DEQSIGA 100 mg /Ml Infusion Solution

Зміст інструкції

1. Deqsiga 100 mg/mL solution for infusion
   1. What is Deqsiga and what it is used for
   2. Cosa deve sapere prima di usare Deqsiga
   3. How to use Deqsiga
   4. Possible side effects
   5. How to store Deqsiga
   6. Contents of the pack and other information

Deqsiga 100 mg/mL solution for infusion

normal human immunoglobulin (IVIg)
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using 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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Deqsiga is and what it is used for
• 2. What you need to know before using Deqsiga
• 3. How to use Deqsiga
• 4. Possible side effects
• 5. How to store Deqsiga
• 6. Contents of the pack and other information

1. What is Deqsiga and what it is used for

Deqsiga belongs to a class of medicines called immunoglobulins. These medicines
contain human antibodies, which are also present in the blood. Antibodies help the body to
fight infections. Medicines like Deqsiga are used in patients who do not have sufficient
quantities of antibodies in the blood and are prone to frequent infections. They can also be used
in patients who need additional antibodies for the treatment of certain inflammatory diseases
(autoimmune diseases).

Deqsiga is used for
Treatment of patients who do not have a sufficient quantity of antibodies (substitute therapy). The patient groups are two:

• 1. patients with congenital deficiency in antibody production (primary immunodeficiency syndromes)
• 2. patients with secondary immunodeficiencies (AIDS) suffering from severe or recurrent infections, ineffective antimicrobial treatment and confirmed specific antibody deficiency (PSAF)*or serum IgG level < 4 g/L.

*PSAF = inability to increase at least 2 times the IgG antibody titer following
pneumococcal vaccination with polysaccharide and polypeptide antigen.

Treatment of patients affected by some inflammatory disorders (immunomodulation). The patient
groups are five:

• 1. patients who do not have sufficient platelets in the blood (primary immune thrombocytopenia, ITP) and are at high risk of bleeding or who will undergo surgery shortly
• 2. patients affected by a disease associated with multiple inflammations of the nerves throughout the body (Guillain-Barré syndrome)

• 3. patients affected by a disease that causes multiple inflammations of different organs of the body (Kawasaki disease)
• 4. patients affected by a rare condition characterized by asymmetrical weakness of the limbs with slow progression without sensory loss (multifocal motor neuropathy, MMN)
• 5. patients affected by chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

2. Cosa deve sapere prima di usare Deqsiga

Non usi Deqsiga

• se è allergico alle human normal immunoglobulins or to any of the other components of this medicine (listed in section 6)
• if you have antibodies against immunoglobulin A (IgA) in your blood. Antibodies against IgA may develop in the case of IgA deficiency. Because Deqsiga contains traces of IgA, you may experience an allergic reaction.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Deqsiga.
Under what circumstances and conditions does the risk of undesirable effects increase?
Immunoglobulins may increase the risk of heart attack, stroke, blood clots in the lungs (pulmonary embolism) or blockage of a blood vessel in the leg (deep vein thrombosis), even if only rarely. You may be at increased risk of developing a blood clot if you have the following conditions:

• overweight
• advanced age
• diabetes
• prolonged bed rest
• high blood pressure
• low blood volume (hypovolemia)
• problems with blood vessels (vascular diseases)
• an increased tendency to blood clotting (thrombophilia or thrombotic events)
• a disease or condition that causes the blood to thicken (hyperviscous blood).

Talk to your doctor or healthcare professional before starting treatment if any of the risk factors listed above apply to you.
Seek immediate medical attention if you experience signs and symptoms such as shortness of breath, chest pain, pain and swelling of a limb, weakness or numbness on one side of the body during or after taking Deqsiga. You will be carefully monitored during all infusions so that any thromboembolic events can be identified and treated immediately.
Immunoglobulins may increase the risk of kidney injury, which can in turn lead to rapid loss of kidney function (acute renal failure), even if only rarely. You may be at greater risk if you have/have had in the past the following conditions:

• kidney problems
• diabetes
• low blood volume (hypovolemia)
• overweight
• you have been prescribed medicines that can damage the kidneys (nephrotoxic medicines).

Before starting treatment, if any of the risk factors mentioned above are present, talk to your doctor or healthcare professional, who will decide whether to reduce the infusion rate or dose or to stop it completely.
If your blood group is A, B or AB and you suffer from a latent inflammatory condition, you may be at increased risk of red blood cell destruction, which can lead to anemia (hemolytic anemia).
Duration of monitoring during infusion
For your safety, treatment with Deqsiga must be supervised by a doctor or healthcare professional, who will carefully adjust the infusion rate according to your needs and monitor you during the infusion and for at least 20 minutes after it has ended. In specific circumstances, additional precautions may be necessary due to the increased likelihood of adverse effects. For example:

• you are receiving Deqsiga at a high infusion rate;
• you are taking Deqsiga for the first time or after a long interruption of treatment (e.g., several weeks or months);
• in rare cases, when switching from one human immunoglobulin product to another;
• you suffer from an untreated infection or latent chronic inflammation.

In these situations, your doctor or healthcare professional will keep you under close observation throughout the infusion and for at least one hour afterwards.
If you notice the onset of adverse effects during the Deqsiga infusion, contact your doctor or healthcare professional immediately, who will assess whether to reduce the infusion rate or stop it completely. The action to be taken will depend on the severity and nature of the reaction.
In what cases may it be necessary to slow down or stop the infusion?
You may be allergic (hypersensitive) to immunoglobulins without knowing it. However, real allergic reactions are rare. They can occur even if you have previously received human immunoglobulins and tolerated them well (see also section 4).
In very rare cases, acute transfusion-related lung injury (TRALI) may occur after the administration of immunoglobulins, which causes an accumulation of fluid in the air space in the lungs, not related to the heart (non-cardiogenic pulmonary edema). TRALI is recognized by severe difficulty breathing (respiratory distress), bluish skin (cyanosis), atypically low oxygen levels in the blood (hypoxia), decreased blood pressure (hypotension) and increased body temperature (fever). Symptoms usually occur during treatment or within 6 hours of its completion.
If you notice these reactions during the Deqsiga infusion, inform your doctor or healthcare professional immediately, who will assess whether to decrease the infusion rate or stop it completely.
Inflammation of the membranes lining the brain and spinal cord
Inflammation of the membranes lining the brain and spinal cord (aseptic meningitis syndrome) has been reported in association with immunoglobulin treatment.
Inform your doctor or healthcare professional immediately if you notice the onset of any of these signs and symptoms, including severe headache, stiff neck, drowsiness, fever, photophobia, nausea and vomiting during or after the infusion.
Sugar content
Although Deqsiga does not contain sugar, it may be diluted with a special sugar solution (5% glucose) which may alter blood sugar levels.
Information about the origin of Deqsiga material
Deqsiga is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients, including:

• careful selection of blood and plasma donors to ensure that those at risk of transmitting infections are excluded;
• testing of each donation and plasma pools to exclude any signs of viruses/infections;
• inclusion of steps in the processing of blood or plasma that can inactivate or remove viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, the possibility of transmitting infections cannot be completely 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 the human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, as well as non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, probably because the antibodies against these infections contained in the product are protective.
It is strongly recommended to record the name and batch number of the medicine each time you receive a dose of Deqsiga, so as to keep a record of the batches used.

Children and adolescents
There are no specific or additional warnings or precautions applicable to children and adolescents.

Other medicines and Deqsiga
Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
The concomitant use of medicines that increase water elimination from the body (loop diuretics) should be avoided during treatment with Deqsiga. The doctor will decide whether to use or continue treatment with loop diuretics.
The infusion of Deqsiga may compromise the effect of some live virus vaccines, such as measles, rubella, mumps and varicella. Therefore, after receiving immunoglobulins, you may need to wait up to 3 months before receiving a live attenuated vaccine. After receiving Deqsiga, you may need to wait up to 1 year before receiving the measles vaccine.
Before being vaccinated, tell the vaccinating doctor about the treatment with Deqsiga.

Effects of Deqsiga on blood tests
Deqsiga contains a wide variety of antibodies, some of which may affect the results of blood tests. Treatment with Deqsiga may interfere with the results of specific blood tests (serological tests).
If you have to undergo a blood test after taking Deqsiga, tell your doctor or healthcare professional that you have been given this medicine.

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 studies with Deqsiga have not been conducted in pregnant or breastfeeding women. However, clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, the fetus and the newborn are expected. If you are breastfeeding and taking Deqsiga, the antibodies in the medicine may also be present in breast milk. No adverse effects on infants/breastfeeding infants are expected.
• Clinical experience with immunoglobulins suggests that no harmful effects on fertility are expected.

Driving and operating machinery
During treatment with Deqsiga, patients may experience adverse effects such as dizziness or nausea that may affect their ability to drive vehicles, ride a bicycle or use machinery.
If these reactions occur, you or your child must wait for the reaction to subside before resuming these activities. Consult your doctor about any adverse effects that you or your child may experience.

3. How to use Deqsiga

Deqsiga is intended for intravenous administration (infusion into a vein). It will be administered to you by a
doctor or nurse. The dose and frequency of the infusion vary depending on the conditions and
body weight of the patient.
At the beginning of the infusion, Deqsiga will be administered to you slowly. Depending on your reaction, the
doctor may gradually increase the infusion rate.

Use in children and adolescents
For children and adolescents (aged between 0 and 18 years), the indications, doses and frequency of
infusion are the same as those indicated for adults.

If you use more Deqsiga than you should
If you take more Deqsiga than you should, the blood may become too dense (hyperviscous). This
may occur particularly if you are a patient at risk, for example, elderly or with kidney
problems.
Make sure you drink enough fluids to avoid dehydration and inform your doctor or healthcare
professional if you experience health problems before the infusion.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects, such as headache or flushing, can be reduced by slowing down the infusion rate.
In rare and isolated cases, the following serious side effects have been reported with immunoglobulin-based
preparations:

• serious hypersensitivity reactions such as a sudden drop in blood pressure or anaphylactic shock (for example, you may feel confused or dizzy, wheezing, swelling of the throat, lips or tongue, rash, abnormal heartbeat or chest pain, or blurred vision), even if you have not experienced hypersensitivity during previous infusions;
• heart attack (for example, when you experience sudden chest pain or shortness of breath);
• stroke (for example, sudden onset of muscle weakness, loss of sensation and/or balance, reduced alertness or difficulty speaking);
• blood clots in the arteries of the lungs (for example, when you experience chest pain, difficulty breathing or coughing up blood);
• blood clot (for example, when you experience redness, pain or swelling in one or both legs);
• acute transfusion-related lung injury (TRALI) (for example, you may experience chest pain, chest discomfort, difficulty breathing);
• temporary non-infectious meningitis (for example, you may experience severe headache, nausea, vomiting, stiff neck, fever and sensitivity to light);
• reversible hemolytic anemia/hemolysis (for example, you may feel confused, weak, abnormally pale, dark urine);
• severe kidney injury (for example, if you experience back-loin pain, fatigue, difficulty passing urine).

Seek immediate medical attention if you experience any of the symptoms listed above
during or after the infusion.
The side effects observed in controlled clinical trials and post-marketing experience are
presented in decreasing order of frequency:

Very common(may affect up to 1 in 10 people):
Headache, high blood pressure, feeling unwell, rash, local reactions (e.g., pain and swelling or other reactions at the infusion site), fever, fatigue.

Common(may affect up to 1 in 10 people):
Low red blood cell count, swollen lymph nodes, decreased appetite, difficulty sleeping, anxiety,
dizziness, migraine, numbness or tingling of the skin or a limb, redness and discomfort
in the eye, fast heartbeat, skin flushing, cough, runny nose, stuffy nose,
pain in the mouth and throat, difficulty breathing, diarrhea, vomiting, abdominal pain,
indigestion, bruising, itchy rash, feeling itchy, skin inflammation, back pain, joint pain, pain in the arms or legs, muscle pain, muscle cramps,
muscle weakness, chills, fluid retention under the skin, flu-like illness, general feeling of being unwell, chest discomfort.

Uncommon(may affect up to 1 in 100 people):
Inflammation of the membranes lining the brain and spinal cord, allergic reactions,
sudden and severe allergic reactions, altered taste, memory loss, difficulty speaking,
impaired balance, pain or swelling in the eyes, feeling dizzy, cold extremities, inflammation of a vein, blood clot in a blood vessel in the lungs, swelling of the mouth and
throat, abdominal bloating, cold sweat, sunburn-like reactions (following exposure
to light), sweating during sleep, muscle contraction, excess protein in the urine,
chest tightness, feeling of warmth, burning sensation, rapid onset of swelling under the
skin, changes in blood test results (e.g., increased kidney and liver function tests and decreased white blood cell and red blood cell count).

Frequency not known(frequency cannot be estimated from the available data):
Destruction of red blood cells, transient ischemic attack, stroke, tremor, low blood pressure, heart attack, blood clot in a deep vein (usually in the leg), fluid accumulation in the
lungs, positive Coombs test, decreased blood oxygen saturation, acute transfusion-related lung injury.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Deqsiga

• 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 box after Exp. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice the presence of particles in the vial or changes in the color of the liquid.
• Do not store at a temperature above 25 °C.
• Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.

6. Contents of the pack and other information

What Deqsiga contains

• The active substance of Deqsiga is normal human immunoglobulin.
• 1 mL of Deqsiga contains 100 mg of human proteins, of which at least 98% is immunoglobulin G (IgG).
• The other components (excipients) are glycine and water for injections.

Description of the appearance of Deqsiga and contents of the pack
Deqsiga is an infusion solution in vials of 50 mL or 100 mL. The solution is clear or
slightly opalescent and colourless or pale yellow.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria

Manufacturer
Baxalta Belgium Manufacturing
SA Boulevard René Branquart 80
7860 Lessines
Belgium
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf.: +45 46 77 10 10
[email protected]

Malta
Τakeda HELLAS S.A.
Tel: +30 210 6387800
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma OÜ
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Τakeda ΕΛΛΑΣ Α.Ε.
Tηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España, S.A.
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Irlanda
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor ehf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
Τakeda ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:
Method of administration

• Deqsiga must be administered exclusively intravenously. Other routes of administration have not been evaluated.
• Deqsiga must be infused intravenously at an initial rate of 0.5 mL/kg body weight/hour for 30 minutes. In case of an adverse reaction, the infusion rate must be reduced or the infusion stopped. If well tolerated, the infusion rate may be gradually increased to a maximum of 6 mL/kg body weight/hour. Clinical data from a limited number of patients also indicate that adult patients with PID can tolerate an infusion rate of up to 8 mL/kg body weight/hour.
• If dilution to lower concentrations is necessary before infusion, Deqsiga may be diluted with 5% glucose solution to a final concentration of 50 mg/mL (5% immunoglobulin).
• Any adverse event related to the infusion must be treated by reducing or stopping the infusion rate.

Incompatibilities
This medicine must not be mixed with other medicines.

Special precautions for storage
The chemical and physical stability of the diluted product (dilution with 5% glucose solution
to a final concentration of 50 mg/mL (5%) immunoglobulin) has been demonstrated for
21 days at a temperature between 2 °C and 8 °C and between 28 °C and 30 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions in use before use are
the responsibility of the user and must not normally exceed 24 hours at a temperature between
2 °C and 8 °C, unless the dilution has taken place under controlled and validated aseptic conditions.

Instructions for handling and disposal

• Before use, the product must be brought to room or body temperature (20 °C-37 °C). Do not use heating devices, including microwave ovens.
• Before administration, Deqsiga must be visually inspected for the presence of particles and colour change. Only administer solutions that appear clear or slightly opalescent and colourless or pale yellow. Do not use if particles or colour change are observed.
• If dilution is necessary, 5% glucose solution is recommended. To make an immunoglobulin solution of 50 mg/mL (5%), Deqsiga 100 mg/mL (10%) must be diluted with an equivalent volume of glucose solution. It is recommended to minimise the risk of microbial contamination during dilution.
• Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Recommended dosage
Replacement therapy
Immunomodulation