Kiovig

human normal immunoglobulin

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This is a summary of the European public assessment report (EPAR) for Kiovig. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kiovig.

What is Kiovig?

Kiovig is a medicine that contains the active substance human normal immunoglobulin. It is available as a solution for infusion (drip) to be given into a vein.

What is Kiovig used for?

Kiovig is used in adults and children who need more antibodies in their blood to help fight infections and other diseases. It is used to treat the following conditions:

  • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
  • hypogammaglobulinaemia (low levels of antibodies) in patients:
    • with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) and frequent bacterial infections after preventive treatment with antibiotics has failed;
    • with multiple myeloma (another cancer of a type of white blood cell) and frequent bacterial infections, in whom vaccination against ‘pneumococcal’ bacteria has failed;
    • who have had haematopoietic (blood)-stem-cell transplantation (when the patient receives stem cells from a matched donor to help restore the bone marrow);
  • acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent bacterial infections.

Kiovig is also used to treat certain immune system disorders:

  • primary immune thrombocytopenia (ITP, a condition where people do not have enough platelets in the blood);
  • Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body;
  • Kawasaki disease, which causes multiple inflammations of several organs in the body;
  • multifocal motor neuropathy (MMN), a disease causing muscle weakness.

The medicine can only be obtained with a prescription.

How is Kiovig used?

Treatment with Kiovig should be started and monitored by a doctor experienced in treating immunodeficiency disorders. Kiovig is given as an infusion into a vein by a doctor or nurse. The dose and frequency of infusions depend on the disease being treated and may need to be adjusted depending on the patient’s response. Kiovig can be diluted before being given. For full details, see the summary of product characteristics (also part of the EPAR).

How does Kiovig work?

The active substance in Kiovig, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. Kiovig works by restoring abnormally low IgG levels to their normal range in the blood. At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.

How has Kiovig been studied?

As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, four small studies were needed to establish the effectiveness and safety of Kiovig in patients.

In the first study, Kiovig was used to replace antibodies in 22 patients with PID who had very low or no levels of immunoglobulin. The main measure of effectiveness was the number of serious bacterial infections and the amount of antibiotic used.

The second study looked at using Kiovig to adjust the immune system in 23 patients with ITP. The main measure of effectiveness was the increase in platelets.

The third and fourth studies were in a total of 28 patients with MMN. The main measures of effectiveness were based on muscle strength and the reduction in patients’ disability.

What benefit has Kiovig shown during the studies?

In the first study, Kiovig was as effective as the standard treatment in preventing infections and reducing antibiotic use. In the second study, Kiovig was shown to be effective in increasing the platelet count. The studies in patients with MMN showed that Kiovig was effective in maintaining muscle strength and reducing disability.

What is the risk associated with Kiovig?

The most common side effects with Kiovig (seen in more than 1 patient in 10) are headache, hypertension (high blood pressure), nausea (feeling sick), rash, tiredness, local reactions such as pain, swelling or itching at the site of injection and pyrexia (fever). Some side effects are more likely to occur when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Kiovig before or for a long time. For the full list of all side effects reported with Kiovig, see the package leaflet.

Kiovig must not be used in people who are hypersensitive (allergic) to human normal immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of human immunoglobulin, especially where they have antibodies against immunoglobulin A (IgA).

Why has Kiovig been approved?

According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children. They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases. The CHMP was satisfied with the studies in patients with MMN, where Kiovig was shown to be effective.

Therefore, the CHMP concluded that Kiovig’s benefits are greater than its risks and recommended that Kiovig be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Kiovig?

A risk management plan has been developed to ensure that Kiovig is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kiovig, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Kiovig

The European Commission granted a marketing authorisation valid throughout the European Union for Kiovig on 19 January 2006.

For more information about treatment with Kiovig, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Kiovig : EPAR - Summary for the public BG = bălgarski 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public ES = español 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public CS = čeština 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public DA = dansk 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public DE = Deutsch 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public ET = eesti keel 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public EL = elliniká 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public EN = English 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public FR = français 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public IT = italiano 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public LV = latviešu valoda 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public LT = lietuvių kalba 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public HU = magyar 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public MT = Malti 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public NL = Nederlands 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public PL = polski 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public PT = português 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public RO = română 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public SK = slovenčina 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public SL = slovenščina 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public FI = suomi 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public SV = svenska 2008-06-13 2015-11-18
Kiovig : EPAR - Summary for the public HR = Hrvatski 2008-06-13 2015-11-18

This EPAR was last updated on 13/05/2016 .

Authorisation details

Product details

Product details for Kiovig
NameKiovig
Agency product numberEMEA/H/C/000628
Active substance

human normal immunoglobulin (IVIg)

International non-proprietary name (INN) or common name

human normal immunoglobulin

Therapeutic area Immunologic Deficiency SyndromesGuillain-Barre SyndromeBone Marrow TransplantationPurpura, Thrombocytopenic, IdiopathicMucocutaneous Lymph Node Syndrome
Anatomical therapeutic chemical (ATC) code J06BA02

Publication details

Publication details for Kiovig
Marketing-authorisation holder

Baxter AG

Revision17
Date of issue of marketing authorisation valid throughout the European Union19/01/2006

Contact address:

Baxter AG
Industriestrasse 67
A-1221 Vienna
Austria

Product information

Product information

28/04/2016  Kiovig -EMEA/H/C/000628 -IAIN/0071/G

Name Language First published Last updated
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13
Kiovig : EPAR - Product Information HR = Hrvatski 2007-10-23 2016-05-13

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27
Kiovig : EPAR - All Authorised presentations HR = Hrvatski 2006-03-22 2010-05-27

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Replacement therapy in adults, and children and adolescents (0-18 years) in:

  • primary immunodeficiency syndromes with impaired antibody production;
  • hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;
  • hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation;
  • hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT);
  • congenital AIDS and recurrent bacterial infections.

Immunomodulation in adults, and children and adolescents (0-18 years) in:

  • primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;
  • Guillain Barré syndrome;
  • Kawasaki disease;
  • multifocal motor neuropathy (MMN).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kiovig : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2007-10-23 2016-05-13
Kiovig-H-C-628-II-37 : EPAR - Assessment Report - Variation HR = Hrvatski 2011-09-12  
CHMP post-authorisation summary of positive opinion for Kiovig HR = Hrvatski 2011-06-24  

Initial marketing-authorisation documents

Name Language First published Last updated
Kiovig : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-03-22  
Kiovig : EPAR - Scientific Discussion HR = Hrvatski 2006-03-22  

Authorised

This medicine is approved for use in the European Union