OCTAPLASMALG 45-70 mg/ml POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

1. What is OctaplasmaLG and what is it used for

OctaplasmaLG is mixed and treated human plasma for viral inactivation. Human plasma is the liquid part of human blood in which cells are found. It contains important human plasma proteins for maintaining normal coagulation characteristics and is used in the same way as fresh frozen plasma (FFP).

OctaplasmaLG helps in cases of complex coagulation factor deficiencies that may be caused by severe liver failure or massive transfusion. OctaplasmaLG can also be administered in emergency situations when a coagulation factor concentrate (such as factor V or factor XI) is not available or when laboratory diagnosis is not possible.

It can also be administered to rapidly reverse the effects of oral anticoagulants (such as coumarin or indanedione), when vitamin K is insufficient due to altered liver function or in emergency situations.

OctaplasmaLG can be administered to patients undergoing plasma exchange to restore coagulation factor balance.

2. What you need to know before you use OctaplasmaLG

Do not use OctaplasmaLG:

• if you are allergic (hypersensitive) to human plasma proteins or to any of the other components of this medicine (listed in section 6).
• if you know you have antibodies against the immunoglobulin called IgA.
• if you have previously suffered reactions to human plasma preparations or FFP.
• if you know you have low protein S levels (a blood protein that depends on vitamin K).

Warnings and precautions

Consult your doctor before starting to use OctaplasmaLG.

Tell your doctor if you have any other illness.

Be especially careful with OctaplasmaLG

• if you have low immunoglobulin A levels.
• if you have previously had reactions to plasma protein, including FFP.
• if you have heart failure or fluid in the lungs (pulmonary edema).
• if you know you have a risk of blood coagulation complications (thrombotic) due to a possible increase in the risk of venous thromboembolism (blood clots that form in the veins).
• in case of increased coagulation inhibition (fibrinolysis).

OctaplasmaLG is not generally recommended for the treatment of von Willebrand disease.

Viral safety

When administering medicines prepared from human plasma or blood, certain measures are taken to prevent the transmission of infections to patients. This involves careful selection of blood and plasma donors to ensure the exclusion of those with a risk of infection, and analysis of each donation and plasma pools for signs of viruses or infections. Manufacturers of these products also include steps in the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, when administering medicines prepared from human plasma or blood, the possibility of transmitting infectious diseases cannot be completely excluded. This also applies to any unknown or emerging virus, as well as other types of infections.

The measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.

These measures may have limited value against certain non-enveloped viruses, such as hepatitis A virus, hepatitis E virus, and parvovirus B19.

It is strongly recommended that the name and batch number of the product be recorded each time a dose of OctaplasmaLG is administered in order to maintain a record of the batch used.

Your doctor may recommend that you be vaccinated against hepatitis A and B viruses if you regularly or repeatedly receive human plasma-derived products.

Children

Some cases of low calcium levels, possibly caused by citrate binding, have been observed during therapeutic plasma exchange in children. It is recommended to monitor calcium levels during this use of OctaplasmaLG.

Other medicines and OctaplasmaLG

During clinical trials, OctaplasmaLG has been administered with several medicines and no interactions have been detected.

With the administration of OctaplasmaLG, you may receive substances (e.g., pregnancy hormone) that cause false-positive test results (e.g., positive pregnancy test without being pregnant).

OctaplasmaLG should not be mixed with other intravenous liquids or medicines except red blood cells and platelets.

To avoid the possibility of blood clots, calcium-containing solutions should not be administered through the same intravenous line as OctaplasmaLG.

No interactions with other medicines are known.

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Using OctaplasmaLG with food and drinks

No effects have been observed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You will receive OctaplasmaLG if your doctor considers it necessary for you.

Driving and using machines

No effects on the ability to drive or use machines have been observed. You are the only one responsible for deciding whether you are fit to drive a vehicle or perform tasks that require much concentration.

OctaplasmaLG excipient warnings

To obtain the list of components, see section 6.

This medicine contains a maximum of 920 mg of sodium (main component of table/cooking salt) per vial. This is equivalent to a maximum of 46% of the recommended daily sodium intake for an adult.

3. How to use OctaplasmaLG

A doctor or nurse will administer OctaplasmaLG to you through an intravenous infusion.

Your dose will depend on your clinical condition and body weight. Your doctor will determine the appropriate amount you should receive.

• Before administering OctaplasmaLG through infusion, it is necessary to perform an ABO blood group compatibility test.
• In emergency cases, the AB blood group of OctaplasmaLG can be administered to all patients.

It is important that the infusion rate does not exceed 1 ml of OctaplasmaLG per kg of your body weight per minute. Calcium gluconate can be administered in another vein to minimize the negative effects of citrate contained in OctaplasmaLG.

You should be under observation for at least 20 minutes after administration in case you develop an allergic reaction (anaphylactic reaction) or shock, in which case the infusion should be stopped immediately.

Use in children and adolescents

Data on use in children and adolescents (0-16 years) are limited.

If you use more OctaplasmaLG than you should

A high dose may cause fluid overload, fluid in the lungs, and/or heart problems.

If you forget to use OctaplasmaLG

Your doctor should supervise the administration and keep your laboratory values within the specified range.

If you stop using OctaplasmaLG

Based on laboratory values, your doctor will decide when to stop administering OctaplasmaLG and assess the potential risks.

Method of administration

This medicine should be injected or infused into the veins after reconstitution with the supplied solvent. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rarely, hypersensitivity reactions may occur. These are usually mild allergic reactions consisting of skin redness, urticaria, or itching. More severe forms can lead to complications such as decreased blood pressure or inflammation of the face or tongue. Severe allergic reactions throughout the body could have a rapid onset and be severe. Symptoms are: decreased blood pressure, increased heart rate, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhea, abdominal or back pain. Severe reactions can lead to shock, loss of consciousness, respiratory failure, and very rarely even death.

The citrate contained in OctaplasmaLG can cause negative effects and be related to low calcium levels, especially if the infusion rate is high, if you have liver function disorders, or if you are undergoing plasma exchange procedures. You may experience symptoms such as: fatigue, tingling sensation (paresthesia), tremors, decreased calcium levels.

OctaplasmaLG may increase the risk of blood clots in the veins of:

• limbs, causing pain and swelling of the limbs;
• lungs, causing chest pain and difficulty breathing;
• brain, causing weakness and/or loss of sensitivity on one side of the body;
• heart, causing chest pain;

In all patients with a risk of increased blood coagulation, special precautions should be taken and appropriate measures considered.

In rare cases, incompatibility between OctaplasmaLG antibodies and blood antigens can cause destruction of your red blood cells (hemolytic transfusion reactions). Symptoms are: chills; fever; irritating cough; difficulty breathing; skin rash; and internal bleeding.

The infusion of OctaplasmaLG may increase certain coagulation factor antibodies.

A high dose or infusion rate may cause an increase in blood volume, fluid in the lungs, and/or heart failure.

Acute respiratory difficulties have been reported during or after the infusion of OctaplasmaLG.

During clinical trials with the predecessor product of OctaplasmaLG and its post-authorization use, the following adverse effects have been identified:

§Spontaneous reporting data

Depending on the type and severity of the adverse reactions, the infusion rate should be reduced or the infusion stopped. Your doctor will take the necessary measures.

Tell your doctor or pharmacist if you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet.

Pediatric population

During plasma exchange procedures, low calcium levels may be observed in children, especially in patients with liver function disorders or in cases of high infusion rates. It is recommended to monitor calcium levels during this use of OctaplasmaLG.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OctaplasmaLG

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after CAD/EXP.

Do not store above 25°C.

Do not freeze.

Protect from light.

The powder should be dissolved just before infusion. The stability of the reconstituted solution has been demonstrated for 8 hours at room temperature (max. 25°C).

However, to prevent contamination, the solution should be used immediately and in a single occasion. The reconstituted product should not be stored in the freezer or refrigerator.

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 further information

Composition of OctaplasmaLG

• The active substance is human plasma proteins, with ABO blood group specificity. One vial contains: 9-14 g (45-70 mg/ml).
• The other components are:

Sodium dihydrogen phosphate dihydrate, citric acid dihydrate, phosphoric acid, and glycine.

Appearance and pack contents

OctaplasmaLG is presented as powder and solvent for solution for infusion in glass vials.

Each OctaplasmaLG pack contains:

• 1 vial with powder for solution for infusion with a stopper and flip-off cap.
• 190 ml of solvent (water for injections) in a bag
• 1 transfer device
• 2 alcohol swabs

Pack size: 1 unit.

The powder is a friable mass of almost white or slightly yellow color.

The solvent is a clear and colorless liquid.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Octapharma S.A.

Avda. Castilla, 2. (P.E. San Fernando)

Ed. Dublín, 2ª Planta

28830 San Fernando de Henares, Madrid

Spain

Manufacturer:

Octapharma AB

Lars Forssells gata 23

SE-112 75 Stockholm, Sweden

Date of the last review of this prospectus: 11/2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Dosage and administration

Dosage

The dose depends on the clinical situation and the underlying disorder, but the initial dose is usually between 12 and 15 ml of OctaplasmaLG/kg of body weight. This dose should increase the patient's plasma coagulation factor levels by approximately 25%.

It is essential to monitor the response, both clinically and by performing measurements, for example, of the activated partial thromboplastin time (APTT), prothrombin time (PT), and/or specific coagulation factor assays.

Dosage for coagulation factor deficiencies:

Adequate hemostatic effect in minor and moderate bleeding or in interventions in patients with coagulation factor disorders is usually achieved after perfusion of between 5 and 20 ml of OctaplasmaLG/kg of body weight. This dose should increase the patient's plasma coagulation factor levels by approximately 10-33%. In cases of major bleeding or surgical intervention, consultation with a hematologist is required.

Dosage for Thrombotic Thrombocytopenic Purpura (TTP) and bleeding in intensive plasma exchange:

For therapeutic plasma exchange procedures, expert advice from a hematologist should be sought.

In TTP patients, the total volume of plasma exchanged should be replaced with OctaplasmaLG.

Method of administration

General instructions

Read all instructions and follow them carefully.

During the procedure described below, aseptic technique should be maintained.

The product is generally reconstituted within approximately 15 minutes at room temperature. If the powder is not dissolved within 30 minutes, the product should be discarded.

After reconstitution, the product should be used immediately.

Reconstitution

1. The reconstitution of OctaplasmaLG should be performed at room temperature. Remove the flip-off closure cap from the powder vial (OctaplasmaLG) to expose the central part of the rubber stopper. Disinfect the rubber stopper with an alcohol swab and let it dry.
2. Remove the blister from the transfer device and close the pinza of the transfer line.
3. Remove the outer packaging of the water for injectable preparations bag. Remove the blue protective cap from the outlet of the bag. Do not touch the rubber stopper of the outlet to maintain sterility.
4. Connect the transfer device to the powder vial (OctaplasmaLG) by piercing the center of the stopper with the cannula. Open the ventilation located next to the cannula.
5. Connect the transfer device to the water for injectable preparations bag by pressing the needle through the blue outlet.
6. Ensure that the transfer device is properly connected, hold/hang the water for injectable preparations bag vertically above the powder vial, and open the pinza. The water for injectable preparations will automatically flow into the powder vial (OctaplasmaLG). Start gently rotating the powder vial during the transfer of the water for injectable preparations.
7. Once the transfer is complete, remove the cannula from the powder vial and discard the transfer device and the empty water for injectable preparations bag.
8. Continue gently rotating the powder vial until the powder is completely dissolved. To avoid foam formation, do not shake the vial. In general, the powder should be completely dissolved within approximately 15 minutes.

The reconstituted solution should be transparent or slightly opalescent.

OctaplasmaLG should be administered by intravenous infusion using a ventilated infusion set with a filter to remove any residual solid particles.

Method of administration

The administration of OctaplasmaLG should be performed specifically for the blood group. In emergency cases, the AB blood group of OctaplasmaLG can be considered as universal plasma, as it can be administered to all patients regardless of their blood group.

After reconstitution, OctaplasmaLG should be administered by intravenous infusion using a ventilated infusion set with filters. Aseptic technique should be used during the infusion.

Citrate toxicity may occur if more than 0.02-0.025 mmol of citrate per kg and minute are administered. Therefore, the infusion rate of OctaplasmaLG should not exceed 1 ml per kg and minute.

The toxic effects of citrate can be minimized by administering calcium gluconate intravenously in another vein.

The reconstituted product should be administered at a tolerable temperature to prevent hypothermia but not exceeding 37°C.

Warnings and precautions for administration:

The infusion should be stopped immediately in case of anaphylactic reaction or shock. Treatment should follow the guidelines for treating shock.

Patients should be observed for at least 20 minutes after administration.

Incompatibilities:

• OctaplasmaLG can be mixed with red blood cells and platelets if ABO compatibility is respected in both preparations.
• OctaplasmaLG should not be mixed with other medications, as inactivation and precipitation may occur.
• To avoid the possibility of clot formation, solutions containing calcium should not be administered through the same intravenous line as OctaplasmaLG.

Interference with serological tests:

The passive transmission of OctaplasmaLG plasma components (e.g., human chorionic gonadotropin β; β-hCG) may cause false laboratory results in the recipient. For example, false positives in pregnancy test results have been reported due to the passive transmission of β-hCG.