human normal immunoglobulin


CSL Behring


Concise Prescribing Info
Human normal Ig
Replacement therapy in patients w/ primary immunodeficiency syndromes eg, congenital hypo- & agammaglobulinaemia, common variable & severe combined immunodeficiency, Wiskott-Aldrich syndrome; myeloma or chronic lymphocytic leukemia w/ severe secondary hypogammaglobulinaemia & recurrent infections. Maintenance therapy after stabilization w/ IVIg in chronic inflammatory demyelinating polyneuropathy (CIDP).
Dosage/Direction for Use
Adult & childn Replacement therapy Loading dose: 0.2-0.5 g/kg SC divided over several days. Maintenance dose: Divided into smaller doses at repeated intervals to reach cumulative mthly dose of 0.4-0.8 g/kg after steady-state IgG levels are attained. CIDP 0.2-0.4 g/kg SC wkly initiated 1 wk after last IVIg infusion.
Hypersensitivity to human Ig, IgA or IgG. Hyperprolinaemia type I & II.
Special Precautions
Discontinue immediately if allergic or anaphylactic type reactions is suspected. Not to be inj intravascularly. Not to exceed 20 mL/hr infusion rate. Arterial & venous thromboembolic events eg, MI, stroke, DVT & pulmonary embolism; preexisting risk factors for thrombotic events eg, in-dwelling vascular catheters, history of vascular disease or thrombotic episodes; CV risk factors eg, history of atherosclerosis &/or impaired cardiac output; acquired or inherited hypercoagulable states, prolonged periods of immobilization, severe hypovolemia, diseases increasing blood viscosity, advanced age, oestrogen use; aseptic meningitis syndrome. Patients w/ anti-IgA Ab, 1st time receiving human normal Ig therapy, or when human normal Ig is switched or long interval since previous infusion. Ensure adequate hydration prior to infusion. Possibility of transmitting infective agents. May interfere w/ serological testing. Pregnancy & lactation. Paed <18 yr.
Adverse Reactions
Nasopharyngitis; headache; rash; infusion site reactions. Dizziness, migraine; HTN; diarrhoea, abdominal pain, nausea, vomiting; pruritus, urticaria; musculoskeletal pain, arthralgia; fatigue, malaise, pyrexia, chest pain, flu-like illness, pain.
Drug Interactions
Impaired efficacy of live attenuated virus vaccine eg, measles, rubella, mumps, varicella.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Hizentra soln for inj 200 mg/mL
10 mL x 1's;20 mL x 1's;5 mL x 1's;50 mL x 1's
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