octaplaslg

Package Leaflet: Information for the User

octaplasLG, solution for infusion
Human plasma proteins compatible with the AB0 blood group system

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor. See section 4.

Table of Contents of the Package Leaflet

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

1. What is octaplasLG and what is it used for

octaplasLG contains human plasma collected from many donors and subjected to a virus inactivation process.
Human plasma is the liquid part of human blood that carries blood cells. It contains human plasma proteins that participate in maintaining normal coagulation and is used in the same way as fresh frozen plasma (FFP).
octaplasLG is used to treat complex deficiencies of coagulation factors, which can be the result of acute liver failure or massive transfusion. octaplasLG may also be administered in emergency situations when a specific coagulation factor concentrate (such as factor V or factor XI) is not available or when laboratory diagnostic tests cannot be performed.
It may also be administered to rapidly reverse the effects of oral anticoagulants (such as coumarin or indanedione derivatives) when the vitamin K level is too low due to liver failure or in emergency situations.
octaplasLG may be administered to patients during plasma exchange to restore coagulation factor balance.

2. Important information before using octaplasLG

When not to use octaplasLG

Warnings and precautions

Before starting treatment with octaplasLG, the patient should discuss it with their doctor.
If the patient has any other diseases, they should inform their doctor.
When to be particularly cautious when using octaplasLG

octaplasLG is not generally recommended for routine treatment of von Willebrand's disease.
Virus safety
For medicines produced from human blood or plasma, measures are taken to prevent the transmission of infectious diseases. These measures include careful selection of blood and plasma donors to exclude carriers of infectious diseases and testing each donation and plasma pool for the presence of viruses/infections. Manufacturers of such products also use virus inactivation or removal procedures during the processing of blood or plasma. Despite these measures, it is not possible to completely eliminate the risk of transmitting infectious diseases when administering medicines produced from human blood or plasma. This also applies to unknown or newly discovered viruses or other pathogens.
Observance of precautions prevents the transmission of enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.
The measures taken may have limited applicability in the case of non-enveloped viruses, such as hepatitis A virus, hepatitis E virus, and parvovirus B19.
It is recommended that each time octaplasLG is administered, the product name and batch number should be recorded to maintain information on the batches used.
In the case of regular/repeated administration of products derived from human plasma, consideration should be given to vaccination against hepatitis A and B viruses.

Children

In children, cases of low calcium levels have been observed during therapeutic plasma exchange, probably caused by binding to citrate. During this type of administration of octaplasLG, it is recommended to monitor calcium levels.

octaplasLG and other medicines

During clinical trials, octaplasLG was administered with various other medicines, with no interactions detected.
During administration of octaplasLG, substances (such as pregnancy hormones) may be administered that can cause false-positive test results (e.g., a positive pregnancy test even if the patient is not pregnant).
octaplasLG should not be mixed with other intravenous fluids or medicines, except for red blood cells and platelets.
To avoid the formation of clots, calcium-containing solutions should be administered through a different intravenous line than octaplasLG.
No interactions with other medicines have been reported.
The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines that are available without a prescription.
octaplasLG with food and drink
No effects have been observed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. octaplasLG will only be administered if the doctor considers it necessary for the patient.

Driving and using machines

No effects on the ability to drive or use machines have been observed. The patient should decide whether they are able to drive or perform tasks that require increased concentration.

Important information about some ingredients of octaplasLG

The list of ingredients is provided in section 6.
The medicine contains a maximum of 920 mg of sodium (the main component of common salt) per bag.
This corresponds to a maximum of 46% of the recommended daily intake of sodium in the diet for adults.

3. How to use octaplasLG

octaplasLG is administered by a doctor or nurse. It is administered by infusion into a vein.
The dose depends on the clinical situation and body weight. The doctor will determine the appropriate amount of medicine the patient should receive.

• Before administering octaplasLG by infusion, it is necessary to check the AB0 blood group compatibility of the patients.
• In emergency situations, octaplasLG of the AB blood group can be administered to all patients.

It is essential to ensure that the infusion rate does not exceed 1 ml of octaplasLG per kg of body weight per minute.
Calcium gluconate can be administered through a different vein to minimize the adverse effects of citrate contained in octaplasLG.
The patient should remain under observation during the infusion of the medicine and for at least 20 minutes after its completion, so that in case of an allergic reaction (anaphylactic reaction) or shock, the infusion can be stopped immediately.
Use in children and adolescents
The amount of data on the use of the medicinal product in children and adolescents (0–16 years) is limited.

Overdose of octaplasLG

High doses may lead to excessive fluid overload, fluid accumulation in the lungs, and/or heart problems.

Missed dose of octaplasLG

The doctor is responsible for supervising the administration of the medicine and monitoring laboratory results and maintaining them within the normal range.

Discontinuation of octaplasLG

The decision to discontinue octaplasLG is made by the doctor based on laboratory results and risk assessment.
Do not use after the expiry date stated on the label.

There are several options for thawing the frozen medicinal product octaplasLG:

Water bath:
Thaw in the outer packaging for at least 30 minutes in a water bath with good water circulation at a temperature between 30°C and 37°C. If necessary, a bag can be used as packaging to provide additional protection for the contents.
Do not contaminate the infusion port with water. The minimum thawing time is 30 minutes at 37°C. The water bath temperature should not exceed 37°C and should not be below 30°C.
The thawing time depends on the number of bags in the water bath. If multiple bags of plasma are thawed simultaneously, the thawing time may be extended, but it should not exceed 60 minutes.
Dry plasma thawing system, such as SAHARA-III:
Place the octaplasLG bags on the thawing plate according to the manufacturer's instructions and thaw the plasma using the rapid heating function. Complete the thawing of the plasma and remove the bags when the display shows a temperature of 37°C for the blood component.
When thawing octaplasLG using a dry plasma thawing system, it is recommended to print a protocol of the heating process of the blood component and error messages in case of a malfunction on a printer.
Other:
Frozen octaplasLG can be thawed using other systems if they have been approved for this purpose.
Before infusion, wait until the bag has reached a temperature of approximately 37°C. The temperature of the octaplasLG medicinal product should not exceed 37°C. Remove the outer packaging and check the bag for cracks or leakage.
Do not shake.
After thawing, the solution has a clear to slightly opalescent appearance and does not contain solid particles or gelatinous matter.
Do not use cloudy solutions or those containing sediment and/or discoloration.
Do not re-freeze the thawed medicinal product octaplasLG. Unused product should be discarded.
Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, hypersensitivity reactions may be observed. These are usually mild allergic reactions involving local or generalized skin redness, urticaria, and itching.
More severe forms may be complicated by a drop in blood pressure or facial or tongue swelling. Severe allergic reactions can have a sudden onset and can be serious.
Symptoms include a drop in blood pressure, rapid heart rate, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, or back pain. Severe reactions can lead to shock, loss of consciousness, respiratory failure, and very rarely even death.
Adverse effects may be caused by the citrate contained in octaplasLG and associated low calcium levels – especially when the infusion is administered at a high rate, the patient has liver function disorders, or is undergoing plasma exchange procedures. The patient may experience symptoms such as fatigue, tingling (paresthesia), tremors, and low calcium levels.
octaplasLG may increase the risk of blood clots in veins:

• of the limbs, causing pain and swelling of the limbs;
• of the lungs, causing pain and shortness of breath;
• of the brain, causing weakness and/or loss of sensation on one side of the body;
• of the heart, causing chest pain; All patients at risk of thrombotic complications should be closely monitored and appropriate measures should be taken.

During clinical trials of the predecessor of octaplasLG and after its introduction to the market, the following side effects were identified:

Rare (≥ 1/10,000 to <1>

Very rare (<1>

Classification of systems and organs

Frequent (≥ 1/100 to <1>

Uncommon (≥ 1/1,000 to <1>

to
<1>

Unknown

Blood and lymphatic system disorders
anemia
bleeding tendencies
Immune system disorders
hypersensitivity severe anaphylactic reaction
and shock
Psychiatric disorders
anxiety
agitation
restlessness
dizziness
tingling sensation
Nervous system disorders
decreased sensation
or feeling
Cardiac disorders
heart failure
irregular heartbeat
increased heart rate

Rare (≥ 1/10,000 to <1>

Very rare (<1>

Classification of systems and organs

Frequent (≥ 1/100 to <1>

Uncommon (≥ 1/1,000 to <1>

to
<1>

Unknown

Vascular disorders and circulation
thrombosis in blood vessels
drop in blood pressure
increase in blood pressure
circulatory failure
redness of the skin
acute respiratory disorders
Respiratory disorders
shortness of breath
respiratory failure
bleeding in the lungs
bronchospasm
fluid in the lungs
shortness of breath
difficulty breathing
Gastrointestinal disorders
vomiting
nausea
abdominal pain
Skin disorders
urticaria
itching
rash
increased sweating
Musculoskeletal and connective tissue disorders
back pain
General disorders and administration site conditions
fever
chest pain
discomfort in the chest
chills
local swelling
general discomfort
reaction at the injection site
Diagnostic tests
positive test results for antibodies
decrease in blood oxygen levels

Rare (≥ 1/10,000 to <1>

Very rare (<1>

Classification of systems and organs

Frequent (≥ 1/100 to <1>

Uncommon (≥ 1/1,000 to <1>

to
<1>

Unknown

Injury, poisoning, and procedural complications
decreased blood volume
citrate toxicity
red blood cell destruction
Spontaneously reported data
Depending on the type and severity of the side effects, the infusion rate should be reduced or the administration of the medicine stopped. The doctor will take appropriate action.
If any of the side effects worsen or if any side effects not listed in the package leaflet occur, the doctor should be informed.

Additional side effects in children

In children, especially those with liver function disorders or in case of high infusion rates, low calcium levels may be observed during therapeutic plasma exchange. During this type of administration of octaplasLG, it is recommended to monitor calcium levels.

Reporting side effects

If side effects occur, including any not listed in the package leaflet, the doctor should be informed. Side effects can be reported directly to:
Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store octaplasLG

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
Store and transport frozen (≤ -18°C).
Store in the original packaging to protect from light.
After thawing, chemical and physical stability has been demonstrated for 5 days at 2–8°C or for 8 hours at room temperature (20–25°C).
From a microbiological point of view, unless the opening method precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Do not use this medicine if the solution is cloudy or contains visible sediment and/or discoloration.
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 octaplasLG contains

• The active substance of the medicine is human plasma protein compatible with the AB0 blood group system. A 200 ml bag contains 9-14 g (45-70 mg/ml).
• The other ingredients are: sodium citrate dihydrate, sodium dihydrogen phosphate dihydrate, and glycine.

What octaplasLG looks like and contents of the pack

octaplasLG is a solution for infusion.
200 ml in a bag.
Pack sizes: 1 and 10.
The frozen solution is (slightly) yellow.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Octapharma (IP) SPRL
65 Allée de la Recherche
1070 Anderlecht
Belgium

Manufacturers:

Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Sweden

Date of last revision of the package leaflet: 11/2024

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Information intended for healthcare professionals only:

Dosage and administration

Dosage

The dosage depends on the clinical situation and the underlying disease, but a commonly accepted initial dose is 12–15 ml of octaplasLG per kg of body weight. This dose should increase the level of coagulation factors in the patient's plasma by approximately 25%.
It is essential to monitor the response to treatment, both clinically and by measurement, e.g., activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factor assays.
Dosage in case of coagulation factor deficiencies:
Adequate hemostatic effect in case of minor and moderate bleeding or during surgical procedures in patients with coagulation factor deficiencies is usually achieved after administration of 5–20 ml of octaplasLG per kg of body weight. This dose should increase the level of coagulation factors in the patient's plasma by approximately 10–33%. In case of severe bleeding or surgical procedures, consultation with a hematologist is recommended.
Dosage in case of thrombotic thrombocytopenic purpura (TTP) and bleeding during intensive plasma exchange:
In case of therapeutic plasma exchange procedures, consultation with a hematologist is recommended.
In patients with thrombotic thrombocytopenic purpura, all removed plasma should be replaced with octaplasLG.

Administration:

octaplasLG must be administered with AB0 blood group compatibility. In emergency situations, octaplasLG of the AB blood group can be treated as universal plasma, as it can be administered to all patients regardless of their blood group.
After thawing, octaplasLG must be administered intravenously using an infusion set with a filter. The infusion must be performed under aseptic conditions.
Citrate toxicity may occur after administration of more than 0.020–0.025 mmol/kg body weight/minute. Therefore, the infusion rate should not exceed 1 ml of octaplasLG per kg of body weight per minute. The toxic effects of citrate can be minimized by administering calcium gluconate through a different vein.
Warnings and precautions for administration:
In case of anaphylactic reaction or shock, the infusion should be stopped immediately.
Treatment of anaphylactic shock should be performed according to guidelines.
Patients should be monitored for at least 20 minutes after administration of the medicine.
Incompatibilities:
octaplasLG can be mixed with red blood cells and platelets if AB0 compatibility of both preparations is maintained.
octaplasLG should not be mixed with other medicinal products, as this may lead to inactivation and precipitation.
To avoid the formation of clots, calcium-containing solutions should not be administered through the same intravenous line as octaplasLG.
Effect on serological tests:
Passive transmission of plasma components from octaplasLG (e.g., human chorionic gonadotropin – β-HCG) may lead to misleading laboratory test results in the recipient. In case of passive transmission of β-HCG, false-positive pregnancy test results have been reported.