OctagamOcta 100 mg/ml solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Octagamocta 100 mg/ml, solution for infusion

Normal human immunoglobulin for intravenous administration (IGIV)

Please read all of this 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

What Octagamocta 100 mg/ml is

This medicine is a solution of human normal 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 your body's immune defense. 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 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 congenital 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 100 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 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 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 causing chronic inflammation of the peripheral parts of the nervous system, leading to muscle weakness and/or numbness, primarily in the legs and arms.
• in patients with multifocal motor neuropathy (MMN), a disorder characterized by slowly progressive, asymmetric limb weakness without sensory loss.
• in adult patients with active dermatomyositis (DM), a disorder causing muscle inflammation and skin changes. Typical symptoms are progressive symmetric muscle weakness and characteristic skin changes such as rash in different parts of the body (e.g., eyelids, cheeks, nose, back, elbows, knuckles) and scaly, rough, dry skin. Octagamocta 100 mg/ml may be used in patients treated with immunosuppressive drugs such as corticosteroids, or when these drugs are contraindicated or not well tolerated.

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

Do not use Octagamocta 100 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) with anti-IgA antibodies and have developed antibodies against immunoglobulins of the A type.

Warnings and precautions

Talk to 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 medicine and the batch number be recorded 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, after a long interval since the previous infusion
• when you have an untreated infection or underlying chronic inflammation

In the event 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 adverse effects

• Very rarely, thromboembolic events such as heart attack, stroke, or blockage of a deep vein (e.g., in the lower leg) or a blood vessel in the lung may occur after administration of the medicine. These types of events, although very rare, occur more frequently in patients with risk factors such as obesity, advanced age, hypertension, diabetes, previous episodes of such events, prolonged periods of immobility, 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, 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 (a condition known as hemolysis).

When should infusions be slowed down or stopped?

• Severe headaches and neck stiffness may rarely occur several hours to 2 days after treatment with this medicine.
• Allergic reactions are rare but may lead to anaphylactic shock, even in patients who have previously tolerated treatments. 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 100 mg/ml. This can cause fluid accumulation unrelated to the heart in the air spaces of the lungs. TRALI is recognized by severe difficulty breathing, 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 notice 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 100 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 infections from being passed 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,
• inclusion of steps in the manufacturing process to inactivate and/or remove viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmission of infectious agents cannot be completely ruled out. 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 infections by hepatitis A virus or parvovirus B19, 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.

Using Octagamocta 100 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 either 0.9% sodium chloride solution or 5% dextrose solution.

Concomitant use of loop diuretics should be avoided.

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

A period of 3 months should elapse after administration of this product before vaccination with live attenuated viruses. In the case of measles, this reduction in effectiveness may persist for up to one year.

Effects on blood tests

If you are to have a blood test after receiving this medicine, inform the person taking the sample 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 testing systems (called glucometers) may misinterpret the maltose contained in this medicine as glucose. This may lead to falsely elevated glucose readings during an infusion or for approximately 15 hours after the infusion ends, potentially resulting in inappropriate insulin administration and causing hypoglycemia (i.e., low blood sugar), which can be fatal.

Additionally, true cases of hypoglycemia may be overlooked and not 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 test system that employs a glucose-specific method. Testing systems based on pyroloquinolinequinone glucose dehydrogenase (GDH-PQQ) or glucose-colorant-oxidoreductase methods must not be used.

The information provided in the test kit materials, including glucose test strips, should be carefully reviewed to determine whether the system is suitable for use with parenteral products containing maltose. If in doubt, consult your treating physician to confirm whether the glucose testing system you are using is appropriate 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 IVIG products frequently cross the placenta, especially during the third trimester. Clinical experience with immunoglobulins indicates that harmful effects during pregnancy, on the fetus, or on the newborn are not expected.

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

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

Driving and using machines:

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

Octagamocta 100 mg/ml contains sodium

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

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

3. How to use Octagamocta 100 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), which must be given by healthcare personnel. The dose and dosing 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 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

It is very unlikely that an overdose will occur, as this medicine is normally administered under medical supervision. However, if you do receive more Octagamocta 100 mg/ml than you should, your blood may become too thick (hyperviscous), which could increase the risk of blood clots. This is especially possible if you are a high-risk patient, for example, if you are elderly or have a 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 100 mg/ml

Consult your doctor to discuss how to proceed.

4. Possible adverse effects

Like all medicines, this type of medicine may produce adverse effects, although not everyone experiences them.

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

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

• Swelling of the face, tongue, and trachea, which may cause severe breathing difficulties
• Sudden allergic reactions with difficulty breathing, rash, wheezing, and drop in blood pressure
• Strokes 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 due to a blood clot
• Angina and difficulty breathing caused by a blood clot in the lung
• Anemia causing shortness of breath or paleness
• Severe kidney disorders 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 in combination with any of the following symptoms: neck stiffness, drowsiness, fever, light sensitivity, nausea, or vomiting (these may be signs of meningitis)

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

The following adverse effects have also been reported:

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

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

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

• Deficiency in different types of blood cells
• Changes in heart rhythm
• Vomiting
• Stroke (cerebral attack)
• Dizziness
• Tingling or prickling sensation in the skin
• Chills
• Blurred vision
• Blood clots in blood vessels
• Blockage of a deep vein
• Blockage of a pulmonary artery
• Back pain
• Chest pain
• Joint or muscle pain
• Involuntary muscle contractions
• Pain in the arms or legs
• Breathing difficulties
• Chills
• Feeling of fatigue, general discomfort, or weakness
• Fluid in the tissues of the limbs
• Skin reactions at the injection site
• Abnormal blood test results (e.g., liver function tests or red blood cell counts)

Other adverse effects that did not occur in 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
• Reduced touch or sensation
• Light sensitivity
• Vision disturbances
• Angina pectoris
• Palpitations
• Lips or other parts of the skin temporarily turning blue
• Circulatory collapse or shock
• Inflammation of veins
• Pale skin
• Cough
• Pulmonary edema (fluid accumulation in the lungs)
• Bronchospasm (difficulty breathing or wheezing)
• Respiratory failure
• Low oxygen levels in the blood
• Diarrhea, abdominal pain
• Hives, skin itching
• Skin redness
• Skin rash
• Skin peeling
• Skin inflammation
• Hair loss
• Muscle weakness or muscle stiffness
• Very painful muscle cramps
• Neck pain
• Kidney pain
• Swelling of the skin (edema)
• Hot flushes, increased sweating
• Chest pain
• Flu-like symptoms
• Sensation of cold or heat
• Drowsiness
• Burning sensation
• Incorrect results in blood glucose measurements

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the label and the box.

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

After first opening, the medicine must be used immediately.

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

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

6. Contents of the pack and other information

Composition of Octagamocta 100 mg/ml:

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

Appearance of the product and contents of the container:

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

Only certain 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 Planta28830 San Fernando de HenaresMadrid

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

(for Germany only)

This medicinal product is authorized in the European Economic Area Member States 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 clear to slightly opalescent and from colorless to slightly yellow.
• Do not use solutions that are cloudy or contain particulate matter.
• Any unused product or waste material should be disposed of in accordance with local requirements.
• This medicine must not be mixed with other medicinal products.
• To ensure complete delivery of any remaining product in the tubing at the end of the infusion, a 0.9% sodium chloride solution or 5% dextrose solution may be flushed through the tubing.