Hold ACTEMRA treatment if a patient develops a serious infection until the infection is controlled.
Monitoring Guidance | All Exposure | |
---|---|---|
There was no clear relationship between decreases in neutrophils <1 x 109/L and the occurrence of serious infections. Neutrophils should be monitored at the time of the second infusion and every 4 to 8 weeks thereafter. |
ACTEMRA (N=188) | |
Neutrophils <1 x 109/L |
3.7% |
Monitoring Guidance | All Exposure | |
---|---|---|
Platelets should be monitored at the time of the second infusion and every 4 to 8 weeks thereafter. | ACTEMRA (N=188) | |
Platelets <50 x 103/µL |
1% | |
Platelets <100 x 103/µL |
N/A |
Monitoring Guidance | All Exposure | |
---|---|---|
ALT and AST levels should be monitored at the time of second infusion and thereafter every 4 to 8 weeks. | ACTEMRA (N=188) | |
ALT ≥3x ULN | 4% | |
AST ≥3x ULN | <1% |
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.
Monitoring Guidance | All Exposure | |
---|---|---|
Assessment of lipid parameters should be performed approximately 4 to 8 weeks following initiation of ACTEMRA therapy. Subsequently, manage patients according to clinical guidelines for the management of hyperlipidemia. | ACTEMRA (N=188) | |
Total cholesterol >1.5x to 2x ULN | 0.5% | |
LDL-C >1.5x to 2x ULN | 0.5% |
LDL-C=low-density lipoprotein cholesterol.
Brunner HI, et al. Ann Rheum Dis. 2015;74:1110-1117.
Brunner HI, et al. Ann Rheum Dis. 2015;74:1110-1117.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Brunner H, Ruperto N, Zuber A, et al. Arthritis & Rheumatism. 2012;64(10S):S682.
Brunner H, Ruperto N, Zuber A, et al. Arthritis & Rheumatism. 2012;64(10S):S682.
Brunner HI, et al. Identification of optimal subcutaneous doses of tocilizumab in children with polyarticular-course juvenile idiopathic arthritis. Presented at the 2017 Pediatric Rheumatology Symposium in Houston, TX; May 17-20, 2017. PRSYM Oral Presentation.
Brunner HI, et al. Identification of optimal subcutaneous doses of tocilizumab in children with polyarticular-course juvenile idiopathic arthritis. Presented at the 2017 Pediatric Rheumatology Symposium in Houston, TX; May 17-20, 2017. PRSYM Oral Presentation.
ACTEMRA [package insert]. South San Francisco, CA: Genentech, Inc.
ACTEMRA [package insert]. South San Francisco, CA: Genentech, Inc.
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