CUVITRU 200 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. Cuvitru 200 mg/ml solution for subcutaneous injection
   1. What is Cuvitru and what is it used for
   2. What you need to know before using Cuvitru
   3. How to use Cuvitru
   4. Possible side effects
   5. How to store Cuvitru
   6. Contents of the pack and other information

Cuvitru 200 mg/ml solution for subcutaneous injection

Normal human immunoglobulin

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Cuvitru and what is it used for

What is Cuvitru
Cuvitru belongs to a class of medicines called “normal human immunoglobulins”. Immunoglobulins are also known as antibodies and are present in the blood of healthy people. Antibodies are part of the immune system (the body's natural defenses) and help the body fight infections.

How Cuvitru works
Cuvitru is prepared from the blood of healthy people. The medicine works in exactly the same way as immunoglobulins naturally present in the blood.

What Cuvitru is used for
Cuvitru is used in patients who have a weakened immune system, who do not have enough antibodies in their blood and are therefore more frequently exposed to infections. Regular and sufficient doses of Cuvitru can increase abnormally low levels of immunoglobulins in the blood to normal levels (replacement therapy).
Cuvitru is prescribed to

• patients with a congenital deficiency in antibody production (primary immunodeficiency syndromes).
• patients with a blood cancer (chronic lymphocytic leukemia) that induces a deficiency in antibody production and recurrent infections, when it is not possible to use antibiotics for preventive purposes.
• patients with a bone marrow cancer (multiple myeloma) and deficient antibody production with recurrent infections.
• patients with reduced antibody production after bone marrow cell transplantation from another person.

2. What you need to know before using Cuvitru

DO NOT use Cuvitru:

• if you are allergic to immunoglobulins or to any of the other ingredients of this medicine (listed in section 6).
• if you have anti-immunoglobulin A (IgA) antibodies in your blood, for example, if you suffer from IgA deficiency. Because Cuvitru contains traces of IgA, you may develop an allergic reaction.
• into a blood vessel (intravenous route) or into a muscle (intramuscular route).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cuvitru.
If Cuvitru remains in silicone-coated syringes for more than two hours, particles may form
that are visible. The detailed instructions provided in section 3 of this leaflet must be carefully
followed. Allergic reactions
You may be allergic to immunoglobulins without knowing it. Allergic reactions such as a
sudden drop in blood pressure or anaphylactic shock (a sudden decrease in blood pressure with other
symptoms, such as swelling of the throat, difficulty breathing and skin rash) are rare but may
occur occasionally even if you have not had problems with similar treatments in the past. You are at
greater risk of allergic reactions if you have IgA deficiency and have anti-IgA antibodies. If you
have IgA deficiency, talk to your doctor or nurse before treatment. Cuvitru contains residues of IgA
that may increase the risk of an allergic reaction. The signs or symptoms of these rare allergic
reactions include:

• feeling of confusion, dizziness or fainting
• skin rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing
• abnormal heart rate, chest pain, bluish colour of the lips or fingers of the hands and feet
• blurred vision. Your doctor or nurse will infuse Cuvitru slowly the first time and will monitor you
  carefully during the first infusions to be able to detect and treat any allergic reaction immediately. ► If
  you notice any of these signs during the infusion, tell your doctor or nurse immediately, who will
  decide whether to slow down the infusion rate or stop the infusion completely.

Monitoring during the infusion
Certain undesirable effects may occur more frequently if:

• you are using Cuvitru for the first time.
• you have switched to Cuvitru after receiving another immunoglobulin.
• a long time has passed since your last Cuvitru administration. ► In these cases, you will be
  monitored carefully during the first infusion and for the first hour after the infusion is stopped. In all
  other cases, monitoring during the infusion and for at least 20 minutes after the administration of
  Cuvitru is recommended.

Particular groups of patients
Your doctor will proceed with particular caution if you are overweight, elderly, diabetic or if you
suffer from high blood pressure, reduced blood volume (hypovolaemia), or if you have problems with
your blood vessels (vascular diseases). In these conditions, immunoglobulins may increase the risk of
heart attack, stroke, pulmonary embolism or deep vein thrombosis, although only in very rare cases.
Your doctor will also proceed with particular caution if you have or have had kidney problems in the
past, or if you are taking medicines that can damage the kidneys (nephrotoxic medicines), as there is a
very rare possibility of developing acute kidney failure.
Inflammation of the membranes lining the brain (aseptic meningitis, AMS)
Infusions of products containing immunoglobulins, including Cuvitru, may lead to
inflammation of the layers lining the brain. Stopping treatment with immunoglobulins may lead to a
reduction of AMS within a few days. The syndrome usually starts within a period of a few hours to 2
days after treatment with immunoglobulins.
If you experience the following signs and symptoms, see your doctor: severe headache, stiff neck,
drowsiness, fever, nausea, vomiting, and sensitivity and discomfort to light, after taking Cuvitru. The
doctor will decide whether further tests are necessary and whether it is appropriate to continue taking
Cuvitru.
Destruction of red blood cells (haemolysis)
Cuvitru contains antibodies against blood groups that can cause destruction of red blood cells and
haemolytic anaemia.
Effects on blood tests
Cuvitru contains many different antibodies, some of which may affect blood tests
(serological tests).
► Before undergoing any blood test, tell your doctor about your treatment with Cuvitru.
Home treatment
You and/or the person caring for you will be instructed to recognise the first signs of adverse effects,
especially allergic reactions. During the infusion, you or the person caring for you must carefully
observe for the first signs of adverse effects (for further information, see section 4, “ Possible
adverse effects”).
► If adverse effects occur, the patient or the person caring for them must immediately stop the
infusion and contact the doctor.
► In the event of a serious adverse effect, the patient or the person caring for them must
immediately seek emergency medical attention.
Information about the starting material of Cuvitru
Cuvitru is made from human plasma (the liquid part of the blood). When medicines are made from
blood or human plasma, certain measures are taken to prevent the transmission of infections to
patients, including:

• careful selection of blood and plasma donors, to ensure the exclusion of those at risk of carrying
  infections, and
• testing of each donation and plasma pools for signs of viruses/infections.
• the inclusion of blood or plasma processing steps that can inactivate or remove viruses.

Despite these measures, when medicines derived from blood or human plasma are administered, the
possibility of transmitting infections cannot be totally excluded. This applies also to viruses that are
unknown or emerging, or to other types of infection.
The measures taken are considered effective for enveloped viruses, such as the human
immunodeficiency virus (HIV), the hepatitis B virus and the hepatitis C virus, as well as for non-
enveloped viruses of hepatitis A and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly
because the antibodies against these infections contained in Cuvitru exert a protective effect.
It is strongly recommended that you record the following data in the treatment diary each time you use
Cuvitru:

• the date of administration
• the batch number of the medicine, and
• the volume injected, the infusion rate, the number and location of the injection sites.

Children and adolescents
The warnings and precautions listed apply to both 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 antiviral vaccines such as those against measles, rubella,
mumps and varicella (live vaccines). Therefore, an interval of 3 months should be allowed to pass after
the administration of Cuvitru before vaccination with certain vaccines. For measles, it may be
necessary to wait even 1 year after having taken the last dose of Cuvitru.
► Inform the doctor or nurse administering the vaccine about your treatment with Cuvitru.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Clinical trials with Cuvitru have not been conducted in pregnant or breastfeeding women. However,
experience with immunoglobulins suggests that no harmful effects on the course of pregnancy or on the
baby are to be expected.
If you are breastfeeding and take Cuvitru, the antibodies in the medicine may also be found in breast
milk and may protect the baby from some infections.
Experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

Driving and using machines
Patients may experience adverse effects (e.g. dizziness or nausea) during treatment with Cuvitru, which
may affect their ability to drive and operate machinery. In such cases, they should wait until these
reactions have subsided.

3. How to use Cuvitru

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.
Cuvitru must be infused under the skin (subcutaneous or SC administration).
Treatment with Cuvitru will be started by the doctor or nurse, but you may be allowed to
use the medicine at home after you have been given the first infusions under
medical supervision and when you (and/or the person who cares for you) have received adequate
training. You and your doctor will decide whether you can use Cuvitru (e.g. using an infusion pump
or by manual administration with a syringe) at home. Do not start treatment with Cuvitru at
home without receiving complete instructions.
Dosage
The doctor will calculate the correct dose for you based on your body weight, any previous treatments
you may have received, and your response to treatment.
The doctor will determine if a loading dose (for adults or children) of at least 1.0-
2.5 ml/kg of body weight divided over several days is necessary. Subsequently, Cuvitru will be
administered at regular intervals, from once a day to once every two weeks; the monthly cumulative dose
will be approximately 1.5-5 ml/kg of body weight. The doctor may adjust the dose based on your
response to treatment.
Do not change the dose or the interval between doses without contacting your doctor. If you think you need to take
Cuvitru more or less often, contact your doctor. If you think you have forgotten a dose, contact your
doctor as soon as possible.
Start of treatment
Treatment will be started by a doctor or nurse experienced in treating patients with
weakened immune systems and in training these patients for home treatment. You will
be carefully monitored during the entire infusion and for at least 1 hour after the infusion is stopped to check how you tolerate the medicine. Initially, the doctor or nurse will use a
slow infusion rate and gradually increase it during the first infusion and subsequent
infusions. As soon as the doctor or nurse has established the correct dose and infusion rate
for you, you may be allowed to administer the treatment at home independently.
Home treatment
You can administer Cuvitru yourself or have it administered by the person who cares for you. You will
be instructed by a doctor or nurse experienced in training and treating patients like
you. The doctor or nurse will stay with you during the first treatments.
You or the healthcare provider will be taught:

• the use of sterile (aseptic) infusion techniques,
• the use of a delivery device (if necessary),
• maintaining a treatment diary and
• the measures to be taken in case of serious adverse effects.

You must carefully follow the doctor's instructions regarding the dose, infusion rate and
infusion schedule of Cuvitru so that the treatment is effective.

Method and route of administration
Selection of the infusion site(s):
The suggested areas for subcutaneous infusion of Cuvitru are the abdomen, thighs, upper
arms or lumbar region. Cuvitru can be infused in multiple sites. Infusion sites must be
at least 10 cm apart. Avoid: bony areas, visible blood vessels, scars and inflamed (irritated) or infected areas. Alternate the sites with each administration as instructed by
the doctor or nurse.

When using device-assisted infusion:
With a multi-needle system, it is possible to use multiple subcutaneous infusion sites
simultaneously. The amount of product infused in a single site is variable and doses greater than 30 ml can be divided according to your preferences.
When using manual administration:
Cuvitru can be administered by syringe into a single infusion site. If administration at further sites is necessary, a new sterile injection needle must be used.
The amount of product infused in a single site is variable and doses greater than 30 ml can be divided according to your preferences.
Infusion rate:
The doctor will determine the appropriate infusion technique and rate for you,
taking into account the individual dose, frequency of administration and product tolerability.

When using device-assisted infusion:
The recommended initial infusion rate is 10 ml/hour per infusion site. If well tolerated,
it can be increased in increments of at least 10 minutes up to 20 ml/hour per site for the first two
infusions. For subsequent infusions, the infusion rate can be increased based on
tolerability.
If you have any doubts about the use of this medicine, please contact your doctor, pharmacist or
nurse.

When using manual administration:
Consult your doctor. Start with an infusion rate that does not cause you discomfort. The infusion must not be painful in any case. The recommended maximum infusion rate is approximately 1-2 ml
per minute. It is possible that larger infusion volumes are tolerated at some injection sites
than at others.
If you have any doubts about the use of this medicine, please contact your doctor, pharmacist or
nurse.
Detailed instructions for use are provided in the paragraph below:
Do not use Cuvitru at home before receiving instructions and training from your doctor or
nurse.
To prepare the Cuvitru vial(s):

• Remove Cuvitru from the box. If the product is stored in the refrigerator, allow the vials to reach room temperature. This may take up to 90 minutes.
• Do not heat or microwave.
• Do not shake the vial(s).

2. Gather everything you need: Gather everything you need: namely: Cuvitru vial(s), infusion materials (set with subcutaneous needle, transfer device(s), syringe(s), sterile tip caps, sterile transparent bandage, adhesive bandage, gauze, sharps container, infusion pump (if used), tubing, infusion log). Prepare a clean work area. When using an infusion pump: program the infusion pump according to the prescribed infusion rates and the manufacturer's instructions. Wash your hands thoroughly and let them dry. Open the materials as indicated by the doctor or nurse.

F a r m a c o

3. Prepare the syringe(s): Remove the cap from the vial. Rub each cap with a sterile alcohol swab and let it dry. Attach a sterile syringe to a vented tip. Insert the vented tip into the center of the vial. Turn the vial upside down and pull back the plunger to draw the solution into the syringe(s). Repeat these steps if you are using more vials to obtain the desired dose. The infusion should be started immediately after transferring Cuvitru into the syringe. If administration is expected to take more than two hours, the necessary dose should be divided and administered at different infusion sites. If Cuvitru remains in silicone-coated syringes for more than two hours, visible particles may form. If using a sterile needle: attach a sterile syringe to the sterile needle and pull back the syringe plunger to draw air equal to the solution being drawn from the vial. Insert the needle into the center of the cap and inject air. Pull back the plunger to draw the desired volume.

d e l

4. Prepare for the infusion: a. When using an infusion pump: Follow the manufacturer's instructions to fill the tubing and use the pump. Connect the syringe containing the solution to the set with the needle. Point the syringe tip upwards and gently push the plunger to eliminate air; fill the set with the needle to its connection. b. When using manual administration: follow the instructions of the nurse or healthcare provider. Connect the syringe containing the solution to the set with the needle. Point the syringe tip upwards and gently push the plunger to eliminate air; fill the set with the needle to the needle connection.	m a c o
5. Prepare the infusion site(s): Select the number of infusion sites based on the total dose volume. Choose the infusion site(s): upper arms, abdomen, thighs or lumbar region. Avoid bony areas, visible blood vessels, scars and inflamed (irritated) or infected areas. Infuse the solution from 1 or more infusion sites simultaneously. Select sites spaced at least 10 cm apart. Alternate sites between successive infusions. Rub the infusion site(s) with a sterile alcohol swab starting from the center of each site and moving outwards in a circular motion. Let the infusion site(s) dry (at least 30 seconds).	d e
i 6. Insert and secure the subcutaneous needle: Remove the needle cap. Firmly grasp and pinch at least 2.5 cm of skin between two fingers. Insert the needle into the skin with a quick movement at a 90-degree angle. Secure and the needle with a sterile bandage (included in the transparent dressing). If using more than one site, repeat the steps. Secure the needle in place by applying a sterile protective dressing to the site(s).

Use in children and adolescents
The same indications, dose and frequency of infusion apply to children and adolescents (ages 0 to 18 years) as to adults.

If you use more Cuvitru than you should
If you think you have used more Cuvitru than you should, contact 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 you have
forgotten a dose, contact your doctor as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects may include chills, headache, dizziness, fever,
vomiting, allergic reactions, nausea, joint pain, low blood pressure and moderate back pain.
Some side effects, such as headache, chills or body aches, can be reduced
by slowing the infusion rate.
Serious side effects
Infusions of medicines like Cuvitru can sometimes cause serious, but rare, allergic reactions. A
sudden drop in blood pressure may occur and, in isolated cases, anaphylactic shock.
Doctors are aware of these possible side effects and will monitor you during
and after the initial infusions.
If you notice any of these signs or symptoms, tell your doctor or nurse immediately:

• feeling of confusion, dizziness or fainting
• rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing
• abnormal heart rate, chest pain, bluish color of the lips or fingers of the hands and feet
• blurred vision. When using Cuvitru at home, you can perform the infusion in the presence of the person providing your care who can help you observe the onset of allergic reactions, stop the infusion and seek help, if necessary.

Cuvitru at home.
The following side effects are very common (may affect more than 1 in 10 people):

• headache
• diarrhea and nausea
• redness and pain at the infusion site
• fatigue

The following side effects are common (may affect up to 1 in 10 people):

• dizziness, migraine and drowsiness
• low blood pressure
• abdominal pain
• itching and hives
• muscle pain
• swelling, itching, rash and bruising at the infusion site
• pain

The following side effects are uncommon (may affect up to 1 in 100 people):

• burning sensation
• pain in the lower abdomen
• edema at the infusion site
• positive blood test for antibodies

The frequency of the following side effect is not known (cannot be estimated based on available data):

• inflammation of the membranes lining the brain (aseptic meningitis) Side effects observed with similar medicines The following side effects have been observed with the infusion of normal human immunoglobulin administered under the skin (subcutaneously). Although these side effects have not yet been observed with Cuvitru, it is possible that someone using Cuvitru may experience them.
• tingling
• tremor
• rapid heartbeat
• shortness of breath
• vocal cord dysfunction
• chest pain
• hardening and/or warmth at the infusion site

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
to https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

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 the packaging after
Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution appears cloudy, has deposits or abnormal
colouration.
Keep the vials in the outer packaging to protect the medicine from light.
Do not store at a temperature above 25 °C.
Do not freeze.
If the product is stored in a refrigerator, the closed vials must be removed from the
refrigerator and placed at room temperature for at least 90 minutes before use. Do not use
heating devices, including microwaves.

6. Contents of the pack and other information

What Cuvitru contains

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

Description of the appearance of Cuvitru and contents of the pack
Cuvitru is an injectable solution in vials of 5, 10, 20, 40 or 50 ml. The solution is clear and
colorless, or pale yellow or light brown.
A 5 ml vial contains: 1 g of normal human immunoglobulin
A 10 ml vial contains: 2 g of normal human immunoglobulin
A 20 ml vial contains: 4 g of normal human immunoglobulin
A 40 ml vial contains: 8 g of normal human immunoglobulin
A 50 ml vial contains: 10 g of normal human immunoglobulin
Pack sizes:
1, 10 or 20 vial(s) containing 5 ml of solution for injection
1, 10, 20 or 30 vial(s) containing 10 ml of solution for injection
1, 10, 20 or 30 vial(s) containing 20 ml of solution for injection
1, 5, 10 or 20 vial(s) containing 40 ml of solution for injection
1 vial containing 50 ml of solution for injection
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestrasse 67, A - 1221 Vienna

Manufacturer
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
7860 Lessines
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria: Cuvitru 200 mg/ml lnjektionslösung zur subkutanen Anwendung
Belgium, France: Cuvitru 200 mg/ml solution injectable par voie sous-cutanée
Czech Republic, Denmark, Finland, Germany, Greece, Italy, Norway, Poland: Cuvitru
Ireland, United Kingdom: Cuvitru 200 mg/ml solution for subcutaneous injection
Netherlands: Cuvitru 200 mg/ml, oplossing voor subcutane injectie
Slovakia, Sweden: Cuvitru 200 mg/ml
Spain: Cuvitru 200 mg/ml, solución inyectable subcutánea