DeqSIGA

Package leaflet: Information for the user

Deqsiga 100 mg/mL solution for infusion

normal human immunoglobulin (IVIg)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because 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 you experience any side effects, including those not listed in this leaflet, contact 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 Deqsiga is 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 blood. Antibodies help the body fight infections. Medicines such as Deqsiga are used in patients who do not have sufficient levels of antibodies in the blood and who are prone to frequent infections. They may also be used in patients who require additional antibodies for the treatment of certain inflammatory conditions (autoimmune diseases).

Deqsiga is used for:

Treatment of patients who do not have sufficient antibody levels (replacement therapy). There are two patient groups:

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

*PSAF = inability to increase IgG antibody titre by at least 2-fold following vaccination with pneumococcal polysaccharide and polypeptide antigen.

Treatment of patients with certain inflammatory disorders (immunomodulation). There are five patient groups:

1. patients with insufficient platelets in the blood (primary immune thrombocytopenia, ITP) who are at high risk of bleeding or who are about to undergo surgery in the near future
2. patients affected by a disease associated with widespread inflammation of nerves throughout the body (Guillain-Barré syndrome)
3. patients affected by a disease causing widespread inflammation in multiple organs of the body (Kawasaki disease)
4. patients affected by a rare condition characterized by slowly progressive, asymmetric limb weakness without sensory loss (multifocal motor neuropathy, MMN)
5. patients affected by chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

2. What you need to know before using Deqsiga

Do not use Deqsiga

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Deqsiga.
Which conditions increase the risk of adverse effects?
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), although this is rare. Your risk of developing a blood clot may be higher if you have any of the following conditions:

• overweight
• advanced age
• diabetes
• prolonged bed rest
• high blood pressure
• low blood volume (hypovolemia)
• blood vessel problems (vascular diseases)
• increased tendency for blood to clot (thrombophilia or thrombotic episodes)
• a disease or condition causing thickening of the blood (hyperviscous blood).

Talk to your doctor or healthcare professional before receiving treatment if any of the above risk factors apply to you.
Seek immediate medical attention if you experience signs or symptoms such as shortness of breath, chest pain, pain and swelling in a limb, weakness or numbness on one side of the body during or after receiving Deqsiga. You will be closely monitored throughout all infusions to promptly detect and treat any thromboembolic events.
Immunoglobulins may increase the risk of kidney damage, which in turn may lead to rapid loss of kidney function (acute kidney failure), although this is rare. Your risk may be higher if you currently have or have previously had:

• kidney problems
• diabetes
• low blood volume (hypovolemia)
• overweight
• treatment with medicines that may harm the kidneys (nephrotoxic medicines).

Before starting treatment, if any of the above-mentioned risk factors apply to you, consult your doctor or healthcare professional, who may decide to reduce the infusion rate or dose, or discontinue treatment completely.
If your blood group is A, B, or AB and you have an underlying inflammatory condition, you may be at increased risk of red blood cell destruction, which may 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 and for at least 20 minutes after the infusion ends. Additional precautions may be required in specific circumstances due to a higher likelihood of adverse effects. For example:

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

In these situations, your doctor or healthcare professional will monitor you closely throughout the entire infusion and for at least one hour afterwards.
If you notice any adverse effects during the infusion of Deqsiga, inform your doctor or healthcare professional immediately. They will assess whether to reduce the infusion rate or stop the infusion completely. The action required will depend on the severity and nature of the reaction.

When might it be necessary to slow down or stop the infusion?
You may be allergic (hypersensitive) to immunoglobulins without knowing it. However, true allergic reactions are rare. They may occur even if you have previously received human immunoglobulins and tolerated them well (see also section 4).
In very rare cases, transfusion-related acute lung injury (TRALI) may occur after administration of immunoglobulins. TRALI causes fluid accumulation in the air spaces of the lungs unrelated to the heart (non-cardiogenic pulmonary edema). TRALI is characterized by severe breathing difficulty (respiratory distress), bluish skin (cyanosis), abnormally low oxygen levels in the blood (hypoxia), drop in blood pressure (hypotension), and increased body temperature (fever). Symptoms usually appear during or within 6 hours after treatment.
If you notice any of these reactions during the infusion of Deqsiga, inform your doctor or healthcare professional immediately. They will assess whether to reduce the infusion rate or stop the infusion completely.

Inflammation of the membranes covering the brain and spinal cord
Inflammation of the membranes covering 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 experience any of the following signs or symptoms, such as severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, or 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 could affect your blood sugar levels.

Information on the source material of Deqsiga
Deqsiga is produced from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, certain measures are taken to prevent transmission of infections to patients, including:

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

Despite these measures, when administering medicines prepared from human blood or plasma, the possibility of transmitting infections cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against 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, to maintain documentation 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
Inform your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.
During treatment with Deqsiga, concomitant use of medicines that increase water elimination from the body (loop diuretics) should be avoided. Your doctor will decide whether to use or continue treatment with loop diuretics.
Infusion of Deqsiga may interfere with the effectiveness of certain 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 vaccination, inform the healthcare professional administering the vaccine that you have received Deqsiga treatment.

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 need to undergo a blood test after receiving Deqsiga, inform your doctor or healthcare professional that you have been administered this medicine.

Pregnancy, breastfeeding, and fertility

• If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
• Clinical studies with Deqsiga have not been conducted in pregnant or breastfeeding women. However, clinical experience with immunoglobulins suggests that harmful effects on pregnancy, the fetus, or the newborn are not expected. If you are breastfeeding while receiving Deqsiga, antibodies from the medicine may also be present in breast milk. No negative effects on newborns/infants are expected.
• Clinical experience with immunoglobulins suggests that no harmful effects on fertility are expected.

Driving and using machines
During treatment with Deqsiga, patients may experience adverse effects such as dizziness or nausea, which could affect their ability to drive, ride a bicycle, or operate machinery.
If these reactions occur, you or your child should wait until the reaction has subsided before resuming these activities. Consult your doctor regarding any adverse effects 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 physician or nurse. The dose and frequency of infusion vary depending on the patient's condition and body weight.
At the beginning of the infusion, Deqsiga will be administered slowly. Depending on your reaction, the physician 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 receive more Deqsiga than you should, your blood may become too thick (hyperviscous). This may particularly occur if you are a patient at risk, for example, elderly patients or those with kidney problems.
Make sure you drink enough fluids to avoid dehydration, and inform your doctor or healthcare professional if you experience any health problems before the infusion.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some side effects, such as headache or hot flushes, may be reduced by slowing the rate of infusion.

Rare and isolated cases of the following serious side effects have been reported with immunoglobulin-based products:

• Severe hypersensitivity reactions such as a sudden drop in blood pressure or anaphylactic shock (for example, you may feel confusion or dizziness, wheezing, swelling of the throat, lips or tongue, skin rash, abnormal heartbeat, chest pain or blurred vision), even if you did not previously show signs of hypersensitivity during earlier infusions;
• Heart attack (for example, when sudden chest pain or breathlessness occurs);
• 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 cough up blood);
• Blood clot (for example, when you notice redness, pain or swelling in one or both legs);
• Transfusion-related acute lung injury (TRALI) (for example, you may feel chest pain, chest discomfort, or difficulty breathing);
• Temporary non-infectious meningitis (for example, you may experience severe headache, nausea, vomiting, stiff neck, fever, and sensitivity to light);
• Reversible haemolytic anaemia/haemolysis (for example, you may feel confused, weak, unusually pale, or have dark urine);
• Severe kidney injury (for example, if you experience lower back pain, fatigue, or difficulty passing urine).

Seek immediate medical attention if you experience any of the symptoms listed above during or after the infusion.

Side effects observed in controlled clinical studies and post-marketing experience are listed below in order of decreasing frequency:

Very common (may affect up to 1 in 10 people):
Headache, high blood pressure, feeling unwell, rash, local reactions (e.g., pain, 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, reduced appetite, difficulty sleeping, anxiety, dizziness, migraine, numbness or tingling of the skin or a limb, eye redness and discomfort, rapid heartbeat, skin redness, cough, runny nose, nasal congestion, mouth and throat pain, difficulty breathing, diarrhoea, vomiting, abdominal pain, indigestion, bruising, itchy rash, itching sensation, skin inflammation, back pain, joint pain, arm or leg pain, muscle pain, muscle cramps, muscle weakness, chills, fluid accumulation under the skin, influenza-like illness, general feeling of being unwell, chest discomfort.

Uncommon (may affect up to 1 in 100 people):
Inflammation of the membranes covering the brain and spinal cord, allergic reactions, sudden and severe allergic reactions, altered taste, memory loss, difficulty speaking, impaired balance, eye pain or swelling, dizziness, feeling cold in the extremities, vein inflammation, blood clot in a blood vessel in the lungs, swelling of mouth and throat, abdominal swelling, cold sweats, sunburn-like reactions (following exposure to light), night sweats, muscle twitching, 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 liver and kidney function tests, decreased white blood cell and red blood cell counts).

Frequency not known (frequency cannot be estimated from the available data):
Destruction of red blood cells, transient ischaemic 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 oxygen saturation in the blood, transfusion-related acute lung injury.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 on the carton 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 colour of the liquid.
• Do not store above 25 °C.
• Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.

6. Package contents and other information

What Deqsiga contains

• The active substance in 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 a solution for infusion in 50 mL or 100 mL vials. The solution is transparent 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Τakeda HELLAS S.A.
Tlf.: +45 46 77 10 10 Tel: +30 210 6387800
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Τakeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Irlanda Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor ehf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Τakeda ΕΛΛΑΣ Α.Ε. Takeda Pharma AB
Τηλ: +30 210 6387800 Tel: 020 795 079
[email protected] [email protected]

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

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

The following information is intended exclusively for healthcare professionals:

Administration method

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

Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Special precautions for storage
Chemical and physical in-use 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 temperatures between 2 °C and 8 °C and between 28 °C and 30 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of in-use storage prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2 °C and 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Instructions for handling and disposal

• Prior to use, the product should be brought to room or body temperature (20 °C–37 °C). Do not use heating devices, including microwave ovens.
• Before administration, Deqsiga should be visually inspected for the presence of particles and discoloration. Administer only solutions that appear clear or slightly opalescent and colorless or pale yellow. Do not use if particles or discoloration are observed.
• If dilution is required, a 5% glucose solution is recommended. To prepare a 50 mg/mL (5%) immunoglobulin solution, Deqsiga 100 mg/mL (10%) must be diluted with an equal volume of glucose solution. Minimizing the risk of microbial contamination during dilution is recommended.
• Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

Dosage recommendations
Replacement therapy

Immunomodulation