Gamten

Package leaflet: Information for the user

Gamten

100 mg/ml infusion solution
Normal human immunoglobulin (IVIg)
Please read all of this leaflet carefully before you start 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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their
symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
See section 4.
Contents of this leaflet:

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

1. What Gamten is and what it is used for

What Gamten is
Gamten is a normal human immunoglobulin solution (IgG), i.e. a solution of human antibodies, administered intravenously (i.e. by infusion into a vein). Immunoglobulins are normal components of the human body and contribute to your body's immune defenses. Gamten contains all IgG activities found in the general population. Adequate doses of this medicine can correct abnormally low IgG levels and restore them to the normal range.
Gamten has a broad spectrum of antibodies against various infectious agents.

What Gamten is used for
Gamten is used as replacement therapy in children, adolescents (aged 0–18 years), and adults in several patient groups:

• Patients with congenital antibody deficiency (primary immunodeficiency syndromes such as congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, and severe combined immunodeficiencies).
• Patients with acquired antibody deficiency (secondary immunodeficiency) caused by specific diseases and/or treatments and who experience severe or recurrent infections.

Gamten may be used for the treatment of susceptible adults, children, and adolescents (0–18 years) who have been exposed to measles or are at risk of measles exposure, and in whom active measles vaccination is not indicated or not recommended.
Gamten may also be used for the treatment of the following autoimmune diseases (immunomodulation):

• In patients with immune thrombocytopenia (ITP), a condition in which platelets are destroyed, resulting in low platelet counts, and who are at high risk of bleeding or require correction of platelet count prior to surgery.
• In patients with Kawasaki disease, a condition causing inflammation of various organs.
• In patients with Guillain-Barré syndrome, a condition causing inflammation of certain parts of the nervous system.
• In patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a disease causing chronic inflammation of peripheral parts of the nervous system, leading to muscle weakness and/or numbness, primarily in the legs and arms.
• In patients with multifocal motor neuropathy (MMN), a disease characterized by slowly progressive, asymmetric limb weakness without loss of sensation.
• In adult patients with active dermatomyositis (DM), a disease involving inflammation of muscles and skin abnormalities. Typical symptoms include progressive, symmetric muscle weakness and characteristic skin changes, such as a rash on various parts of the body (e.g. eyelids, cheeks, nose, back, elbows, knuckles) and scaly, rough, dry skin. Gamten may be used in patients treated with immunosuppressive drugs, such as corticosteroids, or when these drugs are contraindicated or poorly tolerated.

2. What you need to know before using Gamten

Do not use Gamten

• if you are allergic to human immunoglobulin or to any of the other components of Gamten (listed in section 6).
• if you have immunoglobulin A (IgA) deficiency and have developed antibodies against IgA-type immunoglobulins.

Warnings and precautions

Talk to your doctor or pharmacist before using Gamten. It is strongly recommended that, with each administration of Gamten, the product name and batch number be recorded to ensure traceability of the batch used.

Adverse reactions may occur more frequently:

• with high infusion rates
• when receiving Gamten for the first time, or, rarely, after a long interval since the previous infusion
• when you have an untreated infection or underlying chronic inflammation

If an adverse reaction occurs, the rate of administration must be reduced or the infusion stopped. The treatment required for the adverse event will depend on the nature and severity of the side effect.

Conditions and circumstances that increase the risk of side effects

• Very rarely, thromboembolic events such as heart attack, stroke, deep vein thrombosis (e.g. in the calf), or pulmonary vessel occlusion may occur after administration of Gamten. These events, although very rare, occur more commonly in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, dermatomyositis, previous similar events, prolonged immobilization, or use of certain hormones (e.g. oral contraceptives). Ensure adequate hydration; in addition, Gamten should be administered as slowly as possible.

• If you have had kidney problems in the past or have risk factors such as diabetes, overweight, or are over 65 years of age, Gamten should be administered as slowly as possible, as cases of acute renal failure have been reported, albeit very rarely, in patients with these risk factors. Inform your doctor if any of the above conditions have occurred in the past.

• Patients with blood group A, B, or AB, as well as patients with certain inflammatory diseases, are at increased risk of red blood cell destruction (hemolysis) caused by the administered immunoglobulins.

When might it be necessary to slow down or stop the infusion?

• Severe headaches and neck stiffness may rarely occur from several hours up to 2 days after treatment with Gamten.
• Allergic reactions are rare but may lead to anaphylactic shock, even in patients who previously tolerated treatment. A sudden drop in blood pressure or shock may be consequences of an anaphylactic reaction.
• In very rare cases, transfusion-related acute lung injury (TRALI) may occur after receiving immunoglobulins including Gamten. This leads to fluid accumulation unrelated to cardiac causes in the air spaces of the lungs. TRALI is recognized by the sudden onset of severe breathing difficulties, normal heart function, and increased body temperature (fever). Symptoms typically appear within 1–6 hours after administration.

Contact your doctor or healthcare provider immediately if you notice any of these reactions during or after infusion of Gamten. They will decide whether to reduce the infusion rate, stop the infusion completely, or whether further measures are needed.

• Occasionally, immunoglobulin solutions such as Gamten may cause a decrease in white blood cell count. This condition usually resolves spontaneously within 1–2 weeks.

Viral safety

When medicines are prepared from human blood or plasma, certain measures are taken to prevent the risk of transmitting infections to patients. These measures include:

• careful selection of blood and plasma donors to exclude individuals at risk of carrying infectious diseases;
• testing of each donation and pooled plasma batches for signs of viruses/infections;
• manufacturing procedures implemented by producers that can inactivate or remove viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, it cannot be completely ruled out that infectious agents may be transmitted. This also applies to viruses of unknown or emerging nature 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. The measures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, likely due to protective antibodies against these infections present in the medicine.

Children and adolescents

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

Other medicines and Gamten

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or if you have received a vaccination within the last three months.

The infusion line may be flushed before and after administration of Gamten with 0.9% saline solution or 5% dextrose solution.

Concomitant use of loop diuretics should be avoided.

Gamten may impair the efficacy of vaccines containing live attenuated viruses, such as measles, rubella, mumps, and varicella.

Therefore, a period of 3 months should elapse after administration of Gamten before receiving a vaccination with live attenuated virus vaccines. For measles, this period of reduced vaccine efficacy may last up to 1 year.

Effects on blood tests

If you undergo blood tests after receiving Gamten, inform the person taking the sample or your doctor that you have been administered normal human immunoglobulin solution, as this treatment may affect test results.

Blood glucose testing

Some types of blood glucose monitoring systems (so-called glucometers) may misinterpret the maltose present in Gamten as glucose. This may lead to falsely elevated blood glucose readings during an infusion and for approximately 15 hours after the infusion ends, potentially resulting in inappropriate insulin administration and life-threatening hypoglycemia (low blood sugar).

Additionally, actual cases of hypoglycemia may be overlooked if the hypoglycemic state is masked by falsely elevated glucose readings.

Therefore, when administering Gamten or other products containing maltose, blood glucose levels must be measured using test systems based on a glucose-specific method. Systems based on the glucose dehydrogenase-pyrroloquinoline quinone (GDH-PQQ) method or the glucose oxidoreductase colorimetric method must not be used.

Carefully read the product information of the glucose test system, including the test strips, to determine whether the system is suitable for use with parenteral products containing maltose. If in doubt, consult your physician to determine whether the glucose test system you are using is appropriate for use with parenteral products containing maltose.

Gamten with food, drinks, and alcohol

No effects have been observed. Adequate hydration should be ensured prior to infusion when using Gamten.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using any medicine.

The safety of this medicine during human pregnancy has not been evaluated in controlled clinical studies; therefore, it should be administered only with extreme caution in pregnant or breastfeeding women. Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester of pregnancy. Clinical experience with immunoglobulins suggests that harmful effects on the course of pregnancy or on the fetus and newborn are unlikely.

Immunoglobulins are excreted in breast milk. Negative effects on newborns/infants are not expected.

Clinical experience with immunoglobulins suggests that harmful effects on fertility are not expected.

Driving and using machines

Gamten does not affect or affects negligibly the ability to drive or use machines. However, patients who experience adverse reactions during treatment should wait until these symptoms resolve before driving or operating machinery.

Gamten contains sodium

100 ml of this medicine contains 69 mg of sodium (the main component of table salt), equivalent to 3.45% of the recommended maximum daily intake of 2 g of sodium in the diet for an adult.

This should be taken into account by patients on a controlled sodium diet.

3. How to use Gamten

It is your doctor's responsibility to decide whether you should be given Gamten and in what dose.
Gamten is administered by healthcare professionals as an intravenous infusion (infusion into a
vein). The dose and dosing schedule depend on the indication, and may need to be individualized for each patient.

• If you have any doubts about using this product, consult your doctor or pharmacist.

Use in children and adolescents
The administration (intravenous) of Gamten in children and adolescents (0–18 years) is not different from that in adults.
If you receive more Gamten than you should
It is very unlikely that an overdose will occur, as Gamten is generally administered under medical supervision. However, if you do receive more Gamten than you should, your blood may become too thick (hyperviscous), which may increase the risk of developing blood clots. This may occur especially in at-risk patients, for example elderly patients or those with heart or kidney disease. Make sure you maintain adequate hydration.
Inform your doctor if you have any known medical conditions.
If you miss a dose of Gamten
Contact your doctor to discuss how to proceed.

4. Possible side effects

Like all medicines, this type of medicine can cause side effects, although not everyone experiences them.
If you experience any of the side effects listed below (all very rare, and may affect up to 1 in 10,000 infusions), contact your doctor as soon as possible.
In some cases, your doctor may need to stop treatment, reduce the dose, or discontinue treatment:

• Swelling of the face, tongue, and trachea, which may cause significant breathing difficulties;
• Sudden allergic reaction with shortness of breath, rash, wheezing, and drop in blood pressure;
• Stroke, which may cause weakness and/or loss of sensation on one side of the body;
• Heart attack, causing chest pain;
• Blood clot causing pain and swelling in limbs;
• Pulmonary clot, causing chest pain and shortness of breath;
• Anaemia, causing shortness of breath or paleness;
• Severe kidney damage, which may cause failure to pass urine;
• a lung disease called transfusion-related acute lung injury (TRALI), causing difficulty breathing, bluish skin discoloration, fever, and drop in blood pressure;
• Severe headache in combination with any of the following symptoms: neck stiffness, drowsiness, fever, light sensitivity, nausea, vomiting (these may be signs of meningitis). If you experience any of the symptoms listed above, contact your doctor immediately.

The following side effects have also been reported with this medicine:
Common side effects (may affect up to 1 in 10 infusions):

• Hypersensitivity (allergic reaction)
• Headache
• Nausea
• Changes in blood pressure
• Fever

Uncommon side effects (may affect up to 1 in 100 infusions):

• Deficiency of various types of blood cells
• Changes in heart rhythm
• Vomiting
• Stroke
• Dizziness
• Tingling or prickling sensation on the skin
• Tremor
• Blurred vision
• Blood clots in blood vessels
• Blockage of a deep vein
• Blockage of a pulmonary artery
• Back pain
• Chest pain
• Joint or muscle pain
• Involuntary muscle contraction
• Pain in arms or legs
• Breathing difficulties
• Chills
• Feeling of fatigue, malaise, or general weakness
• Fluid accumulation in the tissues of limbs
• Skin reactions at the injection site
• Abnormal blood test results (related to liver function or red blood cells)

Other side effects not observed in clinical studies but reported include:

• Fluid overload
• Low sodium levels in the blood
• Feeling agitated, anxious, confused, or nervous
• Migraine
• Speech disorders
• Loss of consciousness
• Reduced sense of touch or sensitivity
• Light sensitivity
• Visual impairment
• Angina pectoris
• Palpitations
• Temporary bluish discoloration of lips or other skin areas
• Circulatory collapse or shock
• Vein inflammation
• Pale skin
• Cough
• Pulmonary edema (fluid accumulation in the lungs)
• Bronchospasm (difficulty breathing or wheezing)
• Respiratory failure
• Low oxygen levels in the blood
• Diarrhoea, abdominal pain
• Hives, skin itching
• Skin redness
• Skin rash
• Skin peeling
• Skin inflammation
• Hair loss
• Muscle weakness or stiffness
• Severe painful muscle contractions
• Neck pain
• Kidney pain
• Skin swelling (edema)
• Facial flushing, increased sweating
• Chest discomfort
• Flu-like symptoms
• Sensation of cold or heat
• Drowsiness
• Burning sensation
• Incorrect blood glucose measurement readings

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gamten

Keep this medicine out of the sight and reach of children.
Do not use Gamten after the expiry date stated on the label and on the carton.
Store in a refrigerator (2 °C - 8 °C). Keep the container in the outer packaging to protect it from light.
Do not freeze.
The product may be removed from the refrigerator for a single period of up to 9 months and stored at a temperature ≤ 25 °C, provided the expiry date is not exceeded. After this period, the product must not be refrigerated again and must be disposed of. The date when the product was removed from the refrigerator should be recorded on the outer packaging.
After first opening, the medicine should be used immediately.
Do not use Gamten if you notice that the solution is cloudy, shows deposits, or has become strongly discoloured.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gamten contains:
The active substance is human normal immunoglobulin (human antibodies) at a concentration of 100 mg/ml (at least 95% is immunoglobulin G).
The other components are maltose and water for injections.

Description of the appearance of Gamten and package contents:
Gamten is a solution for infusion and is available in vials (2 g/20 ml) or bottles (5 g/50 ml, 6 g/60 ml, 10 g/100 ml, 20 g/200 ml, 30 g/300 ml).
Pack sizes:
2 g in 20 ml
5 g in 50 ml
6 g in 60 ml
10 g in 100 ml
20 g in 200 ml
3 x 10 g in 3x100 ml
3 x 20 g in 3x200 ml
30 g in 300 ml

The solution is clear or slightly opalescent, colourless or pale yellow.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56100 Pisa
Italy

Manufacturers:
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Octapharma AB
SE-112 75 Stockholm, Sweden

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria, Czech Republic, Denmark, Finland,
Octagam 100 mg/ml
France, Hungary, Latvia, Norway, Portugal,
Slovenia, Sweden:
Belgium, Bulgaria, Cyprus, Estonia, Germany,
Iceland, Lithuania, Luxembourg, Malta, Netherlands, Octagam 10%
Poland, Romania, Slovakia, United Kingdom (Northern Ireland):
Italy: Gamten
Spain: Octagamocta 100 mg/ml

This patient information leaflet was last approved on

The following information is intended exclusively for physicians or healthcare professionals:

• The product should be brought to room or body temperature before use.
• The solution should be clear or slightly opalescent, colourless or pale yellow.
• Do not use solutions that are cloudy or contain deposits.
• Any unused product or waste material must be disposed of in accordance with current regulations.
• This medicinal product must not be mixed with other medicinal products.
• For the infusion of any product that may remain in the infusion line at the end of administration, flush the infusion line with 0.9% sodium chloride solution or 5% dextrose solution.