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ARAGAM 50 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

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Aragam®
PACKAGE LEAFLET: INFORMATION FOR THE USER

Vaccination
Tell your doctor if you have planned to take a vaccination.
Aragam may impair the efficacy of vaccines such as measles,
rubella, mumps and varicella. After using Aragam, an interval
of three months should elapse before vaccination with these
vaccines. In case of measles, this impairment may persist for
up to one year.

Aragam 50 mg/ml solution for infusion
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 or
pharmacist.
- 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 or pharmacist.
This includes any possible side effects not listed in the
leaflet. See section 4.

Aragam with food and drink
While using Aragam adequate hydration before infusion
should be taken into account.
Pregnancy, breast feeding and fertility
Clinical experience with immunoglobulins suggests that no
harmful effects on fertility are to be expected.
In pregnant women the safety of this medicine has not been
investigated. Therefore caution should be taken with pregnant
women and women who are breast-feeding. Clinical
experience with immunoglobulins indicate that these are not
expected to have a harmful effect on the course of a pregnancy
nor on the foetus (unborn child) or the newborn.
Immunoglobulins are excreted in breast-milk and can
contribute to the transfer of protective antibodies to the
newborn.
Ask your doctor or pharmacist for advice before taking any
medicine.

What is in this leaflet:
1. What Aragam is and what it is used for
2. What you need to know before you use Aragam
3. How to use Aragam
4. Possible side effects
5. How to store Aragam
6. Contents of the pack and other information
WHAT ARAGAM IS AND WHAT IT IS USED FOR
Aragam is a solution for infusion which contains the human
protein immunoglobulin. Immunoglobulins are antibodies and
normal constituents of human blood and they protect you from
infections. Aragam is used to raise antibody levels in your
blood when the antibody level is too low or if you need
additional antibodies in certain diseases. The administration of
antibodies can also have an effect in case of a disrupted
immune system.

Driving and using machines
The ability to drive and operate machines may be impaired by
some adverse reactions associated with Aragam. Patients who
experience adverse reactions during treatment should wait for
these to resolve before driving or operating machines.

Aragam is used for:
Replacement therapy (treatment of patients who do not have
sufficient antibodies) in adults, and children and adolescents
(0-18 years) in:
 Primary immunodeficiency syndromes (diseases which are
caused by a hereditary disorder of the immune system) with
impaired antibody production.
 Hypogammaglobulinemia (complete or partial lack of the
immune response caused by a complete or partial deficit
of antibodies) and recurrent bacterial infections in patients
with chronic lymphocytic leukaemia (malignant bleeding
disorder), in whom prophylactic antibiotics have failed.
 Hypogammaglobulinemia and recurrent bacterial
infections in plateau phase multiple myeloma (malignant
bone marrow tumour) patients who have failed to respond
to pneumococcal immunisation.
 Hypogammaglobulinemia in patients after allogenic
haematopoietic stem cell transplantation (HSCT).
 Congenital AIDS with recurrent bacterial infections.
Immunomodulation (influencing a disrupted immune
system) in adults, and children and adolescents (0-18 years)
in:
 Primary immune thrombocytopenia (ITP, a bleeding
disorder caused by a reduced number of platelets), in patients
at risk of bleeding or prior to surgery to correct the platelet
count.
 Guillain Barré syndrome (this is a syndrome of unknown
cause at which muscle paralysis occur).
 Kawasaki disease (a very rare disease in children with
defects of the skin, mucous membrane, blood vessels of the
brain and coronary arteries).

Important information about some of the ingredients of
Aragam
Aragam contains glucose 50 mg/ml (5 %). Please note this
may increase your blood glucose levels.. If you are a diabetic,
your doctor will decide if there is a need to monitor your
blood glucose levels and a need for insulin, especially if high
doses of Aragam are given.
Special warnings and special precautions for use
When medicines are made from human blood or plasma,
certain measures are put in place to prevent infections being
passed on to patients. These include careful selection of blood
and plasma donors to make sure those at risk of carrying
infections are excluded, and the testing of each donation and
pools of plasma for signs of virus/infections. Manufacturers of
these products also include steps in the processing of the blood
or plasma that can inactivate or remove viruses. Despite these
measures, when medicines prepared from human blood or
plasma are administered, the possibility of passing on
infection cannot be totally excluded. This also applies to any
unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped
viruses such as human immunodeficiency virus (HIV),
hepatitis B virus and hepatitis C virus, and for the nonenveloped viruses such as hepatitis A virus and parvovirus
B19.
Immunoglobulins have not been associated with hepatitis A or
parvovirus B19 infections possibly because the antibodies
against these infections, which are contained in the product,
are protective.
Batch number control:
It is strongly recommended that every time you receive a dose
of Aragam the name and batch number of the product are
recorded in order to maintain a record of the batches used.

BEFORE YOU USE ARAGAM
Do not use Aragam
 if you are allergic (hypersensitive) to immunoglobulins or
any of the other ingredients of Aragam.
 if you have immunoglobulin A (IgA) deficiency with
antibodies against IgA. Aragam contains a small amount of
IgA which might cause an allergic reaction.
If an allergic reaction occurs, administration of Aragam should
be discontinued immediately.

HOW TO USE ARAGAM
Aragam is given to you by your doctor or nurse. Aragam may
be self-administered if it is an approved practice in your
country and when you have been trained sufficiently. Always
use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Bring Aragam to room or body temperature before use. Start
the intravenous infusion of Aragam as soon as possible after
puncturing the stopper.
The solution should be clear or slightly opalescent. Do not use
solutions that are cloudy or have deposits. Discard any unused
solution.

Take special care with Aragam
You will be observed carefully during the infusion period to
detect potential adverse reactions (unwanted side effects).
Certain adverse reactions may be related to the rate of
infusion, therefore your doctor makes sure that the infusion
rate is suitable for you. If you experience a reaction during
infusion, tell your doctor immediately. The doctor will decide
if the infusion will be discontinued.
Certain adverse reactions may occur more frequently:
 in case of high rate of infusion.
 if you have hypo- or agammaglobulinemia (a complete or
partial lack of antibodies) with or without IgA deficiency.
 if you receive Aragam for the first time.
 in rare cases, when the human normal immunoglobulin
product is replaced by another product or there has been a
long interval since the previous infusion.

Dosage and route of administration
Aragam is intended for infusion into a vein. Dosage will vary
depending on your condition and weight. If you administer
Aragam yourself your doctor will tell you the dose and
infusion rate.
If you use more Aragam than you should
Overdose may lead to fluid overload and hyperviscosity (an
increased thickness of the blood). Tell your doctor
immediately.

Risk factors during treatment with Aragam
Please tell your doctor if any of the following factors concerns
you, since these might be risk factors during the treatment
with Aragam. In particular, tell your doctor if you have:
 renal insufficiency (when your kidneys are not working
well).
 nephrotoxic (toxic for the kidney) medication.
 diabetes (abnormally high glucose levels in the blood)
 history of vascular (blood vessel) diseases or thrombosis
(formation of a clot inside a blood vessel).
 hypertension.
 overweight.
 diseases which increase blood viscosity (thickness of the
blood).
 hypovolemia (a decrease in circulating blood volume).
 advanced age (over 65).

If you forget to use Aragam
Tell your doctor immediately and follow his/her instructions.
Do not take a double dose to make up for a forgotten dose.
If you stop using Aragam
If you have any further questions on the use of this product,
ask your doctor
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Occasional side effects (unknown frequency)
 vomiting,
 arthralgia (joint pain),
 moderate low back pain.
Common side effects which may occur in between 1 in 100
and 1 in 10 infusions are listed below:
 headache
 malaise
 chills
 body temperature increase
Uncommon side effects which may occur in between 1 in
1,000 and 1 in 100 infusions are listed below:
 skin rash
 itching (pruritis)
 hives (urticaria)
 redness of the skin (erythema)
 difficulty in breathing (dyspnoea)
 hypersensitivity
 dizziness
 fatigue
 sweating
 fever
 flu-like symptoms

While using Aragam the following should be taken into
account
 adequate hydration before infusion of Aragam.
 follow-up of urine output.
 follow-up of serum creatinine levels (a substance which is an
indicator of the activity of the kidneys).
 avoiding concomitant use of certain diuretics (so called loop
diuretics).
Effects on blood tests
If you will have blood tests taken, please tell you doctor that
you are using Aragam, since Aragam contains antibodies and
this may result in misleading positive results in antibody tests.
Other medicines and Aragam
Do not mix Aragam with other medicinal products.
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
1

 back pain
 neck pain
 muscle pain (myalgia)
 diarrhoea
 nausea
 increased heart rate (tachycardia)
 lowered blood pressure (hypotension)
Rare side effects which may occur in between 1 in 10,000 and
1 in 1,000 infusions are listed below:
 a sudden fall in blood pressure and in isolated cases,
anaphylactic shock, even if you have not experienced
hypersensitive reactions during previous administrations.
 reversible aseptic meningitis (meningitis without infection).
 reversible haemolytic anemia/haemolysis (disruption of red
cells).
 temporary skin reactions.
 increase in serum creatinine level and/or acute renal failure.
Very rare side effects which may occur in less than 1 in
10,000 infusions are listed below:
 thromboembolic reactions such as myocardial infarction,
stroke, pulmonary embolism and deep vein thromboses
(obstruction of veins).

have failed to respond to
pneumococcal
immunisation
Hypogammaglobulinaemia (< 4 g/l) in
patients after allogenic
haematopoietic stem cell
transplantation
congenital AIDS with
recurrent bacterial
infections
Immunomodulation

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the safety
of this medicine.

The following information is intended for medicinal or
healthcare professionals only:
Posology and method of administration
Aragam must only be administered intravenously.
Start the intravenous infusion of Aragam as soon as possible
after puncturing the stopper. If not used immediately, in-use
storage times and conditions prior to use are the responsibility
of the user. The in-use storage times would normally not be
longer than 24 hours at 2°C – 8°C, unless puncturing has taken
place in controlled and validated aseptic conditions.
If you need large quantities of Aragam, it is also possible to
transfer the contents of several vials to an Ethyl Vinyl Acetate
container (Clintec EVA-parenteral nutrition container,
Baxter, CE0123). A maximum amount of 800 ml of Aragam
can be transferred to such a container using an aseptic
technique. For microbiological reasons, start the infusion as
soon as possible after transfer of Aragam into the EVAcontainer, but not later than 3 hours after the transfer.
The dose and dosage depend on the indication. Aragam is
given as an intravenous infusion under controlled
circumstances at an initial rate of 0.5 ml/kg/hr for 20 minutes.
If well tolerated, the rate of administration may gradually be
increased to 1.0 ml/kg/hr for 20 minutes and thereafter
increased to a maximum of 3.0 ml/kg/hr for the first time user.
In adult patients who receive Aragam on a regular basis with
good tolerance, the infusion rate may be increased to a
maximum of 7.0 ml/kg/hr.
The dose and dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be
individualized for each patient dependent on the
pharmacokinetic and clinical response. The following dosage
regimens are given as a guideline.
The dosage recommendations are summarised in the following
table:
Indication
Dose
Frequency of
injections
Replacement Therapy
Primary
starting dose: every 3-4 weeks
immunodeficiency
0.4 - 0.8 g/kg to obtain IgG
syndromes with impaired
thereafter:
trough level of at
antibody production
0.2 - 0.8 g/kg least 5-6 g/l

every 3-4 weeks
to obtain IgG
trough level of at
least 5-6 g/l

on day 1,
possibly repeated
once within 3
days

Guillain Barré syndrome
Kawasaki disease

0.4 g/kg/d
1.6 – 2 g/kg

0.4 g/kg/d

for 2-5 days
for 5 days
in several doses
for 2 – 5 days in
association with
acetylsalicylic
acid

Instructions for handling and disposal
Bring Aragam to room or body temperature before use. The
solution should be clear or slightly opalescent. Do not use
solutions that are cloudy or have deposits. Discard any unused
solution.

This leaflet was last revised in: February 2016

0.2 - 0.4 g/kg

0.8 - 1.0 g/kg
or

Incompatibilities
Aragam should not be mixed with other medicines.

Manufacturer
Stichting Sanquin Bloedvoorziening
Plesmanlaan 125
1066 CX Amsterdam
The Netherlands

every 3-4 weeks
to obtain IgG
trough level of at
least 5-6 g/l

Primary Immune
thrombocytopenia (ITP),
in patients at high risk of
bleeding or prior to
surgery to correct the
platelet count.

Special precautions
It is strongly recommended that every time you receive a dose
of Aragam the name and batch number of the product are
recorded in order to maintain a record of the batches used.

Marketing Authorisation Holder
Oxbridge Pharma Ltd,
15 Fitzroy House, Lynwood Drive
Worcester Park, Surrey, KT4 7AT
United Kingdom
Telephone:
+44 208 335 4110

0.2 - 0.4 g/kg

every 3-4 weeks

in one dose in
association with
acetylsalicylic
acid

What Aragam looks like and contents of the pack
Aragam is a solution for infusion. The solution is a clear or
slightly opalescent, colourless or pale yellow.
Aragam is supplied in the following pack sizes 20 ml, 50 ml,
100 ml, 200 ml and 400 ml, containing 1 g, 2.5 g, 5 g, 10 g
and 20 g of immunoglobulin, respectively. Not all sizes may
be marketed.

every 3-4 weeks

0.2 - 0.4 g/kg

2 g/kg

CONTENTS OF THE PACK AND OTHER
INFORMATION
What Aragam contains
The active substance is human normal immunoglobulin for
intravenous administration. One ml contains 50 mg
immunoglobulin, of which at least 95% is immunoglobulin G
(IgG). The other ingredients are glucose and water for
injections.

0.2 – 0.4 g/kg

every 3-4 weeks
to obtain IgG
trough level of at
least 5g/l

or

HOW TO STORE ARAGAM
Keep this medicine out of the sight and reach of children.
Store Aragam in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Aragam can be stored at or below 25C up to six months, for
example while travelling, without impairing its efficacy. The
date when taken to room temperature should be marked on the
package. If not used during six months storage at room
temperature the product must be discarded.
Do not use this medicine after the expiry date which is stated
on the label and the carton after EXP.

Replacement therapy in
secondary
immunodeficiency
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

0.2 - 0.4 g/kg

2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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