OCTAGAMOCTA 100 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Octagamocta100 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.,including any possible side effects.

• 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 Octagamocta 100 mg/ml and what is it used for
2. What you need to know before you use Octagamocta 100 mg/ml
3. How to use Octagamocta 100 mg/ml
4. Possible side effects
5. Storage of Octagamocta 100 mg/ml
6. Contents of the pack and further information

1. What is Octagamocta 100 mg/ml and what is it used for

What is Octagamocta 100 mg/ml

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 defence. Octagamocta 100 mg/ml contains all IgG activities present in the normal population. Adequate doses of this medicine can restore abnormally low IgG levels to normal.

Octagamocta 100 mg/ml has a broad spectrum of antibodies against various infectious agents.

What is Octagamocta 100 mg/ml used for

Octagamocta 100 mg/ml 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 agammaglobulinaemia and hypogammaglobulinaemia, 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.

Octagamocta 100 mg/ml can be used for the treatment of adults and children and adolescents (0-18 years) who are at risk of measles or who have been exposed to measles and in whom active vaccination against measles is not indicated or not recommended.

Octagamocta 100 mg/ml can also be used for the treatment of autoimmune diseases (immunomodulation):

• in patients with immune thrombocytopenia (ITP), a condition in which the platelets are destroyed and thus reduced in number and who are at high risk of bleeding or need to correct the platelet count before surgery.
• in patients with Kawasaki disease, a condition that causes inflammation of various 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 causes chronic inflammation of the peripheral nervous system and leads to muscle weakness and/or numbness mainly in the legs and arms.
• in patients with multifocal motor neuropathy (MMN), a condition characterized by slowly progressive asymmetric weakness of the limbs without sensory loss in adult patients with active dermatomyositis (DM), a disorder that causes muscle inflammation and skin changes. Typical symptoms are progressive symmetric muscle weakness and typical skin changes such as rash on different parts of the body (e.g. eyelids, cheeks, nose, back, elbows, knuckles) and dry, scaly skin. Octagamocta 100 mg/ml can be used in patients treated with drugs that suppress the immune system, such as corticosteroids, or if these drugs are contraindicated or not well tolerated.

2. What you need to know before you use Octagamocta 100 mg/ml

Do not use Octagamocta 100 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 an immunoglobulin A (IgA) deficiency with anti-IgA antibodies and if you have developed antibodies against IgA-type immunoglobulins.

Warnings and precautions

Consult your doctor or pharmacist before you start using Octagamocta 100 mg/ml.

It is strongly recommended that each time a dose of Octagamocta 100 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 required for an adverse effect will depend on the nature and severity of the side effect.

Circumstances and conditions that increase the risk of having side effects

• After administration of the medicine, thromboembolic events such as heart attack, stroke and deep vein obstruction, for example in the lower leg, or obstruction of a blood vessel in the lung may occur very rarely. These types of events occur more frequently, although very rarely, in patients with risk factors such as obesity, advanced age, hypertension, diabetes, previous occurrences of these events, prolonged periods of immobilisation and intake of certain hormones (e.g. "the pill"). Ensure adequate fluid intake. In addition, Octagamocta 100 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, being overweight or 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.
• Patient with blood group A, B or AB, as well as patients with certain inflammatory diseases have a higher risk that the administered immunoglobulins destroy the red blood cells (haemolysis).

When should the infusions be reduced or stopped?

• Severe headaches and neck stiffness may occur rarely between several hours and 2 days after treatment with this medicine.
• Allergic reactions are rare, but may induce anaphylactic shock, even in patients who have tolerated previous treatments. A sudden drop in blood pressure or shock may be the consequence of an anaphylactic reaction.
• Acute lung injury caused by transfusion (TRALI) may occur very rarely after receiving immunoglobulins, including Octagamocta 100 mg/ml. This may cause non-cardiogenic fluid accumulation in the lungs. You will recognize TRALI by severe breathing difficulties, normal heart function and elevated body temperature (fever). Symptoms typically occur between 1 and 6 hours after receiving the 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 whether other measures are necessary.

• Sometimes immunoglobulin solutions like Octagamocta 100 mg/ml may cause a reduction in the number of white blood cells. This situation usually resolves spontaneously within 1-2 weeks.

Viral safety

When medicines derived from human plasma or blood are administered, certain measures are taken to prevent the transmission of infectious diseases to patients. These measures include:

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

Despite these measures, when medicines derived from human blood or plasma are administered, the risk of transmission of 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 transmission of hepatitis A or parvovirus B19 infections, possibly due to the protective effect of the antibody content against these infections present in the medicine.

Children and adolescents

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

Using Octagamocta 100 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 vaccinated in the last 3 months.

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

Concomitant use with loop diuretics should be avoided.

Octagamocta 100 mg/ml may reduce the effect of live attenuated virus vaccines such as measles, rubella, mumps and chickenpox.

A period of 3 months should elapse after administration of this product before vaccination with live attenuated virus vaccines. In the case of measles, this reduced effect may persist for 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 test systems (so-called glucose meters) falsely interpret the maltose contained in this medicine as glucose. This may lead to falsely elevated glucose readings during infusion or for up to 15 hours after the end of the infusion and, as a consequence, to inadequate administration of insulin, resulting in hypoglycaemia (i.e. a drop in blood sugar levels), which can be fatal.

Similarly, actual cases of hypoglycaemia may be overlooked and not treated if the hypoglycaemic state is masked by falsely elevated glucose readings.

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

The information leaflet of the blood glucose test kit, including test strips, should be carefully reviewed to determine if the system is suitable for use with parenteral products containing maltose. If in doubt, consult your treating doctor to determine if the glucose test system you are using is suitable for use with parenteral products containing maltose.

Using Octagamocta 100 mg/ml with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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, it should be administered with caution to pregnant and breast-feeding women. It has been shown that IgIV products frequently cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins indicates that no harmful effects are expected during pregnancy, to the foetus or the newborn.

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

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

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, patients who experience side effects during treatment should wait for these to resolve before driving or using machines.

Octagamocta 100 mg/ml contains sodium

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

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

3. How to use Octagamocta 100 mg/ml

Your doctor will decide if you need this medicine and at what dose. This medicine is administered by intravenous infusion (infusion into a vein) which must be given by a healthcare professional. The dose and dosing regimen depend on the indication and may need to be individualised 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 Octagamocta 100 mg/ml in children and adolescents (0-18 years) does not differ from that in adults.

If you receive more Octagamocta 100 mg/ml than you should

Overdose is unlikely because this medicine is usually administered under medical supervision. If, however, you receive more Octagamocta 100 mg/ml than you should, the blood may become too thick (hyperviscous), which may increase the risk of blood clots. This may occur especially if you are an at-risk patient, 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 forget to use Octagamocta 100 mg/ml

Consult your doctor to discuss how to proceed.

4. Possible Adverse Effects

Like all medicines, this type of medicine 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 10,000 people).

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 decreased blood pressure
• Cerebrovascular accidentsthat 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
• Chest pain and breathing difficulties caused by a pulmonary blood clot
• Anemiathat causes breathing difficulties or paleness
• Severe kidney disordersthat can cause difficulty urinating
• A pulmonary conditioncalled transfusion-related acute lung injury (TRALI), which causes difficulty breathing, bluish 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 adverse effects have also been described:

Common adverse effects(may affect 1 in 10 infusions):

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

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

• Lack of different types of blood cells
• Changes in heart rate
• Vomiting
• Stroke (cerebral attack)
• Dizziness
• Feeling of tingling or pinching on the skin
• Chills
• Blurred vision
• Blood clots in blood vessels
• Obstruction of a deep vein
• Obstruction of a pulmonary artery
• Back pain
• Chest pain
• Pain in joints or muscles
• Involuntary muscle contractions
• Pain in the legs or arms
• Respiratory disorders
• Chills

• Feeling of fatigue, general malaise, or weakness
• Fluid in the tissues of the extremities

• Skin reactions at the injection site
• Anomalies in blood test results (i.e., liver function or red blood cell tests)

Other adverse effects that did not occur in clinical studies 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
• Reduced touch or sensitivity
• Sensitivity to light
• Visual impairment
• Chest pain

• Palpitations

• Lips or other parts of the skin temporarily turning blue

• Circulatory collapse or shock

• Inflammation of the veins
• Pallor of the skin
• Cough
• 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
• Inflammation of the skin

• Hair loss

• Muscle weakness or stiffness

• Very painful muscle contraction

• Neck pain
• Kidney pain

• Swelling of the skin (edema)

• Hot flashes, increased sweating
• Chest pain

• Flu-like symptoms

• Feeling of cold or heat
• Drowsiness

• Burning sensation
• Incorrect blood glucose measurements

Reporting Adverse Effects

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

5. Storage of Octagamocta 100 mg/ml

Keep out of sight and reach of children.

Do not use this medicine after the expiration date shown on the label and carton.

Store in the refrigerator (between 2°C and 8°C). Keep the container in the outer packaging to protect it from light. Do not freeze.

The medicine may be kept outside the refrigerator for a single period of up to 9 months (without exceeding the expiration date) and stored at a temperature ≤ 25 °C. At the end of this period, it should not be refrigerated again and should be discarded. The date on which the medicine was removed from the refrigerator should be recorded on the outer carton.

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

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

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Octagamocta 100 mg/ml:

• The active ingredient is normal human immunoglobulin (human antibodies) at a concentration of 100 mg/ml, with 100 mg of protein/ml (of which at least 95% is immunoglobulin G).
• The other components are maltose and water for injectable preparations.

Appearance of the Product and Package Contents:

Octagamocta 100 mg/ml 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).

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 3 x 100 ml

3 x 20 g in 3 x 200 ml

30 g in 300 ml

Not all 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

Manufacturers:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235, A-1100 Vienna, Austria

or

Octapharma AB

Lars Forssells gata 23, 112 51 Stockholm

SE-112 75 Stockholm, Sweden

or

Octapharma GmbH

Elisabeth Selbert Strasse 11, 40764 Langenfeld, Germany

(only for 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:

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 from transparent to slightly opalescent and from 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.
• To finish the infusion of the product that may have remained in the tubes at the end of the infusion, a 0.9% saline solution or 5% dextrose solution can be circulated through the tube.

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