JAKAFI (Page 4 of 12)
2.7 Dose Modifications for Renal or Hepatic Impairment
Moderate to Severe Renal Impairment or End Stage Renal Disease on Dialysis
Modify the Jakafi 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 10. Avoid use of Jakafi in patients with ESRD (CLcr less than 15 mL/min) not requiring dialysis [see Use in Specific Populations ( 8.6)].
| ESRD = end stage renal disease, and CLcr = creatinine clearance | ||
| Renal Impairment Status | Platelet Count | Recommended Starting Dosage |
| Patients with MF | ||
| Moderate or Severe | Greater than 150 x 109 /L | No dose adjustment |
| 100 to 150 x 109 /L | 10 mg twice daily | |
| 50 to less than 100 x 109 /L | 5 mg daily | |
| Less than 50 x 109 /L | Avoid use [see Use in Specific Populations (8.6)] | |
| ESRD on dialysis | 100 to 200 x 109 /L | 15 mg once after dialysis session |
| Greater than 200 x 109 /L | 20 mg once after dialysis session | |
| Patients with PV | ||
| Moderate or Severe | Any | 5 mg twice daily |
| ESRD on dialysis | Any | 10 mg once after dialysis session |
| Patients with aGVHD | ||
| Moderate or Severe | Any | 5 mg once daily |
| ESRD on dialysis | Any | 5 mg once after dialysis session |
| Patients with cGVHD | ||
| Moderate or Severe | Any | 5 mg twice daily |
| ESRD on dialysis | Any | 10 mg once after dialysis session |
Hepatic Impairment
Modify the Jakafi dosage for patients with hepatic impairment according to Table 11.
| Hepatic Impairment Status | Platelet Count | Recommended Starting Dosage |
| Patients with MF Mild, Moderate, or Severe (Child-Pugh Class A, B, C) | Greater than 150 x 109 /L | No dose adjustment |
| 100 x 109 /L to 150 x 109 /L | 10 mg twice daily | |
| 50 to less than 100 x 109 /L | 5 mg daily | |
| Less than 50 x 109 /L | Avoid use [see Use in SpecificPopulations (8.7)] | |
| Patients with PV Mild, Moderate, or Severe (Child-Pugh Class A, B, C) | Any | 5 mg twice 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 | 5 mg once daily |
| 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 dosage for adverse reactions if they occur [see Dosage and Administration (2.4, 2.5)]. |
2.8 Method of Administration
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 thrombocytopenia, gradual tapering of the dose of Jakafi may be considered, 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 one 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.
3. DOSAGE FORMS AND STRENGTHS
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.
4. CONTRAINDICATIONS
None.
5. WARNINGS AND PRECAUTIONS
5.1 Thrombocytopenia, Anemia and Neutropenia
Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia [ see Adverse Reactions ( 6.1)].
Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [ see Dosage and Administration ( 2) ].
Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi.
Severe neutropenia (ANC less than 0.5 × 109 /L) was generally reversible by withholding Jakafi until recovery.
Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [ see Dosage and Administration ( 2)].
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