inal perforation. Promptly eva luate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation [see ADVERSE REACTIONS (6.1)].
5.3 Laboratory Parameters
Rheumatoid Arthritis
Neutropenia
Treatment with ACTEMRA was associated with a higher incidence of neutropenia. Infections have been uncommonly reported in association with treatment-related neutropenia in long-term extension studies and postmarketing clinical experience.
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It is not recommended to initiate ACTEMRA treatment in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2000 per mm 3. In patients who develop an absolute neutrophil count less than 500 per mm 3 treatment is not recommended.
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Monitor neutrophils 4 to 8 weeks after start of therapy and every 3 months thereafter [see CLINICAL PHARMACOLOGY (12.2)]. For recommended modifications based on ANC results see [DOSAGE AND ADMINISTRATION (2.7)].
Thrombocytopenia
Treatment with ACTEMRA was associated with a reduction in platelet counts. Treatment-related reduction in platelets was not associated with serious bleeding events in clinical trials [see ADVERSE REACTIONS (6.1, 6.2)].
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It is not recommended to initiate ACTEMRA treatment in patients with a platelet count below 100,000 per mm 3. In patients who develop a platelet count less than 50,000 per mm 3 treatment is not recommended.
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Monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter. For recommended modifications based on platelet counts see [DOSAGE AND ADMINISTRATION (2.7)].
Elevated Liver Enzymes
Treatment with ACTEMRA was associated with a higher incidence of transaminase elevations. These elevations did not result in apparent permanent or clinically evident hepatic injury in clinical trials [see ADVERSE REACTIONS (6.1, 6.2)]. Increased frequency and magnitude of these elevations was observed when potentially hepatotoxic drugs (e.g., MTX) were used in combination with ACTEMRA.
In one case, a patient who had received ACTEMRA 8 mg per kg monotherapy without elevations in transaminases experienced elevation in AST to above 10× ULN and elevation in ALT to above 16× ULN when MTX was initiated in combination with ACTEMRA. Transaminases normalized when both treatments were held, but elevations recurred when MTX and ACTEMRA were restarted at lower doses. Elevations resolved when MTX and ACTEMRA were discontinued.
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It is not recommended to initiate ACTEMRA treatment in patients with elevated transaminases ALT or AST greater than 1.5× ULN. In patients who develop elevated ALT or AST greater than 5× ULN treatment is not recommended.
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Monitor ALT and AST levels 4 to 8 weeks after start of therapy and every 3 months thereafter. When clinically indicated, other liver function tests such as bilirubin should be considered. For recommended modifications based on transaminases see [DOSAGE AND ADMINISTRATION (2.7)].
Lipid Abnormalities
Treatment with ACTEMRA was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol [see ADVERSE REACTIONS (6.1, 6.2)].
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Assess lipid parameters approximately 4 to 8 weeks following initiation of ACTEMRA therapy, then at approximately 24 week intervals.
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Manage patients according to clinical guidelines [e.g., |
