If an ongoing decline in your blood’s measured adenosine deaminase (ADA) activity occurs, your immune function and clinical status will be monitored closely and precautions will be taken to help reduce your risk of infection. This monitoring will ensure you are maintaining appropriate levels for therapeutic benefit.While you are being treated with Revcovi, your doctor will need to do blood tests to monitor the levels of ADA activity and metabolites and overall immune function.Continuous therapy and adherence to the recommended drug schedule is important for the success of the treatment.What types of monitoring will be needed while I am taking Revcovi? Cancers of the immune system called lymphomas.Skin-related problems: redness and itching at the injection site.Blood and blood cell–related problems: red blood cells being destroyed faster than they can be made, resulting in anemia and higher or lower than normal number of platelets in the blood.Based on reports of side effects of other enzyme replacement therapies used to treat ADA-SCID, which are similar to Revcovi, patients taking Revcovi may also experience:.Cough and vomiting were the most common side effects reported by patients receiving Revcovi.What are the possible side effects of Revcovi? During this delay, it is important to be protected from exposure to infections until your immune system improves. There may be a delay in improvement of your immune system’s function after starting Revcovi treatment.Your doctor should not prescribe Revcovi if you have severely low blood platelet counts. If you have lower than normal platelet counts, you may be at increased risk of bleeding at the injection site.In the past three years there has been an unprecedented increase in the number of gene therapy clinical trials and as the results of these trials start to accumulate, we can hopefully look forward to more success stories, which will hopefully boost the reputation of the gene therapy field.Important Safety Information Warnings and Precautions: But all indications thus far show that this is not the case and it has been argued that the mechanism of the ADA-SCID disease is sufficiently different that this is unlikely to occur. It remains to be seen whether a similar insertional mutagenesis event will occur in the ADA-SCID patients. It is well known that the major setback in the X-linked SCID trial was the unfortunate development of leukemia from retroviral-transduced cells that was corellated with integration of the therapeutic gene near a specific locus. This is exciting news for the gene therapy field and extends on the initial success of the X-linked SCID trials, where gene transfer was demonstrated to fully re-constitute the immune system of boys suffering from this disorder. The results show that 8/10 treated patients demonstrated sufficient re-constitution of their immune system to warrant the cesation of the standard enzyme-replacement therapy (the current standard of care in this disorder). The authors of the current study report the four year follow-up on a group of patients that received transfusion of autologous CD34+ bone marrow cells transduced with a retroviral vector containing the ADA gene. Consequently, the immune system of the afflicted individual is severely compromised or completely lacking. The result is that the substrates for this enzyme accumulate in cells and as immature lymphoid cells of the immune system are particularly sensitive to the toxic effects of these unused substrates, the cells fail to reach maturity. This is a form of severe combined immuno-deficiency (SCID) where there is a lack of the enzyme adenosine deaminase (ADA), coded for by a gene on chromosome 20. A recent article published on the New England Journal of medicine by Aiuti and colleagues reports on the progress of 10 patients that have been treated for ADA-SCID by gene therapy.
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