Flebogamma 5% DIF

Flebogamma 5% DIF Dosage/Direction for Use

human normal immunoglobulin




Full Prescribing Info
Dosage/Direction for Use
The dose and dosage regimen is dependent on the indication.
In replacement therapy, the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.
Replacement Therapy in Primary Immunodeficiency Syndromes: The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4-6 g/L. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4-0.8 g/kg followed by at least 0.2 g/kg every 3 weeks.
The dose required to achieve a trough level of 6 g/L is of the order of 0.2-0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2-4 weeks.
Trough levels should be measured in order to adjust the dose and dosage interval.
Replacement Therapy in Myeloma or Chronic Lymphocytic Leukaemia with Severe Secondary Hypogammaglobulinaemia and Recurrent Infections; Replacement Therapy in Children with AIDS and Recurrent Infections: Recommended Dose: 0.2-0.4 g/kg every 3-4 weeks.
Idiopathic Thrombocytopenic Purpura: For the treatment of an acute episode, 0.8-1 g/kg on day 1, which may be repeated once within 3 days, or 0.4 g/kg daily for 2-5 days. The treatment can be repeated if relapse occurs.
Guillain-Barré Syndrome: 0.4 g/kg/day for 3-7 days. Experience in children is limited.
Kawasaki Disease: 1.6-2 g/kg should be administered in divided doses over 2-5 days or 2 g/kg as a single dose.
Patients should receive concomitant treatment with acetylsalicylic acid.
Allogeneic Bone Marrow Transplantation: Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.
For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting 7 days before transplantation and for up to 3 months after transplantation.
In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.
Administration: Flebogamma 5% DIF should be infused IV at an initial rate of 0.01-0.02 mL/kg/min for the first 30 min. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 mL/kg/min.
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