human normal immunoglobulin


CSL Behring


Zuellig Pharma
Concise Prescribing Info
Human normal Ig
Replacement therapy in primary immunodeficiency syndromes (PID) 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 eg, immune thrombocytopenic purpura (ITP) in childn or adult at high risk of bleeding or prior to surgical interventions to correct platelet count, Guillain-Barré syndrome, Kawasaki disease, & chronic inflammatory demyelinating polyneuropathy (CIDP). Allogeneic bone marrow transplantation.
Dosage/Direction for Use
IV infusion Individualized dosage. Replacement therapy in primary immunodeficiency syndromes Initially 0.4-0.8 g/kg followed by at least 0.2 g/kg every 3-4 wk. Replacement therapy in myelomas or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; replacement therapy in childn w/ congenital AIDS & recurrent infections 0.2-0.4 g/kg every 3-4 wk. Acute immune thrombocytopenic purpura 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-Barré syndrome 0.4 g/kg daily over 5 days. Kawasaki disease (in concomitant use w/ acetylsalicylic acid) 1.6-2 g/kg in divided doses over 2-5 days or 2 g/kg as a single dose. Chronic inflammatory demyelinating polyneuropathy Initially 2 g/kg divided over 2-5 consecutive days followed by maintenance doses of 1 g/kg given on 1 day or divided over 2 consecutive days every 3 wk. Allogeneic bone marrow transplantation Initially 0.5 g/kg wkly, commencing 7 days before the transplant & 3 mth after the transplant. If lack of Ab production persists, a dose of 0.5 g/kg mthly is recommended until IgG Ab levels return to normal.
Hypersensitivity to human normal Ig; & human Ig especially in patients w/ IgA deficiency where the patient has anti-IgA Ab. Hyperprolinaemia.
Special Precautions
High rate of infusion, patients w/ hypogammaglobulinaemia or agammaglobulinaemia w/ or w/o IgA deficiency; 1st time receiving human normal Ig or, when human normal Ig is switched or w/ a long interval since the previous infusion. Ensure adequate hydration prior to infusion. Haemolytic anemia may develop w/ risk factors eg, high doses, whether given as single or divided over several days; blood group A, B & AB; underlying inflammatory state. Aseptic meningitis syndrome may occur. Caution in obese patients & patients w/ preexisting risk factors for thrombotic events eg, advanced age, HTN, DM, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, severe hypovolaemia, diseases which increased blood viscosity. Acute renal failure. Monitor patients for pulmonary adverse reactions. May affect the ability to drive & use machinery. Pregnancy & lactation. Childn.
Adverse Reactions
Headaches (including sinus headache, migraine, head discomfort); nausea, vomiting, diarrhea; skin disorders (including rash, pruritus, urticaria); pain (including back pain, pain in extremity, arthralgia, neck pain, facial pain), pyrexia (including chills, increased body temp, hyperthermia), influenza-like illness (including nasopharyngitis, influenza, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness). Anemia, leukopenia, haemolysis (including haemolytic anemia); arisocytosis (including microcytosis); hypersensitivity; dizziness (including vertigo); palpitations (including tachycardia); HTN (including increased BP, procedural HTN, increased diastolic BP), flushing (including hot flush, hyperaemia, night sweats), hypotension (including decreased BP); dyspnoea (including chest pain, oropharyneal blistering, painful respiration, throat tightness, chest discomfort); abdominal pain (including upper abdominal pain, stomach discomfort, lower abdominal pain, abdominal tenderness; hyperbilirubinaemia (including increased conjugated bilirubin, increased unconjugated blood bilirubin, increased blood bilirubin); myalgia (including muscle spasms, musculoskeletal stiffness, musculoskeletal pain); fatigue, asthenia (including muscular weakness), inj (infusion) site pain; Coombs' direct test positive (Coombs' test positive), decreased Hb (including decreased haematocrit, decreased haptoglobin), increased alanine aminotransferase, increased blood dehydrogenase, increased alanine aminotransferase, increased aspartate aminotransferase.
Drug Interactions
May decrease efficacy of live attenuated vaccines eg, measles, mumps, rubella & chickenpox vaccines.
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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