Prospecto: Information for the User

KIOVIG100mg/ml infusion solution

normal human immunoglobulin

Read this prospectus carefully before starting to use the medication because it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you andshould not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section4.

Contents of theprospectus:

1.What KIOVIG is andfor what it is used

2.What you need to knowbefore starting to use KIOVIG

3.How to use KIOVIG

4.Possible adverse effects

5.Storage of KIOVIG

6.Contents of the package and additional information

KIOVIG belongs to a class of medications called immunoglobulins. These medications contain human antibodies, which are also present in the blood. Antibodies help fight infections. Medications like KIOVIG are used in patients who do not have enough antibodies in the blood andoften suffer from frequent infections. These medications can also be used in patients who need additional antibodies for the treatment of certain inflammatory disorders (autoimmune diseases).

KIOVIG is used for

Treatment of patients who do not have enough antibodies (restitutive treatment). Thereare five groups:

1.Patients with a congenital deficiency in antibody production (primary immunodeficiency syndromes).

2.Patients withsecondary immunodeficiencies (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment anddeficit of specific antibodies(PSAF, by its English acronym)* or IgG in serum <4g/l.

*PSAF = inability to increase at least 2 times the antibody titer IgG against the pneumococcal polysaccharide vaccine and peptide antigen vaccines.

Treatment of patients with certain inflammatory disorders (immunomodulation).

Thereare five groups:

1.Patients who do not have enough platelets in the blood (primary immune thrombocytopenia) andwith a high risk of bleeding or who are about to undergo a surgical procedure soon.

2.Patients with a disease characterized by the multiple inflammation of the nerves of the entire body (Guillain-Barré Syndrome).

3.Patients with a disease that causes the multiple inflammation of various organs of the body (Kawasaki Disease).

4.Patients with a rare disease characterized by asymmetric andprogressive weakness of the limbs without sensory loss (multifocal motor neuropathy, MMN).

5.Patients with chronic inflammatory-demyelinating polyradiculoneuropathy (CIDP).

No use KIOVIG

If you are allergic to immunoglobulins or any of the other components of this medication (listed in section6).

For example, if you have immunoglobulin A deficiency, you may have anti‑immunoglobulin A antibodies in your blood. Since KIOVIG contains trace amounts of immunoglobulin A (up to0.14mg/ml), you may develop an allergic reaction.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use KIOVIG.

Required monitoring period during infusion

• You will be closely monitored during the infusion period of KIOVIG to prevent an allergic reaction. Your doctor will ensure that the infusion rate of KIOVIG is appropriate for your case.
• If KIOVIG is administered at a high rate, if you have a condition characterized by low levels of antibodies in the blood (hypogammaglobulinemia), if you have not received this medication before, or if a long period (for example, several weeks) has passed since the last time you received it, there may be a higher risk of adverse effects. In these cases, you will be closely monitored during the infusion andone hour after the infusion.
• If you have received KIOVIG previously andreceived the last treatment recently, you will only be observed during the infusion andfor at least20minutes after the infusion.

When to stop or reduce the infusion rate

In rare cases, the body may have previously reacted to certain antibodies and, therefore, be sensitized to medications containing antibodies. This can occur especially if you have immunoglobulin A deficiency. In these rare cases, you may experience allergic reactions such as a sudden drop in blood pressure or shock, even if you have previously received treatment with medications containing antibodies.

If you experience an allergic reaction during the infusion of KIOVIG, inform your doctor immediately. According to your doctor's decision, the infusion rate may be reduced or stopped.

Special patient groups

• Your doctor will take special precautions if you are overweight, elderly, diabetic, or have high blood pressure, low blood volume (hypovolemia), or vascular problems. In these cases, immunoglobulins may increase the risk of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis, although in very rare cases.

Inform your doctor if you are diabetic. Although KIOVIG does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which may affect your blood sugar level.

• Your doctor will also take special care if you have or have had kidney problems, orif you have received medications that may have damaged your kidneys (nephrotoxic medications), as there is a very rare risk of severe kidney failure.

Inform your doctor if you have or have had kidney problems. Your doctor will choose the appropriate intravenous immunoglobulin for you.

Information about the original material of KIOVIG

KIOVIG is prepared from human plasma (the liquid part of the blood). When medications are prepared from blood or human plasma, certain measures must be taken to prevent the transmission of infections to patients. These measures include a careful selection of donors to exclude those at risk of being carriers of infectious diseases, analysis of specific infection markers in individual donations and plasma mixtures, and inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering medications derived from human blood or plasma, the possibility of transmission of infectious agents cannot be completely ruled out. This also applies to emerging or unknown viruses or other types of infections.

The measures adopted for the manufacture of KIOVIG are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, andfor non-enveloped viruses such as hepatitis A and parvovirus B19. KIOVIG also contains certain antibodies that can prevent infection with hepatitis A virus andparvovirus B19.

Use of KIOVIG with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

If you have received a vaccine within the last six weeks and up to three months, the infusion of immunoglobulins such as KIOVIG may alter the effectiveness of some live virus vaccines such as measles, mumps, rubella, andvaricella. Therefore, you may need to wait until3months after receiving immunoglobulins before receiving a live attenuated virus vaccine. You may need to wait until1year after receiving immunoglobulins before receiving the measles vaccine.

Effects on blood tests

KIOVIG contains a wide variety of different antibodies, some of which may interfere with blood tests. If you have a blood test after receiving KIOVIG, please inform the analyst or your doctor that you have received the medication.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
• No clinical studies have been conducted with KIOVIG in pregnant women or breastfeeding women. However, medications containing antibodies have been used in pregnant women or breastfeeding women andno adverse effects have been expected during pregnancy or for the baby.
• If you are breastfeeding andreceive KIOVIG, the antibodies in the medication may also be found in breast milk. Therefore, your baby may be protected againstcertain infections.

Driving andusing machines

Patients may experience reactions (e.g., dizziness or nausea) during treatment with KIOVIG that may affect their ability to drive anduse machines. If this occurs, wait until the reactions have disappeared.

KIOVIG is for intravenous administration (infusion into a vein). It will be administered by your doctor or nurse. The dose andinfusion frequency may vary depending on your condition andbody weight.

At the beginning of the infusion, you will receive KIOVIG at a low rate. Your doctor may gradually increase the infusion rate depending on whether you tolerate it well.

Use in children and adolescents

In children and adolescents (0to18years), the same indications, doses, andinfusion frequencies as in adults are used.

If you use more KIOVIG than you should

If you receive more KIOVIG than you should, the blood may become thicker (hyperviscosity). This can occur especially in high-risk patients (for example, elderly patients or patients with kidney problems). Make sure to take the necessary fluids to avoid dehydration and inform your doctor if you have any medical problems.

Like all medicines, this medicine can have side effects, although not everyone will experience them. Some side effects, such as headache or redness, can be avoided by reducing the infusion rate.

The list of side effects observed in treatment with KIOVIG is described below:

• Very common side effects(may affect more than1in every10patients):

Headache, high blood pressure, nausea, rash, local reactions (for example, pain and swelling or other reactions at the infusion site), fever, fatigue.

• Common side effects(may affect up to1in every10patients):

Bronchitis, common cold, low red blood cell count, swollen lymph nodes, decreased appetite, difficulty sleeping, anxiety, dizziness, migraine, numbness or tingling of the skin or an extremity, decreased sense of touch, eye inflammation, increased heart rate, flushing, cough, runny nose, chronic cough or wheezing (asthma), nasal congestion, sore throat, difficulty breathing, diarrhea, vomiting, abdominal pain, indigestion, bruising, itching and hives, dermatitis, skin redness, back pain, joint pain, arm or leg pain, muscle pain, muscle cramps, muscle weakness, chills, fluid accumulation under the skin, flu-like illness, chest pain or discomfort, feeling weak or a sense of weakness, feeling unwell, chills and tremors.

• Rare side effects(may affect up to1in every100patients):

Chronic nasal infection, fungal infections, various infections (of the nose andthroat, kidney or bladder), inflammation of the membranes covering the brain, severe allergic reactions, thyroid disorders, excessive response to stimuli, memory alteration, difficulty speaking, bad taste, balance alteration, involuntary tremor, eye pain or swelling, vertigo, fluid in the middle ear, peripheral coldness, vein inflammation, nasal andthroat inflammation, abdominal distension, rapid skin inflammation, acute skin inflammation, cold sweat, increased skin reaction to the sun, excessive sweating even during sleep, muscle spasms, excessive protein in the urine, chest tightness, feeling hot, feeling burning, swelling, increased respiratory rate, changes in blood test results.

• Unknown frequency (cannot be estimated from available data):

Red blood cell destruction, severe allergic shock with risk of death, transient ischemic attack, stroke, low blood pressure, heart attack, blood clot in a major vein, blood clot in the main pulmonary artery, fluid accumulation in the lungs, positive Coombs test result, decreased oxygen saturation in blood, acute lung injury related to transfusion.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label andin the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not use this medication if you observe particles or discoloration.
• Do not store above25°C.
• Do not freeze.
• Store the packaging in the original packaging to protect it from light.

Composition of KIOVIG

• The active ingredient of KIOVIG is normal human immunoglobulin.
• 1 ml of KIOVIG contains100 mg of human protein, of which at least98%is immunoglobulin G (IgG).
• The other components (excipients) are glycine andwater for injection.

Appearance of the product andcontents of the package

KIOVIG is a solution for infusion in vials of10,25,50,100,200or300ml. The solution is transparent or slightly opalescent, colorless or pale yellow.

Not all presentations may be marketed.

Marketing Authorization Holder:

Takeda Manufacturing Austria AG

Industriestrasse67

A‑1221Vienna

Austria

Phone: +800 66838470

Email: [email protected]

Manufacturer:

Baxalta Belgium Manufacturing SA

Boulevard René Branquart,80

B‑7860Lessines

Belgium

Last review date of this leaflet.

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Administration form

• KIOVIG should only be administered intravenously. Other administration routes have not been evaluated.
• KIOVIG should be infused intravenously at an initial rate of0.5ml/kg of body weight/h for30minutes. If well tolerated, the administration rate can be increased gradually to a maximum of6ml/kg of body weight/h. Clinical data from a limited number of patients also indicate that adult patients with IDPcan tolerate an infusion rate of up to8ml/kg of body weight/h.
• If a dilution to lower concentrations is required prior to infusion, KIOVIG can be diluted with a 5% glucose solution to a final concentration of50mg/ml (5%of immunoglobulin).
• Any case of adverse reaction related to infusion should be treated by reducing theinfusion rate or stopping it.

Special precautions

• Any case of adverse reaction related to infusion should be treated by reducing theinfusion rate or stopping it.
• It is recommended to note the name andbatch number of the product each time KIOVIG is administered.

Incompatibilities

This medicine should not be mixed with other medicines.

Special precautions for storage

• It is recommended to use immediately after dilution. Stability in use of KIOVIG after dilution with a 5% glucose solution to a final concentration of50mg/ml (5%of immunoglobulin) has been demonstrated for21days at2°C to8°C as well as at28°C to30°C, however, these studies did not include the aspect of microbial contamination andsafety.

Handling and disposal instructions

• The product should reach room temperature or body temperature before use.
• KIOVIG should be visually inspected before administration to verify the absence of particles anddecoloration. Only a transparent or slightly opalescent and colorless or pale yellow solution should be used. Do not use if particles or decoloration are observed.
• If dilution is necessary, a 5% glucose solution is recommended. To obtain a solution of immunoglobulin of50mg/ml (5%), KIOVIG100mg/ml (10%%) should be diluted with an equal volume of glucose solution. It is recommended to minimize the risk of microbial contamination during dilution.
• The disposal of unused medicine andall materials that have been in contact with it will be carried out in accordance with local regulations

Dosage recommendations