What are the most common side effects with RETHYMIC? 29 of the patients died, including 23 in the first year after implantation of RETHYMIC. If they are present, then it will be necessary to receive RETHYMIC from a certain group of donors that do not have these proteins.Дeaths: 105 children participated in the clinical studies of RETHYMIC. HLA Typing: If your child has received a hematopoietic cell transplantation (HCT) or a solid organ transplant, they will have a test to look for specific antibodies that could interfere with the effect of RETHYMIC.

If your child has these antibodies, he/she will need to receive RETHYMIC from a donor that does not express those HLA proteins. Talk to your childвЂ™s doctor prior to any vaccinations.ДЄnti-HLA Antibodies: Prior to receiving RETHYMIC your child will be tested for HLA antibodies, which are proteins that may be present in your childвЂ™s blood. Vaccinations: Your child should not receive any vaccinations until he or she has met certain requirements set by your doctor.

Transmission of Serious Infections: Because RETHYMIC is made from human tissue, and animal products are used in the manufacturing process, transmission of infectious diseases may occur. Your childвЂ™s doctor will monitor your child through testing for Epstein-Barr virus (EBV) and cytomegalovirus (CMV), which are two viruses that can cause cancer. Talk to your doctor about the benefits/risks of treatment if your child has pre-existing CMV infection.Д¬ancer: Due to your childвЂ™s weakened immune system, there is increased risk of developing certain cancers. Kidney Disease: Treatment with RETHYMIC is a risk factor for death in patients with pre-existing kidney disease.Д¬ytomegalovirus (CMV) Infection: In clinical studies with RETHYMIC, 3 out of 4 patients with pre-existing CMV infection prior to the implantation with RETHYMIC died. Your doctor will monitor your child regularly including performing blood tests. These events included: low platelets, low white blood cells, protein in urine, low red blood cells, hair loss, poor thyroid function, inflammation of liver, inflammation of the joints, inflammation of the spinal cord, loss of pigment in the skin, eyes and hair, overactive thyroid function, and loss of function of the ovaries. Symptoms of GVHD may include fever, rash, enlarged lymph nodes, inflammation of the gastrointestinal system and/or diarrhea.ДЄutoimmune Disorders: Autoimmune-related adverse events occurred in patients treated with RETHYMIC. Your child will be monitored for GVHD and treated if needed. Graft versus Host Disease (GVHD): RETHYMIC may cause or make pre-existing GVHD worse. Your child should be maintained on immunoglobulin replacement and prophylactic antimicrobials until certain criteria are met as determined by your doctor. Monitor your child closely for signs of infection, including fever. Your childвЂ™s doctor should advise you of infection control measures which should be followed immediately after treatment and until the immune system starts working at a sufficient level. Immune reconstitution is needed for the body to produce cells in the immune system to fight infection. Infection Control: Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC.

Residual thymic tissue