OCTAGAMOCTA 50 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

OCTAGAM®50 mg/ml solution for infusion

Human normal immunoglobulin for intravenous administration (IGIV)

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Octagam 50 mg/ml and what is it used for
2. What you need to know before you use Octagam 50 mg/ml
3. How to use Octagam 50 mg/ml
4. Possible side effects
5. Storage of Octagam 50 mg/ml
6. Contents of the pack and other information

1. What is Octagam 50 mg/ml and what is it used for

This medicine is a solution of human normal immunoglobulin (IgG), i.e. a solution of human antibodies, for intravenous administration (infusion into a vein). Immunoglobulins are normal components of the human body and support the body's immune system. Octagam 50 mg/ml contains all IgG activities present in the normal population. Adequate doses of this medicine can restore abnormally low IgG levels to normal.

Octagam 50 mg/ml has a broad spectrum of antibodies against various infectious agents.

What is Octagam 50 mg/ml used for

This medicine is used as replacement therapy in children, adolescents (0-18 years) and adults in different patient groups:

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

Octagam 50 mg/ml can be used for the treatment of adults and children and adolescents (0-18 years) who are vulnerable and have been exposed to measles or are at risk of exposure to measles and in whom active immunization against measles is not indicated or not recommended.

Octagam 50 mg/ml can also be used for the treatment of the following autoimmune disorders (immunomodulation):

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

2. What you need to know before you use Octagam 50 mg/ml

Do not use Octagam 50 mg/ml:

• If you are allergic to human immunoglobulin or to any of the other ingredients of this medicine (listed in section 6).

• If you have a deficiency of immunoglobulin A (IgA deficiency) and if you have developed antibodies against IgA.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Octagam 50 mg/ml.

It is strongly recommended that each time a dose of Octagam 50 mg/ml is administered, a record should be kept of the name of the medicine and batch number used.

Certain adverse reactions may occur more frequently:

• in case of high infusion rate
• when you receive this medicine for the first time or, in rare cases, when there has been a long interval since the previous infusion
• when you have an untreated infection or underlying chronic inflammation

In case of an adverse reaction, the infusion rate should be reduced or the infusion stopped. The treatment of an adverse effect will depend on the nature and severity of the side effect.

Circumstances and conditions that increase the risk of having adverse effects

• After administration of the medicine, thromboembolic events such as heart attack, stroke, and deep vein obstruction, for example, in the lower leg, or a blood vessel in the lung may occur very rarely. These types of events occur more frequently in patients with risk factors, such as obesity, advanced age, hypertension, diabetes, previous episodes of these events, prolonged periods of immobilization, and intake of certain hormones (e.g., "the pill"). Ensure adequate fluid intake. Additionally, Octagam 50 mg/ml should be administered as slowly as possible.
• If you have had kidney problems in the past or if you have certain risk factors such as diabetes, overweight, or are over 65 years of age, this medicine should be administered as slowly as possible because cases of acute renal failure have been reported in patients with these risk factors. Inform your doctor, even if any of the above circumstances have occurred in the past.
• Patients with blood groups A, B, or AB, as well as patients with certain inflammatory diseases, have a higher risk that the administered immunoglobulins will destroy red blood cells (a condition known as hemolysis).

When should infusions be reduced or stopped?

• Severe headaches and neck stiffness may occur, several hours to 2 days after treatment with this medicine.
• Allergic reactions are rare but can induce anaphylactic shock, even in patients who have tolerated previous treatments. A sudden drop in blood pressure or shock may be consequences of an anaphylactic reaction.
• In very rare cases, acute lung injury caused by transfusion (TRALI) may occur after receiving immunoglobulins, including Octagam 50 mg/ml. This can cause non-cardiogenic fluid accumulation in the lungs. You will recognize TRALI by severe breathing difficulties, normal heart function, and increased body temperature (fever). Symptoms typically occur between 1 and 6 hours after receiving treatment.

Tell your doctor or healthcare professional immediately if you notice such reactions during or after administration of this medicine. He or she will decide whether to reduce the infusion rate or stop it completely or if other measures are necessary.

• Sometimes immunoglobulin solutions like Octagam 50 mg/ml can trigger a reduction in the number of white blood cells. This condition usually resolves spontaneously within 1-2 weeks.

Viral safety

When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent the transmission of infections to patients. Such measures include:

• careful selection of donors to ensure the exclusion of those who are at risk of being carriers of infectious diseases.
• testing for specific infection markers in individual donations and plasma pools for signs of virus/infection.
• inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely excluded. This also applies to emerging or unknown viruses or other types of infections.

These measures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.

The measures taken may have limited value against non-enveloped viruses, such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with the transmission of hepatitis A or parvovirus B19 infections, possibly due to the protective effect of the antibody content against these infections in the medicine.

Children and adolescents

There are no specific or additional warnings or precautions applicable to the pediatric population.

Using Octagam 50 mg/ml with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription, or if you have been given a vaccine in the last three months.

The infusion line should be flushed before and after administration of the medicine, by circulating a 0.9% saline solution or a 5% dextrose solution through it.

Concomitant use with loop diuretics should be avoided.

Octagam 50 mg/ml may reduce the effect of live virus vaccines, such as measles, rubella, mumps, and chickenpox.

A period of 3 months should elapse after administration of this medicine before live virus vaccination. In the case of measles, this reduction may last up to one year.

Effects on laboratory tests

If you are going to have a blood test after being given this medicine, tell the person taking the sample or your doctor that you have been given a human normal immunoglobulin solution, as this treatment may affect the results.

Blood glucose test

Some types of blood glucose testing systems (so-called glucose meters) falsely interpret the maltose contained in this medicine as glucose. This may cause falsely high glucose readings during an infusion or for up to 15 hours after the end of the infusion and, as a consequence, inappropriate administration of insulin, resulting in hypoglycemia (i.e., a drop in blood sugar levels) that could be life-threatening. Similarly, actual hypoglycemia may not be treated if the hypoglycemic state is masked by falsely high glucose readings.

As a consequence, when administering this medicine or other products containing maltose, blood glucose measurement should be performed with a system that uses a glucose-specific method.Systems based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-colorimetric-oxidoreductase methods should not be used.

The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is suitable for use with parenteral products containing maltose. In case of doubt, consult the treating physician to determine if the glucose testing system being used is suitable for use with parenteral products containing maltose.

Using Octagam 50 mg/ml with food, drinks, and alcohol

No effects have been observed. Adequate hydration should be ensured before infusion when using this medicine.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

The safety of this medicine during pregnancy has not been determined in controlled clinical trials and, therefore, should be administered with caution to pregnant and breastfeeding women. It has been shown that IgIV medicines frequently cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins indicates that no harmful effects are expected during pregnancy, either for the fetus or the newborn.

Immunoglobulins are excreted in human breast milk. No negative effects are expected in neonates who are breastfed or in infants.

Clinical experience with immunoglobulins suggests that no harmful effects on fertility are expected.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, patients who experience adverse reactions during treatment should wait until these have resolved before driving or using machines.

Octagam 50 mg/ml contains sodium

100 ml of this medicine contains 35 mg of sodium (a major component of cooking/table salt). This is equivalent to 1.75% of the maximum recommended daily intake of sodium for an adult.

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

3. How to use Octagam 50 mg/ml

Your doctor will decide if you need this medicine and at what dose. This medicine is administered as an intravenous infusion (into a vein) by healthcare professionals. The dose and dosing regimen depend on the indication and may need to be individualized for each patient.

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

Use in children and adolescents

Administration (intravenous) of Octagam 50 mg/ml in children and adolescents (0-18 years) does not differ from that in adults.

If you receive more Octagam 50 mg/ml than you should

Overdose is unlikely because this medicine is usually administered under medical supervision. If, despite this, you receive more Octagam 50 mg/ml than you should, the blood may become too thick (hyperviscous), which can increase the risk of blood clots. This can occur especially if you are a patient at risk, such as if you are elderly or have heart or kidney disease. Ensure adequate hydration. Inform your doctor if you have any known medical problems.

If you miss a dose of Octagam 50 mg/ml

Consult your doctor to discuss how to proceed.

4. Possible Adverse Effects

Like all medicines, this can produce adverse effects, although not all people suffer from them.

Consult your doctor as soon as possible if you experience any of the serious side effects described below (they are all very rareand may affect 1 in every 10,000 infusions).

In some cases, your doctor will decide to interrupt treatment and reduce the dose or suspend treatment:

• Facial, tongue, and tracheal inflammationthat can cause great difficulty breathing
• Sudden allergic reactionswith breathing difficulties, rashes, wheezing, and low blood pressure
• Strokethat can cause weakness and/or loss of sensitivity on one side of the body
• Heart attackwith chest pain
• Pain and inflammation of the limbs caused by a blood clot
• Anemiathat causes breathing difficulties or paleness
• Chest pain and breathing difficulties caused by a blood clot in the lung
• Severe kidney disordersthat can cause difficulty urinating
• A pulmonary conditioncalled transfusion-related acute lung injury (TRALI), which causes difficulty breathing, blue skin, fever, and decreased blood pressure.

• Severe headachein combination with any of the following symptoms, such as neck stiffness, drowsiness, fever, sensitivity to light, nausea, vomiting (these can be signs of meningitis)

If you experience any of the above symptoms, consult your doctor as soon as possible.

The following side effects have also been described:

Frequent adverse effects(may affect up to 1 in every 10 infusions):

• Hypersensitivity (allergic reaction)
• Headache

Uncommon adverse effects(may affect 1 in every 100 infusions):

• Lack of white blood cells
• Changes in heart rate
• Changes in blood pressure
• Vomiting
• Back pain
• Chest pain
• Chills
• Nausea

• Fever
• Feeling of fatigue

• Skin reactions at the injection site
• Abnormalities in blood test results or liver function tests

Other adverse effects that did not occur in clinical trials, but have also been described, 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 on the skin
• Reduced touch or sensitivity
• Sensitivity to light

• Involuntary muscle contractions

• Visual disturbances
• Chest pain

• Palpitations

• Temporary blue discoloration of the lips or other skin areas

• Circulatory collapse or shock

• Venous inflammation
• Pallor
• Cough

• Respiratory disorders

• Pulmonary edema (fluid accumulation in the lungs)
• Bronchospasm (difficulty breathing or wheezing)
• Respiratory failure

• Lack of oxygen in the blood
• Diarrhea, abdominal pain

• Urticaria, skin itching

• Redness of the skin

• Rash
• Scaling of the skin
• Skin inflammation

• Hair loss

• Pain in joints or muscles
• Muscle weakness or stiffness

• Very painful muscle contraction

• Neck pain, pain in legs and arms
• Kidney pain

• Swelling of the skin (edema)

• Hot flashes, increased sweating
• Chest pain

• Flu-like symptoms

• Feeling of cold or heat or general discomfort and weakness
• Drowsiness

• Burning sensation
• Incorrect glucose measurements in blood tests

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Octagamocta 50 mg/ml

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the label and packaging.

Store below 25°C. Do not freeze.

Keep the vial in the outer packaging to protect it from light.

After the first opening, the medicine should be used immediately.

Do not use the medicine if you notice that the solution is cloudy, has sediment, or has an intense color.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofOctagamocta50 mg/ml

• The active ingredient is 50 mg/ml human normal immunoglobulin (human antibodies) (of which at least 95% is immunoglobulin G).
• The other components are maltose, water for injectable preparations.
• The components used in the packaging of Octagamocta 50 mg/ml do not contain latex.

Appearance of the Product and Package Contents

Octagamocta 50 mg/ml is a solution for infusion and is available in vials (2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml, 25 g/500 ml).

Presentation:

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

Only some package sizes may be marketed.

The solution is transparent or slightly opalescent, colorless or slightly yellowish.

Marketing Authorization Holder

Octapharma S.A.

Avda. Castilla, 2 (P.E. San Fernando) Ed. Dublín, 2ª Planta 28830 San Fernando de Henares

Madrid

Manufacturer

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235, A-1100 Vienna, Austria

or

Octapharma S.A.S.

70-72 rue de Marèchal Foch, BP 33, F-67380 Lingolsheim, France

or

Octapharma AB

SE-112 75 Stockholm, Sweden

or

Octapharma GmbH

Elisabeth Selbert Strasse 11, 40764 Langenfeld, Germany

Tel.: +49 (02173) 917 - 0 Fax: +49 (02173) 917 – 111

(only for Germany)

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

This prospectus was last revised in:07/2024

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

• The medicine should be brought to room temperature or body temperature before administration.
• The solution should be transparent to slightly opalescent and colorless to slightly yellowish.
• Do not use cloudy solutions or those with sediment.
• Any unused product or waste material should be disposed of according to local requirements.
• This medicine should not be mixed with other medicines.
• The infusion line should be flushed before and after administration of the medicine, circulating a 0.9% saline solution or a 5% dextrose solution through it.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.es/.