human normal immunoglobulin


CSL Behring


Concise Prescribing Info
Human normal Ig (IVIg)
Replacement therapy in primary immunodeficiency syndromes (PID) w/ impaired Ab production; secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment & either proven specific Ab failure or serum IgG level <4 g/L. Immunomodulation in primary immune thrombocytopenia (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barré syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (CIDP); multifocal motor neuropathy (MMN).
Dosage/Direction for Use
IV Initially infuse at a rate of 0.3 mL/kg/hr for approx 30 min, may be gradually increased to 4.8 mL/kg/hr if well tolerated. If infusion rate of 4.8 mL/kg/hr is well tolerated by PID patient, may be further gradually increased to a max of 7.2 mL/kg/hr. Adult, adolescent & childn (0-18 yr) Individualise dose based on clinical response. PID Initial dose: 0.4-0.8 g/kg, followed by at least 0.2 g/kg every 3-4 wk. Maintenance dose: 0.2-0.8 g/kg every 3-4 wk to obtain IgG trough levels of at least 6 g/L. SID 0.2-0.4 g/kg every 3-4 wk to obtain IgG trough levels of at least 6 g/L. 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. The treatment can be repeated if relapse occurs. Guillain-Barré syndrome 0.4 g/kg daily for 5 days. Kawasaki disease 2 g/kg as a single dose concomitantly w/ ASA. CIDP Initially 2 g/kg divided over 2-5 consecutive days followed by maintenance doses of 1 g/kg over 1-2 consecutive days every 3 wk. MMN Initially 2 g/kg over 2-5 consecutive days followed by maintenance doses of 1 g/kg every 2-4 wk or 2 g/kg every 4-8 wk.
Hypersensitivity. Patients w/ selective IgA deficiency who developed IgA Abs. Patients w/ hyperprolinaemia type I or II.
Special Precautions
Adverse reactions may occur more frequently in case of high infusion rate; in patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency; in patients naïve to human normal Ig, switched from an alternative product, or having a long interval since the previous infusion. Ensure adequate hydration prior to infusion. Monitor urine output & serum creatinine levels. Avoid concomitant use of loop diuretics. Take into account the presence of glucose in the recommended diluent for patients w/ DM requiring dilution to lower conc. Monitor for clinical signs & symptoms of haemolysis & consider treatment discontinuation if they develop during or after an infusion. Aseptic meningitis syndrome may occur more frequently in association w/ high-dose (2 g/kg) IVIg treatment. Administer at the min infusion rate & dose practicable in patients at risk of thrombosis & acute renal failure. Measure baseline blood viscosity in individuals at risk of hyperviscosity. Caution in prescribing & infusing in obese patients & in patients w/ pre-existing risk factors for thrombotic events. Renal parameters should be assessed prior to infusion & at appropriate intervals thereafter. Consider IVIg discontinuation in case of renal impairment. Reports of acute non-cardiogenic pulmonary oedema (transfusion-related acute lung injury). Immediately stop infusion in case of pulmonary adverse reactions. Interference w/ serological testing. Possibility of transmitting infective agents. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Use of IVIg high-dose in childn. Childn w/ CIDP.
Adverse Reactions
Headache; pain, pyrexia, flu-like illness. Anaemia, haemolysis, leukopenia; hypersensitivity; dizziness; HTN, flushing, hypotension; dyspnoea; nausea, vomiting, diarrhoea, abdominal pain; hyperbilirubinaemia; skin disorder (including rash, pruritus, urticaria, maculo-papular rash, erythema, skin exfoliation); myalgia; fatigue, asthenia; decreased Hb, positive Coombs' (direct) test, increased ALT, AST & blood LDH.
Drug Interactions
Impaired efficacy of live attenuated virus vaccines eg, measles, rubella, mumps, & varicella for at least 6 wk & up to 3 mth. In the case of measles, the impairment may persist for up to 1 yr.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Privigen soln for infusion 5 g/50 mL
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