Octaplex, 500 IU powder and solvent for solution for injection.

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OCTAPLEX 500 IU, powder and solvent for solution for infusion. Human prothrombin complex.

OCTAPLEX 1000 IU, powder and solvent for solution for infusion. Human prothrombin complex.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Octaplex is and what it is used for

Octaplex belongs to a group of medicines called coagulation factors. It contains human vitamin K-dependent coagulation factors II, VII, IX, and X.

Octaplex is used to treat and prevent bleeding:

• Caused by medications known as vitamin K antagonists (such as warfarin). These medications block the effect of vitamin K and cause a deficiency of vitamin K-dependent coagulation factors in your body.

Octaplex is used when rapid correction of the deficiency is required.

• In individuals born with a deficiency of vitamin K-dependent coagulation factors II and X. It is used when a purified specific coagulation factor product is not available.

2. What you need to know before using Octaplex

Do not use Octaplex:

• If you are allergic to human prothrombin complex or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to heparin or if heparin has ever caused you a reduction in platelet levels in your blood.
• If you have IgA deficiency with known antibodies against IgA.

Warnings and precautions:

• Seek advice from a specialist physician experienced in the treatment of coagulation disorders while receiving Octaplex.

• If you have an acquired deficiency of vitamin K-dependent coagulation factors (e.g., caused by treatment with vitamin K antagonist medications), Octaplex may only be used when rapid correction of the deficiency is required, such as in cases of major bleeding or emergency surgery. In other cases, reducing the dose of vitamin K antagonists and/or administering vitamin K is usually sufficient.

• If you are receiving a vitamin K antagonist medication (such as warfarin), you may have an increased risk of forming blood clots. In this case, treatment with Octaplex may further increase this risk.

• If you were born with a deficiency of vitamin K-dependent coagulation factors, specific factor replacement should be used if available.

• If an allergic or anaphylactic reaction occurs, the infusion of the medicine will be stopped immediately and appropriate treatment will be administered.

• There is a risk of thrombosis or disseminated intravascular coagulation (a serious condition in which blood clots form throughout the body) when receiving Octaplex (particularly if administered regularly). You will be closely monitored for signs or symptoms of intravascular coagulation or thrombosis.

This is especially important if you have a history of coronary heart disease, liver disease, if you are about to undergo surgery, and also if Octaplex is administered to very young infants.

• There are no data on the use of Octaplex for bleeding during birth due to vitamin K deficiency in newborns.

Viral safety

• When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent transmission of infections to patients. These measures include careful selection of blood and plasma donors to ensure exclusion of those at risk of carrying infections, and testing of individual donations and plasma pools for signs of viruses/infections. Manufacturers of these products also include steps in the processing of blood or plasma capable of inactivating or eliminating viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infection cannot be completely ruled out. This also applies to all unknown or emerging viruses and other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The measures may have limited effectiveness against non-enveloped viruses, such as hepatitis A virus (HAV) and parvovirus B19. Parvovirus B19 infection may be severe in pregnant women (fetal infection) and in individuals with weakened immune systems or suffering from certain types of anemia (e.g., sickle cell disease or hemolytic anemia).

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

• Appropriate vaccination (hepatitis A and B) is recommended if you are receiving human prothrombin complex regularly or repeatedly.

Children and adolescents

There are no data on the use of Octaplex in children and adolescents.

Other medicines and Octaplex

• Octaplex must not be mixed with other medicines.
• Octaplex blocks the effect of vitamin K antagonist medications (such as warfarin), but no interactions with other medicines are known.
• Octaplex may affect the results of coagulation tests that are sensitive to heparin.
• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

• Octaplex should only be used during pregnancy and breastfeeding if clearly necessary. Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

It has not been reported that Octaplex affects the ability to drive or operate machinery.

Important information about some of the ingredients of Octaplex

Heparin may cause allergic reactions and a decrease in blood cell counts that can affect the blood coagulation system. Patients with a history of heparin-induced allergic reactions should avoid medicines containing heparin.

This medicine contains 75–125 mg (500 IU vial) or 150–250 mg (1000 IU vial) of sodium (main component of table/cooking salt) per vial. This corresponds to 3.8–6.3% or 7.5–12.5% of the maximum daily recommended sodium intake for an adult.

3. How to use Octaplex

Treatment with Octaplex must be supervised by a doctor experienced in the treatment of blood coagulation disorders.

• First, the powder is dissolved in water.
• Then the solution is administered into a vein (intravenous route).

The amount of Octaplex you will receive and the duration of your treatment will depend on:

• the severity of your condition,
• the location and severity of the bleeding, and
• your general condition.

If you use more Octaplex than you should

In case of overdose, the risk increases of developing:

• coagulation complications (such as heart attack and blood clots in your veins or lungs),
• disseminated intravascular coagulation (a serious condition in which blood clots form throughout the body).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent: (may affect up to 1 in 10 people)

Blood clots in blood vessels

Uncommon: (may affect up to 1 in 100 people)

Anxiety, increased blood pressure, asthma-like symptoms, coughing up blood, nosebleeds, burning sensation at the injection site, and clots in the device.

Rare (may affect up to 1 in 1,000 people)

S e allergic-type reactions may occur.

A temporary increase in liver function test results (transaminases) has rarely been observed.

Patients treated with Octaplex for replacement therapy may develop neutralizing antibodies (inhibitors) against one or more of the coagulation factors contained in the product. If such inhibitors appear, replacement therapy may become less effective.

Very rare (may affect up to 1 in 10,000 people)

An increase in body temperature (fever) has been observed.

There is a risk of blood clotting after administration of this medicine.

Frequency not known: (cannot be estimated from the available data)

Severe allergic reaction and shock, hypersensitivity, tremor, heart failure, increased heart rate, circulatory failure, drop in blood pressure, respiratory failure, breathing difficulties, nausea, hives, skin rash, chills.

The heparin in this preparation may cause a sudden drop in the number of platelets in the blood. This is an allergic reaction called "heparin-induced thrombocytopenia type II". Rarely, in patients previously not hypersensitive to heparin, this drop in platelet count may occur between 6 and 14 days after starting treatment. In patients with previous hypersensitivity to heparin, this reaction may develop within hours after starting treatment.

Treatment with Octaplex must be stopped immediately in patients who show this allergic reaction. These patients must not receive any medicines containing heparin in the future.

For information on viral safety, see section 2.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Octaplex

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

Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.

Store the vial in the outer packaging to protect it from light and at a temperature below +25°C. Do not freeze.

The powder should always be dissolved immediately before injection. The stability of the solution has been demonstrated for up to 8 hours at +25°C. However, to prevent contamination, the solution should be used immediately and only once.

6. Contents of the pack and other information

Composition of Octaplex per vial and after reconstitution with 20 ml (500 IU)/40 ml (1000 IU) of solvent:

The active substances are:

The specific activity of Factor IX is ? 0.6 IU/mg of protein.

The other components are heparin, trisodium citrate dihydrate and water for injection.

Appearance of the product and contents of the container

Octaplex is presented as a powder and solvent for solution for infusion. It is a white or slightly coloured hygroscopic powder or friable mass in a glass vial. The solvent is water for injection and is supplied in a glass vial. The reconstituted solution is transparent or slightly opalescent and may have a colour.

Octaplex is supplied in a carton containing:

• 1 vial with powder for injectable solution.
• 1 vial with solvent, water for injection.
• 1 Nextaro® transfer device.

Marketing Authorization Holder:

Octapharma S.A.
Avda. Castilla, 2 (P.E. San Fernando)
Ed. Dublin – 2nd Floor
28830 San Fernando de Henares
Madrid
Spain

Manufacturer:

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235
1100 Vienna
Austria

or

Octapharma Lingolsheim S.A.S.
72 Rue du Maréchal Foch
67380 Lingolsheim
France

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Slovakia, Spain, United Kingdom: Octaplex

Czech Republic, Sweden: Ocplex

Italy and Romania: Pronativ

Date of latest revision of this leaflet: 06/2024

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

General information on how to use Octaplex is provided in section 3.

The following information is intended exclusively for healthcare professionals:

Instructions for treatment

Read all instructions and follow them carefully.

An aseptic technique must be maintained throughout the procedure described below.

The product reconstitutes rapidly at room temperature.

The reconstituted solution should be clear or slightly opalescent. Do not use cloudy solutions or those containing particulate matter. Reconstituted products should be inspected visually for possible presence of particles and possible discoloration prior to administration.

Once reconstituted, the solution should be used immediately.

Any unused product or waste material must be disposed of in accordance with local requirements.

Dosage:

Bleeding and prevention of bleeding during treatment with vitamin K antagonists:

The dose will depend on the International Normalized Ratio (INR) prior to treatment and on body weight. Approximate doses (units/kg body weight of reconstituted product) are provided in the table below.

† Units refer to International Units (IU).

The dose is based on body weight up to a maximum of 100 kg. Therefore, for patients weighing more than 100 kg, the maximum single dose (IU of factor IX) should not exceed 2500 IU for an INR of 2 - < 4, 3500 IU for an INR of 4 - 6, and 5000 IU for an INR > 6.

Since these recommendations are empirical and recovery and duration of effect may vary, INR monitoring during treatment is mandatory.

Bleeding and perioperative prophylaxis in congenital deficiency of coagulation factors II and X when specific factor product is not available:

The calculation of the required dose for treatment is based on the empirical observation that approximately 1 IU of factor II or X per kg of body weight increases plasma activity of factor II or X by 0.02 and 0.017 IU/mL, respectively.

?Required units = body weight (kg) × desired increase in factor X (IU/mL) × 60

where 60 (mL/kg) is the reciprocal of the estimated recovery.

?Required units = body weight (kg) × desired increase in factor II (IU/mL) × 50

If individual recovery is known, this value should be used in the calculation.

Reconstitution instructions:

If the concentrate is not completely dissolved or an aggregate forms, the preparation must not be used.

Instructions for infusion:

As a precautionary measure, the patient's pulse should be measured before and during the infusion. If a marked increase in pulse occurs, the infusion rate should be reduced or administration should be interrupted.

1. Properly disinfect the area where the injection is to be administered.
2. Inject the solution intravenously at a rate of 0.12 ml/kg/min (≈ 3 units/kg/min), up to a maximum rate of 8 ml/min (≈ 210 units/min), using an aseptic technique.

There should be no blood return into the syringe due to the risk of fibrin clot formation. Nextaro® is for single use only.

The detailed and up-to-date information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

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