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Tacrolimus by Immunoassay : 1004635
MessageSince the therapeutic ranges also vary according to the commercial test used, consistent use of one assay for individual patients is recommended.
Test Code
TACRIA or 1004635
Alias/See Also
FK506; Prograf; Protopic
CPT Codes
80197
Instructions
Only lavender top tube (EDTA) specimen is acceptable.
Transport Container
Label specimen with both the time of collection and the last drug administration. Transport whole blood (EDTA).
Transport Temperature
Refrigerated.
Specimen Stability
Ambient: 8 hours; Refrigerated: 7 days; Frozen: 6 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Any sample other than whole blood collected in EDTA tube.
Methodology
Chemiluminescent Microparticle Immunoassay (CMIA)
Setup Schedule
Sunday - Saturday
Report Available
1 day
Reference Range
Variable. Patient transplant type and stage dependent. Clinical evaluation is required.
Clinical Significance
Quantitative determination of Tacrolimus in Human Whole Blood is used as an aid in the management of Liver and Kidney allograft patients receiving Tacrolimus therapy.
Tacrolimus, an immunosuppressive drug has been shown to be effective for treatment of organ rejection following liver and kidney transplantation. Clinical studies are in progress regarding its use in other indications. Tacrolimus is bound to proteins, mainly albumin and alpha-1-acid glycoprotein, and is highly bound to erythrocytes. Pharmacokinetics studies indicated that whole blood serves as the more appropriate medium to describe the pharmacokinetic properties of Tacrolimus. Tacrolimus is extensively metabolized in the liver and small intestine and nine of its metabolites have been identified. The use of Tacrolimus is associated with serious toxic side effects e.g. nephrotoxicity. Other side effects include neurotoxicity, insomnia and nausea.
Note:
Numerous factors contribute to variable requirements for optimal blood levels of Tacrolimus e.g. the complexity of the clinical state, individual differences in sensitivity to immunosuppressive and nephrotoxic effects of Tacrolimus, co-administration of other immunosuppressants, type of transplant, and time after transplant. Therefore, no firm therapeutic range exists for Tacrolimus in whole blood. Since the therapeutic ranges also vary according to the commercial test used, consistent use of one assay for individual patients is recommended.
Tacrolimus, an immunosuppressive drug has been shown to be effective for treatment of organ rejection following liver and kidney transplantation. Clinical studies are in progress regarding its use in other indications. Tacrolimus is bound to proteins, mainly albumin and alpha-1-acid glycoprotein, and is highly bound to erythrocytes. Pharmacokinetics studies indicated that whole blood serves as the more appropriate medium to describe the pharmacokinetic properties of Tacrolimus. Tacrolimus is extensively metabolized in the liver and small intestine and nine of its metabolites have been identified. The use of Tacrolimus is associated with serious toxic side effects e.g. nephrotoxicity. Other side effects include neurotoxicity, insomnia and nausea.
Note:
Numerous factors contribute to variable requirements for optimal blood levels of Tacrolimus e.g. the complexity of the clinical state, individual differences in sensitivity to immunosuppressive and nephrotoxic effects of Tacrolimus, co-administration of other immunosuppressants, type of transplant, and time after transplant. Therefore, no firm therapeutic range exists for Tacrolimus in whole blood. Since the therapeutic ranges also vary according to the commercial test used, consistent use of one assay for individual patients is recommended.
Performing Laboratory
med fusion
