Kiovig

Kiovig

human normal immunoglobulin

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Human normal Ig (IVIg)
Indications/Uses
Replacement therapy in adults, childn & adolescents (0-18 yr) in: Primary immunodeficiency syndromes w/ impaired Ab production; secondary immunodeficiencies in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment & either proven specific Ab failure or serum IgG level of <4 g/L. Immunomodulation in adults, childn & adolescents (0-18 yr) in: Primary immune thrombocytopenia, in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease (in conjunction w/ ASA); chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); multifocal motor neuropathy (MMN).
Dosage/Direction for Use
IV Individualised dose based on clinical response. Infusion rate: Initially 0.5 mL/kg/hr for 30 min, may be gradually increased to max 6 mL/kg/hr if well tolerated. Replacement therapy in primary immunodeficiency syndromes Initially 0.4-0.8 g/kg followed by 0.2-0.8 g/kg every 3-4 wk. Secondary immunodeficiencies 0.2-0.4 g/kg every 3-4 wk. Primary immune thrombocytopenia 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. Treatment can be repeated if relapse occurs. Guillain Barré syndrome 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse). Kawasaki disease 2 g/kg as a single dose. Patients should receive concomitant treatment w/ ASA. CIDP Initially 2 g/kg divided over 2-5 consecutive days. Maintenance: 1 g/kg over 1-2 consecutive days every 3 wk. MMN Initially 2 g/kg over 2-5 consecutive days. Maintenance: 1 g/kg every 2-4 wk; or 2 g/kg every 4-8 wk over 2-5 days.
Contraindications
Hypersensitivity to IVIg, or to human Ig, especially in patients w/ Ab against IgA. Patients w/ selective IgA deficiency who developed Ab to IgA.
Special Precautions
Anaphylaxis can develop in patients w/ undetectable IgA who have anti-IgA Ab, & in patients who had tolerated previous treatment w/ human normal Ig. Infusion reactions. Closely monitor & carefully observe patients for any symptoms throughout the infusion period. In case of adverse reaction, either the rate of administration must be reduced, or the infusion stopped. If dilution of Kiovig to lower conc is required for patients suffering from DM, the use of 5% glucose soln for dilution may have to be reconsidered. Ensure adequate hydration prior to initiation of IVIg infusion. Monitor urine output; serum creatinine levels; & for signs & symptoms of thrombosis. Assess blood viscosity in patients at risk for hyperviscosity. Avoid concomitant use of loop diuretics. Risk of thromboembolic events; haemolytic anaemia, hemolysis; transient decrease in neutrophil count &/or episodes of neutropenia. Reports of cases of acute renal failure in patients receiving IVIg therapy; acute noncardiogenic pulmonary edema (transfusion related acute lung injury); aseptic meningitis syndrome. Interference w/ serological testing (eg, Coombs' test). Can lead to false +ve readings in assays that depend on detection of β-D-glucans for diagnosis of fungal infections. Possibility of transmitting infectious agents. May impair ability to drive & operate machines. Pregnancy & lactation. Ped patients may be more susceptible to vol overload.
Adverse Reactions
Headache; HTN; nausea; rash; local reactions (eg, infusion site pain/swelling/reaction/pruritus), pyrexia, fatigue. Bronchitis, nasopharyngitis; anaemia, lymphadenopathy; decreased appetite; insomnia, anxiety; dizziness, migraine, paresthesia, hypoesthesia; conjunctivitis; tachycardia; flushing; cough, rhinorrhoea, asthma, nasal congestion, oropharyngeal pain, dyspnea; diarrhoea, vomiting, abdominal pain, dyspepsia; contusion, pruritus, urticaria, dermatitis, erythema; back pain, arthralgia, pain in extremity, myalgia, muscle spasms, muscular weakness; chills, edema, flu-like illness, chest discomfort, chest pain, asthenia, malaise, rigors.
Drug Interactions
Impaired efficacy of live attenuated virus vaccines (eg, MMR & varicella) for a period of at least 6 wk & up to 3 mth; for measles, impairment may persist up to 1 yr. Avoid concomitant use of loop diuretics.
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.
Presentation/Packing
Form
Kiovig soln for infusion 10 g/100 mL
Packing/Price
1's
Form
Kiovig soln for infusion 2.5 g/25 mL
Packing/Price
1's
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