PATIENT INFORMATION LEAFLET

OCTAPLEX500 IU, powder and solvent for solution for infusion. Human prothrombin complex.

OCTAPLEX1000UI, powder and solvent for solution for infusion. Human prothrombin complex.

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

Contents of the leaflet:

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

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

Octaplex is used to treat and prevent bleeding:

• Caused by medications called 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 the body.

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

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

No use Octaplex:

•If you are allergic to human prothrombin complex or to any of the other components of this medication (listed in section 6).

•If you are allergic to heparin or if heparin has ever caused a reduction in your platelet count in your blood.

•If you have IgA deficiency with known antibodies against IgA.

Warnings and precautions::

• Seek the advice of a specialist doctor experienced in the treatment of coagulation disorders when receiving Octaplex.
• If you have an acquired deficiency of vitamin K-dependent coagulation factors (for example, caused by treatment with vitamin K antagonists), Octaplex can only be used if a rapid correction of the deficiency is necessary, such as in significant bleeding or emergency surgery. In other cases, it is usually sufficient to reduce the dose of vitamin K antagonists and/or administer vitamin K.

• If you are receiving a vitamin K antagonist (such as warfarin), you may have a higher risk of forming blood clots. In this case, treatment with Octaplex may increase the risk.
• If you were born with a deficiency of vitamin K-dependent coagulation factors, the specific coagulation factor should be used if available.

• If any allergic reaction or anaphylactic reaction occurs, your infusion will be stopped immediately and you will be given the appropriate treatment.
• There is a risk of thrombosis or disseminated intravascular coagulation (a serious disease in which clots form throughout the body) when receiving Octaplex (particularly if it has been received 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 to be operated on, and also if Octaplex is given to very small babies.

• No data are available on the use of Octaplex in cases of bleeding during birth due to vitamin K deficiency in newborns.

Viral safety:

• When administering medications derived from human plasma or blood, certain measures must be taken to prevent the transmission of infections to patients. These measures include a careful selection of blood and plasma donors to ensure the exclusion of those at risk of being carriers of infections and the analysis of virus/infection signs in individual donations and plasma mixtures. Manufacturers of these products also include stages in the processing of blood or plasma capable of inactivating or eliminating viruses. Despite these measures, when administering medications prepared from human blood or plasma, the possibility of transmission of 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 for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The measures taken may have limited value against non-enveloped viruses, such as hepatitis A virus (HAV) and parvovirus B19. Parvovirus B19 infection can be serious for pregnant women (fetal infection) and for individuals with immunosuppressed systems or those suffering from certain types of anemia (e.g. sickle cell disease or hemolytic anemia).

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

• It is recommended to be appropriately vaccinated (hepatitis A and B) if you are regularly or repeatedly administered human prothrombin complex.

Children and adolescents:

No data are available on the use of Octaplex in children and adolescents.

Other medications and Octaplex:

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

Pregnancy and breastfeeding:

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

Driving and operating machinery::

No effect on the ability to drive and operate machinery has been described.

Important information about some of the components of Octaplex:

Heparin may cause allergic reactions and a decrease in blood cell count that can affect blood coagulation. Patients with a history of heparin-induced allergic reactions should avoid using medications containing heparin.

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

The treatment with Octaplex should be supervised by a doctor with experience in the treatment of blood coagulation disorders.

• First, the powder is dissolved in water.
• Then the solution is administered through a vein (intravenously).

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

• the severity of your illness

• the location of the bleeding and its severity, and
• your overall condition.

If you use more Octaplex than you should

In case of overdose, there is an increased risk of developing:

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

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

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

Clots in blood vessels

Infrequent:(can 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:(can affect up to 1 in 1,000 people)

Sallergic reactions may occur.

Rarely, a temporary increase in liver test results (transaminases) has been observed.

Patients treated with Octaplex for replacement therapy may develop neutralizing antibodies (inhibitors) against one or more of the clotting factors contained. If these inhibitors appear, replacement therapy will not be very effective.

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

A temporary increase in temperature (fever) has been observed.

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

Unknown frequency:(cannot be estimated from available data).

Severe allergic reaction and shock, hypersensitivity, tremors, heart failure, increased heart rate, circulatory failure, decreased blood pressure, respiratory failure, difficulty breathing, nausea, vomiting, skin rash, chills.

The heparin in this preparation may cause a sudden drop in platelet count 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, this alteration may develop within hours of starting treatment.

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

For information on viral safety, see section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

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

The powder must be dissolved immediately before injection. The solution's stability has been demonstrated for a maximum of 8 hours at +25°C. However, to prevent contamination, the solution must be used immediately and on a single occasion.

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

The active principles are:

The specific activity of Factor IX is?0.6 UI/mg of proteins.

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

Aspect of the product and content of the packaging

Octaplex is presented as a powder and solvent for solution for infusion.It is a white or slightly colored hygroscopic powder or a 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 present color.

Octaplex is presented in a box that contains:

-1 vial with powder for injectable solution.

-1 vial with the solvent, water for injectables

-1 Nextaro®transfer equipment.

Holder of the marketing authorization:

Octapharma S.A.

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

Ed. Dublin – 2nd Floor

28830 San Fernando de Henares

Madrid

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with the following names:

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

Republic of Czech, Sweden: Ocplex

Italy and Romania: Pronativ

Date of the last review of this leaflet: 06/2024

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

The general information on how to use Octaplex is given in section 3.

The following information is only directed at healthcare professionals:

Instructions for treatment

Read all instructions and follow them carefully.

During the procedure described below, follow aseptic technique.

The product is rapidly reconstituted at room temperature.

The reconstituted solution must be clear or slightly opalescent. Do not use turbid or sediment-containing solutions. The reconstituted products must be visually inspected to detect the possible presence of particles and discoloration before administration.

Once reconstituted, the solution must be used immediately.

All unused or waste products 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 body weight. The following table provides approximate doses (units/kg body weight of the reconstituted product).

†Units refers to international units (UI).

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

Since these recommendations are empirical and the recovery and duration of the effect may vary, it is mandatory to monitor the INR during treatment.

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

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

?Units required = body weight (kg) x desired increase in factor X (UI/mL) x 60

where 60 (ml/kg) is the inverse of the estimated recovery.

?Units required = body weight (kg) x desired increase in factor II (UI/mL) x 50

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

Instructions for reconstitution:

If the concentrate does not dissolve completely or forms an aggregate, the preparation must not be used.

Instructions for infusion:

As a precaution, the patient's pulse must be measured before and during infusion. If a marked increase in pulse occurs, reduce the infusion rate or interrupt administration.

2.Properly disinfect the area where the injection is to be applied.

3.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 aseptic technique.

No blood flow should occur in the syringe due to the risk of fibrin clot formation. TheNextaro®is for single use only.

Further detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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