Kiovig

Kiovig

human normal immunoglobulin

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Human normal Ig (IVIg)
Indications/Uses
Replacement therapy in adults, childn & adolescents 0-18 yr in primary immunodeficiency syndromes (PID) w/ impaired Ab production; secondary immunodeficiencies (SID) in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment & either proven specific Ab failure (PSAF) or serum IgG level of <4 g/L. Immunomodulation in adults, childn & adolescents 0-18 yr in primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct 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 Replacement therapy in primary immunodeficiency Initially 0.4-0.8 g/kg. Maintenance dose: 0.2-0.8 g/kg every 3-4 wk to obtain IgG trough level of at least 5-6 g/L. Replacement therapy in secondary immunodeficiency 0.2-0.4 g/kg every 3-4 wk to obtain IgG trough level of at least 5-6 g/L. Congenital AIDS, hypogammaglobulinaemia (<4 g/L) in patients after allogeneic haematopoietic stem cell transplantation 0.2-0.4 g/kg every 3-4 wk. ITP 0.8-1 g/kg given 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 for 5 days. Kawasaki disease 2 g/kg as a single dose w/ ASA. CIDP Initially 2 g/kg divided over 2-5 days. Maintenance dose: 1 g/kg over 1-2 consecutive days every 3 wk. MMN Initially 2 g/kg divided over 2-5 days. Maintenance dose: 1 g/kg every 2-4 wk or 2 g/kg every 4-8 wk over 2-5 days.
Contraindications
Hypersensitivity to IVIg or human Ig, especially in patients w/ anti-IgA Ab. Patients w/ selective IgA deficiency who developed IgA Ab.
Special Precautions
Anaphylaxis in patients w/ undetectable IgA who have anti-IgA Ab; had tolerated previous treatment w/ human normal Ig. Closely monitor in cases of high infusion rate; patients who receive human normal Ig for the 1st time or human normal Ig product is switched or w/ long interval since the previous infusion; w/ untreated infection or underlying chronic inflammation. Monitor for any symptoms throughout infusion period; signs & symptoms of thrombosis & haemolysis; potential adverse signs at hospital during 1st infusion & for 1st hr after 1st infusion. Observe for at least 20 min after administration. Assess blood viscosity in patients at risk for hyperviscosity. Ensure patients are not sensitive to human normal Ig by initially injecting product slowly (0.5 ml/kg/hr). Thromboembolic events eg, MI, CVA eg, stroke, pulmonary embolism & DVT. Obese patients & patients w/ pre-existing risk factors for thrombotic events. Acute non-cardiogenic pulmonary edema. Haemolytic anaemia. Higher incidence of aseptic meningitis syndrome in women. Transient decrease in neutrophil count &/or episodes of neutropenia. May cause +ve direct antiglobulin reaction (Coombs' test). May result in misleading +ve results in serological testing; lead to false +ve readings in assays. Ensure adequate hydration prior to initiation of infusion. Monitor urine output; serum creatinine levels. Assess renal parameters prior to infusion. Avoid in concomitant use of loop diuretics. May affect ability to drive & use machines. Acute renal failure & tubular necrosis, proximal tubular nephropathy & osmotic nephrosis. Pregnancy & lactation. Paed patients may be more susceptible to vol overload.
Adverse Reactions
Headache; HTN; nausea; rash; 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 & pain, asthenia, malaise, rigors.
Drug Interactions
Impaired efficacy of live attenuated virus vaccines eg, MMR, varicella. Concomitant use w/ 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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