Infusion of intravenous gamma globulin (immunoglobulins)

Transcription

1 Infusion of intravenous gamma globulin (immunoglobulins) OBJECTIVES Intravenous gamma globulin therapy is indicated for replacement therapy in patients with primary and secondary antibody deficiency syndromes. The extent of impairment of antibody production may vary substantially and can involve all immune globulin classes, only one immune globulin class, or only IgG subclasses. Intravenous immune globulin is preferable to the intramuscular regime, because it allows for the delivery of high doses, the increase of serum IgG is fast and the infusions are not painful. INDICATIONS Idiopathic thrombocytopenia (ITP) Primary humoral immunodeficiency Pediatric AIDS Demyelinating polyneuropathies (Guillain-Barre syndrome) Replacement therapy for hypo and agammaglobulinemia, Transient antibody deficiency syndrome when there are concomitant infectious problems Antibody deficiency with hyper IgM, IgG subclass deficiency Combined immunodeficiency. Kawasaki disease. Dosage and frequency of administration of IVIG is different from other indications for IVIG administration. Patients with Kawasaki disease may have cardiac compromise and therefore a slower infusion rate is required. Please refer to specific section below for Kawasaki disease (page B-37-1). For further management of this disease, please see separate protocol. PRECAUTIONS Patients with IgA deficiency with class specific antibody to IgA may occasionally react. IgA depleted IVIG are available and maybe more appropriate for this patient population Patients with previous severe systemic reaction may need to be pre-medicated. Prior to commencing infusion, 2ml of blood are taken in a red stopper tube to measure pre-infusion values of IgA. This specimen is sent to the biochemistry laboratory. Patients with IgA deficiency can have an anaphylactic reaction with IVIG infusions. Some specific blood tests are also needed for Kawasaki disease. Check protocol beforehand to avoid unnecessary repeated venipunctures. EQUIPMENT AND SUPPLIES All I.V. immunoglobulin doses will be sent by Blood Bank. Requests for product can be done electronically using Traceline. The dose requested must be entered in grams. Ganunex and Intravenous immunoglobulin 10% 1 gram in 10 ml, 2.5 grams in 25 ml, 5 grams in 50 ml, 10 grams in 100 Gammagard 2% glucose, Iveegam is in a 5% glucose solution maltose. Also to have on hand in case of a reaction: - B-35 -

2 Epinephrine 1:1000: 0.01 mg/kg SC q minutes PRN (IV dose gives patient tremors) Minimum dose 0.1 mg and Maximum dose0.5 mg SC Benadryl (Diphenhydramine): 1 mg/kg IV Solucortef (Hydrocortisone): 5 mg/kg IV Immunoglobulins are only compatible in D5W Infusion pump Soluset X 2 Stopcock 250 ml bag of D5W Gloves Alcohol swabs to clean the connection sites It is recommended to use a 18 gauge needle to penetrate the rubber stopper when dispensing product from 10 ml vial sizes and a 16 gauge needle when dispensing product with 20 ml vial sizes or larger. PROCEDURE 1. Refer to the Guidelines for Administration of a Blood Transfusion including identification of patient and reviewing transfusion reactions. 2. Assure that you have a good IV Line with a proper gauge size. It is recommended that a gauge of be used for an adolescent and a gauge size of for a young child. 3. Wash hands with antiseptic soap. 4. Don gloves 5. Use aseptic technique 6. Prime soluset and stopcock with Immunoglobulin 7. Attach line of D5W to other end of stopcock 8. Do baseline vital signs. 9. Clean connection site with alcohol 10. Attach lines and begin infusion NB. The Alaris infusion pumps can be turned onto their side for the infusion of IVIG to prevent the formation of air bubbles. - B-36 -

3 IVIG PRODUCTS AVAILABLE IN BLOOD BANK Product that is usually used: Gammunex and Intravenous Immunoglobulin for Human Use 10% which should appear clean and clear on visual inspection. If the product is not clear on inspection, it should be returned to Blood Bank with the reason why. No filter is required for this type of IVIG. Also available but rarely used: Gammagard which comes as a powdered solution and is diluted by Blood Bank to a 10% solution. It requires filtration with a 15 micron filtering tubing that comes with the product from Blood Bank. This tubing is to be used to transfer product from bottle to soluset. Iveegam which also comes as a powdered solution and is diluted by Blood Bank to a 10% solution. It too must be filtered with a 15 micron filtering tubing that comes with the product from Blood Bank. This tubing is to be used to transfer product from bottle to soluset. For diabetic patients, please contact Endocrinology as these solutions contain glucose. Vial sizes 10 ml / 1.0 gram 25 ml / 2.5 grams 50 ml / 5.0 grams 100 ml / 10 grams 200 ml / 20 grams DOSAGE FOR ALL INDICATIONS OTHER THAN KAWASAKI DISEASE The dose administered may vary from g/kg depending on clinical response and serum levels of IgG attained. The dosage of gamma globulin and the frequency of its administration are determined by the treating physician. Patients with Severe Combined Immunodeficiency require replacement on a weekly basis of at least 150mg/kg. This dose may need to be adjusted upward depending on serum levels of IgG attained. In exceptional, life threatening instances (ITP, autoimmune hemolysis), patients may receive 1 gram/kg/day for 2 days for a total dose of 2 gm/kg. - B-37 -

4 Gamimmune usually infused at the following rate or at MD's discretion: for Kawasaki disease, rates differ. Please refer to IVIG infusion specific to Kawasaki disease at the end of present protocol. (page B-37-1) 0.01 ml/kg/min for 15 minutes 0.02 ml/kg/min for 15 minutes 0.03 ml/kg/min for 15 minutes 0.04 ml/kg/min for 15 minutes 0.05 ml/kg/min for 15 minutes 0.06 ml/kg/min for 15 minutes Increase as per orders and tolerance (see precautions and complications section) until the end of the infusion. For small children and infants, may not be able to infuse higher volumes (such as > 60 cc/hr) due to fluid overload. The tubing used to infuse stable blood products must be changed every 24 hrs. PRECAUTIONS AND COMPLICATIONS Intravenous gammaglobulin preparations can on occasion cause a precipitous fall in blood pressure and the clinical picture of anaphylaxis. If patient develops fever, chills, shortness of breath or urticaria, contact MD and slow rate to previous tolerated rate. These reactions are sometimes related to the rate of infusion. The patient's vital signs must therefore be monitored continuously and careful observation made for any symptoms throughout the entire infusion. If symptoms disappear, continue infusion at present rate. If reaction persists, then stop the infusion and notify physician again. If the reaction is severe (anaphylactic), stop the infusion, infuse Normal Saline TKVO and contact the physician. Adrenaline should always be available for treatment of any acute anaphylactoid reaction. Other reported complications include aseptic meningitis, renal dysfunction, acute renal failure and osmotic nephrosis. Patients predisposed to acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or those receiving nephrotic drugs. To monitor vital signs: pre-infusion vital signs must be recorded to establish a baseline; check every 15 minutes or every time you increase the rate; check 15 minutes after it is completed. N.B.: Once the patient's tolerance for a particular IVIG preparation is established (normally after 6-8 infusions), vital signs only need to be taken before the infusion, 15 minutes after the start of the IV infusion and then every hour while it is running and 15 minutes after the infusion ends. B-37-a

5 Patients with selective IgA deficiency may have true anaphylactic reactions due to the trace quantities of IgA in most intravenous gammaglobulin preparations. These patients frequently have anti IgA antibodies despite having never received blood or blood products previously. If an anaphylactic or anaphylactoid reaction occurs, the infusion is to be discontinued immediately, the treating physician notified and treatment with adrenaline, antihistamines Diphenhydramine (Benadryl), and/or steroids instituted. When symptoms subside it is usually possible to resume the infusion at a rate which is tolerated by the patient. DOSAGE PROTOCOL OF INTRAVENOUS IMMUNOGLOBULIN FOR KAWASAKI DISEASE SPECIFICALLY (for all others, see Infusion of intravenous gamma globulin above) Dose and frequency: 2 grams/kg x 1 dose to be infused over hours. Start at ml/kg/min for 2 hours. If tolerated, increase to ml/kg/min for 1 hour. If tolerated, increase to ml/kg/min for 1 hour. If tolerated, increase to ml/kg/min for 1 hour. If no fluid overload exists, then increase to ml/kg/min for the remainder of the dose. Progress to next infusion rate only if there is no adverse reaction (hypotension or other sign of anaphylactic reaction (see precautions and complications). Example Patient s weight is 5 kg. Therefore dose at 2 grams/kg = 10 grams Therefore: 0.01 ml/kg/min = 0.01 x 5 = 0.05 ml/min x 60 min = 3 ml/hr for 2 hours 0.02 ml/kg/min = 0.02 x 5 = 0.1 ml/min x 60 min = 6 ml/hr for 1 hours 0.03 ml/kg/min = 0.03 x 5 = 0.15 ml/min x 60 min = 9 ml/hr for 1 hours 0.04 ml/kg/min = 0.04 x 5 = 0.2 ml/min x 60 min = 12 ml/hr for 1 hours 0.05 ml/kg/min = 0.05 x 5 = 0.25 ml/min x 60 min = 15 ml/hr for 5 hours Start infusion at 3 ml/hour for 2 hours, if no reaction occurs, Increase to 6 ml/hour for one hour, if no reaction occurs, Increase infusion to 9 ml/hour for 1 hour if no reaction, Increase to 12 ml/hour for 1 hour, if no reaction, Increase infusion to 15 ml/hour for the rest of the infusion. Confirmation that the product was infused can either be done by sending the tear off part of the requisition back to blood bank or entering this electronically using Traceline. Reviewed - February 1994 Revised April 2000 (P. Farnesi and Dr. Bond, Hematology Revised December 2001 (Transfusion Safety Committee) Revised July 2004 (Dr. B. Mazer, Dr R. Scuccimarri, Dr. H. Rich, and K.Tanguay)approved by NPDQM committee - B-37-b -