Flebogamma DIF

Flebogamma DIF

human normal immunoglobulin

Manufacturer:

Grifols

Distributor:

DKSH
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
Replacement therapy in primary immunodeficiency syndromes eg, congenital agammaglobulinaemia & hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, Wiskott Aldrich syndrome; myeloma or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; childn w/ congenital AIDS & recurrent infections. Immunomodulation of idiopathic thrombocytopenic purpura (ITP), in childn or adults at high risk of bleeding or prior surgery to correct the platelet count; Guillain-Barre syndrome; Kawasaki disease. Allogeneic bone marrow transplantation.
Dosage/Direction for Use
Replacement therapy in primary immunodeficiency syndromes Starting dose: 0.4-0.8 g/kg followed by 0.2-0.8 g/kg 2-4 wkly to achieve IgG trough level of 4-6 g/L. Replacement therapy in myeloma or chronic lymphatic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; replacement therapy in childn w/ AIDS & recurrent infections 0.2-0.4 g/kg 3-4 wk. ITP 0.8-1 g/kg on day 1, may be repeated once w/in 3 days, or 0.4 g/kg daily for 2-5 days. Guillain-Barre syndrome 0.4 g/kg daily for 3-7 days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days or 2 g/kg as a single-dose in combination w/ acetylsalicylic acid. Allogeneic bone marrow transplantation 0.5 g/kg wkly starting 7 days before & up to 3 mth after transplantation for the treatment of infections & prophylaxis of graft versus host disease, & 0.5 g/kg mthly until Ab levels return to normal in persistent lack of Ab production.
Contraindications
Hypersensitivity to homologous Ig especially in IgA deficiency due to Ab against Ig (rare). Fructose intolerance.
Special Precautions
High rate of infusion; patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency, receiving human normal Ig therapy for the 1st time, or when human normal Ig is switched or during long interval since the previous infusion (rare). Obese patients; preexisting risk for thrombotic events. Discontinue use in case of renal impairment. Maintain adequate hydration prior to initiation; monitor urine output & serum creatinine levels; avoid concomitant use w/ loop diuretics. Perform appropriate tests for the presence of antineutrophil Ab if transfusion-related acute lung injury is suspected. May interfere w/ serological test for red cell Ab eg, Coombs' test. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Headache, pyrexia, inj site reaction.
Drug Interactions
Live attenuated virus vaccine.
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Flebogamma DIF soln for infusion 5%
Packing/Price
10 mL x 1's;100 mL x 1's;200 mL x 1's;400 mL x 1's;50 mL x 1's
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