Octaplas lg

Package leaflet: Information for the user

octaplasLG, solution for infusion
Human plasma proteins compatible with ABO blood groups
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the doctor. See section 4.

Contents of the leaflet

1. What octaplasLG is and what it is 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 octaplasLG is and what it is used for

octaplasLG contains human plasma collected from multiple donors and subjected to a viral inactivation process. Human plasma is the liquid component of human blood, which carries blood cells. It contains human plasma proteins involved in maintaining normal blood coagulation and is used in the same way as fresh frozen plasma (FFP).
octaplasLG is used for the treatment of complex deficiencies of coagulation factors, which may result from 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 diagnostic laboratory testing is not feasible.
It may also be administered for the rapid reversal of the effect of oral anticoagulant drugs (coumarin derivatives or indandione derivatives) when vitamin K levels are too low due to liver failure or in emergency situations.
octaplasLG may be administered to patients during plasma exchange to restore the balance of coagulation factors.

2. Important information before using octaplasLG

When not to use octaplasLG

• if the patient has hypersensitivity (allergy) to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has antibodies against immunoglobulin A (IgA).
• if the patient previously experienced a reaction to human plasma products or fresh frozen plasma (FFP).
• if the patient has been diagnosed with low protein S levels (a vitamin K-dependent blood protein).

Warnings and precautions
Discuss with your doctor before starting treatment with octaplasLG.
If the patient has any other medical conditions, they should inform their doctor.
When to exercise special caution when using octaplasLG

• if the patient has low immunoglobulin A (IgA) levels.
• if the patient previously experienced a reaction to plasma proteins, including FFP.
• if the patient suffers from heart failure or fluid in the lungs (pulmonary edema).
• if the patient has a known risk of thrombotic (platelet-related) complications due to increased risk of venous thrombosis (blood clots in veins).
• in case of excessive inhibition of blood clotting (fibrinolysis).

octaplasLG is generally not recommended for routine treatment of von Willebrand disease.
Viral safety
When medicines are manufactured from human blood or plasma, precautions must be taken to prevent transmission of infectious diseases. Such precautions include careful selection of blood and plasma donors to exclude carriers of infectious diseases, and testing of each donation and plasma pool for the presence of virus/infection. Manufacturers of such products also apply virus inactivation or removal procedures during the processing of blood or plasma. Despite these measures, the risk of transmitting infectious diseases by medicines derived from human blood or plasma cannot be completely excluded. This includes unknown or newly emerging viruses or other pathogens.
Precautionary measures are effective in preventing transmission of enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.
These measures may have limited effectiveness against non-enveloped viruses, such as hepatitis A virus, hepatitis E virus, and parvovirus B19.
It is recommended that the product name and batch number of each octaplasLG administration be recorded to maintain traceability of the batches used.
For patients receiving regular or repeated treatments with plasma-derived products, vaccination against hepatitis A and B viruses should be considered.
Children
In children, cases of low calcium levels have been observed during therapeutic plasma exchange, likely due to binding by citrate. Monitoring of calcium levels is recommended when octaplasLG is used in such procedures.
Interaction of octaplasLG with other medicines
In clinical studies, octaplasLG was administered together with various other medicines without detecting any interactions.
Substances (e.g. pregnancy hormones) may be present in octaplasLG that could lead to false-positive test results (e.g. positive pregnancy test despite the patient not being pregnant).
octaplasLG must not be mixed with other intravenous fluids or medicines, except for red blood cells and platelets.
To avoid clot formation, solutions containing calcium should be administered through a separate intravenous line from octaplasLG.
No interactions with other medicines have been reported.
Inform your doctor about all medicines currently or recently taken by the patient, including those available without a prescription.
octaplasLG with food and drink
No influence observed.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. octaplasLG will be administered only if the doctor considers it necessary for the patient.
Driving and operating machinery
No effect on the ability to drive or operate machinery has been observed. The patient should decide individually whether they are able to drive or perform tasks requiring high concentration.
Important information about certain ingredients of octaplasLG
The list of ingredients is provided in section 6.
The medicine contains up to 920 mg of sodium (the main component of table salt) per bag.
This corresponds to a maximum of 46% of the recommended maximum daily dietary sodium intake for adults.

3. How to use octaplasLG

octaplasLG is administered by a doctor or nurse through intravenous infusion.
The dose depends on the clinical condition and body weight. The doctor will determine the appropriate amount of octaplasLG that the patient should receive.

• Before administering octaplasLG by infusion, ABO blood group compatibility must be confirmed in patients.
• In emergency situations, octaplasLG blood group AB may be administered to all patients.

It is important that the infusion rate does not exceed 1 ml of octaplasLG per kg of body weight per minute.
Calcium gluconate may be administered into another vein to minimize adverse effects of citrate contained in octaplasLG.
The patient should remain under observation during the infusion and for at least 20 minutes after completion of the infusion, so that in case of an allergic reaction (anaphylactic reaction) or shock, the infusion can be stopped immediately.

Use in children and adolescents
Data on the use of octaplasLG in children and adolescents (0–16 years) are limited.

Accidental administration of a higher than recommended dose of octaplasLG
High doses may lead to fluid overload, pulmonary fluid accumulation and/or cardiac disturbances.

Missed dose of octaplasLG
The doctor is responsible for overseeing administration of the medicinal product, monitoring laboratory results, and maintaining them within normal ranges.

Discontinuation of octaplasLG treatment
The decision to discontinue administration of octaplasLG is made by the doctor based on laboratory results and assessment of risk factors.

Do not use after the expiry date stated on the label.

There are several methods 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, maintained at a temperature between 30°C and 37°C. If necessary, the bag may be placed in an additional container to provide extra protection of the contents.
Do not allow water to contaminate the entry port. Minimum thawing time is 30 minutes at 37°C. The water bath temperature must not exceed 37°C and should not be lower than 30°C.
Thawing time depends on the number of bags in the water bath. When thawing multiple plasma bags simultaneously, the thawing time may be prolonged but should not exceed 60 minutes.

Dry plasma thawing system, such as SAHARA-III:
Place octaplasLG bags on the thawing plate according to the manufacturer's instructions and thaw the plasma using the rapid heating function. Complete the thawing process and remove the bags when the display indicates a blood component temperature of 37°C.
When thawing octaplasLG using a dry plasma thawing system, it is recommended to print out, using a printer, the heating protocol for the blood component and any error messages in case of malfunction.

Other methods:
Frozen octaplasLG may be thawed using other systems, provided they have been approved for this purpose.

Prior to infusion, allow the bag to warm to approximately 37°C. The temperature of the medicinal product octaplasLG must not exceed 37°C. Remove the outer packaging and inspect the bag for cracks or leaks.
Do not shake.

After thawing, the solution should be clear to slightly opalescent and free from solid particles or gelatinous material.
Do not use solutions that are cloudy or contain precipitate and/or discoloration.
Do not refreeze thawed octaplasLG. Unused product must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hypersensitivity reactions may rarely occur. These are usually mild allergic-type reactions involving localised or generalised skin redness, urticaria (hives), and itching.
Severe forms may be complicated by a drop in blood pressure or swelling of the face or tongue. Severe systemic allergic reactions may have a sudden onset and can be serious. Symptoms include low blood pressure, rapid heartbeat, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhoea, abdominal or back pain. Severe reactions may lead to shock, loss of consciousness, respiratory failure, and very rarely even death.
Negative effects may be caused by citrate contained in octaplasLG and associated low calcium levels – especially when the infusion is administered rapidly, the patient suffers from liver function disorders, or undergoes plasma exchange procedures. The patient may experience symptoms such as fatigue, tingling sensations (paraesthesiae), tremors, and low calcium levels.
octaplasLG may increase the risk of blood clots in veins:

• in limbs, causing limb pain and swelling;
• in the lungs, causing chest pain and breathlessness;
• in the brain, causing weakness and/or loss of sensation on one side of the body;
• in the heart, causing chest pain.
  Particular caution and appropriate preventive measures should be taken in all patients at increased risk of blood clots. In rare cases, incompatibility between antibodies in octaplasLG and antigens in the patient's blood may cause destruction of red blood cells (haemolytic transfusion reaction). Symptoms include chills, fever, dry cough, difficulty breathing, rash, and internal bleeding. Infusion of octaplasLG may lead to an increase in antibodies against clotting factors. High doses or rapid infusion rates may cause increased blood volume, fluid in the lungs and/or heart failure. Acute respiratory disturbances have been reported during or after infusion of octaplasLG.

During clinical trials of the predecessor product to octaplasLG and following market introduction, the following adverse reactions have been identified:
System organ Very Common Uncommon Rare Very rare Unknown
class (≥ 1/100 to (≥ 1/1000 to (≥ 1/10,000 to (< 1/10,000)
< 1/10) < 1/100) < 1/1000)
Blood and lymph anaemia
system disorders
tendency to bleed
Immune system hypersensitivity severe anaphylactic
disorders reaction and shock
Psychiatric disorders anxiety
restlessness
agitation
Nervous system disorders dizziness
reduced sense of touch
or sensation
tingling sensation
Cardiac disorders heart failure
irregular heartbeat
increased heart rate
System organ Very Common Uncommon Rare Very rare Unknown
class (≥ 1/100 to (≥ 1/1000 to (≥ 1/10,000 to (< 1/10,000)
< 1/10) < 1/100) < 1/1000)
Vascular and blood vessel thrombosis
circulatory system in blood vessels
disorders
decrease in blood pressure
increase in blood pressure
circulatory failure
skin redness
Respiratory disorders lack of oxygen acute respiratory respiratory
failure distress
bleeding in the lungs
bronchoconstriction
fluid in the lungs
shortness of breath
difficulty breathing
Gastrointestinal disorders lack of appetite vomiting abdominal pain
nausea
Skin and subcutaneous hypersensitivity rash
disorders urticaria
itching
increased sweating
Musculoskeletal and back pain
connective tissue disorders
General disorders and fever chest pain at site of
administration
discomfort in the chest
chills
local swelling
general discomfort
reaction at site of
administration
Investigations positive test results
for presence of
antibodies
decreased blood oxygen
levels
System organ Very Common Uncommon Rare Very rare Unknown
class (≥ 1/100 to (≥ 1/1000 to (≥ 1/10,000 to (< 1/10,000)
< 1/10) < 1/100) < 1/1000)
Injury, poisoning and decreased blood volume
procedural complications
citrate intoxication
destruction of red blood
cells

Spontaneously reported data
Depending on the type and severity of adverse reactions, the infusion rate should be reduced or administration of the medicine discontinued. The physician will take appropriate actions.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor immediately.

Additional adverse reactions in children
In children, especially in patients with liver function disorders or when high infusion rates are used, low calcium levels may be observed during therapeutic plasma exchange procedures. Monitoring of calcium levels is recommended when using octaplasLG in such situations.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can also be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store octaplasLG

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Expiry date".
Store and transport in a frozen state (≤ -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 method of opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions during use.
Do not use this medicine if the solution is cloudy or contains visible particles or discoloration.
Medicines must not be disposed of via wastewater or household waste. Ask a 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 is human plasma proteins compatible with the ABO blood group system. A 200 ml bag contains 9-14 g (45-70 mg/ml).
• Other ingredients: disodium 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 Authorisation Holder
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

Manufacturers:
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Sweden

Information intended exclusively for medical professionals:

Dosage and administration
Dosage
The dosage depends on the clinical situation and underlying disease. However, a commonly accepted initial dose is 12–15 ml of the medicinal product octaplasLG per kg of body weight. This dose is expected to increase plasma levels of coagulation factors by approximately 25%.
It is important to monitor the treatment response both clinically and by laboratory measurements, such as activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factor assays.

Dosage in coagulation factor deficiencies:
An appropriate haemostatic effect in cases of mild to moderate bleeding or during surgical procedures in patients with coagulation factor deficiency is usually achieved with a dose of 5–20 ml of the medicinal product octaplasLG per kg of body weight. This dose is expected to increase plasma levels of coagulation factors by approximately 10–33%. In cases of severe bleeding or major surgical procedures, consultation with a specialist in haematology is recommended.

Dosage in thrombotic thrombocytopenic purpura (TTP) and bleeding during intensive plasma exchange:
In therapeutic plasma exchange procedures, consultation with a specialist in haematology is recommended.
In patients with thrombotic thrombocytopenic purpura (TTP), the entire volume of plasma removed should be replaced with octaplasLG.

Administration:
The medicinal product octaplasLG must be administered according to ABO blood group compatibility. In emergency situations, AB group octaplasLG can be considered as universal plasma, as it may be administered to all patients regardless of 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 when administering more than 0.020–0.025 mmol/kg body weight per minute. Therefore, the infusion rate should not exceed 1 ml of octaplasLG per kg body weight per minute. The toxic effects of citrate can be minimized by administering calcium gluconate through a separate intravenous line.

Warnings and precautions for administration:
If an anaphylactic reaction or shock occurs, the infusion must be stopped immediately. Treatment of anaphylactic shock should follow established guidelines.
Patients should be monitored for at least 20 minutes after administration of the product.

Incompatibilities:
The medicinal product octaplasLG may be mixed with red blood cells and platelets provided that ABO compatibility between both products is maintained.

The medicinal product octaplasLG must not be mixed with other medicinal products, as this may lead to inactivation and precipitation.

To avoid clot formation, calcium-containing solutions must not be administered through the same intravenous line as octaplasLG.

Effect on serological test results:
Passive transfer of plasma components from the medicinal product octaplasLG (e.g., human chorionic gonadotropin – β-HCG) may lead to misleading laboratory test results in the recipient. Passive transfer of β-HCG has been reported to cause false-positive pregnancy test results.