100 mg / ml Infusion solution
Human normal immunoglobulin (IVIg)

1. What Gamunex is and what it is used for

What Gamunex is

Gamunex contains human, normal immunoglobulin ( antibodies ) in the form of highly purified protein extracted from human plasma (a substance in the blood from blood donors). The medicine belongs to the group of intravenous immunoglobulins. These are used to treat conditions that mean that the body’s defense system against diseases is not working properly.

What Gamunex is used for

Treatment of adults, children, and adolescents (0–18 years) who do not have enough antibodies (replacement therapy) for example:

  • primary immunodeficiency syndrome (PID), a congenital antibody is
  • acquired immunodeficiency / SID) with severe or recurrent infections , ineffective antimicrobial therapy and either established specific antibody deficiency or serum IgG of less than 4 g / l.

Treatment of adults, children, and adolescents (0-18 years) with certain autoimmune diseases (immune modulation). There are five groups:

  • Primary immunothrombocytopenia (ITP), a condition in which the number of platelets in the bloodstream is greatly reduced. Platelets play an important role in the coagulation process and a reduced number can cause unwanted bleeding and bruising. It is also used in patients at high risk of bleeding or before surgery to correct platelet counts .
  • Guillain-Barré syndrome , in which the immune system damages the nerves and prevents them from functioning properly.
  • Kawasaki disease (in this case together with acetylsalicylic acid treatment), a disease in children when the blood vessels ( arteries ) in the body are enlarged.
  • Chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressive disease that causes weakness in the arms and legs, numbness, pain and fatigue.
  • Multifocal motor neuropathy (MMN), a rare disease that causes slowly progressing weakness in the arms and legs without loss of sensation.

Treatment of adults from 18 years of age:

  • Serious, acute exacerbation ‘s ( relapses ) of myasthenia gravis , a disease that causes severe muscle weakness mainly affects swallowing ability, speech and breathing.

2. What you need to know before using Gamunex

Do not use Gamunex

  • if you are allergic to human normal immunoglobulins or to any of the other ingredients of this medicine (listed in section 6).
  • if you do not have enough IgA- type immunoglobulins in your blood and have developed antibodies to IgA .

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Gamunex.

Infusion reactions and hypersensitivity

Some side effects may be due to the infusion rate. The recommended infusion rate (see section 3. “How to use Gamunex”) should therefore be followed.

Some side effects may occur more often:

  • at high infusion rate
  • in patients who are completely devoid of gamma globulins or have low gamma globulin levels (agammaglobulinemia or hypogammaglobulinemia ) with or without IgA deficiency
  • in patients receiving human, normal immunoglobulin for the first time or, in rare cases, when changing immunoglobulin preparations or after a long treatment interruption.

Any complications can often be avoided by ensuring:

  • that you are not hypersensitive to human immunoglobulin by initially giving Gamunex by slow infusion (0.1 ml / kg / hour)
  • that you are carefully monitored for any symptoms throughout the infusion period. Especially if you are receiving human immunoglobulin for the first time, if you have switched from another immunoglobulin or if you have not received treatment for a while, you should be checked for any side effects during the first infusion and for one hour thereafter.

If side effects occur, the infusion rate should be reduced or the infusion discontinued until the symptoms have disappeared. If symptoms persist even after the infusion has been stopped, appropriate treatment should be instituted. In the event of a shock reaction (anaphylactic shock with a sharp drop in blood pressure), treatment with the drug should be stopped immediately and standard medical treatment for shock should be given.

Patients with kidney problems and other risk factors

Cases of renal dysfunction and acute renal failure have been reported with intravenous immunoglobulins. You are at particularly high risk if you have certain risk factors such as previous impaired renal function ( renal insufficiency ), diabetes ( diabetes mellitus ), or decreased blood volume ( hypovolemia ). Other circumstances that are considered risk factors are if you are overweight or are being treated at the same time with drugs that have harmful effects on the kidneys and/or if you are older than 65 years. In any case, you must take the following precautions:

  • Drink enough fluids before starting treatment
  • Your doctor should check the amount of urine and measure your kidney function
  • Do not use at the same time certain drugs that increase urine production (loop diuretics).

In your case, the infusion rate should be as slow as possible and the immunoglobulin product should be used in the lowest possible concentration. If a kidney dysfunction occurs, your doctor will consider discontinuing immunoglobulin therapy.

Hemolysis (abnormal breakdown of red blood cells )

Immunoglobulins are often reported to increase the risk of red blood cell destruction ( hemolysis ) in both adults and children. If you have received high doses of IVI g for either one day or for several days and have blood type A, B, or AB and/or have an underlying inflammatory disease, you may be at increased risk of destruction of red blood cells ( hemolysis ).

In post-approval reports, it has been observed that IVIg high-dose indications in children, especially Kawasaki disease, are associated with an increased frequency of reports of hemolytic reactions compared to other IVIg indications in children.

Seek medical attention if you develop pallor, fatigue (feeling weak), dark urine, shortness of breath, or palpitations (fast heart rate).

Isolated cases of hemolysis-related renal failure / renal failure with fatal outcomes have occurred.

Information about the security of the infection you

When medicines are made from human blood or human plasma, certain measures are taken to prevent the transmission of infection to patients. These include:

  • careful selection of blood and plasma donors to ensure that those who can carry the infection are excluded,
  • testing each donation and pool of plasma for signs of virus / infection,
  • inclusion of steps in the manufacturing process that can inactivate or remove viruses .

Despite these measures, the risk of transmission of infection can not be completely ruled out when using drugs prepared from human blood or human plasma. This also applies to any unknown or new viruses and other types of infection.

Measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus. However, the measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and/or parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly due to the antibodies present in the product protecting against infection.

This medicine contains less than 1 mmol sodium (23 mg) per single dose (up to 2g / kg), ie essentially ‘sodium-free.

It is strongly recommended that each time you receive a dose of this medicine, the product name and batch number should be noted in order to track the used product kits.

Other medicines and Gamunex

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

Avoid using concomitant medications that increase the excretion of fluid from the body (loop diuretics) while you are being treated with Gamunex.

Effects on vaccines: Gamunex may impair the effectiveness of certain types of vaccines (live attenuated viral vaccines). In the case of rubella, mumps, and chickenpox, it should be at least 3 months after you have received this medicine before you are vaccinated. In the case of measles, the period is up to 1 year.

Pregnancy and breastfeeding

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

Driving and using machines

Dizziness and other reactions can sometimes occur and can affect the ability to drive and use machines. If this happens, wait until the problems disappear before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Gamunex

Gamunex is injected into your veins ( intravenous administration ) by your doctor. Dose one depends on your illness and body weight and is calculated by your doctor (see the section for healthcare professionals at the end of this leaflet).

At the beginning of infusion one, Gamunex is injected slowly. Depending on how you feel, your doctor may then gradually increase the infusion rate.

If you stop using Gamunex

If treatment with this drug is stopped, your clinical condition may worsen. Talk to the doctor in charge if you want to end treatment with this medicine prematurely.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gamunex can cause side effects, although not everybody gets them.

In rare and isolated cases, the following side effects of immunoglobulin drugs have been reported. Seek immediate care if you get any of the following side effects during or after the infusion:

  • Sudden drop in blood pressure and, in some cases, anaphylactic shock (signs of this include skin rash, low blood pressure , fast or irregular heartbeat, wheezing, coughing, sneezing and difficulty breathing), even if you have not shown signs of an allergic reaction to previous treatment.
  • Cases of transient non- infectious meningitis (signs of this are headache, avoidance of or intolerance to light, neck stiffness).
  • Cases of transient decrease in the number of red blood cells in the blood ( reversible haemolytic anemia / haemolysis).
  • Cases of transient reactions affecting the skin.
  • Increased serum creatinine (a test that measures kidney function) and / or acute renal failure (signs of this are low back pain, fatigue, decreased urine output).
  • Thromboembolic reactions such as myocardial infarction (tightness around the chest and rapid heartbeat), stroke (muscle weakness in the face, arm or leg, difficulty speaking or difficulty understanding what others are saying), congestion in the lung (shortness of breath, chest pain and fatigue), deep vein thrombosis ( pain and swelling in an arm or leg).
  • Cases of transfusion-related acute lung injury (TRALI) leading to hypoxia, difficulty breathing, rapid breathing, bluish discoloration of skin or mucous membranes, fever and low blood pressure .

In clinical trials with Gamunex, the following side effects have been observed:

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

  • headache
  • fever.

The following side effects were uncommon (may affect up to 1 in 100 infusions ):

  • dizziness
  • hives (hives, redness , itching of the skin)
  • itching
  • rash
  • nausea
  • vomiting
  • high blood pressure
  • pharyngitis
  • cough
  • nasal congestion
  • wheezing
  • joint pain
  • back pain
  • flu-like illness
  • fatigue
  • freezing
  • impotence
  • muscle aches.

The following side effects were rare (may affect up to 1 in 1000 people ):

  • hemolytic anemia (degradation of red blood cells )
  • respiratory distress
  • sinusitis
  • skin flaking
  • anxiety
  • decreased hemoglobin value
  • digestive problems
  • contusion
  • redness
  • skeletal muscle stiffness
  • redness in the palms
  • lost voice
  • decreased white blood cell count
  • dermatitis ( inflammation of the skin) or contact dermatitis
  • abdominal pain
  • diarrhea
  • low blood pressure
  • neck pain
  • pain in the skeletal muscles
  • chest pain
  • feeling sick
  • injection site reaction
  • urethritis (inflammation of the urethra, which makes it painful and difficult to urinate)
  • viral infection of the upper respiratory tract ( acute infection of viruses in the nose, sinuses and throat)
  • lymphocytosis (increased number of a certain type of blood cell )
  • hypersensitivity ( allergic reaction )
  • photosensitivity of the eyes
  • hypertensive crisis ( acute increase in blood pressure)
  • hyperemia (increased amount of blood)
  • hemoglobinuria (abnormally high concentration in urine of the protein that carries oxygen)
  • high blood pressure
  • presence of free hemoglobin ( hemoglobin circulates outside red blood cells )
  • elevated lowering (increased rate at which red blood cells sink in a test tube).

What countermeasures should be taken if side effects occur?

If side effects occur, the infusion rate should be reduced or the infusion stopped until the symptoms have disappeared. If symptoms persist even after the infusion has been stopped, appropriate treatment should be started.

In case of a severe hypersensitivity reaction with the drop in blood pressure and shortness of breath, and also a severe generalized allergic reaction (anaphylactic shock ), the use of this medicine should be stopped immediately and appropriate countermeasures should be initiated.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gamunex

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 carton and vial. The shelf life is 3 years.

Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Keep the vial in the outer carton.

The medicinal product can be stored in the outer carton for a single period of up to 6 months at room temperature (maximum 25 ° C). In this case, the shelf life of the medicine expires after 6 months, regardless of the original expiry date. The new expiration date must be noted on the outer carton. However, the new expiry date must not be later than the printed expiry date. Refrigerator storage after this date is not possible.

Once the individual vial has been opened, the contents must be used immediately. Any residue must be discarded. Continued storage, even in a refrigerator, is not allowed due to the possible growth of bacteria.

6. Contents of the packaging and other information

Content declaration

The active substance is human normal immunoglobulin (IVI g ). 1 ml of this medicine contains 100 mg of protein with an IgG content of at least 98% in water for injections.

A vial of 10 ml containing: 1 g of normal human

A vial of 50 ml: 5 g of normal human

A vial of 100 ml containing 10 g of human normal immunoglobulin

A vial of 200 ml: 20 g of normal human

A vial of 400 ml: 40 g of normal human

The distribution of IgG subclasses is approximately 62.8% (IgG 1 ), 29.7% (IgG 2 ), 4.8% (IgG 3 ), 2.7% (IgG 4 ).

Maximum IgA content: 84 micrograms / ml.

The other ingredients are glycine and water for injections.

What the medicine looks like and contents of the pack

Gamunex is an infusion solution. The solution is ready to be slightly opalescent and colorless or pale yellow.

Gamunex is available in pack sizes of 10 ml, 50 ml, 100 ml, 200 ml, and 400 ml. The carton contains a glass vial with a stopper (made of chlorobutyl), a pull-off hanging label, and a package leaflet.

Marketing Authorisation Holder

Grifols Deutschland GmbH

Colmarer Straße 22

60528 Frankfurt

Germany

Tel: + 49-69-660 593 100

Manufacturer

Instituto Grifols, SA

Can Guasc, 2 – Parets del Vallès

08150 Barcelona

Spain

Muhammad Nadeem

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