Privigen

Privigen

human normal immunoglobulin

Manufacturer:

CSL Behring

Distributor:

DKSH
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
Replacement therapy in 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; childn w/ congenital AIDS & recurrent infections. Immune thrombocytopenic purpura (ITP) in childn or adult at high risk of bleeding or prior to surgical interventions to correct the platelet count; Guillain-Barre syndrome, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP). Allogeneic bone marrow transplantation.
Dosage/Direction for Use
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 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 over 5 days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days or 2 g/kg as single dose. CIDP Initially 2 g/kg divided over 2-5 consecutive days followed by 1 g/kg maintenance dose 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 pre-transplant & continued 3 mth post-transplant. Persistent lack of Ab production 0.5 g/kg mthly until normal Ab levels.
Contraindications
Hypersensitivity to human Ig particularly in IgA deficiency where patient has anti-IgA Ab. Hyperprolinaemia.
Special Precautions
Hypersensitivity. Not indicated in patients w/ selective IgA deficiency. High rate of infusion; patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency, 1st time receiving human normal Ig therapy, or when human normal Ig is switched or long interval since previous infusion. Haemolytic anaemia; aseptic meningitis syndrome; obese patients, preexisting risk factors for thrombotic events; risk factors for acute renal failure; transfusion-related acute lung injury. Monitor for any symptoms throughout therapy. Ensure adequate hydration prior to infusion. Possibility of transmitting infective agents. May affect ability to drive or operate machines. Discontinue use in case of renal impairment. Pregnancy & lactation. Paed. Elderly >65 yr.
Adverse Reactions
Headache, sinus & tension headache, migraine, head discomfort; pain, back, neck & facial pain, pain in extremity, arthralgia, pyrexia, chills, flu-like illness, nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness. Anaemia, haemolysis, haemolytic anaemia, leukopenia; hypersensitivity; dizziness, vertigo; HTN, flushing, hot flush, hyperaemia, hypotension; dyspnoea, chest pain & discomfort, painful respiration; nausea, vomiting, diarrhoea, abdominal pain; hyperbilirubinaemia; skin disorder & exfoliation, rash, pruritus, urticaria, maculopapular rash, erythema; myalgia, muscle spasms, musculoskeletal stiffness & pain; fatigue, asthenia, muscular weakness; decreased Hb, red blood cell count, haematocrit, positive direct Coombs' test, increased alanine aminotransferase, aspartate aminotransferase & blood lactate dehydrogenase.
Drug Interactions
Impaired efficacy of live attenuated virus vaccine.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA - Immunoglobulins, normal human ; Used in passive immunizations.
Presentation/Packing
Form
Privigen soln for infusion 10%
Packing/Price
100 mL x 1's;200 mL x 1's;25 mL x 1's;50 mL x 1's
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