irradiated blood and components

Irradiated blood and blood components are cellular blood products that have been subjected to radiation with gamma rays or X-rays. Irradiated blood and components are used for transfusion in patients at risk for transfusion-associated graft-versus-host disease (TA-GVHD). Blood products that are irradiated include whole blood, and cellular components such as red blood cells, platelets and granulocytes, types of white cells (immune cells) in the blood.

Transfusion-associated graft-versus-host disease is a rare but usually fatal condition in which the lymphocytes (T-cells) in the donor blood product attack the recipient’s tissue, in patients who are immunosuppressed and are unable to produce an immune response. TA-GVHD can attack the blood-forming (hematopoietic) cells as well as other tissue leading to fatal complications.

Washing and leukocyte-reducing processes can remove most of the lymphocytes in the blood products, but cannot completely eliminate them. Subjecting the blood components to 25 Gray (Gy) irradiation inactivates the lymphocytes and renders them incapable of division and proliferation, thus preventing TA-GVHD. Only blood components that are likely to contain lymphocytes require irradiation. Components such as cryoprecipitate and thawed plasma are not associated with GVHD, however, fresh plasma may contain lymphocytes.

• Do not use irradiation for hematopoietic progenitor cell and donor lymphocyte infusions, because it will prevent their ability to grow and proliferate, defeating the purpose it is intended for.
• Irradiation is not to be used for blood and component infusion in patients with the following conditions:
  • Human immunodeficiency virus (HIV) infection
  • Most solid tumors
  • Isolated humoral immunodeficiency
  • Hemophilia, an inherited bleeding disorder
  • Receiving routine immunosuppressive medications such as corticosteroids
  • Hemoglobin disorders such as sickle cell disease or thalassemia, who have not had a hematopoietic progenitor cell transplant
• Irradiation shortens the life span of red blood cells (RBCs) to 28 days or less, and they can leak potassium into the extracellular fluid within a few days after irradiation. This can be dangerous in large volume or rapid infusions, or when infused close to the heart through a central venous catheter, especially in infants. Stored irradiated RBCs should be washed before infusion in such patients.
• Extracellular free hemoglobin concentration also increases more rapidly during storage in irradiated red cells than in those that are not irradiated.
• Irradiation of 25 Gray is not known to affect platelet function significantly.
• All irradiated blood component transfusions must be given using blood administration sets containing 170- to 260-micron filters or 20- to 40-micron microaggregate filters, unless transfusion is given via a bedside leukocyte reduction filter.
• No other medications or fluids other than normal saline should be simultaneously given through the same line as irradiated blood components without prior consultation with the medical director of the blood bank.
• Monitor patients for signs of transfusion reaction, including vital signs, before, during, and after transfusion. If a transfusion reaction is suspected, stop the transfusion, assess and stabilize the patient, and notify the blood bank to initiate an investigation.
• Please see the specific component monograph on the prescription label for full safety information.
• Consult with the blood bank medical director or a hematologist if you have questions regarding special transfusion requirements.

Common side effects of irradiated blood and components include:

• Hemolytic transfusion reactions that destroy red blood cells 
• Feverish (febrile) non-hemolytic reactions
• Transfusion related acute lung injury (TRALI)
• Transfusion-associated circulatory overload (TACO)
• Allergic reactions such as:
  • Hives (urticaria)
  • Itching (pruritus)
  • Wheezing
  • Shortness of breath (dyspnea)
  • Low blood pressure (hypotension)
• Serious allergic (anaphylactic) reactions including:
  • Swelling under the skin and mucous membrane (angioedema)
  • Respiratory distress
  • Shock
• Transfusion-associated graft-versus-host disease (TA-GVHD)
• Transfusion-transmitted infections and septic reactions
• Post-transfusion bruising (purpura)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult and Pediatric

Prevention of Transfusion Associated Graft Versus Host Disease

• Please see specific component monograph (i.e., Red Blood Cells (RBCs), Platelets, Granulocytes, or Whole Blood) for dosing as there is no difference on dosing irradiated blood products from non-irradiated blood products.

Other Indications and Uses

Prevention of Transfusion Associated Graft Versus Host Disease (TA-GVHD) in cellular blood products given to

• Patients receiving products from first-degree relatives* or HLA-matched donors regardless of the patient’s immune status
• Immunocompromised patients such as
  • Infants (particularly premature) up to 4, 6, or 12 months depending on institutional policy
  • Intrauterine transfusion* and/or neonatal exchange transfusion recipients
  • Congenital immunodeficiency disorders of cellular immunity (i.e., severe combined immunodeficiency [SCID], DiGeorge syndrome)*
  • Hematopoietic progenitor cell transplant recipients*
  • Hodgkin’s disease*, Leukemia, or Lymphoma patients
  • Patients treated with nucleoside analogs (i.e., fludarabine)
  • Patients requiring granulocyte transfusions*
  • Solid Organ Tumor patients undergoing intense chemotherapy (controversial and not universal)
  • Solid organ transplant recipient (controversial and not universal)
  • Aplastic anemia with severe lymphocytopenia (controversial and not universal)
• Irradiation of thawed plasma and cryoprecipitate are not necessary as they have never been associated with TA-GVHD. Fresh liquid plasma (never frozen) may have a small amount of viable lymphocytes and should be irradiated if the patient has indications for irradiated cellular blood products.

The starred indications are considered absolute indications for irradiation of cellular blood products. Many of the other indications listed are considered probable or controversial indications depending upon the linkage of TA-GVHD to these conditions. Utilization of irradiated products for these conditions should be based upon institutional policy as well as patient specific determinants.

Consult with your blood bank medical director for questions regarding indications of irradiated blood products.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Irradiated blood and components have no severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Please see the specific component monograph on the prescription label for information on irradiated blood and components use during pregnancy.