Octagam 5%

Octagam 5% infusion solution
Human normal immunoglobulin (IVIg)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
See section 4.
Contents of the leaflet

1. What Octagam 5% is and what it is used for
2. Important information before using Octagam 5%
3. How to use Octagam 5%
4. Possible side effects
5. How to store Octagam 5%
6. Contents of the pack and other information

1. What Octagam 5% is and what it is used for

What Octagam 5% is
Octagam 5% is a solution of normal human immunoglobulin (IgG) (i.e. a solution of human antibodies) for intravenous administration (i.e. infusion into a vein). Immunoglobulins are normal components of the human body and support its immune system. Octagam 5% contains all IgG antibodies present in the normal human population. Appropriate doses of this medicinal product can restore abnormally low immunoglobulin levels to normal.
Octagam 5% includes a broad spectrum of antibodies against various infectious agents.

What Octagam 5% is used for
Octagam 5% is used for replacement therapy in children, adolescents (0–18 years) and adults in various patient groups:

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

Octagam 5% may also be used for treatment of susceptible individuals, including adults, children and adolescents (aged 0–18 years), who have been exposed to measles or are at risk of exposure to measles, and in whom active vaccination against measles is contraindicated or not recommended.

Octagam 5% may additionally be used in the treatment of the following autoimmune disorders (immunomodulation):

• In patients with immune thrombocytopenia (ITP) — a disorder in which platelets are destroyed and their number is reduced — in whom there is a high risk of bleeding or correction of platelet count is required prior to surgical procedures;
• In patients with Kawasaki disease — a condition leading to inflammation of various organs;
• In patients with Guillain-Barré syndrome — a disorder causing inflammation of certain parts of the nervous system;
• In patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) — a disease causing chronic inflammation in the peripheral nervous system, resulting in numbness or muscle weakness, primarily in the arms and legs;
• In patients with multifocal motor neuropathy (MMN) — a condition characterized by slowly progressive, asymmetric limb weakness without loss of sensation.

2. Important information before using Octagam 5%

When not to use Octagam 5%

• if the patient has a known allergy to human immunoglobulin or to any of the other ingredients of Octagam 5% (listed in section 6),
• if the patient has immunoglobulin A deficiency (IgA deficiency) and has developed antibodies against IgA immunoglobulins.

Warnings and precautions

Before starting treatment with Octagam 5%, discuss this with your doctor or pharmacist. It is strongly recommended that each time Octagam 5% is administered to a patient, the name and batch number of the product should be recorded to maintain traceability between the patient and the batch of medicine used.

Adverse reactions may occur more frequently:

• if the infusion rate is too high,
• in patients receiving Octagam 5% for the first time, or, in rare cases, after a long interval since the last infusion,
• if the patient has an untreated infection or a chronic inflammatory condition.

If adverse reactions occur, the infusion rate should be reduced or the infusion stopped. The required management of an adverse event will depend on the nature and severity of the reaction.

Circumstances and conditions increasing the risk of adverse reactions

• Very rarely, thromboembolic events such as myocardial infarction (heart attack), stroke, or deep vein thrombosis (e.g. in the calf) or pulmonary embolism may occur after administration of Octagam 5%. These events, although very rare, occur more frequently in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, previous history of such events, prolonged immobilization, or use of certain hormones (e.g. oral contraceptives). In such cases, adequate hydration should be ensured, and Octagam 5% should be administered at the lowest possible infusion rate.

• If the patient has had previous kidney problems or has certain risk factors such as diabetes, obesity, or is over 65 years of age, Octagam 5% should be administered at the lowest possible infusion rate, as cases of acute kidney failure, although very rare, have been reported in patients with such risk factors. If any of the above conditions apply to the patient, even if they occurred in the past, this should be reported to the doctor.

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

When might it be necessary to reduce the infusion rate or stop the infusion?

• Rarely, severe headache and neck stiffness may occur within a few hours to 2 days after administration of Octagam 5%.
• Allergic reactions are rare, but this medicine may cause anaphylactic shock, even in patients who previously tolerated it well. A sudden drop in blood pressure or shock may result from an anaphylactic reaction.
• Very rarely, acute transfusion-related lung injury (TRALI) may occur after administration of immunoglobulins, including Octagam 5%. TRALI leads to fluid accumulation in the lung air spaces, unrelated to heart disease. Symptoms of TRALI include severe shortness of breath and elevated body temperature (fever), while heart function remains normal. Symptoms typically appear within 1 to 6 hours after administration of the medicine.

If the patient experiences any of the above reactions during or after the infusion of Octagam 5%, they should immediately inform their doctor or healthcare professional. The doctor or healthcare professional will decide whether to reduce the infusion rate, stop the infusion completely, and whether further actions are required.

• Occasionally, immunoglobulin solutions such as Octagam 5% 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, precautions must be taken to prevent the transmission of infectious diseases. These precautions include:

• careful selection of blood and plasma donors to exclude carriers of infectious diseases,
• testing of individual donations and plasma pools for the presence of virus/infection,
• virus inactivation or removal procedures used by manufacturers during blood or plasma processing.

Despite these measures, it is not possible to completely exclude the risk of transmitting infectious agents when administering medicines derived from human blood or plasma. This includes unknown or emerging viruses or other pathogens. Precautions taken help prevent transmission of enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. However, these measures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19. Immunoglobulins are not associated with hepatitis A or parvovirus B19 infections, likely due to protective antibodies present in the product against these infections.

Children and adolescents

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

Octagam 5% and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without prescription, and about any vaccination received within the last three months.

The infusion line may be flushed before and after administration of Octagam 5% with 0.9% sodium chloride solution or 5% dextrose solution.

Concomitant use of loop diuretics should be avoided.

Octagam 5% may reduce the effectiveness of vaccines containing live attenuated viruses, such as measles, mumps, rubella, and varicella vaccines.

Vaccination with live attenuated virus vaccines should be delayed by at least three months after administration of immunoglobulin. For measles vaccination, reduced effectiveness may persist for up to 1 year.

Effect on blood test results

Patients undergoing blood tests after receiving Octagam 5% should inform the person drawing blood or the doctor that they have received human normal immunoglobulin, as this may affect test results.

Blood glucose measurement

Some types of blood glucose monitoring systems (so-called glucometers) may incorrectly identify maltose present in Octagam 5% as glucose. This may lead to falsely elevated glucose readings during infusion and for approximately 15 hours after the infusion ends, potentially resulting in inappropriate insulin administration and life-threatening hypoglycemia (low blood sugar). Additionally, true hypoglycemia may go untreated due to falsely elevated glucose readings.

Therefore, during administration of Octagam 5% or other products containing maltose,
blood glucose levels should be measured using a glucose-specific assay method.
Systems based on glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) or glucose oxidoreductase should not be used.

Carefully read the information provided with the glucose monitoring system, including test strips, to determine whether the system is suitable for use during concomitant administration of parenteral medicines containing maltose. If in doubt, consult the treating physician to confirm whether the glucose monitoring system is appropriate for use during such treatment.

Octagam 5% with food, drink, and alcohol

No interactions have been observed. When administering Octagam 5%, adequate hydration should be ensured prior to infusion.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The safety of this medicine in pregnant women has not been established in controlled clinical trials, and therefore it should be administered to pregnant women and breastfeeding mothers with particular caution. It has been shown that IVIg products cross the placenta, increasingly so during the third trimester. Clinical experience with immunoglobulins suggests they do not have harmful effects on pregnancy, fetal development, or the newborn.

Immunoglobulins are excreted in human milk. No adverse effects on breastfed infants/children are expected.

Clinical experience with immunoglobulins suggests no harmful effect on fertility is anticipated.

Driving and operating machinery

Octagam 5% has no effect or a negligible effect on the ability to drive or operate machinery. However, patients who experience adverse reactions during treatment should not drive or operate machinery until these symptoms have resolved.

Octagam 5% contains sodium

100 ml of this medicine contains 35 mg of sodium (the main component of table salt). This corresponds to 1.75% of the maximum daily sodium intake recommended by WHO for adults. This should be taken into account in patients who are monitoring their dietary sodium intake.

3. How to use Octagam 5%

The need for treatment and the dose of Octagam 5% are determined by the doctor. Octagam 5% is administered as an intravenous infusion (into a vein) by medical personnel. The dose and dosing regimen depend on the indication and require individual determination for each patient.

• If in doubt about how to use the medicine, consult your doctor or pharmacist.

Use in children and adolescents

Administration (intravenous) of Octagam 5% to children and adolescents (0–18 years) does not differ from administration to adults.

Accidental overdose of Octagam 5%

Overdose is very unlikely, as Octagam 5% is usually administered under medical supervision. However, if a patient receives a higher dose of Octagam 5% than recommended, their blood may become too thick (excessively viscous), increasing the risk of blood clots. This is particularly possible if the patient is in a risk group, e.g. elderly, or has heart or kidney disease. Adequate hydration should be ensured. Inform the doctor of any health problems.

Missing a dose of Octagam 5%

Discuss further management with your doctor.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur, contact your doctor immediately (adverse reactions occur very rarely
and may occur less frequently than 1 in 10,000 infusions).
In some cases, the doctor may need to stop administering the medicine, reduce the dose, or discontinue treatment:

• Swelling of the face, tongue, or windpipe causing significant breathing difficulties;
• Sudden allergic reaction with shortness of breath, rash, wheezing, and drop in blood pressure;
• Stroke causing 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;
• Anaemia causing shortness of breath or paleness;
• Blood clot in the lungs causing chest pain and shortness of breath;
• Severe kidney problems leading to inability to pass urine;
• Lung disease known as acute transfusion-related lung injury (TRALI), causing breathing difficulties, 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 any of the above adverse reactions occur, contact your doctor immediately.

Additionally, the following adverse reactions have been reported:
Common adverse reactions (may occur in 1 infusion out of 10):

• Hypersensitivity (allergic reaction);
• Headache.

Uncommon adverse reactions (may occur in 1 infusion out of 100):

• Low white blood cell count;
• Changes in heart rhythm;
• Changes in blood pressure;
• Vomiting;
• Back pain;
• Chest pain;
• Chills;
• Nausea;
• Fever;
• Feeling of fatigue;
• Skin reactions at the injection site;
• Blood test results indicating abnormal liver function.

Other adverse reactions not observed in clinical trials but also reported include:

• Fluid overload;
• Low sodium levels in blood;
• Feeling of restlessness, anxiety, confusion, or nervousness;
• Migraine;
• Speech disturbances;
• Loss of consciousness;
• Dizziness;
• Skin tingling sensation;
• Reduced sensation or touch perception;
• Light sensitivity;
• Involuntary muscle spasms;
• Impaired vision;
• Angina pectoris;
• Palpitations;
• Transient bluish discoloration of lips or other parts of the skin;
• Respiratory depression or shock;
• Phlebitis (vein inflammation);
• Pale skin;
• Cough;
• Breathing difficulties;
• Pulmonary oedema (fluid accumulation in the lungs);
• Bronchospasm (difficulty breathing or wheezing);
• Respiratory failure;
• Low oxygen levels in blood;
• Diarrhoea, abdominal pain;
• Urticaria, itchy skin;
• Skin redness;
• Skin rash;
• Skin peeling;
• Skin inflammation;
• Hair loss;
• Joint or muscle pain;
• Muscle weakness or stiffness;
• Severe and painful muscle cramps;
• Neck, leg, or arm pain;
• Kidney pain;
• Skin swelling (oedema);
• Hot flushes, excessive sweating;
• Feeling of discomfort in the chest;
• Flu-like symptoms;
• Feeling of cold or heat, or general malaise and weakness;
• Drowsiness;
• Burning sensation;
• False blood glucose readings.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Octagam 5%

Keep the medicine out of the sight and reach of children.
Do not use Octagam 5% after the expiry date stated on the label and carton.
Store below 25°C. Do not freeze. Keep the container in the outer packaging to protect from light.
The medicine should be used immediately after first opening.
Do not use Octagam 5% if cloudiness, precipitate or strong discoloration of the solution is visible.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Octagam 5% contains
The active substance is normal human immunoglobulin (human antibodies), solution 5% (containing at least 95% immunoglobulin G).
The other components of the medicine are maltose and water for injections.
The components used in the packaging of Octagam 5% do not contain latex.

What Octagam 5% looks like and contents of the pack
Octagam 5% is an infusion solution available in vials (1 g/20 ml) or bottles (2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml, 25 g/500 ml).
Pack sizes:
1 g in 20 ml
2.5 g in 50 ml
5 g in 100 ml
10 g in 200 ml
2 x 10 g in 2 x 200 ml
3 x 10 g in 3 x 200 ml
25 g in 500 ml
Not all pack sizes may be marketed.
The solution is clear or slightly opalescent, colourless or slightly yellow.

Marketing Authorisation Holder and Manufacturer
Octapharma (IP) SPRL
Route de Lennik 451
1070 Anderlecht
Belgium

Manufacturer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Octapharma
72 rue de Marèchal Foch, F-67380 Lingolsheim, France
Octapharma AB
Lars Forssells gata 23
SE-112 75 Stockholm, Sweden
Octapharma GmbH
Elisabeth-Selbert-Strasse 11
40764 Langenfeld
Germany

This medicine is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, the Netherlands, Iceland, Latvia, Lithuania,
Luxembourg, Malta, Norway, Portugal, Romania, Octagam 50 mg/ml
Slovenia, Sweden, Hungary, Italy, and the United Kingdom (Northern Ireland):
Austria, Bulgaria, Germany, Poland, Slovakia: Octagam 5%
Spain: Octagamocta 50 mg/ml

The following information is intended for medical or healthcare personnel only:

• Warm the product to room temperature or body temperature prior to use.
• The solution should be clear to slightly opalescent and colorless to pale yellow.
• Do not use the solution if it is cloudy or contains precipitate.
• Any unused product or waste material must be disposed of in accordance with local regulations.
• This medicinal product must not be mixed with other medicinal products.
• The infusion line may be flushed before and after administration of Octagam 5% with 0.9% sodium chloride solution or 5% dextrose solution.