Jakafi

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below. Myelofibrosis ( 2.2 ) The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count:
• Greater than 200 × 10 9 /L:
• JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily.
• 100 x 10 9 /L to 200 x 10 9 /L:
• JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily.
• 50 x 10 9 /L to less than 100 x 10 9 /L:
• JAKAFI 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Polycythemia Vera ( 2.3 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. Acute Graft-Versus-Host Disease ( 2.4 ) The starting dose of JAKAFI is 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily. Chronic Graft-Versus-Host Disease ( 2.5 ) The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily. 2.1 Monitoring to Assess Safety Prior to JAKAFI/JAKAFI XR treatment:
• Perform a complete blood count (CBC) [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/JAKAFI XR :
• Perform a CBC 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 to 12 weeks following initiation of JAKAFI/JAKAFI XR therapy [see Warnings and Precautions ( 5.5 )] . 2.2 Recommended Dosage for Myelofibrosis The recommended starting dose of JAKAFI/JAKAFI XR is based on platelet count (Table 1). Doses may be titrated based on safety and efficacy. Table 1:
• JAKAFI/JAKAFI XR Starting Doses for Myelofibrosis Platelet Count JAKAFI Starting Dose JAKAFI XR Starting Dose Greater than 200 x 10 9 /L 20 mg orally twice daily 44 mg orally once daily 100 x 10 9 /L to 200 x 10 9 /L 15 mg orally twice daily 33 mg orally once daily 50 x 10 9 /L to less than 100 x 10 9 /L 5 mg orally twice daily 11 mg orally once daily Dose Modification Guidelines for Hematologic Toxicity for Patients With Myelofibrosis Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose Reductions JAKAFI dose reductions should be considered if the platelet counts decrease as outlined in Table 2 with the goal of avoiding dose interruptions for thrombocytopenia. Table 2:
• Myelofibrosis:
• JAKAFI Dosing Recommendations for Thrombocytopenia for Patients Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose at Time of Platelet Decline Platelet Count 25 mg Twice Daily 20 mg Twice Daily 15 mg Twice Daily 10 mg Twice Daily 5 mg Twice Daily New Dose New Dose New Dose New Dose New Dose 100 to less than 125 x 10 9 /L 20 mg twice daily 15 mg twice daily No change No change No change 75 to less than 100 x 10 9 /L 10 mg twice daily 10 mg twice daily 10 mg twice daily No change No change 50 to less than 75 x 10 9 /L 5 mg twice daily 5 mg twice daily 5 mg twice daily 5 mg twice daily No change Less than 50 x 10 9 /L Hold Hold Hold Hold Hold JAKAFI XR dose reductions should be considered if the platelet counts decrease as outlined in Table 3, with the goal of avoiding dose interruptions for thrombocytopenia. Table 3:
• Myelofibrosis:
• JAKAFI XR Dosing Recommendations for Thrombocytopenia for Patients Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Dose at Time of Platelet Decline Platelet Count 55 mg Once Daily 44 mg Once Daily 33 mg Once Daily 22 mg Once Daily 11 mg Once Daily New Dose New Dose New Dose New Dose New Dose 100 to less than 125 x 10 9 /L 44 mg once daily 33 mg once daily No change No change No change 75 to less than 100 x 10 9 /L 22 mg once daily 22 mg once daily 22 mg once daily No change No change 50 to less than 75 x 10 9 /L 11 mg once daily 11 mg once daily 11 mg once daily 11 mg once daily No change Less than 50 x 10 9 /L Hold Hold Hold Hold Hold Treatment Interruption and Restarting Dosing Interrupt treatment for platelet counts less than 50 x 10 9 /L or absolute neutrophil count (ANC) less than 0.5 x 10 9 /L. After recovery of platelet counts above 50 × 10 9 /L and ANC above 0.75 × 10 9 /L, dosing may be restarted. When restarting JAKAFI, begin with a dose that is at least 5 mg twice daily below the dose at interruption. When restarting JAKAFI XR, begin with a dose that is at least 11 mg once daily below the dose at interruption. The maximum allowable dose that may be used in restarting JAKAFI/JAKAFI XR after a previous interruption is outlined in Table 4 for thrombocytopenia and in Table 5 for neutropenia. Table 4:
• Myelofibrosis:
• Maximum Restarting Doses for JAKAFI/JAKAFI XR After Safety Interruption for Thrombocytopenia for Patients Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater Current Platelet Count Maximum Dose When Restarting JAKAFI Treatment Maximum Dose When Restarting JAKAFI XR Treatment Greater than or equal to 125 x 10 9 /L 20 mg twice daily 44 mg once daily 100 to less than 125 x 10 9 /L 15 mg twice daily 33 mg once daily 75 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 22 mg once daily for at least 2 weeks; if stable, may increase to 33 mg once daily 50 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 11 mg once daily for at least 2 weeks; if stable, may increase to 22 mg once daily Less than 50 x 10 9 /L Continue hold Table 5:
• Myelofibrosis:
• Maximum Restarting Doses for JAKAFI/JAKAFI XR After Safety Interruption for Neutropenia (ANC < 0.5 x 10 9 /L) Current Neutrophil Count Maximum Dose When Restarting JAKAFI Treatment Maximum Dose When Restarting JAKAFI XR Treatment ANC ≥ 0.75 x 10 9 /L For patients on 5 mg twice daily prior to interruption, restart at 5 mg once daily OR For patients with dose greater than 5 mg twice daily prior to interruption, restart at 5 mg twice daily below the largest dose in the week prior to interruption For patients on 11 mg once daily prior to the first interruption, restart at 11 mg once daily. Discontinue for a second interruption OR For patients with dose greater than 11 mg once daily prior to interruption, restart at 11 mg once daily below the largest dose in the week prior to interruption Dose Modification Based on Insufficient Response for Patients With Myelofibrosis Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater If the response is insufficient and platelet and neutrophil counts are adequate, JAKAFI doses may be increased in 5 mg twice daily increments to a maximum of 25 mg twice daily. JAKAFI XR doses may be increased in 11 mg once daily increments to a maximum of 55 mg once daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every 2 weeks. 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 computed tomography (CT) or magnetic resonance imaging (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. Based on limited clinical data, long-term maintenance at a JAKAFI 5 mg twice daily dose has not shown responses and continued use at this dose should be limited to patients in whom the benefits outweigh the potential risks. Discontinue JAKAFI/JAKAFI XR if there is no spleen size reduction or symptom improvement after 6 months of therapy. Dose Modifications for Hematologic Toxicity for Patients With Myelofibrosis Starting Treatment With Platelet Counts of 50 × 10 9 /L to Less Than 100 × 10 9 /L This section applies only to patients with platelet counts of 50 × 10 9 /L to less than 100 × 10 9 /L prior to any treatment with JAKAFI/JAKAFI XR. See dose modifications in Section 2.2 ( Dose Modification Guidelines for Hematologic Toxicity for Patients With Myelofibrosis Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater ) for hematological toxicity in patients whose platelet counts were 100 × 10 9 /L or more prior to starting treatment with JAKAFI/JAKAFI XR. Dose Reductions Reduce the dose of JAKAFI/JAKAFI XR for platelet counts less than 35 x 10 9 /L as described in Table 6. Table 6:
• Myelofibrosis:
• Dosing Modifications for Thrombocytopenia for Patients With Starting Platelet Count of 50 × 10 9 /L to Less Than 100 × 10 9 /L Platelet Count JAKAFI Dosing Recommendations JAKAFI XR Dosing Recommendations 25 × 10 9 /L to less than 35 × 10 9 /L AND the platelet count decline is 20% or greater during the prior 4 weeks For patients with dose greater than 5 mg twice daily, reduce the dose by 5 mg twice daily. For patients on 5 mg twice daily, reduce the dose to 5 mg once daily. For patients on 5 mg once daily, maintain dose at 5 mg once daily. Reduce dose by 11 mg once daily. For patients on 11 mg once daily, interrupt dosing. 25 × 10 9 /L to less than 35 × 10 9 /L AND the platelet count decline is less than 20% during the prior 4 weeks Less than 25 × 10 9 /L Interrupt dosing. Treatment Interruption and Restarting Dosing Interrupt treatment for platelet counts less than 25 x 10 9 /L or ANC less than 0.5 x 10 9 /L. After recovery of platelet counts above 35 × 10 9 /L and ANC above 0.75 × 10 9 /L, dosing may be restarted. For patients on a dose higher than 5 mg twice daily, when restarting JAKAFI, begin with a dose that is at least 5 mg twice daily below the largest dose in the week prior to interruption. For patients on JAKAFI 5 mg twice daily in the week prior to interruption, when restarting, reduce the dose to 5 mg once daily. When restarting JAKAFI XR, begin with a dose that is at least 11 mg once daily below the largest dose in the week prior to the treatment interruption. For patients on JAKAFI XR 11 mg once daily prior to the first interruption, continue JAKAFI XR 11 mg once daily. Discontinue JAKAFI XR for a second interruption. Dose Modifications Based on Insufficient Response for Patients With Myelofibrosis and Starting Platelet Count of 50 x 10 9 /L to Less Than 100 x 10 9 /L Do not increase doses during the first 4 weeks of therapy, and do not increase the dose more frequently than every 2 weeks. If the response is insufficient as defined in Section 2.2 (see Dose Modification Based on Insufficient Response for Patients With Myelofibrosis Starting Treatment With a Platelet Count of 100 × 10 9 /L or Greater ) , doses may be increased from JAKAFI 5 mg once daily to JAKAFI 5 mg twice daily, or from JAKAFI 5 mg twice daily to a maximum of 10 mg twice daily, if the following conditions are met. For patients on JAKAFI XR 11 mg once daily, dose may be increased to a maximum of 22 mg once daily if:
• the platelet count has remained at least 40 x 10 9 /L, and the platelet count has not fallen by more than 20% in the prior 4 weeks, and the ANC is more than 1 x 10 9 /L, and the dose has not been reduced or interrupted for an adverse event or hematological toxicity in the prior 4 weeks. Continuation of treatment for more than 6 months should be limited to patients in whom the benefits outweigh the potential risks. Discontinue JAKAFI/JAKAFI XR if there is no spleen size reduction or symptom improvement after 6 months of therapy. Dose Modification for Bleeding Interrupt treatment for bleeding requiring intervention regardless of current platelet count. Once the bleeding event has resolved, consider resuming treatment at the prior dose if the underlying cause of bleeding has been controlled. If the bleeding event has resolved but the underlying cause persists, consider resuming treatment with JAKAFI/JAKAFI XR at a lower dose. 2.3 Recommended Dosage for Polycythemia Vera The recommended starting dose of JAKAFI is 10 mg orally twice daily. The recommended starting dose of JAKAFI XR is 22 mg orally once daily. Doses may be titrated based on safety and efficacy. Dose Modification Guidelines for Patients With Polycythemia Vera Dose Reductions Dose reductions should be considered for hemoglobin and platelet count decreases as described in Table 7. Table 7:
• Polycythemia Vera:
• Dose Reductions Hemoglobin and/or Platelet Count JAKAFI Dosing Recommendations JAKAFI XR Dosing Recommendations Hemoglobin 10 to less than 12 g/dL AND platelet count 75 to less than 100 x 10 9 /L Dose reductions should be considered with the goal of avoiding dose interruptions for anemia and thrombocytopenia. Hemoglobin 8 to less than 10 g/dL OR platelet count 50 to less than 75 x 10 9 /L Reduce dose by 5 mg twice daily. For patients on 5 mg twice daily, reduce the dose to 5 mg once daily. Reduce dose by 11 mg once daily. For patients on 11 mg once daily, interrupt dosing. Hemoglobin less than 8 g/dL OR platelet count less than 50 x 10 9 /L Interrupt dosing. Treatment Interruption and Restarting Dosing Interrupt treatment for hemoglobin less than 8 g/dL, platelet counts less than 50 x 10 9 /L or ANC less than 1 x 10 9 /L. After recovery of the hematologic parameter(s) to acceptable levels, dosing may be restarted. Table 8 illustrates the dose that may be used in restarting JAKAFI/JAKAFI XR after a previous interruption. Table 8:
• Polycythemia Vera:
• Restarting Doses for JAKAFI/JAKAFI XR After Safety Interruption for Hematologic Parameter(s) Use the most severe category of a patient’s hemoglobin, platelet count, or ANC abnormality to determine the corresponding maximum restarting dose. Hemoglobin, Platelet Count, or ANC JAKAFI Maximum Restarting Dose JAKAFI XR Maximum Restarting Dose Hemoglobin less than 8 g/dL OR platelet count less than 50 x 10 9 /L OR ANC less than 1 x 10 9 /L Continue hold Hemoglobin 8 to less than 10 g/dL OR platelet count 50 to less than 75 x 10 9 /L OR ANC 1 to less than 1.5 x 10 9 /L 5 mg twice daily Continue JAKAFI treatment for at least 2 weeks; if stable, may increase dose by 5 mg twice daily. or no more than 5 mg twice daily less than the dose which resulted in dose interruption 11 mg once daily Continue JAKAFI XR treatment for at least 2 weeks; if stable, may increase dose by 11 mg once daily. or no more than 11 mg once daily less than the dose which resulted in dose interruption Hemoglobin 10 to less than 12 g/dL OR platelet count 75 to less than 100 x 10 9 /L OR ANC 1.5 to less than 2 x 10 9 /L 10 mg twice daily or no more than 5 mg twice daily less than the dose which resulted in dose interruption 22 mg once daily or no more than 11 mg once daily less than the dose which resulted in dose interruption Hemoglobin greater than or equal to 12 g/dL OR platelet count greater than or equal to 100 x 10 9 /L OR ANC greater than or equal to 2 x 10 9 /L 15 mg twice daily or no more than 5 mg twice daily less than the dose which resulted in dose interruption 33 mg once daily or no more than 11 mg once daily less than the dose which resulted in dose interruption JAKAFI Patients who had required dose interruption while receiving a dose of 5 mg twice daily, may restart JAKAFI at a dose of 5 mg twice daily or 5 mg once daily, but not higher, once hemoglobin is greater than or equal to 10 g/dL, platelet count is greater than or equal to 75 × 10 9 /L, and ANC is greater than or equal to 1.5 × 10 9 /L. JAKAFI XR Patients who had required dose interruption while receiving a dose of 11 mg once daily, may restart JAKAFI XR at a dose of 11 mg once daily, but not higher, once hemoglobin is greater than or equal to 10 g/dL, platelet count is greater than or equal to 75 × 10 9 /L, and ANC is greater than or equal to 1.5 × 10 9 /L. Dose Management After Restarting Treatment After restarting JAKAFI/JAKAFI XR following treatment interruption, doses may be titrated, but the maximum total daily dose should not exceed 5 mg twice daily (JAKAFI) or 11 mg once daily (JAKAFI XR) less than the dose that resulted in the dose interruption. An exception to this is dose interruption following phlebotomy-associated anemia, in which case the maximal total daily dose allowed after restarting JAKAFI/JAKAFI XR would not be limited. Dose Modifications Based on Insufficient Response for Patients With Polycythemia Vera If the response is insufficient and platelet, hemoglobin, and neutrophil counts are adequate, doses may be increased:
• JAKAFI:
• in 5 mg twice daily increments to a maximum of 25 mg twice daily. JAKAFI XR:
• in 11 mg once daily increments to a maximum of 55 mg once daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every 2 weeks. Consider dose increases in patients who meet all of the following conditions:
• Inadequate efficacy as demonstrated by 1 or more of the following:
• Continued need for phlebotomy WBC greater than the upper limit of normal range Platelet count greater than the upper limit of normal range Palpable spleen that is reduced by less than 25% from baseline Platelet count greater than or equal to 140 x 10 9 /L Hemoglobin greater than or equal to 12 g/dL ANC greater than or equal to 1.5 x 10 9 /L 2.4 Recommended Dosage for Acute Graft-Versus-Host Disease JAKAFI The recommended starting dose of JAKAFI is 5 mg given orally twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with JAKAFI. JAKAFI XR The recommended starting dose of JAKAFI XR is 11 mg given orally once daily. Consider increasing the dose to 22 mg once daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with JAKAFI XR. Treatment Completion Consider tapering JAKAFI/JAKAFI XR after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. Taper JAKAFI/JAKAFI XR by one dose level approximately every 8 weeks using the dose levels shown in Table 9. If aGVHD signs or symptoms recur during or after the taper of JAKAFI/JAKAFI XR, consider retreatment. Table 9:
• Reduced Dose Levels for Patients With aGVHD or cGVHD Dose Level Recommended JAKAFI Dose Recommended JAKAFI XR Dose Maximum dose 10 mg twice daily 22 mg once daily Reduced dose level -1 5 mg twice daily 11 mg once daily Reduced dose level -2 5 mg once daily
• Do not use JAKAFI XR Dose Modification Guidelines for Patients With Acute Graft-Versus-Host Disease Monitor CBC, including platelet count and ANC, and bilirubin prior to initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as indicated clinically. Modify the dose of JAKAFI/JAKAFI XR for adverse reactions as described in Table 10. See Table 9 for the recommended dose when a dose reduction is needed. Patients who are unable to tolerate JAKAFI at a dose of 5 mg once daily should have treatment interrupted until their clinical and/or laboratory parameters recover. Table 10:
• Dose Modifications for Adverse Reactions in Patients With Acute GVHD Laboratory Parameter Dosing Recommendations Clinically significant thrombocytopenia after supportive measures Reduce dose by 1 dose level. When platelets recover to previous values, dosing may return to prior dose level. ANC less than 1 x 10 9 /L considered related to JAKAFI/JAKAFI XR Hold JAKAFI/JAKAFI XR up to 14 days; resume at 1 dose level lower upon recovery. See Table 9 for reduced dose levels. Total bilirubin elevation, no liver GVHD 3−5 x ULN:
• Continue JAKAFI/JAKAFI XR at 1 dose level lower until recovery . > 5−10 x ULN:
• Hold JAKAFI/JAKAFI XR for up to 14 days until bilirubin ≤ 1.5 x ULN; resume at current dose upon recovery. Total bilirubin > 10 x ULN:
• Hold JAKAFI/JAKAFI XR for up to 14 days until bilirubin ≤ 1.5 x ULN; resume at 1 dose level lower upon recovery. Total bilirubin elevation, liver GVHD > 3 × ULN:
• Continue JAKAFI/JAKAFI XR at 1 dose level lower until recovery. 2.5 Recommended Dosage for Chronic Graft-Versus-Host Disease JAKAFI The recommended starting dose of JAKAFI is 10 mg given orally twice daily. JAKAFI XR The recommended starting dose of JAKAFI XR is 22 mg given orally once daily. Treatment Completion Consider tapering JAKAFI/JAKAFI XR after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. Taper JAKAFI/JAKAFI XR by 1 dose level approximately every 8 weeks using the dose levels shown in Table 9. If GVHD signs or symptoms recur during or after the taper of JAKAFI/JAKAFI XR, consider retreatment. Dose Modification Guidelines for Patients With Chronic Graft-Versus-Host Disease Monitor CBC, including platelet count and ANC, and bilirubin prior to initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as indicated clinically. Modify the dose of JAKAFI/JAKAFI XR for adverse reactions as described in Table 11. See Table 9 for the recommended dose when a dose reduction is needed. Patients who are unable to tolerate JAKAFI at a dose of 5 mg once daily should have treatment interrupted until their clinical and/or laboratory parameters recover. Table 11:
• Dose Modifications for Adverse Reactions in Patients With Chronic GVHD Parameter Dosing Recommendations Platelet count less than 20 × 10 9 /L Reduce JAKAFI/JAKAFI XR by 1 dose level. See Table 9 for reduced dose levels. If resolved within 7 days, dosing may return to initial dose level. If not resolved within 7 days, then maintain at 1 dose level lower. ANC less than 0.75 × 10 9 /L considered related to JAKAFI/JAKAFI XR Reduce JAKAFI/JAKAFI XR by 1 dose level; resume at initial dose level upon recovery. ANC less than 0.5 × 10 9 /L considered related to JAKAFI/JAKAFI XR Hold JAKAFI/JAKAFI XR for up to 14 days; resume at 1 dose level lower upon recovery. May resume initial dose level when ANC greater than 1 × 10 9 /L. Total bilirubin:
• 3-5 × ULN Continue JAKAFI/JAKAFI XR at 1 dose level lower until recovery. If resolved within 14 days, then increase by 1 dose level. If not resolved within 14 days, then maintain the reduced dose level. Total bilirubin:
• > 5-10 × ULN Hold JAKAFI/JAKAFI XR for up to 14 days until resolved; resume at current dose upon recovery. If not resolved within 14 days, then resume at 1 dose level lower upon recovery. Total bilirubin:
• > 10 × ULN Hold JAKAFI/JAKAFI XR for up to 14 days until resolved; resume at 1 dose level lower upon recovery. If not resolved within 14 days, discontinue. Other Adverse Reactions:
• Grade 3 Continue JAKAFI/JAKAFI XR at 1 dose level lower until recovery. Other Adverse Reactions:
• Grade 4 Discontinue JAKAFI/JAKAFI XR. 2.6 Dose Modifications for Concomitant Use With Strong CYP3A4 Inhibitors or Fluconazole Modify the JAKAFI/JAKAFI XR dosage when coadministered with strong CYP3A4 inhibitors or doses of less than or equal to 200 mg of fluconazole [see Drug Interactions ( 7 ) ] , according to Table 12.
• Avoid concomitant use of JAKAFI/JAKAFI XR with fluconazole doses of greater than 200 mg daily. Table 12:
• Dose Modifications for Concomitant Use With Strong CYP3A4 Inhibitors or Fluconazole For patients coadministered strong CYP3A4 inhibitors or doses of less than or equal to 200 mg of fluconazole Recommended JAKAFI Dose Modification Recommended JAKAFI XR Dose Modification Starting dose for patients with MF with a platelet count:
• Greater than or equal to 100 x 10 9 /L 10 mg twice daily 22 mg once daily 50 x 10 9 /L to less than 100 x 10 9 /L JAKAFI 5 mg once daily
• Do not use JAKAFI XR Starting dose for patients with PV:
• 5 mg twice daily 11 mg once daily If on stable dose for patients with MF or PV:
• JAKAFI:
• Greater than or equal to 10 mg twice daily JAKAFI XR:
• Greater than or equal to 22 mg once daily Reduce dose by 50% (round up to the closest available tablet strength) JAKAFI:
• 5 mg twice daily JAKAFI 5 mg once daily
• Do not use JAKAFI XR JAKAFI:
• 5 mg once daily JAKAFI XR:
• 11 mg once daily
• Avoid strong CYP3A4 inhibitor or fluconazole treatment or interrupt JAKAFI/JAKAFI XR treatment for the duration of strong CYP3A4 inhibitor or fluconazole use Starting dose for patients with aGVHD:
• Fluconazole doses of less than or equal to 200 mg JAKAFI 5 mg once daily
• Do not use JAKAFI XR Other CYP3A4 inhibitors Monitor blood counts more frequently for toxicity and modify the JAKAFI/JAKAFI XR dosage for adverse reactions if they occur [see Dosage and Administration ( 2.4 , 2.5 )] . Starting dose for patients with cGVHD:
• Fluconazole doses of less than or equal to 200 mg JAKAFI 5 mg twice daily JAKAFI XR 11 mg once daily Other CYP3A4 inhibitors Monitor blood counts more frequently for toxicity and modify the JAKAFI/JAKAFI XR dosage for adverse reactions if they occur [see Dosage and Administration ( 2.4 , 2.5 )] . 2.7 Dose Modifications for Renal or Hepatic Impairment Moderate to Severe Renal Impairment or End Stage Renal Disease on Dialysis Modify the JAKAFI/JAKAFI XR dosage for patients with moderate (CLcr 30 to 59 mL/min) to severe (CLcr 15 to 29 mL/min) renal impairment or end stage renal disease (ESRD) on dialysis according to Table 13.
• Avoid use of JAKAFI/JAKAFI XR in patients with ESRD (CLcr less than 15 mL/min) not requiring dialysis [see Use in Specific Populations ( 8.6 )] . Table 13:
• Dose Modifications for Renal Impairment CLcr = creatinine clearance; ESRD = end stage renal disease Renal Impairment Status Platelet Count JAKAFI Recommended Starting Dosage JAKAFI XR Recommended Starting Dosage Patients with MF Moderate or Severe Greater than 150 x 10 9 /L No dose adjustment 100 to 150 x 10 9 /L JAKAFI 10 mg twice daily JAKAFI XR 22 mg once daily 50 to less than 100 x 10 9 /L JAKAFI 5 mg once daily
• Do not use JAKAFI XR Less than 50 x 10 9 /L
• Avoid use [see Use in Specific Populations ( 8.6 )] ESRD on dialysis 100 to 200 x 10 9 /L JAKAFI 15 mg once after dialysis session
• Do not use JAKAFI XR Greater than 200 x 10 9 /L JAKAFI 20 mg once after dialysis session
• Do not use JAKAFI XR Patients with PV Moderate or Severe Any JAKAFI 5 mg twice daily JAKAFI XR 11 mg once daily ESRD on dialysis Any JAKAFI 10 mg once after dialysis session
• Do not use JAKAFI XR Patients with aGVHD Moderate or Severe Any JAKAFI 5 mg once daily
• Do not use JAKAFI XR ESRD on dialysis Any JAKAFI 5 mg once after dialysis session
• Do not use JAKAFI XR P atients with cGVHD Moderate or Severe Any JAKAFI 5 mg twice daily JAKAFI XR 11 mg once daily ESRD on dialysis Any JAKAFI 10 mg once after dialysis session
• Do not use JAKAFI XR Hepatic Impairment Modify the JAKAFI/JAKAFI XR dosage for patients with hepatic impairment according to Table 14. Table 14:
• Dose Modifications for Hepatic Impairment Hepatic Impairment Status Platelet Count JAKAFI Recommended Starting Dosage JAKAFI XR Recommended Starting Dosage Patients with MF Mild, Moderate, or Severe (Child-Pugh Class A, B, C) Greater than 150 x 10 9 /L No dose adjustment 100 x 10 9 /L to 150 x 10 9 /L 10 mg twice daily 22 mg once daily 50 to less than 100 x 10 9 /L JAKAFI 5 mg once daily
• Do not use JAKAFI XR Less than 50 x 10 9 /L
• Avoid use [see Use in Specific Populations ( 8.7 )] Patients with PV Mild, Moderate, or Severe (Child-Pugh Class A, B, C) Any 5 mg twice daily 11 mg once daily Patients with aGVHD Mild, Moderate, or Severe based on NCI criteria without liver GVHD Any No dose adjustment Stage 1, 2 or 3 Liver aGVHD Any No dose adjustment Stage 4 Liver aGVHD Any JAKAFI 5 mg once daily
• Do not use JAKAFI XR Patients with cGVHD Mild, Moderate, or Severe based on NCI criteria without liver GVHD Any No dose adjustment Score 1 or 2 Liver cGVHD Any No dose adjustment Score 3 Liver cGVHD Any Monitor blood counts more frequently for toxicity and modify the JAKAFI/JAKAFI XR dosage for adverse reactions if they occur [see Dosage and Administration ( 2.4 , 2.5 )] . 2.8 Method of Administration JAKAFI JAKAFI is dosed orally and can be administered with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose. When discontinuing JAKAFI therapy for reasons other than potentially life-threatening toxicities, gradually taper the dose of JAKAFI, for example by 5 mg twice daily each week. For patients unable to ingest tablets, JAKAFI can be administered through a nasogastric tube (8 French or greater) as follows:
• Suspend 1 tablet in approximately 40 mL of water with stirring for approximately 10 minutes. Within 6 hours after the tablet has dispersed, the suspension can be administered through a nasogastric tube using an appropriate syringe. The tube should be rinsed with approximately 75 mL of water. The effect of tube feeding preparations on JAKAFI exposure during administration through a nasogastric tube has not been evaluated. JAKAFI XR JAKAFI XR is dosed orally and can be administered with or without food. Swallow JAKAFI XR tablets whole. Do not split, chew, or crush. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose. When discontinuing JAKAFI XR therapy for reasons other than potentially life-threatening toxicities, gradually taper the dose of JAKAFI XR, for example by 11 mg once daily each week for JAKAFI XR.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Myelofibrosis The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of MF in pediatric patients have not been established.
• Polycythemia Vera The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of PV in pediatric patients have not been established.
• Acute Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of steroid-refractory aGVHD has been established for treatment of pediatric patients 12 years and older.
• Use of JAKAFI in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of JAKAFI in
• adults [ see Clinical Studies ( 14.3 )] and additional pharmacokinetic and safety data in pediatric patients.
• The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of steroid-refractory aGVHD has not been established in pediatric patients younger than 12 years old.
• Chronic Graft-Versus-Host Disease The safety and effectiveness of JAKAFI for treatment of cGVHD after failure of one or two lines of systemic therapy has been established for treatment of pediatric patients 12 years and older.
• Use of JAKAFI in pediatric patients with cGVHD after failure of one or two lines of systemic therapy is supported by evidence from adequate and well-controlled trials of JAKAFI in
• adults and adolescents [ see Clinical Studies ( 14.4 )] and additional pharmacokinetic and safety data in pediatric patients.
• The safety and effectiveness of JAKAFI/JAKAFI XR for treatment of cGVHD has not been established in pediatric patients younger than 12 years old.
• Other Myeloproliferative Neoplasms, Leukemias, and Solid Tumors The safety and effectiveness of ruxolitinib were assessed but not established in a single-arm trial (NCT01164163) in patients with relapsed or refractory solid tumors, leukemias, or myeloproliferative neoplasms.
• The patients included 18 children (age 2 to < 12 years) and 14 adolescents (age 12 to < 17 years).
• Overall, 19% of patients received more than 1 cycle.
• No new safety signals were observed in pediatric patients in this trial.
• The safety and effectiveness of ruxolitinib in combination with chemotherapy for treatment of high-risk, de novo CRLF2 rearranged or JAK pathway–mutant Ph-like acute lymphoblastic leukemia (ALL) were assessed but not established in a single-arm trial (NCT02723994).
• The patients included 2 infants (age < 2 years), 42 children (age 2 to < 12 years) and 62 adolescents (age 12 to < 17 years).
• No new safety signals were observed in pediatric patients in this trial.
• Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures.
• When administered starting at postnatal Day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures (eg, bone mineral content, peripheral quantitative computed tomography, and x-ray analysis) occurred at doses ≥ 5 mg/kg/day.
• When administered starting at postnatal Day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day.
• Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period.
• These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the total number of patients with MF in clinical studies with JAKAFI, 52% were 65 years and older, while 15% were 75 years and older.
• No overall differences in safety or effectiveness of JAKAFI were observed between these patients and younger patients.
• Clinical studies of JAKAFI in patients with aGVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.
• Of the total number of patients with cGVHD treated with JAKAFI in clinical trials, 11% were 65 years and older.
• No overall differences in safety or effectiveness of JAKAFI were observed between these patients and younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
• Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ( 5.1 )] Risk of Infection [see Warnings and Precautions ( 5.2 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancer [see Warnings and Precautions ( 5.4 )] Lipid Elevations [ see Warnings and Precautions ( 5.5 )] Major Adverse Cardiovascular Events (MACE) [ see Warnings and Precautions ( 5.6 )] Thrombosis [ see Warnings and Precautions ( 5.7 )] Secondary Malignancies [ see Warnings and Precautions ( 5.8 )] In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia.
• The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea.
• ( 6.1 ) In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia.
• The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema.
• ( 6.1 ) In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia.
• The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infections.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• The safety of JAKAFI XR has been established from adequate and well-controlled studies of JAKAFI in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease [see Clinical Studies ( 14 )] .
• Below is a display of the adverse reactions of JAKAFI in these adequate and well-controlled studies.
• Myelofibrosis The safety of JAKAFI was assessed in 617 patients in 6 clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with MF in 2 Phase 3 studies.
• In these 2 Phase 3 studies, patients had a median duration of exposure to JAKAFI of 9.5 months (range:
• 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months.
• One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily.
• In patients starting treatment with 15 mg twice daily (pretreatment platelet counts of 100 to 200 × 10 9 /L) and 20 mg twice daily (pretreatment platelet counts greater than 200 × 10 9 /L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy.
• In a double-blind, randomized, placebo-controlled study of JAKAFI, among the 155 patients treated with JAKAFI, the most frequent adverse reactions were thrombocytopenia and anemia [see Table 14] .
• Thrombocytopenia, anemia, and neutropenia are dose-related effects.
• The 3 most frequent nonhematologic adverse reactions were bruising, dizziness, and headache [see Table 13 ] .
• Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with JAKAFI and 11% of patients treated with placebo.
• Table 15 presents the most common nonhematologic adverse reactions occurring in patients who received JAKAFI in the double-blind, placebo-controlled study during randomized treatment.
• Table 15:
• Myelofibrosis:
• Nonhematologic Adverse Reactions Occurring in Patients on JAKAFI in the Double-Blind, Placebo-Controlled Study During Randomized Treatment JAKAFI (N = 155) Placebo (N = 151) Adverse Reactions All Grades National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
• (%) Grade 3 (%) Grade 4 (%) All Grades (%) Grade 3 (%) Grade 4 (%) Bruising Includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura. 23 < 1 0 15 0 0 Dizziness Includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis. 18 < 1 0 7 0 0 Headache 15 0 0 5 0 0 Urinary Tract Infections Includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present. 9 0 0 5 < 1 < 1 Weight Gain Includes weight increased, abnormal weight gain. 7 < 1 0 1 < 1 0 Flatulence 5 0 0 < 1 0 0 Herpes Zoster Includes herpes zoster and post-herpetic neuralgia. 2 0 0 < 1 0 0 Description of Selected Adverse Reactions Anemia In the 2 Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks.
• One patient (< 1%) discontinued treatment because of anemia.
• In patients receiving JAKAFI, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1 g/dL below baseline.
• This pattern was observed in patients regardless of whether they had received transfusions during therapy.
• In the randomized, placebo-controlled study, 60% of patients treated with JAKAFI and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment.
• Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with JAKAFI and 1.7 in placebo treated patients.
• Thrombocytopenia In the 2 Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks.
• Thrombocytopenia was generally reversible with dose reduction or dose interruption.
• The median time to recovery of platelet counts above 50 x 10 9 /L was 14 days.
• Platelet transfusions were administered to 5% of patients receiving JAKAFI and to 4% of patients receiving control regimens.
• Discontinuation of treatment because of thrombocytopenia occurred in < 1% of patients receiving JAKAFI and < 1% of patients receiving control regimens.
• Patients with a platelet count of 100 x 10 9 /L to 200 x 10 9 /L before starting JAKAFI had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 x 10 9 /L (17% versus 7%).
• Neutropenia In the 2 Phase 3 clinical studies, 1% of patients reduced or stopped JAKAFI because of neutropenia.
• Table 16 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with JAKAFI or placebo in the placebo-controlled study.
• Table 16:
• Myelofibrosis:
• Worst Hematology Laboratory Abnormalities in the Placebo-Controlled Study Presented values are worst Grade values regardless of baseline.
• JAKAFI (N = 155) Placebo (N = 151) Laboratory Parameter All Grades National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
• (%) Grade 3 (%) Grade 4 (%) All Grades (%) Grade 3 (%) Grade 4 (%) Thrombocytopenia 70 9 4 31 1 0 Anemia 96 34 11 87 16 3 Neutropenia 19 5 2 4 < 1 1 Additional Data From the Placebo-Controlled Study 25% of patients treated with JAKAFI and 7% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT).
• The incidence of greater than or equal to Grade 2 elevations was 2% for JAKAFI with 1% Grade 3 and no Grade 4 ALT elevations. 17% of patients treated with JAKAFI and 6% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST).
• The incidence of Grade 2 AST elevations was < 1% for JAKAFI with no Grade 3 or 4 AST elevations. 17% of patients treated with JAKAFI and < 1% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol.
• The incidence of Grade 2 cholesterol elevations was < 1% for JAKAFI with no Grade 3 or 4 cholesterol elevations.
• Polycythemia Vera In a randomized, open-label, active-controlled study, 110 patients with PV resistant to or intolerant of hydroxyurea received JAKAFI and 111 patients received best available therapy (BAT) [see Clinical Studies ( 14.2 )] .
• The most frequent adverse reaction was anemia.
• Discontinuation for adverse events, regardless of causality, was observed in 4% of patients treated with JAKAFI.
• Table 17 presents the most frequent nonhematologic adverse reactions occurring up to Week 32.
• Table 17:
• Polycythemia Vera:
• Nonhematologic Adverse Reactions Occurring in ≥ 5% of Patients on JAKAFI in the Open-Label, Active-Controlled Study up to Week 32 of Randomized Treatment JAKAFI (N = 110) Best Available Therapy (N = 111) Adverse Reactions All Grades National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
• (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Diarrhea 15 0 7 < 1 Dizziness Includes dizziness and vertigo. 15 0 13 0 Dyspnea Includes dyspnea and dyspnea exertional. 13 3 4 0 Muscle Spasms 12 < 1 5 0 Constipation 8 0 3 0 Herpes Zoster Includes herpes zoster and post-herpetic neuralgia. 6 < 1 0 0 Nausea 6 0 4 0 Weight Gain Includes weight increased and abnormal weight gain. 6 0 < 1 0 Urinary Tract Infections Includes urinary tract infection and cystitis. 6 0 3 0 Hypertension 5 < 1 3 < 1 Clinically relevant laboratory abnormalities are shown in Table 18.
• Table 18:
• Polycythemia Vera:
• Selected Laboratory Abnormalities in the Open-Label, Active-Controlled Study up to Week 32 of Randomized Treatment Presented values are worst Grade values regardless of baseline.
• JAKAFI (N = 110) Best Available Therapy (N = 111) Laboratory Parameter All Grades National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
• (%) Grade 3 (%) Grade 4 (%) All Grades (%) Grade 3 (%) Grade 4 (%) Hematology Anemia 72 < 1 < 1 58 0 0 Thrombocytopenia 27 5 < 1 24 3 < 1 Neutropenia 3 0 < 1 10 < 1 0 Chemistry Hypercholesterolemia 35 0 0 8 0 0 Elevated ALT 25 < 1 0 16 0 0 Elevated AST 23 0 0 23 < 1 0 Hypertriglyceridemia 15 0 0 13 0 0 Acute Graft-Versus-Host Disease In a single-arm, open-label study, 71
• adults (ages 18-73 years) were treated with JAKAFI for aGVHD failing treatment with steroids with or without other immunosuppressive drugs [see Clinical Studies ( 14.3 )] .
• The median duration of treatment with JAKAFI was 46 days (range: 4 to 382 days).
• There were no fatal adverse reactions to JAKAFI.
• An adverse reaction resulting in treatment discontinuation occurred in 31% of patients.
• The most common adverse reaction leading to treatment discontinuation was infection (10%).
• Table 19 shows the adverse reactions other than laboratory abnormalities.
• Table 19:
• Acute Graft-Versus-Host Disease:
• Nonhematologic Adverse Reactions Occurring in ≥ 15% of Patients in the Open-Label, Single Cohort Study JAKAFI (N = 71) Adverse Reactions Selected laboratory abnormalities are listed in Table 20 below.
• All Grades National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
• (%) Grade 3-4 (%) Infections (pathogen not specified) 55 41 Edema 51 13 Hemorrhage 49 20 Fatigue 37 14 Bacterial infections 32 28 Dyspnea 32 7 Viral infections 31 14 Thrombosis 25 11 Diarrhea 24 7 Rash 23 3 Headache 21 4 Hypertension 20 13 Dizziness 16 0 Selected laboratory abnormalities during treatment with JAKAFI are shown in Table 20.
• Table 20:
• Acute Graft-Versus-Host Disease:
• Selected Laboratory Abnormalities Worsening from Baseline in the Open-Label, Single Cohort Study JAKAFI (N = 71) Worst grade during treatment Laboratory Parameter All Grades National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
• (%) Grade 3-4 (%) Hematology Anemia 75 45 Thrombocytopenia 75 61 Neutropenia 58 40 Chemistry Elevated ALT 48 8 Elevated AST 48 6 Hypertriglyceridemia 11 1 Chronic Graft-Versus-Host Disease In a Phase 3, randomized, open-label, multi-center study, 165 patients were treated with JAKAFI and 158 patients were treated with BAT for cGVHD failing treatment with steroids with or without other immunosuppressive drugs [ see Clinical Studies ( 14.4 )] ; sixty-five patients crossed over from BAT to treatment with JAKAFI, for a total of 230 patients treated with JAKAFI.
• The median duration of exposure to JAKAFI for the study was 49.7 weeks (range:
• 0.7 to 144.9 weeks) in the JAKAFI arm.
• One hundred and nine (47%) patients were on JAKAFI for at least 1 year.
• There were 5 fatal adverse reactions to JAKAFI, including 1 from toxic epidermal necrolysis and 4 from neutropenia, anemia and/or thrombocytopenia.
• An adverse reaction resulting in treatment discontinuation occurred in 18% of patients treated with JAKAFI.
• An adverse reaction resulting in dose modification occurred in 27%, and an adverse reaction resulting in treatment interruption occurred in 23%.
• The most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia.
• The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infection.
• Table 21 presents the most frequent nonlaboratory adverse reactions occurring up to Cycle 7 Day 1 of randomized treatment.
• Table 21:
• Chronic Graft-Versus-Host Disease:
• All-Grade (≥ 10%) and Grades 3-5 (≥ 3%) Nonlaboratory Adverse Reactions Occurring in Patients in the Open-Label, Active-Controlled Study up to Cycle 7 Day 1 of Randomized Treatment Adverse Reaction Grouped terms that are composites of applicable adverse reaction terms.
• JAKAFI (N = 165) Best Available Therapy (N = 158) All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) Infections and infestations Infections (pathogen not specified) 45 15 44 16 Viral infections 28 5 23 5 Musculoskeletal and connective tissue disorders Musculoskeletal pain 18 1 13 0 General disorders and administration site conditions Pyrexia 16 2 9 1 Fatigue 13 1 10 2 Edema 10 1 12 1 Vascular disorders Hypertension 16 5 13 7 Hemorrhage 12 2 15 2 Respiratory, thoracic and mediastinal disorders Cough 13 0 8 0 Dyspnea 11 1 8 1 Gastrointestinal disorders Nausea 12 0 13 2 Diarrhea 10 1 13 1 Clinically relevant laboratory abnormalities are shown in Table 22.
• Table 22:
• Chronic Graft-Versus-Host Disease:
• Selected Laboratory Abnormalities in the Open-Label, Active-Controlled Study up to Cycle 7 Day 1 of Randomized Treatment Presented values are worst Grade values regardless of baseline.
• Laboratory Test JAKAFI (N = 165) Best Available Therapy (N = 158) All Grades National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
• (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) Hematology Anemia 82 13 75 8 Neutropenia 27 12 23 9 Thrombocytopenia 58 20 54 17 Chemistry Hypercholesterolemia 88 10 85 8 Elevated AST 65 5 54 6 Elevated ALT 73 11 71 16 Gamma glutamyltransferase increased 81 42 75 38 Creatinine increased 47 1 40 2 Elevated lipase 38 12 30 9 Elevated amylase 35 8 25 4
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of JAKAFI.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
• Infections and Infestations:
• herpes simplex virus reactivation and/or dissemination Metabolism and Nutrition disorders:
• hypoglycemia (class effect)

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Thrombocytopenia, Anemia, and Neutropenia Inform patients that JAKAFI/JAKAFI XR is associated with thrombocytopenia, anemia and neutropenia, and of the need to monitor CBC before and during treatment.
• Advise patients to observe for and report bleeding [see Warnings and Precautions ( 5.1 )] .
• Infections Inform patients of the signs and symptoms of infection and to report any such signs and symptoms promptly.
• Inform patients regarding the early signs and symptoms of herpes zoster and of PML, and advise patients to seek the advice of a clinician if such symptoms are observed [see Warnings and Precautions ( 5.2 )] .
• Symptom Exacerbation Following Interruption or Discontinuation of Treatment Inform patients that after discontinuation of treatment, signs and symptoms from myeloproliferative neoplasms may flare.
• Instruct patients not to interrupt or discontinue JAKAFI/JAKAFI XR therapy without consulting their healthcare provider [see Warnings and Precautions ( 5.3 )] .
• Non-Melanoma Skin Cancer Inform patients that JAKAFI/JAKAFI XR may increase their risk of certain NMSCs.
• Advise patients to inform their healthcare provider if they have ever had any type of skin cancer or if they observe any new or changing skin lesions [see Warnings and Precautions ( 5.4 )] .
• Lipid Elevations Inform patients that JAKAFI/JAKAFI XR may increase blood cholesterol, and of the need to monitor blood cholesterol levels [see Warnings and Precautions ( 5.5 )] .
• Major Adverse Cardiovascular Events Advise patients that events of MACE including myocardial infarction, stroke, and cardiovascular death, have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated.
• Advise patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions ( 5.6 )] .
• Thrombosis Advise patients that events of DVT and PE have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated.
• Advise patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions ( 5.7 )] .
• Secondary Malignancies Advise patients, especially current or past smokers and patients with a known secondary malignancy (other than a successfully treated NMSC), that lymphoma and other malignancies (excluding NMSC) have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated [see Warnings and Precautions ( 5.8 )] .
• Drug-Drug Interactions Advise patients to inform their healthcare providers of all medications they are taking, including over-the-counter medications, herbal products and dietary supplements [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .
• Dialysis Inform patients on dialysis that their dose should not be taken before dialysis but only following dialysis [see Dosage and Administration ( 2.7 )] .
• Lactation Inform women not to breastfeed during treatment with JAKAFI/JAKAFI XR and for 2 weeks after the final dose [see Use in Specific Populations ( 8.2 )] .
• Compliance Advise patients to continue taking JAKAFI/JAKAFI XR every day for as long as their physician tells them and that this is a long-term treatment.
• Patients should not change dose or stop taking JAKAFI/JAKAFI XR without first consulting their physician.
• Patients should be aware that after discontinuation of treatment, signs and symptoms from myeloproliferative neoplasms are expected to return.
• Manufactured for:
• Incyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803 JAKAFI is a registered trademark of Incyte.
• JAKAFI XR is a trademark of Incyte.
• Patent Information: www.incyte.com/patents © 2026 Incyte Corporation.
• All rights reserved.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS JAKAFI :
• 5 mg tablets - round and white with "INCY" on one side and "5" on the other. 10 mg tablets - round and white with "INCY" on one side and "10" on the other. 15 mg tablets - oval and white with "INCY" on one side and "15" on the other. 20 mg tablets - capsule-shaped and white with "INCY" on one side and "20" on the other. 25 mg tablets - oval and white with "INCY" on one side and "25" on the other.
• JAKAFI XR :
• 11 mg extended-release tablets - round and light pink with “I” on one side and “11” on the other. 22 mg extended-release tablets - round and light yellow with “I” on one side and “22” on the other. 33 mg extended-release tablets - round and pink with “I” on one side and “33” on the other. 44 mg extended-release tablets - round and grey with “I” on one side and “44” on the other. 55 mg extended-release tablets - round and yellow with “I” on one side and “55” on the other.
• JAKAFI tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.
• ( 3 ) JAKAFI XR extended-release tablets: 11 mg, 22 mg, 33 mg, 44 mg and 55 mg.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• JAKAFI (ruxolitinib) tablets are available as follows:
• JAKAFI Trade Presentations NDC Number Strength Description Tablets per Bottle 50881-005-60 5 mg Round tablet with “INCY” on one side and “5” on the other 60 50881-010-60 10 mg Round tablet with “INCY” on one side and “10” on the other 60 50881-015-60 15 mg Oval tablet with “INCY” on one side and “15” on the other 60 50881-020-60 20 mg Capsule-shaped tablet with “INCY” on one side and “20” on the other 60 50881-025-60 25 mg Oval tablet with “INCY” on one side and “25” on the other 60 JAKAFI XR (ruxolitinib) extended-release tablets are available as follows:
• JAKAFI XR Trade Presentations NDC Number Strength Description Tablets per Bottle 50881-011-08 11 mg Round light pink tablet with “I” on one side and “11” on the other 30 50881-022-08 22 mg Round light yellow tablet with “I” on one side and “22” on the other 30 50881-033-08 33 mg Round pink tablet with “I” on one side and “33” on the other 30 50881-044-08 44 mg Round grey tablet with “I” on one side and “44” on the other 30 50881-055-08 55 mg Round yellow tablet with “I” on one side and “55” on the other 30 Store JAKAFI/JAKAFI XR at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
• Dispense in a tight container.
• Protect from light.

Quoted from the official label, section “How Supplied”.

What is in it

• Ruxolitinib phosphate is a kinase inhibitor with the chemical name ( R )-3-(4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-1 H -pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36.
• Ruxolitinib phosphate has the following structural formula:
• Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8.
• JAKAFI (ruxolitinib) tablets are for oral administration.
• Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients:
• colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.
• JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration.
• Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients:
• colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate.
• In addition, the film coating contains the following inactive ingredients:
• colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides.
• Ruxolitinib phosphate structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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