ACTEMRA Monitoring Guidelines
Monitoring guidelines and dose modifications for RA patients treated with ACTEMRA
- In ACTEMRA clinical studies, labs were generally drawn at the time of infusion
Neutrophils
- 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 experience
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It is not recommended to initiate ACTEMRA treatment in patients with a low neutrophil count, ie absolute neutrophil count (ANC) <2000/mm3
- In patients who develop an ANC <500/mm3 treatment is not recommended
- Neutrophils should be monitored every 4 to 8 weeks
- ACTEMRA should not be administered to patients with an active infection, including localized infections
Lipids
- Treatment with ACTEMRA was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol
- Assessment of lipid parameters should be performed approximately 4 to 8 weeks following initiation of ACTEMRA therapy, then at approximately 6-month intervals
- Patients should be managed according to clinical guidelines for the management of hyperlipidemia
Platelets
- 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
- It is not recommended to initiate ACTEMRA treatment in patients with a platelet count <100,000/mm3
- In patients who develop a platelet count <50,000/mm3 treatment is not recommended
- Platelets should be monitored every 4 to 8 weeks
Liver Function Tests - Hepatic Transaminases
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In ACTEMRA clinical studies, in patients experiencing liver enzyme elevation, modification of treatment regimen, such as reduction in the dose of concomitant DMARD, interruption of ACTEMRA or reduction in ACTEMRA dose, resulted in decrease or normalization of liver enzymes
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It is not recommended to initiate ACTEMRA treatment in patients with elevated transaminases ALT or AST<1.5x ULN
- In patients who develop elevated ALT or AST <5x ULN, treatment is not recommended
- ALT and AST levels should be monitored every 4 to 8 weeks. When clinically indicated, other liver function tests such as bilirubin should be considered
INDICATION
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
IMPORTANT SAFETY INFORMATION
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA.
- If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations and hypersensitivity reactions. Other potential risks of ACTEMRA include demyelinating disorders, malignancies, and changes to certain lab parameters.
Common adverse reactions include upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.
Please see full Prescribing Information including Boxed Warning for additional important safety information.
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