Optiglobin

1. What is Optiglobin and what is it used for

Optiglobin contains normal human immunoglobulins (also called antibodies).
Immunoglobulins are normal components of human blood that help the body fight infections. Optiglobin is used to increase the level of antibodies in the blood when the level of antibodies is too low or when additional antibodies are needed in certain diseases. (e.g. immunological disorders).
Optiglobin is used in adults, children, and adolescents (from 0 to 18 years) in the following situations:
Replacement therapy, to increase low levels of immunoglobulins to normal levels in patients:

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

Immunomodulationin the treatment of certain immunological disorders in patients:

• who do not have enough platelets in the blood (primary immune thrombocytopenia, ITP) and who are at high risk of bleeding or will undergo surgery in the near future.
• with Guillain-Barré syndrome, an acute disease characterized by inflammation of the peripheral nerves, which causes severe muscle weakness.
• with Kawasaki disease, an acute disease that mainly affects young children, characterized by inflammation of blood vessels in the body.

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

• with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), an immunological disorder that attacks the peripheral nerves and causes slowly progressive muscle weakness and numbness of the limbs.
• with multifocal motor neuropathy (MMN) with immunological disorder of motor nerves, causing progressive asymmetric weakness of the limbs.

2. Important information before using Optiglobin

Please read this section carefully. Before starting treatment with Optiglobin, discuss it with your doctor.

When not to use Optiglobin:

• if you are allergic to immunoglobulins or any of the other ingredients of this medicine (listed in section 6). Patients with a corn allergy may exhibit hypersensitivity reactions to glucose, which is a component of Optiglobin.
• if you have a lack of immunoglobulin A (IgA) with the presence of antibodies against IgA. Optiglobin contains a small amount of IgA, which may cause an allergic reaction in these individuals.
• if you have uncontrolled diabetes and blood sugar levels exceed the normal level (uncontrolled diabetes).
• if you have glucose intolerance.
• if you have recently experienced hyperosmolar coma (loss of consciousness due to very high blood sugar levels, leading to severe dehydration and high blood concentration).
• if you have high blood sugar levels (hyperglycemia) for reasons other than diabetes.
• if you have high levels of lactic acid in the blood (hyperlactatemia).

Warnings and precautions

In order to improve the identifiability of biological medicinal products, the name and batch number (located on the vial label and box) 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 side effects (adverse reactions). Some side effects may be related to the infusion rate. Therefore, the doctor should ensure that the infusion rate is suitable for the patient. If a 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 side effects. In the following cases, patients should be monitored during and after the infusion:

• in patients receiving Optiglobin for the first time;
• in cases where the product containing normal human immunoglobulins is replaced with another product or when a long time has passed since the previous infusion;
• in patients with untreated infection or concomitant chronic inflammatory condition.

Allergic reactions are rare, but they can occur even if the patient has previously received human immunoglobulins and tolerated them well. If an allergic reaction occurs, the administration of Optiglobin should be stopped immediately. In case of a severe hypersensitivity reaction, the doctor or medical staff should be notified immediately. See also section 4: "Possible side effects".
PIL Optiglobin 100 mg/ml
(26-MAR-2024)
Version 12.0 IVIg
In case of severe breathing difficulties, with a rise in body temperature within 1-6 hours after treatment, contact a doctor or medical staff immediately. This may indicate acute lung injury related to blood transfusion (TRALI). TRALI can occur very rarely after immunoglobulin administration. See also section 4: "Possible side effects".

Risk factors during treatment with Optiglobin

Please inform your doctor or other medical staff if you have any of the following risk factors, as they may be relevant during treatment with Optiglobin. In particular, inform medical staff:

• if you have kidney problems (renal insufficiency);
• if you are taking medications that may harm your kidneys;
• if you have heart, liver, or kidney disease or conditions that affect water reabsorption in the kidneys (vasopressin effect);
• if you are taking certain diuretics (loop diuretics);
• if you have diabetes (abnormally high blood glucose levels). Optiglobin contains 50 mg of glucose per milliliter, which may affect blood glucose levels;
• if you have a history of vascular diseases (vascular diseases) or thrombosis (blood clot formation);
• if you have high blood pressure;
• if you are overweight;
• if you have a disease that increases blood viscosity (thickens the blood);
• if you have hypovolemia (decreased circulating blood volume);
• if you are elderly (over 65 years old);
• if you have signs of sepsis, severe brain injury, or shock;
• if you have had a head injury in the last 24 hours;
• if you have recently had a stroke (Optiglobin contains glucose, so blood glucose levels may rise, which can worsen the effects of a stroke on the brain and hinder its recovery);
• if you have metabolic disorders due to starvation or malnutrition;
• if you have a low level of thiamine (vitamin B1) in your body.

During treatment with Optiglobin, the following should be considered:

• it is essential to ensure that the patient is adequately hydrated and producing sufficient urine before administering Optiglobin;
• it may be necessary to check the serum creatinine level (a substance that indicates kidney function);
• it may be necessary to monitor blood glucose and/or electrolyte levels. This is particularly important if the patient is taking medications that enhance the effect of vasopressin.

Effect on laboratory tests

If blood tests are necessary, inform your doctor or medical staff that you are using Optiglobin, as the solution contains antibodies that may cause false-positive test results for the presence of antibodies.

Optiglobin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
PIL Optiglobin 100 mg/ml
(26-MAR-2024)
Version 12.0 IVIg
Vaccinations
Inform your doctor if you are planning to be vaccinated or have been vaccinated recently. Optiglobin may interfere with the effectiveness of some live viral vaccines, such as measles, rubella, mumps, and chickenpox vaccines. After using Optiglobin, a three-month interval should be maintained before vaccinating with these vaccines. For measles vaccine, this interval may be up to one year.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The safety of 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 adverse effects on fertility, pregnancy, the fetus (unborn child), or the newborn are expected. When administering Optiglobin to pregnant women, especially during childbirth, and in combination with oxytocin, there may be an increased risk of hyponatremia (low sodium levels in the blood).
When Optiglobin is used in breastfeeding women, the immunoglobulins in this medicine can also be found in breast milk. No adverse effects on newborns/infants are expected.

Newborns

Newborns, especially premature and low-birth-weight infants, are more susceptible to increased risk of hypoglycemia or hyperglycemia and should be closely monitored during treatment with Optiglobin to ensure adequate blood glucose control and avoid potential long-term side effects.

Driving and using machines

Some side effects of Optiglobin may impair your ability to drive or operate machines. Patients who experience side effects during treatment should wait until they resolve before driving or operating machines.

Optiglobin contains glucose

Optiglobin contains 50 mg of glucose per milliliter (5% glucose), which may cause an increase in blood glucose levels. If you have diabetes, your doctor will decide whether to monitor blood glucose levels and administer insulin, especially when high doses of Optiglobin are used.

Information on viral safety of Optiglobin

Optiglobin is manufactured from human plasma. For medicines produced from human blood or plasma, certain measures are taken to prevent the 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 donation and plasma pool for signs of viral infection and

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

• processing steps that can inactivate or remove viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, it is not possible to completely eliminate the risk of transmitting an infection. This includes viruses and other types of infections that are not yet known or have emerged recently.
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.
The use of immunoglobulins has not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections present in the product have a protective effect.

3. How to use Optiglobin

Optiglobin is administered to the patient by a doctor or medical staff. Optiglobin may be self-administered by the patient if it is an accepted practice in the country and the patient has been properly trained.
This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Before use, Optiglobin should be brought to room or body temperature. The intravenous infusion of Optiglobin should be started immediately after the cap has been pierced.
The solution should be clear or slightly opalescent, colorless or pale yellow to pink. Do not use solutions that are cloudy or contain sediment. Any unused solution should be discarded.

Dosage and administration

Optiglobin is intended for intravenous infusion. The dose and frequency of infusions will vary depending on the patient's condition and body weight. At the start of the infusion, Optiglobin will be administered at a slow 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 about the dose and infusion rate.

Use in children and adolescents

Children and adolescents (from 0 to 18 years) have the same indications, dosing, and infusion frequency as adults.

Overdose of Optiglobin

In case of overdose, there is a risk of fluid overload, and the blood may become too thick (overly viscous), which can increase the risk of blood clots. This may occur especially in patients with risk factors, such as the elderly or patients with kidney or heart disorders. Inform your doctor or medical staff about any medical problems.
PIL Optiglobin 100 mg/ml
(26-MAR-2024)
Version 12.0 IVIg

Missed dose of Optiglobin

Inform your doctor or medical staff immediately and follow their instructions. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Optiglobin can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using Optiglobin and contact your doctor or medical staff immediately:

• allergic reactions with symptoms such as a sudden drop in blood pressure, severe dizziness, and swelling of the lips, tongue, or throat, and difficulty breathing (rare side effect);
• chest pain, shortness of breath, or pain in one leg 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 leg vein (deep vein thrombosis) (very rare side effect);
• severe breathing difficulties, with a rise in body temperature within 1-6 hours after treatment, which may be caused by acute lung injury related to blood transfusion (TRALI) (see also section 2) (very rare side effect).

Other side effects that may occur with the use of human normal immunoglobulins are:

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

Other side effects reported for Optiglobin are:
Uncommon side effects(may occur in less than 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 (i.e., fatigue, chills, fever, flu-like syndrome).

Rare side effects(may occur in less than 1 in 1,000 infusions):

• low white blood cell count (leukopenia, neutropenia), migraine, dizziness, palpitations, rapid heart rate, high blood pressure, low blood pressure, shortness of breath, diarrhea, excessive sweating.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Optiglobin

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store the vial in the outer carton to protect from light.
Within the expiration date, Optiglobin can be stored at a temperature up to 25°C for a period of up to six months without the possibility of returning it to the refrigerator. Any unused product should be discarded after this period. The date of transfer to room temperature should be noted on the outer carton.
Do not use this medicine after the expiration date stated on the vial label and carton:
Expiration date (EXP). The expiration date refers to the last day of the month stated.
Do not use this medicine if the solution is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Optiglobin contains

• The active substance is human normal immunoglobulin for intravenous administration. One milliliter contains 100 mg of immunoglobulins, of which at least 95% is immunoglobulin G (IgG).
• The other ingredients are glucose (as glucose monohydrate) 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, colorless 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 authorization holder and manufacturer

Prothya Biosolutions Netherlands B.V.
Plesmanlaan 125
NL-1066 CX Amsterdam
Netherlands
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Germany: Optiglobin 100 mg/ml,
Belgium, Cyprus, Finland, Iceland, Netherlands, Sweden: Nanogam 100 mg/ml Solution for infusion.
Poland: Optiglobin

Date of last revision of the leaflet:

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

Information intended for healthcare professionals only:

Dosage and administration

Optiglobin should only be administered intravenously.
From a microbiological point of view, Optiglobin should be used immediately after the rubber cap has been pierced. If the solution is not administered immediately after preparation, the user is responsible for the storage conditions of the medicine before administration, and the preparation of the medicine for administration should not exceed 24 hours at a temperature of 2°C to 8°C, unless the piercing of the cap takes place in controlled and validated aseptic conditions.
For patients requiring large amounts of Optiglobin, the contents of several vials can also be transferred to a single container made of ethylene-vinyl acetate copolymer (Clintec EVA - container for parenteral nutrition, Baxter, CE0123). These containers can be filled with Optiglobin at a volume of at least 20% but not exceeding 80% of the total container capacity (applies to containers with a capacity of 500 ml and 1 liter). At each stage of preparation, aseptic technique should be used. For microbiological reasons, the infusion should be started as soon as possible after transferring Optiglobin to the EVA container, but no later than 3 hours after transfer.
Optiglobin is administered as an intravenous infusion under controlled conditions, with an initial rate of 0.5 ml/kg/h for 20 minutes. In patients receiving Optiglobin for the first time, if the medicine is well tolerated, the infusion rate can be gradually increased to 1.0 ml/kg/h for 20 minutes, and then 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 can be started at the last well-tolerated infusion rate or lower. If the infusion is well tolerated, the infusion rate can be gradually increased in patients regularly using Optiglobin by 1.0 ml/kg/h every 20 minutes to a maximum of 7.0 ml/kg/h.
The dose and dosing schedule depend on the indication for use. The dose may need to be individualized for each patient based on clinical response. The dose based on body weight may need to be modified in patients who are underweight or overweight.
In replacement therapy, the dose may need to be individualized for each patient based on pharmacokinetic and clinical responses.
Dosing recommendations are summarized in the following table:

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

Special precautions

In case of side effects, reduce the infusion rate or discontinue the infusion.
To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Incompatibilities

Optiglobin should not be mixed with other medicines.
Optiglobin should not be administered using the same infusion equipment as blood transfusions.

Instructions for handling and disposal of the product

Before use, Optiglobin should be brought to room or body temperature.
The solution should be clear or slightly opalescent, colorless or pale yellow to pink. Do not use solutions that are cloudy or contain sediment.
Any unused product or waste should be disposed of in accordance with local regulations.