Octagam 5%

Patient Information Leaflet: User Information

Octagam 5% Solution for Infusion

Human Normal Immunoglobulin (IVIg)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

What is Octagam 5%?

Octagam 5% is a solution of normal human immunoglobulin (IgG) 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 that occur in the normal human population. Appropriate doses of this medicinal product can restore abnormally low levels of immunoglobulin to normal.
Octagam 5% covers a broad spectrum of antibodies against various infectious agents.

What is Octagam 5% 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 immune deficiencies, such as congenital agammaglobulinemia and hypogammaglobulinemia, common variable immune deficiency, severe combined immune deficiencies)
• Patients with acquired antibody deficiency (secondary immune deficiency) caused by certain diseases and/or treatments and who have severe or recurrent infections

Octagam 5% can be used to treat susceptible adults, children, and adolescents (0-18 years) who have been exposed to measles or are at risk of measles exposure and for whom active measles vaccination is contraindicated or not recommended.
Octagam 5% may also be used to treat the following autoimmune disorders (immunomodulation):

• in patients with immune thrombocytopenia (ITP) - a disorder in which platelets are destroyed and their number is reduced - who have a high risk of bleeding or need to correct platelet count before surgery;
• in patients with Kawasaki disease - a disease that leads to inflammation of various organs;
• in patients with Guillain-Barré syndrome - a disease that leads to inflammation of certain parts of the nervous system;
• in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - a disease that leads to chronic inflammation in the peripheral nervous system, causing numbness or weakness mainly in the arms and legs;
• in patients with multifocal motor neuropathy (MMN) - a condition characterized by slowly progressive asymmetric weakness of the limbs without sensory loss.

2. Important information before using Octagam 5%

When not to use Octagam 5%

• if the patient has been found to be hypersensitive to human immunoglobulin or any of the other ingredients of Octagam 5% (listed in section 6),
• if the patient has immunoglobulin A (IgA) deficiency and if the patient has antibodies against IgA.

Warnings and precautions

Before starting treatment with Octagam 5%, discuss it with a doctor or pharmacist.
It is strongly recommended that in each case of administering Octagam 5% to a patient, the name and batch number of the medicine be recorded in order to maintain a link between the patient and the batch of the administered medicine.
Certain side effects may occur more frequently:

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

In case of side effects, reduce the infusion rate or stop the infusion. The required action in case of an adverse event will depend on the nature and severity of the side effect.
Circumstances and conditions that increase the risk of side effects

• In very rare cases, after administration of Octagam 5%, thromboembolic events such as myocardial infarction, stroke, and deep vein thrombosis, for example, in the leg or blood vessels in the lungs, may occur. These events occur more frequently, although still very rarely, in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, history of such events, prolonged immobilization, and taking certain hormones (e.g., oral contraceptives). In such a situation, balanced fluid intake should be ensured, and Octagam 5% should be administered at the lowest possible rate.
• If the patient has had kidney problems in the past or if they have certain risk factors, such as diabetes, overweight, or age over 65, Octagam 5% will be administered at the lowest possible rate, as there have been reports of acute kidney failure, although very rare, in patients with these risk factors. If any of the above circumstances apply to the patient, even if it occurred in the past, they should inform their doctor.

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

• Rarely, within a few hours to 2 days after receiving Octagam 5%, severe headaches and stiffness of the neck may occur.
• Allergic reactions occur rarely, but this medicine may cause anaphylactic shock, even in patients who have tolerated it well in the past. A sudden drop in blood pressure or shock may be a consequence of an allergic reaction.
• In very rare cases, after administration of immunoglobulins, including Octagam 5%, acute post-transfusion pulmonary edema (TRALI) may occur, leading to non-cardiogenic pulmonary edema. Symptoms include severe shortness of breath and elevated body temperature (fever), and cardiac function remains normal. Symptoms usually occur 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 or stop it completely and whether further action is necessary.

• Sometimes, immunoglobulin solutions, such as Octagam 5%, may cause a decrease in white blood cell count. This condition usually resolves on its own within 1-2 weeks.

Viral safety
In the case of medicines derived from human blood or plasma, measures should be taken to prevent the transmission of infectious diseases. These measures 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 viruses/infections,
• virus inactivation or removal procedures used by manufacturers in the processing of blood or plasma. Despite these measures, when administering medicines manufactured from human blood or plasma, it is not possible to completely exclude the risk of transmitting infectious agents. This applies to unknown or emerging viruses or other pathogens. Maintaining safety measures prevents the transmission of enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. The measures taken may have limited applicability in the case of 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 the protection provided by the antibodies present in this product against these infections.

Children and adolescents

Regarding children and adolescents, there are no special or additional warnings or precautions.

Octagam 5% and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription or have been vaccinated in the last three months.
The infusion line can be flushed before and after administration of Octagam 5% with 0.9% sodium chloride solution or 5% dextrose solution.
Avoid concomitant administration of loop diuretics.
Octagam 5% may reduce the effectiveness of live attenuated virus vaccines, such as measles, rubella, mumps, and chickenpox vaccines.
Vaccination with live attenuated virus vaccines should be performed with an interval of three months from the administration of immunoglobulin. In the case of measles vaccine, this effectiveness may be reduced for up to 1 year.

Effect on laboratory tests

Patients undergoing blood tests after receiving Octagam 5% should inform the person taking the blood or the doctor that they received a human normal immunoglobulin solution, as this may affect the test results.
Blood glucose test
Certain types of systems used to measure blood glucose levels (so-called glucometers) may incorrectly recognize the maltose contained in Octagam 5% as glucose. This can lead to falsely elevated glucose readings during infusion and for about 15 hours after the end of the infusion, resulting in inappropriate insulin administration leading to life-threatening hypoglycemia (i.e., low blood sugar level). Also, in cases of true hypoglycemia, treatment may not be initiated due to falsely altered elevated glucose readings.

Therefore, during administration of Octagam 5% or other maltose-containing products, blood glucose levels should be measured using a system that uses a glucose-specific method. Do not use systems based on

pyrroloquinolinequinone-dependent glucose dehydrogenase (GDH-PQQ) or glucose oxidoreductase.
Read carefully the information about the glucose measurement system, including test strips, to determine if the system is suitable for testing during concomitant use of parenterally administered maltose-containing drugs. In case of doubts, consult the treating doctor to determine if the glucose measurement system is suitable for testing during concomitant use of parenterally administered maltose-containing drugs.

Octagam 5% with food, drink, and alcohol

No interactions have been observed. When using the product, ensure adequate hydration before infusion.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
The safety of using 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 caution. It has been shown that IVIg medicinal products cross the placenta, which increases during the third trimester. Clinical experience with immunoglobulins suggests that they do not have a harmful effect on the course of pregnancy, fetal development, or the newborn.
Immunoglobulins are excreted into human milk. No adverse effect on breastfed newborns/children is expected.
Clinical experience with immunoglobulins suggests that they are not expected to have a harmful effect on fertility.

Driving and using machines

Octagam 5% has no or negligible influence on the ability to drive and use machines. However, patients who experience side effects during treatment should not drive or operate machines until these side effects have resolved.

Octagam 5% contains sodium

100 ml of this medicine contains 35 mg of sodium (the main component of common salt). This corresponds to 1.75% of the WHO-recommended maximum daily intake of sodium for adults. This should be taken into consideration in patients controlling their sodium intake.

3. How to use Octagam 5%

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

• In case of doubts about the use of the medicine, consult a doctor or pharmacist.

Use in children and adolescents

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

Receiving a higher dose of Octagam 5% than recommended

Overdose is very unlikely, as Octagam 5% is usually administered under the supervision of a doctor. If, despite this, a patient receives a higher dose of Octagam 5% than recommended, their blood may become too thick (overly viscous), which may increase the risk of blood clots. This may occur especially if the patient is at risk, for example, is elderly or has heart or kidney disease. Ensure adequate hydration. Inform your doctor about any health problems.

Missing a dose of Octagam 5%

Discuss with your doctor and determine the next steps.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any of the following side effects, contact your doctor immediately (these side effects are very rareand may occur less frequently than 1 in 10,000 infusions).
In some cases, the doctor may need to stop administering the medicine and reduce the dose or discontinue treatment:

• Swelling of the face, tongue, and tracheathat can cause significant breathing difficulties;
• Anaphylactic reactionwith shortness of breath, rash, wheezing, and low blood pressure;
• Strokethat can cause weakness and/or loss of sensation on one side of the body;
• Myocardial infarctioncausing chest pain;
• Blood clotcausing pain and swelling of the limbs;
• Anemiacausing shortness of breath or pallor;
• Blood clot in the lungscausing chest pain and shortness of breath;
• Severe kidney problemsleading to inability to urinate;
• Lung diseaseknown as acute post-transfusion pulmonary edema (TRALI) causing difficulty breathing, cyanosis, fever, and low blood pressure;
• Severe headacheaccompanied by any of the following symptoms: stiffness of the neck, drowsiness, fever, sensitivity to light, nausea, vomiting (these may be symptoms of meningitis). In case of any of the above side effects, contact your doctor immediately.

In addition, the following side effects have been reported:
Common side effects(may occur in 1 in 10 infusions):

• Hypersensitivity (allergic reaction);
• Headache.

Uncommon side effects(may occur in 1 in 100 infusions):

• Low white blood cell count;
• Changes in heart rhythm;
• Changes in blood pressure;
• Vomiting;
• Back pain;
• Chest pain;
• Chills;
• Nausea;
• Fever;
• Fatigue;
• Infusion site reactions;
• Blood test results indicating abnormal liver function.

Other side effects that did not occur in clinical trials but have also been reported are:

• Fluid overload;
• Low sodium levels in the blood;
• Feeling of agitation, anxiety, confusion, or nervousness;
• Migraine;
• Speech disorders;
• Loss of consciousness;
• Dizziness;
• Feeling of tingling of the skin;
• Reduced sensation or feeling of touch;
• Sensitivity to light;
• Involuntary muscle contractions;
• Impaired vision;
• Angina pectoris;
• Palpitations;
• Transient cyanosis of the lips or other skin areas;
• Respiratory or anaphylactic shock;
• Phlebitis;
• Pallor;
• Cough;
• Respiratory disorders;
• Pulmonary edema (fluid accumulation in the lungs);
• Bronchospasm (difficulty breathing or wheezing);
• Respiratory failure;
• Hypoxemia;
• Diarrhea, abdominal pain;
• Urticaria, itching of the skin;
• Redness of the skin;
• Rash;
• Exfoliative dermatitis;
• Dermatitis;
• Hair loss;
• Joint or muscle pain;
• Muscle weakness or stiffness;
• Severe and painful muscle spasms;
• Pain in the neck, legs, or arms;
• Kidney pain;
• Edema (swelling);
• Hot flashes, excessive sweating;
• Discomfort in the chest;
• Flu-like symptoms;
• Feeling of cold or heat or general malaise and weakness;
• Drowsiness;
• Feeling of burning;
• False blood glucose readings.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C

• 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Octagam 5%

Keep the medicine out of sight and reach of children.
Do not use Octagam 5% after the expiration date stated on the label and carton.
Store at a temperature below 25°C. Do not freeze. Keep the container in the outer packaging to protect it from light.
Use the medicine immediately after opening.
Do not use Octagam 5% if the solution is cloudy, contains sediment, or is strongly colored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What does Octagam 5% contain?

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

What does Octagam 5% look like and what does the pack contain?

Octagam 5% is a solution for infusion and is 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, colorless or slightly yellow.

Marketing authorization holder and manufacturer

Octapharma (IP) SPRL
65 Allée de la Recherche
1070 Anderlecht
Belgium

Manufacturer

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Octapharma
72 rue de Maréchal 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 authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Netherlands, Iceland, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovenia, Sweden, Hungary, Italy, and the United Kingdom (Northern Ireland):
Octagam 50 mg/ml
Austria, Bulgaria, Germany, Poland, Slovakia:
Octagam 5%
Spain:
Octagamocta 50 mg/ml

Date of approval of the leaflet: 15.07.2024

The following information is intended for healthcare professionals only:

• Before use, the product should be warmed to room temperature or body temperature.
• The solution should be clear to slightly opalescent and colorless to light yellow.
• Do not use a cloudy or sediment-containing solution.
• Any unused product or waste should be disposed of in accordance with local regulations.
• This medicinal product should not be mixed with other medicinal products.
• The infusion line can be flushed before and after administration of Octagam 5% with 0.9% sodium chloride solution or 5% dextrose solution.