Haemoctin 1000 powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Haemoctin 500

Haemoctin 1000 Powder and solvent for solution for injection

Coagulation Factor VIII, human plasma-derived

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

• Keep this leaflet. 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. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Haemoctin is and what it is used for

Haemoctin is a medicinal product derived from human plasma. It contains coagulation factor VIII, which is necessary for normal blood clotting. After reconstituting the powder with water for injectable preparations, the solution is ready for intravenous injection.

Haemoctin is used for the treatment and prevention of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency).

Haemoctin does not contain von Willebrand factor in pharmacologically effective amounts, and therefore is not suitable for the treatment of von Willebrand disease.

2. What you need to know before using Haemoctin

Do not use Haemoctin

• If you are allergic to coagulation factor VIII or to any of the other components of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.

Warnings and precautions

The development of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII-containing medicines. These inhibitors, especially in large amounts, prevent the treatment from working properly, so you and your child will be carefully monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with Haemoctin, consult your doctor immediately.

If you have cardiovascular risk factors, treatment with Haemoctin may increase cardiovascular risk. If you are unsure about this, you should discuss it with your doctor.

Catheter-related complications: If a central venous access device (CVAD) is required, the risk of associated complications should be considered, including local infections, bacteremia, and thrombosis at the catheter insertion site.

Viral safety

When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent infections from being transmitted to patients. These measures include:

• careful selection of donors, to exclude those at risk of carrying infectious diseases,
• testing for specific markers of viruses/infections in individual donations and plasma pools,
• inclusion of steps in the manufacturing process to inactivate/remove viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmission of infectious agents cannot be entirely excluded. This also applies to emerging viruses or those of unknown nature, and other types of infections.

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

Your doctor may recommend that you consider vaccination against hepatitis A and B if you receive factor VIII products derived from human plasma regularly or repeatedly.

It is highly recommended that each time you receive a dose of Haemoctin, the name of the medicine and the batch number administered should be recorded, in order to maintain a record of the batches used.

Children and adolescents

The warnings and precautions mentioned for adults also apply to children and adolescents.

Other medicines and Haemoctin

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Haemoctin and other medicines have been reported.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

Due to the low incidence of haemophilia A in women, there is no experience regarding the use of factor VIII during pregnancy or breast-feeding. Animal studies during pregnancy or lactation have not been conducted.

Driving and use of machines

The influence of Haemoctin on the ability to drive and use machines is negligible or none.

Haemoctin contains sodium

Haemoctin 500/1000: contains up to 32.2 mg (1.40 mmol) of sodium (main component of table/cooking salt) per vial. This corresponds to 1.61% of the maximum daily recommended sodium intake for an adult.

3. How to use Haemoctin

Haemoctin is prepared for intravenous administration (injection into a vein). Treatment must be administered under the supervision of a physician experienced in the treatment of haemophilia A. Follow exactly the administration instructions for Haemoctin provided by your doctor. Consult your doctor if you have any doubts.

The dose and duration of treatment depend on the severity of factor VIII deficiency, the location and extent of bleeding, and your clinical condition. Your doctor will determine the appropriate dose for you.

Ensure that you work under sterile conditions at all stages of the process.

Reconstitution of the concentrate:

• Allow the vials of solvent (water for injections) and the product to reach room temperature. If a water bath is used to warm the vials, take great care to avoid contact of water with the closure caps or vial stoppers. Otherwise, the medicine could become contaminated.
• Very important for correct use of the transfer system: before opening, ensure that the white lower part of the transfer system rests directly on the bottom of the blister (Fig. 1a: correct / Fig. 1b: incorrect). If incorrect: push the transfer system downward in the blister until the white lower part rests directly on the bottom of the blister (Fig. 1c).
• Remove the closure caps from both the solvent vial and the product vial to expose the central parts of the rubber stoppers (Fig. 2). Clean the rubber stoppers of both the product and solvent vials with a disinfectant.
• Remove the remaining packaging of the transfer system (Fig. 3).
• Place the solvent vial on a flat surface. Attach the blue part of the transfer system (from inside the blister) to the upright solvent vial (Fig. 4). Do not twist the transfer system!
• Remove the rest of the blister from the transfer system. Do not squeeze the blister! The white part of the transfer system is now visible (Fig. 5).
• Place the product vial on a flat surface.
• Invert the assembly of the transfer system with the solvent vial. Insert the tip of the white part of the adapter through the stopper into the product vial (Fig. 6). The vacuum inside the product vial will cause the solvent to transfer automatically into the product vial.
• Gently swirl the product vial to assist in dissolving the powder. Do not shake vigorously, to avoid foam formation! The resulting solution should be clear or slightly opalescent.
• Unscrew the blue part of the transfer system together with the solvent vial by turning counterclockwise (Fig. 7). Discard the solvent vial together with the blue part of the transfer system. The Luer-Lock connector is now visible.

The reconstituted solution should be used immediately. Do not use solutions that are cloudy or contain visible particles.

Injection:

• Once the powder is fully dissolved as described, screw the provided syringe onto the Luer-Lock connector of the product vial with the white part of the transfer system (Fig. 8). This allows easy transfer of the dissolved medicine into the syringe. A separate filter is not required, as the transfer system already includes an integrated filter.
• Carefully disconnect the syringe from the vial with the white part of the transfer system. Using the provided butterfly needle, administer the solution immediately by slow intravenous injection. The injection rate must not exceed 2–3 mL/minute.
• After using the butterfly needle, replace the protective cap as a safety measure.

If you use more Haemoctin than you should

If you think you have been given too much Haemoctin, inform your doctor immediately; he or she will decide on the appropriate treatment.

If you forget to use Haemoctin

In this case, your doctor will decide whether continuing the treatment is necessary.

If you interrupt treatment with Haemoctin

Do not interrupt treatment with Haemoctin without consulting your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you notice any of the following effects, inform your doctor immediately:

• skin redness,
• burning sensation and itching at the infusion site,
• chills,
• flushing,
• headache,
• hives,
• hypotension,
• lethargy,
• nausea,
• restlessness,
• tachycardia,
• chest tightness,
• tingling,
• vomiting,
• wheezing.

These may be signs of a severe allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

The following adverse reactions have also been reported with Haemoctin

Frequency not known: frequency cannot be estimated from the available data

• Shock (anaphylactic), allergic reaction
• Skin redness, itching, hives

In children who have not previously received treatment with factor VIII-containing medicines, inhibitor antibodies may develop very commonly (more than 1 in 10 patients). However, in patients who have previously been treated with factor VIII (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this occurs, the medicines you or your child are taking may no longer work properly, and you or your child may experience persistent bleeding. In this case, contact your doctor immediately.

Adverse effects in children and adolescents

Except for the development of inhibitors (antibodies), adverse reactions in children are expected to be the same as those in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Haemoctin

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

Store the vials in the outer packaging to protect them from light.

Do not store above 25°C. Do not freeze.

Do not use Haemoctin after the expiry date stated on the vial label and the carton.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Haemoctin

• The active substance is human coagulation factor VIII.
• The other components are glycine, sodium chloride, sodium citrate, and calcium chloride.
• The solvent vial contains water for injections.

Appearance of the product and contents of the pack

Haemoctin is supplied as a lyophilized powder. Water for injections is used as the solvent. The reconstituted solution is clear or slightly opalescent.

Haemoctin 500: contains 1 vial with 500 IU and 1 vial with 5 ml of water for injections (100 IU/ml)

Haemoctin 1000: contains 1 vial with 1000 IU and 1 vial with 5 ml of water for injections (200 IU/ml)

Each pack contains:

• One disposable syringe
• A transfer system with integrated filter
• A butterfly-type needle

Marketing Authorization Holder and Manufacturer

Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Telephone: +49 6103 801-0
Fax: +49 6103 801-150
E-mail: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Grifols Movaco, S.A.
Can Guasc, s/n – Parets del Vallès
08150 Barcelona
Spain

Date of the most recent revision of this leaflet: 04/2023

This information is intended for healthcare professionals only:

Monitoring of treatment

During treatment, adequate monitoring of factor VIII levels is recommended to determine the appropriate dose and frequency of repeated infusions. Individual patient response to factor VIII may vary, resulting in different half-lives and recovery levels. Doses based on body weight may need to be adjusted in patients with below-normal weight or overweight. In the case of major surgery, accurate monitoring of replacement therapy using coagulation tests (plasma factor VIII activity) is essential.

When using a one-stage coagulation assay based on activated partial thromboplastin time (aPTT) in vitro to determine factor VIII activity in patient blood samples, the results of plasma factor VIII activity may be significantly affected by both the type of aPTT reagent and the reference standard used in these assays. There may also be significant discrepancies between results obtained by one-stage aPTT-based coagulation assays and those obtained by chromogenic assays according to the European Pharmacopoeia. This is particularly important when changing laboratories and/or reagents used in testing.

Dosage

The dose and duration of replacement therapy depend on the severity of factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.

The number of units of factor VIII administered is expressed in International Units (IU), corresponding to the current World Health Organization (WHO) standard for factor VIII-containing products. Plasma factor VIII activity may be expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for plasma factor VIII).

One International Unit (IU) of factor VIII activity is equivalent to the amount of factor VIII present in 1 ml of normal human plasma.

On-demand treatment

The calculation of the required factor VIII dose is based on the empirical finding that 1 International Unit (IU) of factor VIII per kg of body weight raises plasma factor VIII activity by 1% to 2% of normal activity.

The required dose can be determined using the following formula:

Units required = body weight (kg) × desired increase in factor VIII (%) × 0.5

The amount to be administered and the frequency of administration should always be guided by clinical efficacy in each individual case.

In the following bleeding episodes, factor VIII activity should not fall below the indicated plasma activity level (as % of normal) for the corresponding period. The following table may be used as a dosage guideline in bleeding episodes and surgery:

Prophylaxis

For long-term prophylaxis of bleeding episodes in patients with severe hemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg of body weight, administered every 2 or 3 days. In certain cases, especially in younger patients, it may be necessary to shorten the intervals between administrations or to use higher doses.

Administration method:

Intravenous route. It is recommended not to administer more than 2–3 ml per minute.

Only the infusion set supplied should be used, as treatment failure may occur due to adsorption of human coagulation factor VIII onto the internal surface of certain infusion sets.

Haemoctin must not be mixed with other medicinal products.