Label: information for the user

Octagamocta100 mg/ml, solution for infusion

Normal human immunoglobulin for intravenous administration (IGIV)

What is Octagamocta 100 mg/ml

This medicine is a solution of normal human immunoglobulin (IgG), that is a solution of human antibodies, for intravenous administration (infusion into a vein). Immunoglobulins are normal components of the human body and support the immune defense of your body. Octagamocta 100 mg/ml contains all the activities of IgG that are present in the normal population. Appropriate doses of this medicine can restore abnormally low levels of IgG to normal levels.

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

What Octagamocta 100 mg/ml is 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 agammaglobulinemia and congenital 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.

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

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

• in patients with immune thrombocytopenia (ITP), a condition in which platelets are destroyed and, consequently, their number is reduced and who have a high risk of bleeding or need to correct 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 causes chronic inflammation of the peripheral parts of the nervous system and that causes muscle weakness and/or numbness mainly in legs and arms.
• in patients with multifocal motor neuropathy (NMM), a condition characterized by a slow, asymmetric, progressive weakness of the limbs without sensory loss in patients adults with active dermatomyositis (DM), a disorder that causes muscle inflammation and skin changes. Typical symptoms are progressive, symmetrical muscle weakness and typical skin changes such as rash in different parts of the body (e.g., eyelids, cheeks, nose, back, elbows, knuckles) and scaly, rough, and dry skin.Octagamocta 100 mg/ml can be used in patients treated with immunosuppressive drugs, such as corticosteroids, or if these drugs are contraindicated or not tolerated well.

No use Octagamocta 100 mg/ml

• If you are allergic to human immunoglobulin or any of the other components of this medication (including those listed in section 6).
• If you have a deficiency of immunoglobulin A (IgA deficiency) with anti-IgA antibodies and if you have developed antibodies against type A immunoglobulins.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Octagamocta 100 mg/ml.

It is strongly recommended that, each time a dose of Octagamocta 100 mg/ml is administered, the name of the medication and batch number administered be recorded in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

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

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

Circumstances and conditions that increase the risk of adverse effects

• After administration of the medication, thromboembolic events such as heart attack, stroke, and deep vein thrombosis, for example in the lower leg, or pulmonary vessel thrombosis may occur in very rare cases. 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 immobilization, and ingestion 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, obesity, or more than 65 years of age, this medication 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 circumstances mentioned above 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 of the administered immunoglobulins destroying red blood cells (which is known as hemolysis).

When is it necessary to reduce or stop infusions?

• Headaches and neck stiffness may occur rarely between several hours and 2 days after treatment with this medication.
• 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 consequences of anaphylactic shock.
• In very rare cases, acute lung injury caused by transfusion (TRALI) may occur after receiving immunoglobulins, including Octagamocta 100 mg/ml. This may cause an accumulation of non-cardiac fluid in the lung spaces. 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 the treatment.

Inform your doctor or healthcare professional immediately if you notice any of these reactions during or after administration of this medication. They will decide whether to reduce the infusion rate or stop it completely or if other measures are necessary.

• Sometimes, solutions of immunoglobulin like Octagamocta 100 mg/ml may trigger a reduction in white blood cell count. This situation usually resolves spontaneously within 1-2 weeks.

Viral safety

When administering medications derived from human plasma or blood, certain measures must be taken to prevent infections from passing to patients. Such measures include:

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

Despite these measures, when administering medications derived from human blood or plasma, the possibility of transmission of infectious agents cannot be excluded entirely. This also applies to emerging viruses or of unknown nature or other types of infections.

These measures are considered effective for 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 virus or parvovirus B19 infections, possibly due to the protective effect of the antibodies against these infections present in the medication.

Children and adolescents

No specific or additional warnings or precautions apply to the pediatric population.

Use of Octagamocta 100 mg/ml with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those obtained without a prescription, or if you have received a vaccine in the past three months.

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

Concomitant use with diuretics should be avoided.

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

After administration of this product, a period of 3 months should elapse before vaccination with live attenuated viruses. In the case of measles, this reduction in effect may persist for up to 1 year.

Effects on blood tests

If you are to have a blood test after receiving this medication, inform the person who will be taking the sample or your doctor that you have been administered a solution of human normal immunoglobulin, as this treatment may affect the results.

Glucose blood test

Some types of glucose blood test systems (designated glucometers) may interpret maltose contained in this medication as glucose. This may cause falsely elevated glucose readings during infusion or within 15 hours after infusion has ended, and may lead to inadequate insulin administration, resulting in hypoglycemia (i.e., a decrease in blood sugar levels), which may be fatal.

Similarly, authentic hypoglycemia cases may be overlooked and not treated if the hypoglycemic state is masked by falsely elevated glucose readings.

As a result, when administering this medication or other products containing maltose, blood glucose measurement should be performed with a system using a specific method for glucose. Systems based on the glucose dehydrogenase pyrroloquinoline quinone (GDH PQQ) or glucose-colorant-oxidorreductase methods should not be used.

Review the information provided with the test kit for glucose blood tests, including glucose strips, to determine if the system is suitable for use with parenteral products containing maltose. If in doubt, consult the doctor treating you to determine if the glucose test system being used is suitable for use with parenteral products containing maltose.

Use of Octagamocta 100 mg/ml with food, beverages, and alcohol

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication during pregnancy has not been determined in controlled clinical trials and should therefore be administered with caution to pregnant women and lactating women.The immunoglobulins have been shown to cross the placenta frequently, especially during the third trimester.Clinical experience with immunoglobulins indicates that no adverse effects should be expected during pregnancy, in the fetus, or in the newborn.

Immunoglobulins are excreted in human breast milk. No adverse effects are expected in breastfed infants or in lactating women.

Clinical experience with immunoglobulins suggests that no adverse effects should be expected on fertility.

Driving and operating machinery:

This medication has no influence, or this is insignificant, on the ability to drive or operate machinery.However, patients who experience adverse reactions during treatment should wait until these have resolved before driving or operating machinery.

Octagamocta 100 mg/ml contains sodium

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

Patients with a sodium-controlled diet should be aware of this.

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

• If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents

The intravenous administration of Octagamocta 100 mg/ml in children and adolescents (0-18 years) does not differ from that of adults.

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

It is very unlikely that an overdose will occur because this medicine is normally administered under medical supervision. If, despite this, you receive more Octagamocta 100 mg/ml than you should, your blood may become too thick (hyperviscous), which may increase the risk of blood clots. This may occur especially if you are a high-risk patient, such as if you are advanced in age or have a heart or kidney disease. Make sure you are well hydrated. Inform your doctor if you have any known medical condition.

If you forgot to use Octagamocta 100 mg/ml

Consult your doctor to discuss how to proceed.

Like all medicines, this type of medicine can produce adverse effects, although not all people will experience them.

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

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

• Face, tongue, and tracheal inflammationthat can cause great difficulty breathing
• Acute allergic reactionswith respiratory difficulty, hives, wheezing, and decreased blood pressure
• Cerebrovascular accidentsthat can cause weakness and/or numbness on one side of the body
• Heart attackwith chest pain
• Limbs pain and inflammation caused by ablood clot
• Chest angina and breathing difficulty caused by ablood clot in the lung
• Anemiathat causes breathing difficulty or paleness
• Severe kidney disordersthat can cause difficulty urinating
• Apulmonary affectioncalled acute transfusion-related lung injury (TRALI, in English), which causes breathing difficulty, blue skin, fever, and decreased blood pressure.
• Intense headachein combination with any of the following symptoms, such asneck stiffness, drowsiness, fever, light sensitivity, nausea, vomiting (these may 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:

Frequent adverse effects(can affect 1 in 10 infusions):

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

Rare adverse effects(can affect 1 in 100 infusions):

• Lack of different types of blood cells
• Changes in heart rhythm
• Vomiting
• Stroke (cerebral attack)
• Dizziness
• Sensation of tingling or pinching in the skin
• Chills
• Blurred vision
• Coagulation in blood vessels
• Deep vein obstruction
• Pulmonary artery obstruction
• Back pain
• Chest pain
• Muscle or joint pain
• Involuntary muscle contractions
• Pain in the legs or arms
• Respiratory disorders
• Chills

• Sensation of fatigue, general discomfort, or weakness
• Liquid accumulation in the tissues of the limbs

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

The following adverse effects that did not occur in clinical studies, but have also been described, are:

• Fluid overload
• Sodium levels in the blood too low

• Sensation of agitation, anxiety, confusion, or nervousness

• Migraine
• Speech disorders
• Loss of consciousness
• Reduced tactile or sensitivity
• Light sensitivity
• Visual alteration
• Chest angina

• Palpitations

• Lips or other parts of the skin temporarily blue

• Circulatory collapse or shock

• Vein inflammation
• Pale 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

• Skin redness

• Dermatological eruption
• Skin peeling
• Skin inflammation

• Hair loss

• Muscle weakness or muscle rigidity

• Severe muscle contraction

• Neck pain,
• Kidney pain

• Lymphedema (skin swelling)

• Hot flashes, increased sweating
• Chest pain

• Flu-like symptoms

• Sensation of cold or heat
• Drowsiness

• Sensation of burning
• Incorrect results in 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 them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not usethismedicineafter the expiration date that appears on the label and in the box.

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

The medicine may remain outside the refrigerator for a single period of up to 9 months (without exceeding the expiration date) and be 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 has been removed from the refrigerator should be recorded on the outer packaging.

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

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

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 proteins/ml (of which at least 95% is immunoglobulin G).
• The other components are maltose and water for injection preparations.

Appearance of the product and contents of the package:

Octagamocta 100 mg/ml is a perfusion solution 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 gin20 ml

5 gin50 ml

6 gin60 ml

10 gin100 ml

20 gin200 ml

3 x 10 gin3 x 100 ml

3 x 20 gin3 x 200 ml

30 gin300 ml

Only some package sizes may be commercially available.

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

Marketing Authorization Holder:

Octapharma S.A.

Avda. Castilla, 2.(P.E. San Fernando)
Ed. Dublín, 2nd Floor
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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

This leaflet was last revised on:07/2024

The following information is directed exclusively to healthcare professionals:

• The medication should be taken to room temperature or body temperature before administration.
• The solution should be from transparent to slightly opalescent and colorless to slightly yellow.
• Do not use turbid or sediment-containing solutions.
• All unused products or waste materials should be disposed of in accordance with local requirements.
• This medication should not be mixed with other medications.
• To complete the perfusion of the product that may remain in the tubes at the end of the perfusion, a 0.9% saline solution or a 5% dextrose solution can be circulated through the tube.

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