perform a complete blood count [see Warnings and Precautions (5.1)].
- Inquire about past infections, including tuberculosis, herpes simplex, herpes zoster, and hepatitis B [see Warnings and Precautions (5.2)].
During treatment with Jakafi:
- Perform a complete blood count every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Warnings and Precautions (5.1)].
- Assess lipid parameters approximately 8-12 weeks following initiation of Jakafi therapy [see Warnings and Precautions (5.5)].
2.2 Recommended Dosage for Myelofibrosis
The recommended starting dose of Jakafi is based on platelet count (Table 1). Doses may be titrated based on safety and efficacy.
|Platelet Count||Starting Dose|
|Greater than 200 x 109 /L||20 mg orally twice daily|
|100 x 109 /L to 200 x 109 /L||15 mg orally twice daily|
|50 x 109 /L to less than 100 x 109 /L||5 mg orally twice daily|
Dose Modification Guidelines for Hematologic Toxicity for Patients with Myelofibrosis Starting Treatment with a Platelet Count of 100 x 109 /L or Greater
Treatment Interruption and Restarting Dosing
Interrupt treatment for platelet counts less than 50 x 109 /L or absolute neutrophil count (ANC) less than 0.5 x 109 /L.
After recovery of platelet counts above 50 x 109 /L and ANC above 0.75 x 109 /L, dosing may be restarted. Table 2 illustrates the maximum allowable dose that may be used in restarting Jakafi after a previous interruption.
|Current Platelet Count||Maximum Dose When Restarting Jakafi Treatment *|
|Greater than or equal to 125 x 109 /L||20 mg twice daily|
|100 to less than 125 x 109 /L||15 mg twice daily|
|75 to less than 100 x 109 /L||10 mg twice daily for at least 2 weeks; if stable, may increase to 15 mg twice daily|
|50 to less than 75 x 109 /L||5 mg twice daily for at least 2 weeks; if stable, may increase to 10 mg twice daily|
|Less than 50 x 109 /L||Continue hold|
Following treatment interruption for ANC below 0.5 x 109 /L, after ANC recovers to 0.75 x 109 /L or greater, restart dosing at the higher of 5 mg once daily or 5 mg twice daily below the largest dose in the week prior to the treatment interruption.
Dose Reductions Dose reductions should be considered if the platelet counts decrease as outlined in Table 3 with the goal of avoiding dose interruptions for thrombocytopenia.
|Dose at Time of Platelet Decline|
|Platelet Count||25 mg twicedaily||20 mg twicedaily||15 mg twicedaily||10 mg twicedaily||5 mg twicedaily|
|100 to less than 125 x 109 /L||20 mg twicedaily||15 mg twicedaily||No Change||No Change||No Change|
|75 to less than 100 x 109 /L||10 mg twicedaily||10 mg twicedaily||10 mg twicedaily||NoChange||NoChange|
|50 to less than 75 x 109 /L||5 mg twicedaily||5 mg twicedaily||5 mg twicedaily||5 mg twicedaily||NoChange|
|Less than 50 x 109 /L||Hold||Hold||Hold||Hold||Hold|
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