Yimmugo 100 mg/mL solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.

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

1. Patients who are born with a lack of antibodies (primary immunodeficiency syndromes, PID)
2. Acquired lack of antibodies (secondary immunodeficiency syndrome, SID) in patients who suffer from severe or recurrent infections and ineffective antimicrobial treatment with either proven specific antibody failure or low immunoglobulin G level (< 4 g/L)

1. Patients with a lack of blood platelets (primary immune thrombocytopenia, ITP), who will have surgery in the near future or are at risk of bleeding
2. Patients with a disease that is associated with multiple inflammations of the peripheral nerves (Guillain-Barré syndrome)
3. Patients with a disease which causes inflammation of several organs of the body escpecially the blood vessels (Kawasaki’s disease)
4. Patients with a chronic disease that is characterised by inflammation of the peripheral nerves. This disease causes muscle weakness and/or numbness mainly in the legs and upper limbs (Chronic inflammatory demyelinating polyneuropathy, CIDP)
5. Patients with a disease of the motor nerves characterized by slow progressive weakness of arms and legs (Multifocal motor neuropathy, MMN)

• if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6)
• if you have an insufficient amount of immunoglobulin A (IgA), especially if you have antibodies against IgA in your blood. This might lead to severe allgeric reaction (anaphylaxis)

Before using this medicine:

Talk to your doctor, pharmacist or nurse before using Yimmugo if you:

• have an active infection or underlying chronic inflammation
• if you are allergic to immunoglobulins (see section "Do not use Yimmugo")
• have or had a kidney disease
• have received medicines that may harm your kidneys

In very rare cases immunoglobulins may increase the risk of heart attack, stroke, lung embolism, or deep vein thrombosis. Talk to your doctor, pharmacist or nurse, if you:

• are overweight, elderly or diabetic
• have high blood pressure, low blood volume (hypovolaemia) or thicker blood than normal (high blood viscosity)
• have been bedridden for a long time, have problems with your blood vessels (vascular diseases) or other risks for thrombotic events (blood clots)

In all of the above cases, your doctor will take special care of you.

Monitoring during and after the infusion is required, if you:

• have not received this medicine before or if there has been a long break (e.g. several weeks) since you last received it (monitoring after infusion: at least 1 hour by your doctor or nurse)
• have been given Yimmugo recently (monitoring after infusion: at least 20 minutes by your doctor or nurse)

Slowing or stopping of infusion may be required, if you:

• experience any symptoms during the infusion such as headache, flushing, chills, muscle pain, wheezing, rapid heart rate, lower back pain, nausea and low blood pressure. In rare cases these are signs of an allergic reaction. Another reason can be that the infusion rate might be too high and should be slowed (this is called an infusion-related reaction). Tell your doctor immediately about any symptoms appearing during infusion
• experience severe difficulty breathing (respiratory distress), rapid breathing (tachypnoe), abnormally low levels of oxygen in the blood (hypoxia) and increased body temperature (fever). These are symptoms of transfusion-related acute lung injury (TRALI). TRALI occurs in very rare cases after receiving immunoglobulins. This will lead to non-heart related accumulation of fluid in the air spaces of the lungs (non-cardiogenic pulmonary oedema). The symptoms typically appear 1 to 6 hours after receiving treatment. Tell your doctor immediately if you notice such reactions during the Yimmugo infusion. Your doctor will stop the infusion immediately.
• experience fever, neck pain and headache. These are symptoms of aseptic meningitis syndrome (AMS, inflammation of the membrane that covers the brain and spinal cord). AMS has been reported with immunoglobulin infusion. Stopping the immunoglobulin treatment resulted in remission of AMS within several days without further consequences. Your doctor can tell you more about the condition and its symptoms.

Based on your condition, your doctor will decide the approporiate infusion rate, the duration of the treatment, whether the treatment with Yimmugo needs to be stopped and/or whether additional medical measures need to be initiated.

• This medicine can contain blood group antibodies. These can rarely increase the risk of red blood cell breakdown (haemolysis). Your doctor will monitor the clinical signs and symptoms of haemolysis and haemolytic anaemia.
• Low concentration of white blood cells (neutropenia) has been reported with immunoglobulins. This condition resolves spontaneously within 7 to 14 days. Your doctor can tell you more about the symptoms.
• Yimmugo can affect blood tests for a certain time. Tell your doctor about your treatment with Yimmugo prior to having any blood tests.

Yimmugo is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, everything is done to prevent infective agents being passed on to patients through administration of these medicines. All blood donors are tested for viruses and infections. In addition, processing of the blood or plasma includes steps that can inactivate or remove viruses.

Despite these precautionary measures, when medicines prepared from human blood or plasma are given, the risk of passing on infections cannot be totally excluded.

The measures taken are considered effective for viruses such as:

• human immunodeficiency virus (HIV)
• hepatitis B virus (HBV)
• hepatitis C virus (HCV)
• hepatitis A virus (HAV)
• parvovirus B19

It is strongly recommended that every time you are given a dose of Yimmugo your doctor records the name and batch number of the product. The batch number provides information about the particular starting materials of your medicine. If necessary, a connection between you and the starting material used can thereby be made.

The special warnings and precautions for adults also apply to children and adolescents.

Tell your doctor if you are using, have recently used or might use any other medicines.

Yimmugo can reduce the effectiveness of some vaccines such as:

• measles
• rubella
• mumps
• chicken pox

You may have to wait up to 3 months before you can have some vaccines and up to a year before you can have a measles vaccine.

Please avoid using loop diuretics (medicines that make your kidney pass out more fluid) together with Yimmugo.

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

Your doctor will decide if Yimmugo may be used during pregnancy and breast-feeding.

Yimmugo has a minor influence on the ability to drive and use machines. If you experience reactions such as nausea or dizziness, you should wait for these to resolve before driving or using machines.

Yimmugo is intended only for administration via a vein (intravenous infusion). It is given to you by your doctor or nurse. Your doctor will decide the dose, frequency and infusion rate depending on your condition and your body weight. The product should be brought to room or body temperature before use.

At the start of treatment the infusion rate will be slow. Afterwards, if you feel well, your doctor or nurse may gradually increase the infusion rate.

Use in children and adolescents (0–18 years) is the same as that for adults.

Please talk to your doctor about how to proceed.

Your blood may become too thick (hyperviscous). This is more likely to happen in children or if you are elderly or have problems with your heart or kidneys. Make sure that you drink adequate fluids so you are not dehydrated and tell your doctor about any medical problems.

• rash
• itching
• wheezing
• difficulty breathing
• swelling of the eyelids, face, lips, throat or tongue
• extremely low blood pressure with symptoms like dizziness, confusion, fainting, fast pulse

This can be an allergic or in rare cases a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

Frequencies given below have been calculated based on number of patients treated.

Very common (may occur in more than 1 in 10 patients)

• headache

Common (may occur in up to 1 in 10 patients)

• dizziness
• tiredness (fatigue), chills, fever
• nausea, abdominal or oral pain
• increased blood pressure, positive Coombs test result
• skin reaction
• back pain, pain in arms and legs
• difficulty breathing (dyspnoea), pain in the mouth and throat (oropharyngeal pain)
• decreased number of white blood cells (neutropenia), decreased number of red blood cells (haemolysis)
• difficulty balancing (vertigo), ringing in the ears (tinnitus)
• allergic/anaphylactic reaction
• confusion
• flushing

• vomiting, joint pain and low blood pressure
• decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels ((reversible) haemolytic reactions) and haemolytic anaemia requiring transfusion
• a sudden fall in blood pressure and, in isolated cases, anaphylactic shock
• temporary skin reactions (including cutaneous lupus erythematosus)
• formation of blood clots which may enter your circulation (thromboembolic reactions) causing heart attack (myocardial infarction), stroke, clots in the blood vessels of the lung (pulmonary embolism), blood clots in a vein (deep vein thrombosis)
• cases of temporary acute inflammation of the protective membranes covering the brain and spinal cord (reversible aseptic meningitis)
• cases of blood test results which indicate that kidney function is impaired and/or sudden kidney failure
• cases of Transfusion Related Acute Lung Injury (TRALI) see also section “Warnings and precautions”

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is human normal immunoglobulin
  1 mL contains 100 mg human normal immunoglobulin (purity of at least 96% IgG). The IgG subclass distribution is approx. 62% IgG1, 32% IgG2, 4% IgG3 and 1% IgG4. The maximum IgA content is 500 micrograms/mL.
• The other ingredients are: glycine, polysorbate 80 and water for injections.

Yimmugo is a solution for infusion. The solution should be clear or slightly opalescent and colourless to pale yellow.

50 mL, 100 mL or 200 mL of solution in a vial (Type II glass) with a stopper (bromobutyl) and a flip off cap (plastic).

Pack with 1 vial with 50 mL, 100 mL or 200 mL solution.

Not all pack sizes may be marketed.