Skip to Content

CUVITRU 200 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

View full screen / Print PDF » Download PDF ⇩
Transcript
LE-07-36116

Package leaflet: Information for the user

Cuvitru 200 mg/ml solution for subcutaneous
injection
Human normal immunoglobulin

▼This medicine is subject to additional monitoring. This will allow

quick identification of new safety information. You can help by
reporting any side effects you may get. See the end of section 4 for
how to report side effects.
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 with a cancer of the blood (chronic lymphocytic
leukaemia) that leads to a lack of antibody production and
recurrent infections when preventative antibiotics cannot be used.
- patients with cancer of the bone marrow (multiple myeloma) and
lack of antibody production with recurrent infections.
- patients with low antibody production following transplantation of
bone marrow cells from another person.

2 What you need to know before you use Cuvitru

Do NOT use Cuvitru:
- if you are allergic to immunoglobulins or any of the other
ingredients of this medicine (listed in section 6).
- if you have antibodies against immunoglobulin A (IgA) in your
blood. This may occur if you have IgA deficiency. Since Cuvitru
contains trace amounts of IgA, you might have an allergic reaction.
- into a blood vessel (intravenously) or a muscle (intramuscularly).
Warnings and precautions
Talk to your doctor pharmacist or nurse before using Cuvitru.
Allergic reactions
You may be allergic to immunoglobulins without knowing it. Allergic
reactions such as sudden fall in blood pressure or anaphylactic shock
(a sharp fall in blood pressure with other symptoms such as swelling
of the throat, breathing difficulties and skin rash) are rare but they can
occasionally occur even if you have not previously had problems with
similar treatments. You are at increased risk of allergic reactions if you
have IgA deficiency with anti IgA antibodies. Tell your doctor or nurse
prior to treatment if you have IgA deficiency. Cuvitru contains residual
amounts of IgA which may increase the risk of an allergic reaction.
Signs or symptoms of these rare allergic reactions include:
- feeling light headed, dizzy or faint
- skin rash and itchiness, swelling in the mouth or throat, difficulty
breathing, wheezing
- abnormal heart rate, chest pain, blueness of lips or fingers and
toes
- blurred vision
Your doctor or nurse will first infuse Cuvitru slowly, and carefully
monitor you throughout the first infusions so that any allergic reaction
can be detected and treated immediately.
► If you notice any of these signs during the infusion, tell your
doctor or nurse immediately. He or she will decide whether to
slow down the infusion rate or stop the infusion completely.
Monitoring during infusion
Certain side effects may occur more frequently if:
- you are receiving Cuvitru for the first time.
- you have received another immunoglobulin and have been
switched to Cuvitru.
- there has been a long interval since you last received Cuvitru.
► In such cases, you will be closely monitored during your first
infusion and for the first hour after your infusion has stopped.
In all other cases it is recommended that you are monitored during
the infusion and for at least 20 minutes after you receive Cuvitru.
Special patient groups
Your doctor will take special care if you are overweight, elderly,
diabetic, or if you suffer from high blood pressure, low blood volume
(hypovolaemia), or problems with your blood vessels (vascular
diseases). In these conditions, immunoglobulins may increase

LE0736116 V2.indd 1

the risk of cardiac infarction, stroke, lung embolism, or deep vein
thrombosis, although only in very rare cases.
Your doctor will also take special care if you have or had previously
problems with your kidneys, or if you receive medicinal products that
may harm your kidney (nephrotoxic medicinal products), as there is a
very rare chance of acute kidney failure.
Inflammation of the layers lining the brain (aseptic meningitis, AMS)
Infusions of immunoglobulin products may result in inflammation
of the layers lining the brain. Discontinuation of immunoglobulin
treatment may result in reduction of AMS within several days. The
syndrome usually begins within several hours to 2 days following
immunoglobulin treatment.
Contact your doctor if you experience the following signs and
symptoms: severe headache, neck stiffness, drowsiness, fever,
nausea, vomiting and sensitivity to, and discomfort from light, after
receiving Cuvitru. Your doctor will decide if further tests are necessary
and whether Cuvitru should be continued
Destruction of red blood cells (haemolysis)
Cuvitru contains blood group antibodies that may cause destruction
of red blood cells and haemolytic anaemia.
Effects on blood tests
Cuvitru contains many different antibodies, some of which can affect
blood tests (serological tests).
► Tell your doctor about your treatment with Cuvitru before any
blood test.
Home treatment
You and/or your caregiver will be trained to detect early signs of side
effects, especially allergic reactions. During the infusion you or your
caregiver must look out for first signs of side effects (for further details
see section 4, “Possible side effects”).
► If you experience any side effects, you or your caregiver must
stop the infusion immediately and contact a doctor.
► If you experience a severe side effect, you or your caregiver
must seek emergency treatment immediately.
Information on the source material of Cuvitru
Cuvitru is made from human plasma (the liquid part of blood). 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
viruses/infections.
- the inclusion of 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 non‑enveloped 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 Cuvitru, are protective.
It is strongly recommended that every time you use Cuvitru the
following data are recorded in your treatment diary:
- the date of administration,
- the batch number of the medicine, and
- the injected volume, flow rate, the number and location of injection
sites.
Children and adolescents
The listed warnings and precautions apply both to adults and
children.
Other medicines and Cuvitru
Tell your doctor, pharmacist, or nurse if you are taking, have recently
taken or might take any other medicines.
Vaccinations
Cuvitru may reduce the effect of some virus vaccines such as
measles, rubella, mumps and chicken pox (live virus vaccines).
Therefore, after receiving Cuvitru, you may have to wait for up to
3 months before receiving certain vaccines. You may have to wait
for up to 1 year after receiving the last dose Cuvitru before you can
receive your measles vaccine.
► Please tell your vaccinating doctor or nurse about your
treatment with Cuvitru.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
No clinical trials have been made with Cuvitru in pregnant or breastfeeding women. But experience with immunoglobulins suggests that
there are no harmful effects on the course of pregnancy or the baby to
be expected.
If you are breast-feeding and receive Cuvitru, the antibodies of the
medicine can also be found in the breast milk and may also protect
your baby from certain infections.
Experience with immunoglobulins suggests that no harmful effects on
fertility are to be expected.
Driving and using machines
Patients may experience side effects (for example dizziness or
nausea) during treatment with Cuvitru that might affect the ability to
drive and use machines. If this happens, you should wait until the
reactions have disappeared.

Dosing
Your doctor will calculate the correct dose for you based on your
body weight, any previous treatment you may have received and your
response to treatment.
Your doctor will determine whether you need a loading dose (for
adults or children) of at least 1.0 to 2.5 ml/kg of body weight divided
over several days. Following this, you will be given Cuvitru on a
regular basis, from daily to once every two weeks; the cumulative
dose per month will be about 1.5 to 5 ml/kg of body weight. Your
doctor may adjust your dose depending on your response to the
treatment.
Do not change the dose or dosing interval without contacting your
doctor. If you think you should receive Cuvitru more or less frequently,
please speak to your doctor. If you think you have missed a dose,
please speak to your doctor as soon as possible.
Starting treatment
Your treatment will be started by a doctor or nurse experienced in
treating patients with a weak immune system and in guiding patients
for home treatment. You will be watched carefully throughout the
infusion and for at least 1 hour after stopping the infusion to see how
well you tolerate the medicine. In the beginning your doctor or nurse
will use a slow infusion speed and gradually increase it during the
first infusion and in the following infusions. Once the doctor or nurse
has found the right dose and speed of infusion for you, you may be
allowed to give the treatment to yourself at home.
Home treatment
Cuvitru can be administered by yourself or your caregiver. You will
be trained by a doctor or nurse experienced in the guidance and
treatment of patients like you. The doctor or nurse will be with you for
the first few treatments.
You or your caregiver will be instructed in:
- germ free (aseptic) infusion techniques,
- the use of an administration device (if needed),
- keeping a treatment diary, and
- measures to be taken in case of severe side effects.
You must carefully follow your doctor’s instructions regarding the
dose, infusion speed and schedule for infusing Cuvitru so that your
treatment works for you.
Method and route of administration
Selection of Infusion Site(s):
Suggested areas for subcutaneous infusion of Cuvitru are abdomen,
thighs, upper arms, or lower back. Cuvitru may be infused into
multiple infusion sites. Infusion sites should be at least 10 cm
apart, Avoid: bony areas, visible blood vessels, scars and any
areas of inflammation (irritation) or infection. Rotate sites with each
administration as directed by your doctor or nurse.
Multiple subcutaneous infusion sites can be used at the same time
by a multi-needle set. The amount of product infused into a single
site varies and doses over 30 ml may be divided according to your
preference.
Infusion rate:
The recommended initial infusion rate is 10 ml per hour per
infusion site. If well tolerated this may be increased at intervals
of at least 10 minutes to 20 ml per hour per site for the initial two
infusions. For further infusions, the infusion rate may be increased as
tolerated.
If you have any further questions on the use of this medicine, please
ask your doctor, pharmacist or nurse.
Detailed Instructions for use are provided in the section below:
Do not use Cuvitru at home until you get instructions and training from
your doctor or nurse.
Prepare Cuvitru vial(s):
• Remove Cuvitru from the box. In case the product is stored in a
refrigerator allow vials to reach room temperature. This may take
up to 90 minutes.
• Do not apply heat or place in microwave.
• Do not shake the vial(s).

3 How to use Cuvitru

Always use this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
Cuvitru has to be infused under the skin (subcutaneous or SC
administration).
Treatment with Cuvitru will be started by your doctor or nurse, but you
may be allowed to use the medicine at home once you have received
the first few infusions under medical supervision and you (and/or your
caregiver) have been adequately trained. You and your doctor will
decide if you can use Cuvitru at home. Do not begin treatment with
Cuvitru at home until you have received complete instructions.

24/06/16 8:25 AM

1. Check the vial(s):
• Do not use beyond expiry date.
• Do not use if the protective cap is
missing or broken.
• Look at the color: it should be clear
and colorless to pale yellow or light
brown.
• Do not use if the solution is cloudy
or has particles.
2. Gather all supplies
• Gather all supplies:
Items include: vial(s) of Cuvitru, infusion
supplies: subcutaneous needle set,
transfer device(s), syringe(s), sterile tip
caps, sterile clear bandage, tape, gauze,
sharps container, infusion pump, infusion
log.
• Clean work area.
• Program the infusion pump
according to prescribed infusion
rates and manufacturer’s
instructions.
• Wash hands thoroughly and allow
to dry.
• Open supplies as shown by your
doctor or nurse.

3. Prepare the syringe(s):
• Remove the cap from the vial.
• Wipe each stopper with a sterile
alcohol wipe and allow to dry.
• Attach a sterile syringe to a vented
spike.
• Insert the vented spike into the
center of the vial.
• Turn the vial upside down and pull
back on the plunger to pull the
solution into the syringe(s).
• Repeat these steps, if using
multiple vials to achieve the desired
dose.
If using a sterile needle: Attach a sterile
syringe to the sterile needle and pull back
the plunger of syringe to fill with air which
should equal the amount of the solution
you will be taking from the vial.  Insert the
needle into the center of the stopper, and
inject air in. Pull back on the plunger to
withdraw the desired volume.

4. Prepare the infusion pump and
tubing:
• Use manufacturer directions for
filling the tubing and using the
pump.
• Attach the syringe filled with
solution to the needle set.
• Point the syringe tip up and gently
push the plunger of the syringe to
remove the air and fill the needle
set up to the needle hub.
5. Prepare the infusion site(s):
• Select the number of infusion sites
based on the volume of the total
dose.
• Choose infusion site(s): upper
arms, abdomen, thighs, or lower
back
• Avoid: bony areas, visible blood
vessels, scars and any areas of
inflammation (irritation) or infection.
• Infuse the solution from 1 or
multiple infusion sites at the same
time.
• Select sites at least 10 cm apart.
• Rotate sites between future
infusions.
• Wipe the infusion site(s) with a
sterile alcohol wipe beginning at
the center of each infusion site and
moving outward in circular motion.
Allow the infusion site(s) to dry
(at least 30 seconds).

6. Insert and secure the
subcutaneous needle set:
• Remove the needle cover. Firmly
grasp and pinch at least 2.5 cm of
skin between two fingers.
• Insert needle with a rapid motion
straight into the skin at a 90 degree
angle. Tape needle in place
with sterile tape (included on
transparent dressing).
• If more than one site is used,
repeat the steps.
• Check for proper needle placement
by pulling back on the syringe
plunger to check for blood return in
the tubing of the needle set.
• If blood is seen in the tubing,
remove and discard the
subcutaneous needle and repeat
steps 4, 5 and 6 with a new
subcutaneous needle and infusion
site.
• Secure the needle set in place
by applying a sterile protective
dressing over the site(s).
7. Start the infusion
• Follow the manufacturer’s
instructions to turn pump on and
start the infusion
• Check infusion site(s) occasionally
throughout the infusion.
8. Remove subcutaneous needle(s)
from the infusion site(s) when the
infusion is complete:
• Remove the needle set by
loosening the tape on all edges.
• Pull the needle wings straight up
and out.
• Gently press a small piece of gauze
over the needle site and cover with
a dressing.
• Throw away the needle(s) into the
sharps container.
9. Record the infusion:
• Remove the peel-off label from the
vial(s), which has the product lot
number and expiry date, and place
the label in your treatment diary/
infusion log.
• Write down the date, time, dose,
site(s) of infusion (to assist in
rotating sites) and any reactions
after each infusion.
• Throw away the disposable
supplies, vials, and unused solution
as recommended by your doctor or
nurse.

Use in children and adolescents
The same indications, dose and frequency of infusion as for adults
apply for children and adolescents (age 0 to 18).
If you use more Cuvitru than you should
If you think that you used more Cuvitru than you should, speak to your
doctor as soon as possible.
If you forget to use Cuvitru
Do not infuse a double dose of Cuvitru to make up for a missed dose.
If you think that you have missed a dose speak to your doctor as soon
as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects such as
chills, headache, dizziness, fever, vomiting, allergic reactions, feeling
sick (nausea), joint pain, low blood pressure and moderate low back
pain, although not everybody gets them.
Certain side effects, such as headache, chills, or body aches, may be
reduced by slowing the infusion rate.
Serious side effects
Infusions of medicines like Cuvitru can occasionally result in serious,
but rare, allergic reactions. You may experience a sudden fall in blood
pressure and, in isolated cases, anaphylactic shock. Doctors are
aware of these possible side effects and will monitor you during and
after the initial infusions.
Tell your doctor or nurse immediately if you notice any of the following:
- feeling light‑headed, dizzy or faint,
- skin rash and itchiness, swelling in the mouth or throat, difficulty
breathing, wheezing,
- abnormal heart rate, chest pain, blueness of lips or fingers and
toes,
- blurred vision
When using Cuvitru at home, you may perform the infusion in the
presence of your caregiver who will help you watch out for allergic
reactions, stop the infusion, and get help if necessary.
Please also see section 2 of this leaflet about the risk of allergic
reactions and using Cuvitru at home.
The following side effects are very common (may affect more than 1
in 10 people):
- headache
- diarrhoea, and nausea
- redness, and pain at the site of infusion
- tiredness
The following side effects are common (may affect more than 1 in
100 people):
- dizziness, migraine, and drowsiness
- decreased blood pressure
- abdominal pain
- itching, and rash
- muscular pain
- swelling, itching, rash, and bruising at the site of infusion
- pain
The following side effects are uncommon (may affect more than 1 in
1000 people):
- burning sensation
- abdominal pain lower
- oedema at the site of infusion
- positive blood tests for antibodies

Side effects seen with similar medicines
The following side effects have been observed with infusion of human
normal immunoglobulin given under the skin (subcutaneously).
Although these side effects have so far not been seen with Cuvitru, it
is possible that someone using Cuvitru may get them.
- tingling
- trembling
- fast heart beat
- shortness of breath
- vocal cord dysfunction
- pain in chest
- hardening and/or warmth at the site of infusion
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the national reporting system
listed below. By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5. How to store Cuvitru

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP. The expiry date refers to the last day of
that month.
Do not use this medicine if you notice that the solution is cloudy, has
particles or changed color.
Keep the vials in the outer carton in order to protect from light.
Do not store above 25°C.
Do not freeze.
In case the product is stored in a refrigerator, the unopened vials
must be removed from refrigeration and placed at room temperature
for a minimum of 90 minutes prior to use. Do not use heating devices
including microwaves.

6. Contents of the pack and other information

What Cuvitru contains
- The active substance is human normal immunoglobulin.
- 1ml of Cuvitru contains 200 mg of human protein of which
at least 98% is immunoglobulin G (IgG). The other ingredients
are glycine and water for injections.
What Cuvitru looks like and contents of the pack
Cuvitru is a solution for injection in vials of 5, 10, 20 or 40 ml. The
solution is clear and colourless or pale-yellow or light-brown.
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
Not all presentations may be marketed.
Marketing Authorisation Holder
Baxter Innovations GmbH
A‑1221 Vienna
Austria
Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
7860 Lessines
Belgium
This leaflet was last revised in
June 2016

LE-07-36116

LE0736116 V2.indd 2

24/06/16 8:25 AM

LE-07-36117

Package leaflet: Information for the user

Cuvitru 200 mg/ml solution for
subcutaneous injection
Human normal immunoglobulin

▼This medicine is subject to additional monitoring. This
will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
See the end of section 4 for how to report side effects.

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 with a cancer of the blood (chronic
lymphocytic leukaemia) that leads to a lack of antibody
production and recurrent infections when preventative
antibiotics cannot be used.
- patients with cancer of the bone marrow (multiple
myeloma) and lack of antibody production with
recurrent infections.

- patients with low antibody production following
transplantation of bone marrow cells from another
person.
2 What you need to know before you use Cuvitru

Do NOT use Cuvitru:
- if you are allergic to immunoglobulins or any of the other
ingredients of this medicine (listed in section 6).
- if you have antibodies against immunoglobulin A
(IgA) in your blood. This may occur if you have IgA
deficiency. Since Cuvitru contains trace amounts of
IgA, you might have an allergic reaction.
- into a blood vessel (intravenously) or a muscle
(intramuscularly).
Warnings and precautions
Talk to your doctor pharmacist or nurse before using
Cuvitru.

Allergic reactions
You may be allergic to immunoglobulins without knowing
it. Allergic reactions such as sudden fall in blood pressure
or anaphylactic shock (a sharp fall in blood pressure
with other symptoms such as swelling of the throat,
breathing difficulties and skin rash) are rare but they can
occasionally occur even if you have not previously had
problems with similar treatments. You are at increased
risk of allergic reactions if you have IgA deficiency with
anti IgA antibodies. Tell your doctor or nurse prior to
treatment if you have IgA deficiency. Cuvitru contains
residual amounts of IgA which may increase the risk of an
allergic reaction. Signs or symptoms of these rare allergic
reactions include:
- feeling light headed, dizzy or faint
- skin rash and itchiness, swelling in the mouth or throat,
difficulty breathing, wheezing
- abnormal heart rate, chest pain, blueness of lips or
fingers and toes
- blurred vision
Your doctor or nurse will first infuse Cuvitru slowly, and
carefully monitor you throughout the first infusions so
that any allergic reaction can be detected and treated
immediately.
► If you notice any of these signs during the infusion,
tell your doctor or nurse immediately. He or she will
decide whether to slow down the infusion rate or
stop the infusion completely.
Monitoring during infusion
Certain side effects may occur more frequently if:
- you are receiving Cuvitru for the first time.
- you have received another immunoglobulin and have
been switched to Cuvitru.
- there has been a long interval since you last received
Cuvitru.
► In such cases, you will be closely monitored during
your first infusion and for the first hour after your
infusion has stopped.
In all other cases it is recommended that you are
monitored during the infusion and for at least 20 minutes
after you receive Cuvitru.

Special patient groups
Your doctor will take special care if you are overweight,
elderly, diabetic, or if you suffer from high blood pressure,
low blood volume (hypovolaemia), or problems with
your blood vessels (vascular diseases). In these
conditions, immunoglobulins may increase the risk of
cardiac infarction, stroke, lung embolism, or deep vein
thrombosis, although only in very rare cases.
Your doctor will also take special care if you have or
had previously problems with your kidneys, or if you
receive medicinal products that may harm your kidney
(nephrotoxic medicinal products), as there is a very rare
chance of acute kidney failure.

LE0736117 V2.indd 1

Inflammation of the layers lining the brain (aseptic
meningitis, AMS)
Infusions of immunoglobulin products may result in
inflammation of the layers lining the brain. Discontinuation
of immunoglobulin treatment may result in reduction of AMS
within several days. The syndrome usually begins within
several hours to 2 days following immunoglobulin treatment.
Contact your doctor if you experience the following
signs and symptoms: severe headache, neck stiffness,
drowsiness, fever, nausea, vomiting and sensitivity to,
and discomfort from light, after receiving Cuvitru. Your
doctor will decide if further tests are necessary and
whether Cuvitru should be continued
Destruction of red blood cells (haemolysis)
Cuvitru contains blood group antibodies that may cause
destruction of red blood cells and haemolytic anaemia.

Effects on blood tests
Cuvitru contains many different antibodies, some of which
can affect blood tests (serological tests).
► Tell your doctor about your treatment with Cuvitru
before any blood test.
Home treatment
You and/or your caregiver will be trained to detect early
signs of side effects, especially allergic reactions. During
the infusion you or your caregiver must look out for first
signs of side effects (for further details see section 4,
“Possible side effects”).
► If you experience any side effects, you or your
caregiver must stop the infusion immediately and
contact a doctor.
► If you experience a severe side effect, you or
your caregiver must seek emergency treatment
immediately.

Information on the source material of Cuvitru
Cuvitru is made from human plasma (the liquid part of
blood). 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 viruses/infections.
- the inclusion of 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 non‑enveloped 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
Cuvitru, are protective.

Starting treatment
Your treatment will be started by a doctor or nurse
experienced in treating patients with a weak immune
system and in guiding patients for home treatment. You
will be watched carefully throughout the infusion and for
at least 1 hour after stopping the infusion to see how well
you tolerate the medicine. In the beginning your doctor
or nurse will use a slow infusion speed and gradually
increase it during the first infusion and in the following
infusions. Once the doctor or nurse has found the right
dose and speed of infusion for you, you may be allowed
to give the treatment to yourself at home.

Home treatment
Cuvitru can be administered by yourself or your caregiver.
You will be trained by a doctor or nurse experienced in the
guidance and treatment of patients like you. The doctor or
nurse will be with you for the first few treatments.
You or your caregiver will be instructed in:
- germ free (aseptic) infusion techniques,
- the use of an administration device (if needed),
- keeping a treatment diary, and
- measures to be taken in case of severe side effects.
You must carefully follow your doctor’s instructions
regarding the dose, infusion speed and schedule for
infusing Cuvitru so that your treatment works for you.
Method and route of administration

Selection of Infusion Site(s):
Suggested areas for subcutaneous infusion of Cuvitru
are abdomen, thighs, upper arms, or lower back.
Cuvitru may be infused into multiple infusion sites.
Infusion sites should be at least 10 cm apart, Avoid:
bony areas, visible blood vessels, scars and any areas
of inflammation (irritation) or infection. Rotate sites with
each administration as directed by your doctor or nurse.

Multiple subcutaneous infusion sites can be used at the
same time by a multi-needle set. The amount of product
infused into a single site varies and doses over 30 ml may
be divided according to your preference.
Infusion rate:
The recommended initial infusion rate is 10 ml per hour
per infusion site. If well tolerated this may be increased
at intervals of at least 10 minutes to 20 ml per hour per
site for the initial two infusions. For further infusions, the
infusion rate may be increased as tolerated.
If you have any further questions on the use of this
medicine, please ask your doctor, pharmacist or nurse.

Detailed Instructions for use are provided in the section
below:
Do not use Cuvitru at home until you get instructions and
training from your doctor or nurse.
Prepare Cuvitru vial(s):
• Remove Cuvitru from the box. In case the product
is stored in a refrigerator allow vials to reach room
temperature. This may take up to 90 minutes.
• Do not apply heat or place in microwave.
• Do not shake the vial(s).

It is strongly recommended that every time you use
Cuvitru the following data are recorded in your treatment
diary:
- the date of administration,
- the batch number of the medicine, and
- the injected volume, flow rate, the number and location
of injection sites.
Children and adolescents
The listed warnings and precautions apply both to adults
and children.
Other medicines and Cuvitru
Tell your doctor, pharmacist, or nurse if you are taking,
have recently taken or might take any other medicines.

Vaccinations
Cuvitru may reduce the effect of some virus vaccines
such as measles, rubella, mumps and chicken pox (live
virus vaccines). Therefore, after receiving Cuvitru, you
may have to wait for up to 3 months before receiving
certain vaccines. You may have to wait for up to 1 year
after receiving the last dose Cuvitru before you can
receive your measles vaccine.
► Please tell your vaccinating doctor or nurse about
your treatment with Cuvitru.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

No clinical trials have been made with Cuvitru in
pregnant or breast-feeding women. But experience with
immunoglobulins suggests that there are no harmful effects
on the course of pregnancy or the baby to be expected.
If you are breast-feeding and receive Cuvitru, the
antibodies of the medicine can also be found in the
breast milk and may also protect your baby from certain
infections.
Experience with immunoglobulins suggests that no
harmful effects on fertility are to be expected.

Driving and using machines
Patients may experience side effects (for example
dizziness or nausea) during treatment with Cuvitru that
might affect the ability to drive and use machines. If
this happens, you should wait until the reactions have
disappeared.
3 How to use Cuvitru

Always use this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Cuvitru has to be infused under the skin (subcutaneous
or SC administration).
Treatment with Cuvitru will be started by your doctor
or nurse, but you may be allowed to use the medicine
at home once you have received the first few infusions
under medical supervision and you (and/or your
caregiver) have been adequately trained. You and your
doctor will decide if you can use Cuvitru at home. Do
not begin treatment with Cuvitru at home until you have
received complete instructions.

Dosing
Your doctor will calculate the correct dose for you based
on your body weight, any previous treatment you may
have received and your response to treatment.
Your doctor will determine whether you need a loading
dose (for adults or children) of at least 1.0 to 2.5 ml/kg
of body weight divided over several days. Following this,
you will be given Cuvitru on a regular basis, from daily to
once every two weeks; the cumulative dose per month
will be about 1.5 to 5 ml/kg of body weight. Your doctor
may adjust your dose depending on your response to the
treatment.

Do not change the dose or dosing interval without
contacting your doctor. If you think you should receive
Cuvitru more or less frequently, please speak to your
doctor. If you think you have missed a dose, please speak
to your doctor as soon as possible.

24/06/16 9:14 AM

1. Check the vial(s):
• Do not use beyond
expiry date.
• Do not use if the
protective cap is
missing or broken.
• Look at the color: it
should be clear and
colorless to pale yellow
or light brown.
• Do not use if the
solution is cloudy or has
particles.
2. Gather all supplies
• Gather all supplies:
Items include: vial(s)
of Cuvitru, infusion supplies:
subcutaneous needle set,
transfer device(s), syringe(s),
sterile tip caps, sterile clear
bandage, tape, gauze, sharps
container, infusion pump,
infusion log.
• Clean work area.
• Program the infusion
pump according
to prescribed
infusion rates and
manufacturer’s
instructions.
• Wash hands thoroughly
and allow to dry.
• Open supplies as
shown by your doctor or
nurse.
3. Prepare the syringe(s):
• Remove the cap from
the vial.
• Wipe each stopper with
a sterile alcohol wipe
and allow to dry.
• Attach a sterile syringe
to a vented spike.
• Insert the vented spike
into the center of the
vial.
• Turn the vial upside
down and pull back
on the plunger to pull
the solution into the
syringe(s).
• Repeat these steps,
if using multiple vials
to achieve the desired
dose.
If using a sterile needle:
Attach a sterile syringe to the
sterile needle and pull back
the plunger of syringe to fill
with air which should equal
the amount of the solution
you will be taking from the
vial. Insert the needle into
the center of the stopper,
and inject air in. Pull back on
the plunger to withdraw the
desired volume.
4. Prepare the infusion
pump and tubing:
• Use manufacturer
directions for filling the
tubing and using the
pump.
• Attach the syringe filled
with solution to the
needle set.
• Point the syringe tip up
and gently push the
plunger of the syringe
to remove the air and fill
the needle set up to the
needle hub.
5. Prepare the infusion
site(s):
• Select the number of
infusion sites based on
the volume of the total
dose.
• Choose infusion site(s):
upper arms, abdomen,
thighs, or lower back
• Avoid: bony areas,
visible blood vessels,
scars and any areas of
inflammation (irritation)
or infection.
• Infuse the solution from
1 or multiple infusion
sites at the same time.
• Select sites at least
10 cm apart.
• Rotate sites between
future infusions.
• Wipe the infusion site(s)
with a sterile alcohol
wipe beginning at the
center of each infusion
site and moving outward
in circular motion.
Allow the infusion
site(s) to dry (at least
30 seconds).

6. Insert and secure the
subcutaneous needle set:
• Remove the needle
cover. Firmly grasp
and pinch at least
2.5 cm of skin between
two fingers.
• Insert needle with a
rapid motion straight
into the skin at a
90 degree angle. Tape
needle in place with
sterile tape (included on
transparent dressing).
• If more than one site is
used, repeat the steps.
• Check for proper needle
placement by pulling
back on the syringe
plunger to check for
blood return in the
tubing of the needle set.
• If blood is seen in
the tubing, remove
and discard the
subcutaneous needle
and repeat steps 4,
5 and 6 with a new
subcutaneous needle
and infusion site.
• Secure the needle set
in place by applying
a sterile protective
dressing over the
site(s).
7. Start the infusion
• Follow the
manufacturer’s
instructions to turn
pump on and start the
infusion
• Check infusion site(s)
occasionally throughout
the infusion.
8. Remove subcutaneous
needle(s) from the
infusion site(s) when the
infusion is complete:
• Remove the needle set
by loosening the tape
on all edges.
• Pull the needle wings
straight up and out.
• Gently press a small
piece of gauze over the
needle site and cover
with a dressing.
• Throw away the
needle(s) into the
sharps container.
9. Record the infusion:
• Remove the peel-off
label from the vial(s),
which has the product
lot number and expiry
date, and place the
label in your treatment
diary/infusion log.
• Write down the date,
time, dose, site(s) of
infusion (to assist in
rotating sites) and any
reactions after each
infusion.
• Throw away the
disposable supplies,
vials, and unused solution
as recommended by your
doctor or nurse.

Use in children and adolescents
The same indications, dose and frequency of infusion as
for adults apply for children and adolescents (age 0 to 18).
If you use more Cuvitru than you should
If you think that you used more Cuvitru than you should,
speak to your doctor as soon as possible.
If you forget to use Cuvitru
Do not infuse a double dose of Cuvitru to make up for a
missed dose. If you think that you have missed a dose
speak to your doctor as soon as possible.

The following side effects are uncommon (may affect
more than 1 in 1000 people):
- burning sensation
- abdominal pain lower
- oedema at the site of infusion
- positive blood tests for antibodies

Side effects seen with similar medicines
The following side effects have been observed with
infusion of human normal immunoglobulin given under
the skin (subcutaneously). Although these side effects
have so far not been seen with Cuvitru, it is possible that
someone using Cuvitru may get them.
- tingling
- trembling
- fast heart beat
- shortness of breath
- vocal cord dysfunction
- pain in chest
- hardening and/or warmth at the site of infusion

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the national reporting system listed below. By reporting
side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5. How to store Cuvitru

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label and carton after EXP. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice that the solution is
cloudy, has particles or changed color.

Keep the vials in the outer carton in order to protect from
light.
Do not store above 25°C.
Do not freeze.

In case the product is stored in a refrigerator, the
unopened vials must be removed from refrigeration and
placed at room temperature for a minimum of 90 minutes
prior to use. Do not use heating devices including
microwaves.
6. Contents of the pack and other information

What Cuvitru contains
- The active substance is human normal
immunoglobulin.
- 1ml of Cuvitru contains 200 mg of human protein of
which at least 98% is immunoglobulin G (IgG). The
other ingredients are glycine and water for injections.

What Cuvitru looks like and contents of the pack
Cuvitru is a solution for injection in vials of 5, 10, 20 or
40 ml. The solution is clear and colourless or pale-yellow
or light-brown.
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
Not all presentations may be marketed.
Marketing Authorisation Holder
Baxter Innovations GmbH
A‑1221 Vienna
Austria

Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
7860 Lessines
Belgium
This leaflet was last revised in
June 2016

4. Possible side effects

Like all medicines, this medicine can cause side effects
such as chills, headache, dizziness, fever, vomiting,
allergic reactions, feeling sick (nausea), joint pain, low
blood pressure and moderate low back pain, although not
everybody gets them.
Certain side effects, such as headache, chills, or body
aches, may be reduced by slowing the infusion rate.

Serious side effects
Infusions of medicines like Cuvitru can occasionally result
in serious, but rare, allergic reactions. You may experience
a sudden fall in blood pressure and, in isolated cases,
anaphylactic shock. Doctors are aware of these possible
side effects and will monitor you during and after the
initial infusions.
Tell your doctor or nurse immediately if you notice any of
the following:
- feeling light‑headed, dizzy or faint,
- skin rash and itchiness, swelling in the mouth or throat,
difficulty breathing, wheezing,
- abnormal heart rate, chest pain, blueness of lips or
fingers and toes,
- blurred vision
When using Cuvitru at home, you may perform the
infusion in the presence of your caregiver who will help
you watch out for allergic reactions, stop the infusion, and
get help if necessary.
Please also see section 2 of this leaflet about the risk of
allergic reactions and using Cuvitru at home.
The following side effects are very common (may affect
more than 1 in 10 people):
- headache
- diarrhoea, and nausea
- redness, and pain at the site of infusion
- tiredness

The following side effects are common (may affect more
than 1 in 100 people):
- dizziness, migraine, and drowsiness
- decreased blood pressure
- abdominal pain
- itching, and rash
- muscular pain
- swelling, itching, rash, and bruising at the site of
infusion
- pain
LE-07-36117

LE0736117 V2.indd 2

24/06/16 9:14 AM

Expand view ⇕

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.

Hide