OctagamOcta 50 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OCTAGAMOCTA® 50 mg/ml solution for infusion

Normal human immunoglobulin for intravenous administration (IGIV)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

This medicine is a solution of normal human 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. Octagamocta 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.

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

What Octagamocta 50 mg/ml is 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 who experience severe or recurrent infections.

Octagamocta 50 mg/ml can be used for the treatment of adults and children and adolescents (0–18 years) who are susceptible and who have been exposed to measles or are at risk of exposure to measles, and in whom active measles vaccination is not indicated or not recommended.

Octagamocta 50 mg/ml can also be used in 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 are at high risk of bleeding or require correction of platelet count prior to surgery.
• In patients with Kawasaki disease, a condition causing inflammation of various organs.
• In patients with Guillain-Barré syndrome, a condition causing inflammation of certain parts of the nervous system.
• In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease resulting in chronic inflammation of the peripheral parts of the nervous system and causing muscle weakness and/or numbness, primarily in the legs and arms.
• In patients with multifocal motor neuropathy (MMN), a condition characterized by slowly progressive, asymmetric limb weakness without sensory loss.

2. What you need to know before using Octagamocta 50 mg/ml

Do not use Octagamocta 50 mg/ml:

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

• If you have immunoglobulin A deficiency (IgA deficiency) and have developed antibodies against immunoglobulins of the A type.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Octagamocta 50 mg/ml.

It is strongly recommended that each time a dose of Octagamocta 50 mg/ml is administered, the name of the medicine and the batch number used should be recorded in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

• If the infusion rate is high
• When receiving this medicine for the first time, or, rarely, when there has been a prolonged 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. Management of an adverse effect will depend on the nature and severity of the side effect.

Circumstances and conditions that increase the risk of adverse effects

• Very rarely, thromboembolic events such as heart attack, stroke, deep vein thrombosis (e.g., in the lower leg), or pulmonary vessel occlusion may occur after administration of the medicine. These types of events occur more frequently in patients with risk factors such as obesity, advanced age, hypertension, diabetes, previous episodes of such events, prolonged immobilization, and use of certain hormones (e.g., “the pill”). Ensure adequate fluid intake. In addition, Octagamocta 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, as cases of acute renal failure have been reported in patients with these risk factors. Inform your doctor, even if any of the above-mentioned circumstances occurred in the past.
• Patients with blood groups A, B, or AB, as well as patients with certain inflammatory diseases, have an increased risk that the administered immunoglobulins will destroy red blood cells (known as hemolysis).

When should infusions be slowed down or stopped?

• Severe headaches and neck stiffness may rarely occur between several hours and 2 days after treatment with this medicine.
• Allergic reactions are rare, but may lead to anaphylactic shock, even in patients who previously tolerated the treatment. A sudden drop in blood pressure or shock may be consequences of an anaphylactic reaction.
• In very rare cases, transfusion-related acute lung injury (TRALI) may occur after receiving immunoglobulins, including Octagamocta 50 mg/ml. This may cause fluid accumulation unrelated to the heart in the air spaces of the lungs. TRALI is recognized by severe breathing difficulties, normal heart function, and an increase in body temperature (fever). Symptoms typically appear between 1 and 6 hours after receiving the treatment.

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

• Sometimes immunoglobulin solutions such as Octagamocta 50 mg/ml may 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 are taken to prevent transmission of infections to patients. These measures include:

• Careful selection of donors to ensure exclusion of those at risk of carrying infectious diseases.
• Testing of individual donations and plasma pools for specific markers of infection indicating the presence of viruses/infection.
• Inclusion of manufacturing steps designed to inactivate or remove 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 and 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 effectiveness 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 antibodies against these infections present in the medicine.

Children and adolescents

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

Use of Octagamocta 50 mg/ml with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, or if you have received a vaccine within the last three months.

The infusion line should be flushed before and after administration of the medicine using 0.9% saline solution or 5% dextrose solution.

Concomitant use of loop diuretics should be avoided.

Octagamocta 50 mg/ml may reduce the effectiveness of live virus vaccines, such as those for measles, rubella, mumps, and varicella.

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

Effects on blood tests

If you are to have a blood test after receiving this medicine, inform the person performing the test or your doctor that you have been administered a normal human immunoglobulin solution, as this treatment may affect test results.

Blood glucose testing

Some types of blood glucose monitoring systems (called glucometers) may misinterpret the maltose present in this medicine as glucose. This may lead to falsely elevated glucose readings during or for approximately 15 hours after the infusion, potentially resulting in inappropriate insulin administration and subsequent hypoglycemia (i.e., low blood sugar), which could be fatal. Likewise, true hypoglycemic episodes may not be treated if the hypoglycemic state is masked by falsely elevated glucose readings.

Therefore, when administering this medicine or other products containing maltose, blood glucose measurement must be performed using a system that employs a glucose-specific method. Systems based on pyrroloquinolinequinone glucose dehydrogenase (GDH-PQQ) or glucose-colorant-oxidoreductase methods must not be used.

Carefully review the product information of the blood glucose monitoring system, including the test strips, to determine whether the system is suitable for use with parenteral products containing maltose. If in doubt, consult your treating physician to confirm whether your current glucose monitoring system is appropriate for use with parenteral products containing maltose.

Use of Octagamocta 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 become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of this medicine during pregnancy has not been established in controlled clinical trials and therefore should be used with caution in pregnant and breastfeeding women. It has been shown that IgIV preparations frequently cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on pregnancy, the fetus, or the newborn are expected.

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

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

Driving and use of machines

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

Octagamocta 50 mg/ml contains sodium

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

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

3. How to use Octagamocta 50 mg/ml

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

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

Use in children and adolescents

The intravenous administration of Octagamocta 50 mg/ml in children and adolescents (0–18 years) does not differ from that in adults.

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

It is very unlikely that an overdose will occur because this medicine is normally administered under medical supervision. However, if you do receive more Octagamocta 50 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, for example, if you are elderly or have heart or kidney disease. Make sure you are well hydrated. Inform your doctor if you have any known medical conditions.

If you forget to use Octagamocta 50 mg/ml

Consult your doctor to discuss how to proceed.

4. Possible adverse effects

Like all medicines, this one may cause adverse effects, although not everyone experiences them.

Contact your doctor as soon as possible if you experience any of the following serious side effects (all are very rare and may affect 1 in 10,000 infusions):

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

• Swelling of the face, tongue, and trachea, which may cause severe difficulty breathing

• Sudden allergic reactions with breathing difficulties, rash, wheezing, and low blood pressure

• Stroke that may cause weakness and/or loss of sensation on one side of the body

• Heart attack with chest pain

• Pain and swelling in the limbs caused by a blood clot

• Anemia causing shortness of breath or paleness

• Angina and shortness of breath caused by a blood clot in the lung

• Severe kidney problems that may cause difficulty urinating

• A lung condition called transfusion-related acute lung injury (TRALI), which causes difficulty breathing, bluish skin, fever, and low blood pressure

• Severe headache accompanied by any of the following symptoms: neck stiffness, drowsiness, fever, light sensitivity, nausea, vomiting (these may be signs of meningitis)

If you experience any of the symptoms listed above, contact your doctor immediately.

The following side effects have also been reported:

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

• Hypersensitivity (allergic reaction)
• Headache

Uncommon adverse effects (may affect 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

• Feeling of tiredness

• Skin reactions at the injection site

• Abnormal blood test results or liver function tests

Other adverse effects that did not occur during clinical studies but have also been reported include:

• Fluid overload

• Low sodium levels in the blood

• Feeling restless, anxious, confused, or nervous

• Migraine

• Speech disorders

• Loss of consciousness

• Dizziness

• Tingling sensation in the skin

• Reduced touch or sensation

• Light sensitivity

• Involuntary muscle contractions

• Vision disturbances

• Angina

• Palpitations

• Bluish discoloration of lips or other parts of the skin temporarily

• Circulatory collapse or shock

• Inflammation of the veins

• Pale skin

• Cough

• Respiratory disorders

• Pulmonary edema (fluid accumulation in the lungs)

• Bronchospasm (difficulty breathing or wheezing)

• Respiratory failure

• Low oxygen levels in the blood

• Diarrhea, abdominal pain

• Hives, itchy skin

• Skin redness

• Skin rash

• Skin peeling

• Skin inflammation

• Hair loss

• Joint or muscle pain

• Muscle weakness or stiffness

• Very painful muscle cramps

• Neck pain, pain in legs and arms

• Kidney pain

• Swelling of the skin (edema)

• Hot flushes, increased sweating

• Chest pain

• Flu-like symptoms

• Sensation of cold or heat, or general malaise and weakness

• Drowsiness

• Burning sensation

• Incorrect results in blood glucose measurements

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the label and on the packaging.

Store below 25°C. Do not freeze.

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

After first opening, the medicine should be used immediately.

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

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

6. Contents of the pack and other information

Composition of Octagamocta 50 mg/ml

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

Appearance of the product and contents of the pack

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).

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

Only some pack sizes may be marketed.

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

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 Maréchal 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

(for Germany only)

This medicine is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

This patient information leaflet was last reviewed in: 07/2024

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

• The medicine should be brought to room temperature or body temperature before administration.
• The solution should range from transparent to slightly opalescent and from colorless to slightly yellow.
• Do not use solutions that are cloudy or contain precipitates.
• Any unused product or waste material must be disposed of in accordance with local requirements.
• This medicine must not be mixed with other medicinal products.
• The infusion line should be flushed before and after administration of the medicine by running through it either 0.9% sodium chloride solution or 5% dextrose solution.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):
http://www.aemps.es/