Hizentra

Human normal Ig (SCIg)

Replacement therapy in primary immunodeficiency syndromes w/ impaired Ab production; hypogammaglobulinaemia & recurrent bacterial infections in chronic lymphocytic leukaemia patients, in whom prophylactic antibiotics have failed or are contraindicated; hypogammaglobulinaemia & recurrent infections in multiple myeloma patients; hypogammaglobulinaemia in pre- & post-allogeneic haematopoietic stem cell transplantation patients. Immunomodulatory therapy in patients w/ chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance after stabilization w/ IVIg.

SC Can simultaneously use >1 infusion device. No limit to the number of infusion sites, should be at least 5 cm apart. Infusion site may change every 5-15 mL in infants & childn; may give doses up to 50 mL/site in adults. Device-assisted infusion: Initial infusion rate should not exceed 20 mL/hr/site, can be gradually increased to 35 mL/hr/site for the following 2 infusions if well-tolerated. Manual push infusion: Initial infusion rate should not exceed 30 mL/hr/site (0.5 mL/min/site), can be increased up to 120 mL/hr/site (2 mL/min/site) if well-tolerated. Adult & childn (0-18 yr) Replacement therapy Individualise dose based on clinical response & serum IgG trough levels. Should achieve IgG trough levels (measured before next infusion) of at least 5-6 g/L & aim to be w/in reference serum IgG interval for age. Loading dose: 0.2-0.5 g/kg (1-2.5 mL/kg), may be divided over several days. Maintenance dose: Administer at repeated intervals to reach a cumulative mthly dose of 0.4-0.8 g/kg (2-4 mL/kg). Immunomodulatory therapy in CIDP Initiate therapy 1 wk after the last IVIg infusion. Initial dose may be a 1:1 conversion from previous IVIg dose (calculated as wkly dose). Recommended dose: 0.2-0.4 g/kg/wk administered in 1 or 2 sessions over 1 or 2 consecutive days. Patient's individual clinical response should be the primary consideration in dose adjustment. Recommended max dose: 0.4 g/kg wkly in case of clinical deterioration.

Hypersensitivity. Patients w/ hyperprolinaemia type I or II. Must not be given intravascularly.

Adverse reactions may occur more frequently in patients naïve to human normal Ig, switched from an alternative product, or having a long interval since the previous infusion (>8 wk). Immediate discontinuation in case of hypersensitivity reactions. Closely monitor patients throughout the infusion period & for at least 20 min thereafter. Patients could develop shock if accidentally administered into a blood vessel. Patients at increased risk for thrombosis should receive normal Ig products at the slowest infusion rate practicable & should be monitored for thrombotic complications. Measure baseline blood viscosity in individuals at risk of hyperviscosity. Monitor for hemolysis, particularly those at increased risk. Reports of aseptic meningitis syndrome. Possibility of transmitting infective agents. Interference w/ serological testing. Maintenance therapy in CIDP for periods >18 mth. May impair ability to drive or operate machinery. Pregnancy & lactation. Paed patients <18 yr w/ CIDP.

Headache; rash; infusion site reaction. Dizziness, migraine; HTN; diarrhoea, abdominal pain, nausea, vomiting; pruritus, urticaria; musculoskeletal pain, arthralgia; fatigue (including malaise), pyrexia, chest pain, flu-like illness, pain.

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.

Vaccines, Antisera & Immunologicals

J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.

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