Optiglobin

PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg
PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg

Package leaflet: Information for the user

Optiglobin 100 mg/ml, solution for infusion
Human normal immunoglobulin (IVIg)
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Optiglobin is and what it is used for
2. Important information before using Optiglobin
3. How to use Optiglobin
4. Possible side effects
5. How to store Optiglobin
6. Contents of the pack and other information

1. What Optiglobin is and what it is used for

Optiglobin contains normal human immunoglobulins (also known as antibodies).
Immunoglobulins are natural components of human blood that help the body fight infections.
Optiglobin is used to increase antibody levels in the blood when antibody levels are too low or when additional antibodies are needed in certain diseases (e.g., immune-mediated disorders).

Optiglobin is used in adults, children, and adolescents (aged 0–18 years) in the following situations:

Replacement therapy, to raise low immunoglobulin levels to normal in patients:

• who were born with limited or no ability to produce immunoglobulins (primary immunodeficiency syndromes).
• who have had a disease or treatment leading to a confirmed lack of immunoglobulin production (secondary immunodeficiency) and who suffer from severe or recurrent infections that do not respond to antimicrobial treatment.

Immunomodulation, in the treatment of certain immune-mediated disorders in patients:

• with insufficient platelet count (primary immune thrombocytopenia, ITP) who are at high risk of bleeding or who are about to undergo surgery in the near future.
• with Guillain-Barré syndrome, an acute disease characterized by inflammation of the peripheral nerves, causing severe muscle weakness.
• with Kawasaki disease, an acute illness affecting mainly young children, characterized by inflammation of blood vessels throughout the body.

PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg

• with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), an immune-mediated disorder affecting peripheral nerves, causing slowly progressive muscle weakness and numbness of the limbs.
• with multifocal motor neuropathy (MMN), an immune-mediated disorder of motor nerves, causing progressive asymmetric limb weakness.

2. Important information before using Optiglobin

Please read this section carefully. Before starting treatment with this medicine, discuss it with your
doctor.
When not to use Optiglobin:

• if the patient is allergic to immunoglobulins or to any of the other ingredients of this medicine (listed in section 6). Patients with corn allergy may show hypersensitivity reactions to glucose, which is an ingredient of Optiglobin.
• if the patient has immunoglobulin A (IgA) deficiency with the presence of antibodies against IgA. Optiglobin contains a small amount of IgA, which may cause an allergic reaction in these individuals.
• if the patient has inadequately treated diabetes and blood glucose levels exceed the normal range (uncontrolled diabetes).
• if the patient has glucose intolerance.
• if the patient has recently experienced hyperosmolar coma (loss of consciousness due to very high blood sugar levels leading to severe dehydration and high blood concentration (high osmolality)).
• if the patient has high blood sugar (hyperglycaemia) due to causes other than diabetes.
• if the patient has high levels of lactate in the blood (hyperlactataemia).

Warnings and precautions
To improve traceability of biological medicinal products, the name and batch number (shown on the vial and outer packaging, abbreviated as Lot) of the administered product should be clearly recorded.
Before starting treatment with Optiglobin, discuss it with your doctor or pharmacist.
During the infusion and for at least 20 minutes after administration, the patient should be closely monitored for potential adverse reactions (undesirable side effects). Some adverse reactions may be related to the infusion rate. Therefore, the doctor should ensure that the infusion rate is appropriate for the individual patient. If any reaction occurs during or after the infusion, the doctor should be notified immediately. The doctor will decide whether to discontinue the infusion.
In certain circumstances, special precautions may be necessary due to an increased risk of adverse reactions. Patients should be monitored during infusion and for the first hour after infusion in the following situations:

• in patients receiving Optiglobin for the first time;
• when switching from another product containing normal human immunoglobulins to a different product, or when a long time has passed since the last infusion;
• in patients with untreated infection or coexisting chronic inflammatory conditions.

Allergic reactions are rare but may occur even if the patient has previously received human immunoglobulins and tolerated them well. If an allergic reaction occurs, administration of Optiglobin must be stopped immediately. In the event of a serious hypersensitivity reaction, contact the doctor or medical personnel immediately. See also section 4: "Possible side effects".
PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg
If severe breathing difficulties occur, accompanied by an increase in body temperature within 1–6 hours after receiving treatment, contact the doctor or medical personnel immediately. This may indicate acute transfusion-related lung injury (TRALI). TRALI may occur very rarely after administration of immunoglobulins. See also section 4: "Possible side effects".
Risk factors during treatment with Optiglobin
Inform the doctor or other healthcare professional if any of the following risk factors apply to the patient, as they may increase the risk during treatment with Optiglobin. In particular, inform healthcare professionals:

• if the patient currently has or has previously had kidney problems (kidney failure);
• if the patient is taking medicines that may damage the kidneys;
• if the patient has heart, liver or kidney disease, or conditions affecting water reabsorption in the kidneys (vasopressin effect);
• if the patient is taking certain diuretics (so-called loop diuretics);
• if the patient has diabetes (abnormally high blood glucose levels). Optiglobin contains 50 mg of glucose per millilitre, which may affect blood glucose levels;
• if the patient has a history of vascular diseases (blood vessel disorders) or thrombosis (blood clot formation within blood vessels);
• if the patient has high blood pressure;
• if the patient is overweight;
• if the patient has a disease that increases blood viscosity (thickens the blood);
• if the patient has hypovolemia (reduced circulating blood volume);
• if the patient is elderly (over 65 years of age);
• if the patient shows signs of sepsis, severe brain injury or shock;
• if the patient has suffered a head injury within the last 24 hours;
• if the patient has recently had a stroke (Optiglobin contains glucose, so blood sugar levels may rise, which could worsen the stroke's impact on the brain and impair recovery);
• if the patient has metabolic disorders due to starvation or malnutrition;
• if the patient has low levels of thiamine (vitamin B1) in the body. The following should be considered during treatment with Optiglobin:
• it is important to ensure that the patient is adequately hydrated and producing an adequate volume of urine before infusion of Optiglobin;
• it may be necessary to check the patient's serum creatinine levels (a substance indicating kidney function);
• monitoring of blood glucose and/or electrolyte levels may be required. This is particularly important if the patient is taking medicines that enhance the vasopressin effect.

Effect on blood test results
If blood tests are required, inform the doctor or healthcare professional that the patient is receiving Optiglobin, as the Optiglobin solution contains antibodies that may cause false-positive results in antibody tests.
Optiglobin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg
Vaccinations
Inform the doctor if the patient is scheduled for vaccination or has recently been vaccinated. Optiglobin may negatively affect the effectiveness of certain live viral vaccines, such as those against measles, rubella, mumps and varicella. A three-month interval should be observed between administration of Optiglobin and vaccination with these vaccines. For the measles vaccine, this interval may extend up to 1 year.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of using this medicine in pregnant or breastfeeding women has not been studied. However, immunoglobulins have been used in pregnant and breastfeeding women.
Based on clinical experience with immunoglobulins, no harmful effects on fertility, pregnancy, the foetus (unborn child), or the newborn are expected. When Optiglobin is administered to pregnant women during labour, especially in combination with oxytocin, there may be an increased risk of hyponatraemia (low sodium levels in the blood).
When Optiglobin is administered to breastfeeding women, immunoglobulins present in the medicine may also be found in breast milk. No negative effects on breastfed newborns/infants are expected.
Newborns
Newborns – particularly those born prematurely and with low birth weight – are at increased risk of developing abnormally low or high blood glucose levels (hypo- or hyperglycaemia). Therefore, they should be closely monitored during treatment with Optiglobin to ensure appropriate blood glucose control and to avoid potential long-term adverse effects.
Driving and operating machinery
Some adverse reactions of Optiglobin may impair the ability to drive or operate machinery. Patients who experience adverse reactions during treatment should wait until symptoms resolve before driving or operating machinery.
Optiglobin contains glucose
Optiglobin contains 50 mg of glucose per millilitre (5% glucose), which may cause an increase in blood glucose levels. If the patient has diabetes, the doctor will decide whether blood glucose monitoring and insulin administration are necessary, especially when high doses of Optiglobin are administered.
Information on virological safety of Optiglobin
Optiglobin is manufactured from human plasma. For medicines derived from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors to exclude individuals at risk of carrying infections,
• testing of each donated batch and plasma pool for signs of viruses/infection, and

PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg

• manufacturing steps capable of inactivating or removing viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, transmission of infection cannot be completely ruled out. This includes viruses and other types of infections currently unknown or newly emerging.
The measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B and C viruses, as well as non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Administration of immunoglobulins has not been associated with transmission of hepatitis A virus or parvovirus B19, possibly because the antibodies against these infections present in the product are protective in nature.

3. How to use Optiglobin

Optiglobin is administered to the patient by a doctor or trained medical personnel. In countries where it is an accepted practice and if the patient has been adequately trained, Optiglobin may be self-administered by the patient.
This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before use, bring Optiglobin to room temperature or body temperature. The intravenous infusion of Optiglobin should be started immediately after piercing the stopper.
The solution should be clear or slightly opalescent, colourless or pale yellow to pink. Do not use solutions that are cloudy or contain precipitates. Any unused solution must be discarded.

Dosage and method of administration
Optiglobin is intended for intravenous infusion. The dose and frequency of infusions will vary depending on the patient's condition and body weight. Initially, Optiglobin will be infused at a low rate. If the medicine is well tolerated, the doctor may gradually increase the infusion rate. For patients self-administering Optiglobin, the doctor will inform the patient of the appropriate dose and infusion rate.

Use in children and adolescents
Children and adolescents (aged 0–18 years) have the same indications, dosage, and frequency of infusions as adults.

Use of a higher than recommended dose of Optiglobin
If a higher than recommended dose of Optiglobin is administered, there is a risk of fluid overload, and the blood may become too thick (excessively viscous), increasing the risk of blood clots. This may be particularly relevant in patients with risk factors, such as elderly patients or those with impaired kidney or heart function. Inform the doctor or trained medical personnel about such medical conditions.

PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg

Missed dose of Optiglobin
Promptly inform your doctor or trained medical personnel and follow their instructions. Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, administration of the medicine should be stopped immediately and you should contact your doctor or healthcare professional without delay:

• allergic reactions with symptoms such as sudden drop in blood pressure, severe dizziness and swelling of the lips, tongue or throat, and breathing difficulties (rare adverse reaction);
• chest pain, shortness of breath or leg pain, or severe headache. These symptoms may be caused by a heart attack (myocardial infarction), stroke, blood clot in the lungs (pulmonary embolism) or blood clot in a blood vessel of the lower limb (deep vein thrombosis) (very rare adverse reaction);
• severe breathing difficulties, accompanied by an increase in body temperature within 1 to 6 hours after receiving the treatment, which may be due to acute lung injury related to blood transfusion (TRALI) (see also section 2) (very rare adverse reaction).

Other adverse reactions that may occur with the use of human normal immunoglobulins include:

• inflammation (swelling) of the protective membranes of the brain and spinal cord not caused by bacteria (aseptic meningitis);
• increased serum creatinine concentration and/or acute kidney failure;
• breakdown of red blood cells (hemolytic reactions, hemolytic anemia);
• vomiting;
• joint pain (arthralgia).

Other adverse reactions reported for Optiglobin include:
Uncommon adverse reactions (may occur in up to 1 in 100 infusions):

• hypersensitivity reactions, headache, nausea, skin disorders (such as rash, redness, urticaria, itching, blisters, skin peeling), back pain, neck pain, muscle pain, malaise (e.g. fatigue, chills, fever, flu-like syndrome).

Rare adverse reactions (may occur in up to 1 in 1,000 infusions):

• low white blood cell count in blood (leukopenia, neutropenia), migraine, dizziness, palpitations, rapid heartbeat, high blood pressure, low blood pressure, shortness of breath, diarrhoea, excessive sweating.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Optiglobin

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store the vial in the outer packaging to protect from light.
During its shelf life, Optiglobin may be stored at temperatures up to 25°C for a period of up to six months, without the possibility of returning it to the refrigerator. Any unused medicine after this period must be discarded. The date of removal from refrigeration should be recorded on the outer packaging.
Do not use this medicine after the expiry date stated on the vial label and on the carton after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Do not use this medicine if the solution appears cloudy or if particles are present in the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Optiglobin contains

• The active substance is human normal immunoglobulin for intravenous administration. One ml contains 100 mg of immunoglobulins, of which at least 95% is immunoglobulin G (IgG).
• Other ingredients: glucose (as monohydrate glucose) and water for injections.

What Optiglobin looks like and contents of the pack
Optiglobin is a solution for infusion. The solution is clear or slightly opalescent, colourless or pale yellow to pink.
Pack sizes: 1 vial containing 1 g/10 ml, 2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 30 g/300 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Prothya Biosolutions Netherlands B.V.
Plesmanlaan 125
NL-1066 CX Amsterdam
The Netherlands
[email protected]
This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria, Germany: Optiglobin 100 mg/ml,
Belgium, Cyprus, Finland, Iceland, The Netherlands, Sweden: Nanogam 100 mg/ml Solution for infusion.
Poland: Optiglobin
PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg
Information intended exclusively for healthcare professionals:
Dosage and method of administration
Optiglobin must be administered intravenously only.
From a microbiological standpoint, Optiglobin should be used immediately after piercing the rubber stopper. If the solution is not administered immediately after preparation, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at a temperature of 2°C to 8°C, unless the stopper was pierced under controlled and validated aseptic conditions.
For patients requiring large volumes of Optiglobin, the contents of several vials may be transferred into a single container made of ethylene-vinyl acetate copolymer (Clintec EVA – parenteral nutrition container, Baxter, CE0123). These containers may be filled with Optiglobin to a volume of at least 20% but not exceeding 80% of the total container capacity (applies to 500 ml and 1 litre containers). Aseptic technique must be maintained at every stage of preparation. From a microbiological perspective, the infusion should be started as soon as possible after transferring Optiglobin into the EVA container, but no later than 3 hours after transfer.
Optiglobin is administered as an intravenous infusion under controlled conditions, starting at an initial rate of 0.5 ml/kg/h for 20 minutes. In patients receiving Optiglobin for the first time, if the product is well tolerated, the infusion rate may be gradually increased to 1.0 ml/kg/h for 20 minutes, then up to a maximum of 3.0 ml/kg/h. In adult patients who receive Optiglobin at regular intervals and tolerate it well, the infusion rate for subsequent infusions may be initiated at the last well-tolerated rate or a lower rate. If the infusion is well tolerated, the infusion rate may be gradually increased by 1.0 ml/kg/h every 20 minutes in patients regularly receiving Optiglobin, up to a maximum of 7.0 ml/kg/h.
The dose and dosing regimen depend on the indication. The dose may require individual adjustment for each patient based on clinical response. Doses based on body weight may require adjustment in patients who are underweight or overweight.
In replacement therapy, the dose may require individual adjustment for each patient based on pharmacokinetic and clinical response.
Dosage recommendations are summarised in the table below:

PIL Optiglobin 100 mg/ml (26-MAR-2024) Version 12.0 IVIg

Special precautions
If adverse reactions occur, the intravenous infusion rate should be reduced or the infusion discontinued.

To improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly documented.

Incompatibilities
Optiglobin must not be mixed with other medicinal products.
Optiglobin must not be administered using the same infusion equipment as blood transfusions.

Instructions for handling and disposal
Before use, Optiglobin should be brought to room temperature or body temperature.
The solution should be clear or slightly opalescent, colourless or pale yellow to pink. Do not use solutions that are cloudy or contain particulate matter.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.