You Know About the Risk of Over-immunosuppression
- Potent immunosuppressive drugs have reduced
the incidence of allograft rejection while increasing susceptibility
to infection and malignancy2
- Over-immunosuppressed patients are at increased
risk for opportunistic infections, including reactivation of latent
- 50%-75% of transplant patients will have evidence
of microbial invasion in the first year posttransplant3
- Immunosuppressant drug labeling must now include
stronger warnings about the increased risk for viral infections
related to over-immunosuppression4
- The FDA recently recommended that transplant
patients be monitored closely for signs of over-immunosuppression
to reduce the risk of infection4
- Immunosuppressant drug monitoring is insufficient
for determining the level of immunosuppression or directing changes
in treatment regimens5
- ImmuKnow detects changes in CD4 cell ATP production,
a known biomarker of global immune function7,8
The ImmuKnow assay is used to assess cell‐mediated
immunity in immunosuppressed patients and is intended to be used as
an adjunct to current immune function assessments. Used over time,
the ImmuKnow assay provides important qualitative information about
changes in immune function.
Working from a baseline established for each patient,
the ImmuKnow assay is repeated regularly for longitudinal, individualized
assessment of changes in global immune status.
2. Fishman JA. Infection in solid-organ
transplant recipients. N Engl J Med. 2007;357:2601-2614. 3. American
Society of Transplantation. Infectious disease guidelines for transplantation.
Am J Transplant. 2004;4(suppl 10):5-166. 4. The U.S. Food and Drug Administration.
Information for healthcare professionals: immunosuppressant drugs:
required labeling changes. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm.
Accessed August 14, 2009. 5. The U.S. Food and Drug Administration. Class
II Special Controls Guidance Document: cyclosporine and tacrolimus
assays; guidance for industry and FDA. 2002. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092778.htm.
Accessed August 19, 2009. 7. Augustine NH, Pasi BM, Hill HR. Comparison
of ATP production in whole blood and lymphocyte proliferation in response
to phytohemagglutinin. J Clin Lab Anal. 2007;21:265-270. 8. Sottong
PR, Rosebrock JA, Britz JA, Kramer TR. Measurement of T-lymphocyte
responses in whole-blood cultures using newly synthesized DNA and ATP.
Clin Diagn Lab Immunol. 2000;7:307-311.