Cuvitru 200 mg/ml solution for subcutaneous injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human normal immunoglobulin

Available from:

Baxalta Innovations GmbH

ATC code:

J06BA01

INN (International Name):

Human normal immunoglobulin

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

immunoglobulins, normal human, for extravascular adm.

Authorization status:

Marketed

Authorization date:

2016-07-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CUVITRU 200 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION
Human normal immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cuvitru is and what it is used for
2.
What you need to know before you use Cuvitru
3.
How to use Cuvitru
4.
Possible side effects
5.
How to store Cuvitru
6.
Contents of the pack and other information
1
WHAT CUVITRU IS AND WHAT IT IS USED FOR
WHAT CUVITRU IS
Cuvitru belongs to a class of medicines called “human normal
immunoglobulins”. Immunoglobulins are also
known as antibodies and are found in healthy people’s blood.
Antibodies are part of the immune system (the
body’s natural defences) and help your body to fight infections.
HOW CUVITRU WORKS
Cuvitru has been prepared from the blood of healthy people. The
medicine works in exactly the same way as
the immunoglobulins naturally present in the blood.
WHAT CUVITRU IS USED FOR
Cuvitru is used in patients with a weak immune system, who do not have
enough antibodies in their blood
and tend to get frequent infections. Regular and sufficient doses of
Cuvitru can raise abnormally low
immunoglobulin levels in your blood to normal levels (replacement
therapy).
Cuvitru is prescribed to
-
patients with inborn lack of antibody production (primary
immunodeficiency syndromes).
-
patients who experience severe or recurrent infections due to a
weakened immune system resulting
from other conditions or treatments (secondary immunodeficiency
syndromes).
2
WHAT YOU NEED TO

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2024
CRN00DP27
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cuvitru 200 mg/ml solution for subcutaneous injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (SCIg)
One ml contains:
Human normal immunoglobulin ……………200 mg
(purity of at least 98% IgG)
Each vial of 5 ml contains: 1 g of human normal immunoglobulin
Each vial of 10 ml contains: 2 g of human normal immunoglobulin
Each vial of 20 ml contains: 4 g of human normal immunoglobulin
Each vial of 40 ml contains: 8 g of human normal immunoglobulin
Each vial of 50 ml contains: 10 g of human normal immunoglobulin
Distribution of IgG subclasses (approx. values):
IgG1 ≥56.9%
IgG2 ≥26.6%
IgG3 ≥3.4%
IgG4 ≥1.7%
The maximum IgA content is 280 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless or pale yellow or light-brown.
pH of 4.6 to 5.1 (measured by dilution at 1% in saline).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications for subcutaneous administration (SCIg)
_Replacement therapy in adults, and children and adolescents (0‑18
years) in:_

Primary immunodeficiency (PID) syndromes with impaired antibody
production (see section 4.4).

Secondary immunodeficiencies (SID) in patients who suffer from severe
or recurrent infections, ineffective
antimicrobial treatment and either proven specific antibody failure
(PSAF)* or serum IgG level of <4g/l.
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide and polypeptide antigen
vaccines
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Health Products Regulatory Authority
13 February 2024
CRN00DP27
Page 2 of 10
Replacement therapy should be initiated and monitored under the
supervision of a physician experienced in the treatment of
immunodeficiency.
Posology
The dose and dose regimen is dependent on th