HEMATOLOGY
HEMATOLOGY LABORATORY VALUES WERE FURTHER EXAMINED IN 7 PHASE 3 CLINICAL TRIALS
* Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX
o These adverse events have also been reported in postmarketing experience
* ZYVOX has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hours
* The reported ranges for thrombocytopenia among study patients were 0.3% to 10.0% for ZYVOX-treated patients and 0.4% to 7.0% for patients treated with comparators
* Thrombocytopenia associated with the use of ZYVOX appears to be dependent on duration of therapy (generally greater than 2 weeks)
ANOTHER ANALYSIS OF THE HEMATOLOGY LABORATORY VALUES IN THESE TRIALS WAS CONDUCTED
* This analysis was published in Antimicrobial Agents and Chemotherapy
* In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters have risen toward pretreatment levels
o Discontinuation of therapy with ZYVOX should be considered in patients who develop or have worsening myelosuppression
* Complete blood counts should be monitored weekly in patients:
o Taking ZYVOX for longer than 2 weeks
o With preexisting myelosuppression
o Taking concomitant drugs that produce bone marrow suppression
o With a chronic infection who have received previous or concomitant antibiotic therapy
IN A RECENT STUDY OF FEBRILE, NEUTROPENIC CANCER PATIENTS TREATED WITH EITHER ZYVOX OR VANCOMYCIN, HEMATOLOGIC OUTCOMES WERE SIMILAR85
* From the analysis, published in Clinical Infectious Diseases, this randomized, double-blind, multicenter, multinational study (excluding the United States) demonstrated similar hematologic effects between ZYVOX and vancomycin 85
* The incidence of bleeding complications was 11.2% for patients treated with ZYVOX and 12.6% for patients treated with vancomycin in the intent-to-treat population85
* The authors concluded that mean platelet counts remained nearly identical between treatment groups throughout the study, as did time to recovery of the platelet count85
* Between-group distribution was similar for abnormal hemoglobin values85:
o 35.6% for patients treated with ZYVOX 85
o 38.1% for patients treated with vancomycin 85
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than 2 weeks, those with preexisting myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.
* Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX
o These adverse events have also been reported in postmarketing experience
* ZYVOX has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hours
* The reported ranges for thrombocytopenia among study patients were 0.3% to 10.0% for ZYVOX-treated patients and 0.4% to 7.0% for patients treated with comparators
* Thrombocytopenia associated with the use of ZYVOX appears to be dependent on duration of therapy (generally greater than 2 weeks)
ANOTHER ANALYSIS OF THE HEMATOLOGY LABORATORY VALUES IN THESE TRIALS WAS CONDUCTED
* This analysis was published in Antimicrobial Agents and Chemotherapy
* In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters have risen toward pretreatment levels
o Discontinuation of therapy with ZYVOX should be considered in patients who develop or have worsening myelosuppression
* Complete blood counts should be monitored weekly in patients:
o Taking ZYVOX for longer than 2 weeks
o With preexisting myelosuppression
o Taking concomitant drugs that produce bone marrow suppression
o With a chronic infection who have received previous or concomitant antibiotic therapy
IN A RECENT STUDY OF FEBRILE, NEUTROPENIC CANCER PATIENTS TREATED WITH EITHER ZYVOX OR VANCOMYCIN, HEMATOLOGIC OUTCOMES WERE SIMILAR85
* From the analysis, published in Clinical Infectious Diseases, this randomized, double-blind, multicenter, multinational study (excluding the United States) demonstrated similar hematologic effects between ZYVOX and vancomycin 85
* The incidence of bleeding complications was 11.2% for patients treated with ZYVOX and 12.6% for patients treated with vancomycin in the intent-to-treat population85
* The authors concluded that mean platelet counts remained nearly identical between treatment groups throughout the study, as did time to recovery of the platelet count85
* Between-group distribution was similar for abnormal hemoglobin values85:
o 35.6% for patients treated with ZYVOX 85
o 38.1% for patients treated with vancomycin 85
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than 2 weeks, those with preexisting myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.