SPRYCEL (Page 3 of 9)
Laboratory Abnormalities
Myelosuppression was commonly reported in all patient populations. The frequency of Grade 3 or 4 neutropenia, thrombocytopenia, and anemia was higher in patients with advanced phase CML than in chronic phase CML (Tables 4 and 5). Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
In patients who experienced severe myelosuppression, recovery generally occurred following dose interruption or reduction; permanent discontinuation of treatment occurred in 2% of patients with newly diagnosed chronic phase CML and 5% of patients with resistance or intolerance to prior imatinib therapy [see Warnings and Precautions (5.1)].
Grade 3 or 4 elevations of transaminase or bilirubin and Grade 3 or 4 hypocalcemia, hypokalemia, and hypophosphatemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML. Elevations in transaminase or bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3 or 4 hypocalcemia during the course of SPRYCEL therapy often had recovery with oral calcium supplementation.
Laboratory abnormalities reported in patients with newly diagnosed chronic phase CML are shown in Table 4. There were no discontinuations of SPRYCEL therapy in this patient population due to biochemical laboratory parameters.
| SPRYCEL(n=258) | Imatinib(n=258) | |
|---|---|---|
| Percent (%) of Patients | ||
| CTC grades: neutropenia (Grade 3 ≥0.5–<1.0 × 109 /L, Grade 4 <0.5 × 109 /L); thrombocytopenia (Grade 3 ≥25–<50 × 109 /L, Grade 4 <25 × 109 /L); anemia (hemoglobin Grade 3 ≥65–<80 g/L, Grade 4 <65 g/L); elevated creatinine (Grade 3 >3–6 × upper limit of normal range (ULN), Grade 4 >6 × ULN); elevated bilirubin (Grade 3 >3–10 × ULN, Grade 4 >10 × ULN); elevated SGOT or SGPT (Grade 3 >5–20 × ULN, Grade 4 >20 × ULN); hypocalcemia (Grade 3 <7.0–6.0 mg/dL, Grade 4 <6.0 mg/dL); hypophosphatemia (Grade 3 <2.0–1.0 mg/dL, Grade 4 <1.0 mg/dL); hypokalemia (Grade 3 <3.0–2.5 mmol/L, Grade 4 <2.5 mmol/L). | ||
| Hematology Parameters | ||
| Neutropenia | 22 | 20 |
| Thrombocytopenia | 19 | 10 |
| Anemia | 11 | 7 |
| Biochemistry Parameters | ||
| Hypophosphatemia | 5 | 24 |
| Hypokalemia | 0 | 2 |
| Hypocalcemia | 3 | 2 |
| Elevated SGPT (ALT) | <1 | 1 |
| Elevated SGOT (AST) | <1 | 1 |
| Elevated Bilirubin | 1 | 0 |
| Elevated Creatinine | <1 | 1 |
Laboratory abnormalities reported in patients with CML resistant or intolerant to imatinib who received the recommended starting doses of SPRYCEL are shown by disease phase in Table 5.
| Advanced Phase CML | ||||
|---|---|---|---|---|
| Chronic Phase CML | 140 mg Once Daily | |||
| 100 mg Once Daily (n=165) | Accelerated Phase (n=157) | Myeloid Blast Phase (n=74) | Lymphoid Blast Phase (n=33) | |
| Percent (%) of Patients | ||||
| CTC grades: neutropenia (Grade 3 ≥0.5–<1.0 × 109 /L, Grade 4 <0.5 × 109 /L); thrombocytopenia (Grade 3 ≥25–<50 × 109 /L, Grade 4 <25 × 109 /L); anemia (hemoglobin Grade 3 ≥65–<80 g/L, Grade 4 <65 g/L); elevated creatinine (Grade 3 >3–6 × upper limit of normal range (ULN), Grade 4 >6 × ULN); elevated bilirubin (Grade 3 >3–10 × ULN, Grade 4 >10 × ULN); elevated SGOT or SGPT (Grade 3 >5–20 × ULN, Grade 4 >20 × ULN); hypocalcemia (Grade 3 <7.0–6.0 mg/dL, Grade 4 <6.0 mg/dL); hypophosphatemia (Grade 3 <2.0–1.0 mg/dL, Grade 4 <1.0 mg/dL); hypokalemia (Grade 3 <3.0–2.5 mmol/L, Grade 4 <2.5 mmol/L). | ||||
| Hematology Parameters | ||||
| Neutropenia | 36 | 58 | 77 | 79 |
| Thrombocytopenia | 23 | 63 | 78 | 85 |
| Anemia | 13 | 47 | 74 | 52 |
| Biochemistry Parameters | ||||
| Hypophosphatemia | 10 | 13 | 12 | 18 |
| Hypokalemia | 2 | 7 | 11 | 15 |
| Hypocalcemia | <1 | 4 | 9 | 12 |
| Elevated SGPT (ALT) | 0 | 2 | 5 | 3 |
| Elevated SGOT (AST) | <1 | 0 | 4 | 3 |
| Elevated Bilirubin | <1 | 1 | 3 | 6 |
| Elevated Creatinine | 0 | 2 | 8 | 0 |
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