KIOVIG

What it is

KIOVIG is a normal immunoglobulin (human) . It is available in vials containing 1.0 g in 10 mL, 2.5 g in 25 mL, 5.0 g in 50 mL, 10.0 g in 100 mL, 20.0 g in 200 mL or 30.0 g in 300 mL of active normal immunoglobulin (Human) at a concentration of 100 mg/mL . The active ingredient is a human plasma-derived immunoglobulin produced from large pools of human plasma by a modified Cohn-Oncley cold ethanol fractionation . A triple step of viral inactivation—solvent detergent, nano-filtration, and incubation at low pH and elevated temperature—has been incorporated into the downstream purification to reduce possible viral transmission . It is presented as a solution for intravenous and subcutaneous injection .

Approved indications

KIOVIG administered intravenously is indicated for replacement therapy in: — Primary immunodeficiency disorders (PID) — Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment KIOVIG administered intravenously is also indicated for immunomodulation in: — Idiopathic thrombocytopenia purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count — Guillain Barré Syndrome — Kawasaki Disease — Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults — Multifocal Motor Neuropathy (MMN) KIOVIG administered subcutaneously is indicated for replacement therapy in primary immunodeficiency disorders (PID) .

Dosing overview

The dose and dosage regimen are dependent on the indication . In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response . KIOVIG is recommended for administration by intravenous infusion for all indications .

For subcutaneous administration in primary immunodeficiency disorders, each subject began subcutaneous therapy with KIOVIG at 130% of the weekly equivalent of the intravenous dose .

Key safety warnings

KIOVIG should be at room temperature during administration . KIOVIG should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed. Only clear or slightly opalescent and colourless or pale-yellow solutions are to be administered .

Regulatory history

KIOVIG was first listed on the ARTG on 2 September 2008 across six strengths (1 g/10 mL, 2.5 g/25 mL, 5.0 g/50 mL, 10.0 g/100 mL, and 20.0 g/200 mL) . A 30 g/300 mL strength was added on 29 May 2013 . On 20 July 2021, the TGA approved KIOVIG for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults, extending the approved therapeutic uses for KIOVIG administered intravenously .