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HEALTHCARE OPERATIONS UTILIZATION PROTOCOLS 2007 Unlabeled uses: IGIVs may also be useful in chronic fatigue syndrome; quinidine-induced thrombocytopenia; chronic inflammatory demyelinating polyneuropathy; Guillain-Barre syndrome Dosing Recommendations 1. Immunodeficiency syndrome a. Sandoglobulin: Administer 100–400 mg/kg/month by infusion. Increase to 300mg/kg if IgG serum level is 100mg/kg are recommended. c. Gammar-P IV: Administer 200 to 400mg/kg every 3 to 4 weeks in adults. d. Gamimune N: Administer 100 to 200mg/kg/month. The dosage may be given more frequently or increased as high as 400 mg/kg (8 mL/kg) if the clinical response is inadequate or the level of IgG is insufficient e. Iveegam: 200mg/kg/month. Doses of 800 mg/kg/month have been tolerated f. Polygam S/D: 100mg/kg/month. An initial dose of 200 to 400 mg/kg may be administered to individualize treatment. g. Venoglobulin-S: 200mg/kg/month -4- This guideline is to be used in the decision-making process and does not represent standards of care of an individual patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into account the unique problems and circumstances of the individual patient. They are proprietary documents and may not be copied or distributed without express permission.
HEALTHCARE OPERATIONS UTILIZATION PROTOCOLS 2007 2. ITP a. Sandoglobulin: 400mg/kg for 2 to 5 consecutive days b. Venoglobulin-S: 2000mg/kg over < 5 days for induction therapy. Maintenance therapy: 1000 mg/kg may be administered as needed to maintain platelet counts of 30,000/mm 3 in children and 20,000/mm 3 in adults or to prevent bleeding episodes in the interval between infusions. c. Gamimune N: 400mg/kg may be given as a single infusion. If an adequate response does not result, the dose can be increased to 800 to 1000mg/kg given as a single infusion. Maintenance: If platelet count falls to < 30,000/mm 3 or if the patient manifests clinically significant bleeding, 400mg/kg may be given as a single infusion. If an adequate response does not result, the dose can be increased to 800 to 1000mg/kg given as a single infusion. Maintenance infusions may be administered intermittently as clinically indicated to maintain a platelet count > 30,000/mm 3 . d. Gammagard S/D: 1000mg/kg. Need for additional doses can be determined by clinical response and platelet count. Give up to 3 doses on alternate days if required. e. Polygam S/D: 1g/kg. A need for additional doses can be determined by clinical response and platelet count. Give up to three separate doses on alternate days, if required 3. CLL a. Gammagard S/D: 1000mg/kg b. Polygam S.D: 1g/kg 4. Kawasaki syndrome – Iveegam only: 400mg/kg/day for 4 consecutive days or a single dose of 2000mg/kg given over a 10-hour period. Initiate treatment within 10 days of onset of the disease. Treatment regimen should include aspirin, 100mg/kg each day through the 14 th day of illness, then 3 to 5mg/kg/day thereafter for 5 weeks. 5. Bone Marrow Transplantation - Gamimune N only: 500mg/kg (10ml/kg) beginning on days 7 and 2 pre-transplant or at the time conditioning therapy for transplantation is begun, then weekly through the 90-day post-transplant period. 6. Pediatric HIV infection - Gamimune N only: 400mg/kg (8ml/kg) every 28 days. Bibliography 1. NIH Consensus Development Conference. Intravenous Immunoglobulin Prevention and Treatment of Disease. JAMA; December 26, 1990-Vol 264. No.24; 3189-3193 2. Knapp MJ, et al. Drug Reviews: Clinical uses of intravenous immune globulin. Clinical Pharmacy; Vol 9 Jul 1990:509-529 3. Consensus Statement. Recommendations for Off-Label Use of Intravenously Administered Immunoglobulin Preparations. JAMA, June 21, 1995-Vol 273. No.23; -5- This guideline is to be used in the decision-making process and does not represent standards of care of an individual patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into account the unique problems and circumstances of the individual patient. They are proprietary documents and may not be copied or distributed without express permission.
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