FanhdI 100 IU FVIII/120 IU FVW per ml powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fanhdi 25 IU FVIII/30 IU FVW per ml, powder and solvent for solution for injection

Fanhdi 50 IU FVIII/60 IU FVW per ml, powder and solvent for solution for injection

Fanhdi 100 IU FVIII/120 IU FVW per ml, powder and solvent for solution for injection

human coagulation factor VIII and von Willebrand factor complex

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fanhdi is and what it is used for

Fanhdi belongs to a group of medicines called antihemorrhagics: coagulation factors: von Willebrand factor and blood coagulation factor VIII in combination.

This medicine is used for:

Hemophilia A

Fanhdi is indicated for the treatment and prophylaxis (prevention) of bleeding in patients with hemophilia A (congenital factor VIII deficiency). These patients do not have sufficient functional factor VIII. Fanhdi works by increasing the amount of factor VIII in the blood, thereby enabling blood to clot.

This product may be useful in the management of acquired factor VIII deficiency.

Von Willebrand Disease

Fanhdi is indicated for the treatment of bleeding, and for the treatment and prophylaxis of surgical bleeding, in patients with von Willebrand disease (VWD) when treatment with desmopressin (DDAVP) alone is ineffective or contraindicated.

Patients may have different types of VWD. All types of VWD are inherited disorders in which bleeding may last longer than expected. This may be due to a lack of von Willebrand factor (VWF) in the blood or to VWF not functioning properly.

2. What you need to know before using Fanhdi

Do not use Fanhdi

If you are allergic to human coagulation factor VIII and von Willebrand factor complex or to any of the other ingredients of this medicine (listed in section 6).

If you have any doubts about the above, consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Fanhdi.

• There is a remote possibility that you may experience an anaphylactic reaction (a sudden, severe allergic reaction). If you notice skin rash or widespread hives, feel chest tightness, dizziness, lightheadedness, nausea, or feel faint when standing up, you may be having an anaphylactic reaction to Fanhdi. If this occurs, stop administering the product immediately and seek medical assistance.

• Your doctor may want to perform tests to ensure that the dose of Fanhdi you are receiving is sufficient to achieve and maintain adequate factor VIII levels.

The development of inhibitors (antibodies) is a known complication that may occur during treatment with any factor VIII-containing medicine. These inhibitors, especially in large amounts, can 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 Fanhdi, consult your doctor immediately.

• If you have previously developed factor VIII inhibitors and have switched from one factor VIII product to another, you may be at risk of developing inhibitors again.

• In the treatment of von Willebrand disease, there is a risk of thrombotic events, particularly in patients with clinical risk factors. Therefore, your doctor should perform tests to detect early signs of thrombosis and initiate treatment for vascular thromboembolism according to current guidelines.

• Patients with von Willebrand disease, especially those with type 3, may develop neutralizing antibodies (inhibitors) against von Willebrand factor. Von Willebrand factor inhibitors are antibodies present in the blood that block the von Willebrand factor you are using. If expected plasma von Willebrand factor activity levels are not achieved, or if bleeding is not controlled with the appropriate dose, your doctor should test for the presence of von Willebrand factor inhibitors. This can make von Willebrand factor less effective in controlling bleeding.

• If you require a central venous access device (CVAD) for administration of Fanhdi, your doctor must consider the risk of CVAD-related complications, including local infections, presence of bacteria in the blood (bacteremia), and formation of a blood clot in the vessel (thrombosis) at the catheter insertion site.

• When medicines are manufactured from human blood or plasma, a number of measures are taken to prevent possible transmission of infections to patients. These measures include careful selection of blood and plasma donors to ensure exclusion of donors at risk of infections, testing of each donation and pooled plasma for possible viruses or infections, and inclusion of several steps in the manufacturing process that can inactivate or eliminate viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This applies also to 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, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus. However, the measures may have limited effectiveness against non-enveloped viruses such as parvovirus B19.

Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with weakened immune systems or certain types of anemia (e.g., sickle cell anemia or hemolytic anemia).

Your doctor may recommend that you consider vaccination against hepatitis A and B if you receive regular or repeated infusions of plasma-derived factor VIII concentrates.

Each time a dose of Fanhdi is administered, it is recommended to record the name and batch number of the medicine to maintain a record of the batches used.

See also section 4.

Children and adolescents

The warnings and precautions listed above apply to both adults and children.

Use of Fanhdi with other medicines

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

No interactions between human coagulation factor VIII and von Willebrand factor complex and other medicines have been observed.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy and breastfeeding, the FVIII/FVW complex may be used only if clearly indicated.

Driving and use of machines

There is no evidence that Fanhdi affects the ability to drive vehicles or operate machinery.

Sodium content

The residual sodium content in Fanhdi, originating from the manufacturing process, does not exceed 23 mg per vial in the 250, 500, and 1000 IU presentations, and 34.5 mg per vial in the 1500 IU presentation. This corresponds to 1.15% and 1.72%, respectively, of the maximum daily sodium intake recommended for an adult. However, depending on the patient's weight and dosage, the patient may receive more than one vial.

3. How to use Fanhdi

The product must be administered intravenously. The administration rate must not exceed 10 ml/min.

Follow exactly the administration instructions provided by your doctor or the medical staff at the hemophilia center. If you have any doubts, consult your doctor or pharmacist.

The amount of Fanhdi you need depends on several factors, such as your body weight, clinical condition, and the location and severity of bleeding. Your doctor will calculate the required dose of Fanhdi, as well as how frequently and at what intervals it should be administered to achieve the necessary blood level of factor VIII or von Willebrand factor.

Your doctor will advise you on the duration of your treatment with Fanhdi.

Preparation of the solution:

Ensure that you work under optimal conditions throughout all steps of the process to prevent product contamination.

1. Warm the vial and the solvent syringe to room temperature, without exceeding 30 °C.
2. Attach the plunger to the solvent syringe.
3. Unseal the filter. Remove the cap from the cone of the solvent syringe and attach the syringe to the filter.
4. Unseal the vial adapter and attach it to the filter-syringe assembly.
5. Unseal the vial and disinfect the stopper with one of the alcohol wipes provided.
6. Insert the spike of the adapter into the vial.
7. Transfer all the solvent from the syringe into the vial.
8. Gently rotate the vial, taking care not to create foam, until complete dissolution is achieved. Do not shake. As with all parenteral products, do not use if the solution is incomplete or contains particles.
9. Detach the filter-syringe assembly from the rest of the setup to facilitate subsequent aspiration, then immediately reattach the filter-syringe assembly to the vial.
10. Invert the vial and draw the solution into the syringe.

Administration

Prepare the patient's injection site. Detach the syringe from the rest of the assembly and inject the product using the butterfly needle supplied, at a rate of 3 ml/min intravenously. The administration rate must not exceed 10 ml/min to avoid vasomotor reactions.

The injection equipment supplied with the medicine is recommended. If medical infusion systems are used, check the compatibility of the system with the pre-filled syringe. An adapter may be required to ensure proper product administration.

Administration equipment must not be reused. Under no circumstances should any unused portion be saved, even if stored in a refrigerator.

If you use more Fanhdi than you should

There have been no reported cases of overdose with human coagulation factor VIII and von Willebrand factor complex. However, if you have used more Fanhdi than prescribed, contact your doctor or pharmacist immediately.

In case of overdose or accidental administration, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to use Fanhdi

• Proceed immediately with the next administration and continue at regular intervals as directed by your doctor.
• Do not administer a double dose to make up for missed doses.

4. Possible adverse effects

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

In rare cases, you may notice one or more of the following adverse effects after administration of Fanhdi:

• Pruritus, local reactions at the injection site (e.g. burning or tingling sensation and transient redness)
• Allergic reactions (e.g. chest tightness/general feeling of discomfort, difficulty breathing, dizziness, nausea and mild drop in blood pressure which may cause dizziness upon standing)
• Unusual taste in the mouth
• Fever
• Tachycardia
• Restlessness
• Headache
• Somnolence
• Vomiting
• Chills

Anaphylactic shock cannot be completely ruled out either. If you notice any of the following symptoms during administration:

• Chest tightness/general feeling of discomfort
• Dizziness
• Mild hypotension (slight decrease in blood pressure with dizziness upon standing)
• Nausea

these may be early signs of hypersensitivity and anaphylactic reaction. If an allergic or anaphylactic reaction occurs, administration must be stopped immediately and you should consult your doctor without delay.

Haemophilia A

In children who have not previously received treatment with factor VIII-containing medicines, inhibitory antibodies may develop very frequently (more than 1 in 10 patients); however, in patients who have previously received factor VIII treatment (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 such a case, contact your doctor immediately.

Von Willebrand disease

When using a FVW product containing FVIII to treat VWD, continued treatment may lead to excessive increase of FVIII in the blood. This may increase the risk of altered blood flow (thrombosis).

If you are a patient with known clinical or laboratory risk factors, you should be monitored for early signs of thrombosis. Your doctor should implement prevention (prophylaxis) of thrombotic episodes according to current recommendations.

Especially if you are a patient with type 3 von Willebrand disease, in very rare cases, neutralizing antibodies (inhibitors) to von Willebrand factor may develop. If such inhibitors appear, von Willebrand factor becomes less effective in controlling bleeding. If bleeding continues, the presence of these inhibitors should be tested in your blood. These antibodies may be associated with anaphylactic reactions. Therefore, patients experiencing anaphylactic reactions should be evaluated for the presence of inhibitors. In such cases, consult your doctor immediately.

For information on viral safety, see section 2.

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 Medicinal Products: www.notificaRAM.es

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

5. Storage of Fanhdi

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

Do not store above 30 °C. Do not freeze.

Do not use this medicine after the expiry date stated on the packaging after "EXP".

Do not use this medicine if the solution appears cloudy or contains sediments. The solution is generally clear or slightly opalescent.

After reconstitution, the solution should be discarded if particles or any discoloration are observed.

After reconstitution, the product is chemically and physically stable for 4 hours at 25 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user.

Any unused product and waste material should be disposed of in accordance with local requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fanhdi

• The active substance is the human coagulation factor VIII and von Willebrand factor complex. Once reconstituted, Fanhdi contains 25 IU FVIII/30 IU VWF per ml, 50 IU FVIII/60 IU VWF per ml, or 100 IU FVIII/120 IU VWF per ml. See below “Fanhdi presentations”.

• The other components are albumin, histidine, and arginine.

Appearance of the product and contents of the pack

Vial containing white or pale yellow powder and syringe with water for injectable preparations (solvent).

Contents of the pack: 1 vial of lyophilized powder, 1 pre-filled syringe of solvent, and accessories (vial adapter, filter, 2 alcohol swabs, and butterfly needle).

Fanhdi presentations

Fanhdi 25 IU FVIII/30 IU VWF per ml

Presented as a powder for injectable solution containing 250 IU of human coagulation factor VIII and 300 IU of human von Willebrand factor per vial, reconstituted with 10 ml of water for injection.

Fanhdi 50 IU FVIII/60 IU VWF per ml

Presented as a powder for injectable solution containing 500 IU of human coagulation factor VIII and 600 IU of human von Willebrand factor per vial, reconstituted with 10 ml of water for injection.

Fanhdi 100 IU FVIII/120 IU VWF per ml

Presented as a powder for injectable solution containing 1000 IU of human coagulation factor VIII and 1200 IU of human von Willebrand factor per vial, reconstituted with 10 ml of water for injection.

Or

Presented as a powder for injectable solution containing 1500 IU of human coagulation factor VIII and 1800 IU of human von Willebrand factor per vial, reconstituted with 15 ml of water for injection.

Marketing Authorization Holder and Manufacturer Responsible

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona – SPAIN

Date of the most recent review of this summary: 12/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es//

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This information is intended for healthcare professionals only:

Dosage

Hemophilia A

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

The number of factor VIII units administered is expressed in International Units (IU), relative to the current World Health Organization (WHO) standard for factor VIII concentrates. Plasma factor VIII activity is expressed as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor VIII in plasma).

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

On-demand treatment

The calculation of the required factor VIII dose is based on the empirical observation that 1 International Unit (IU) of factor VIII per kg of body weight increases plasma factor VIII activity by 2.1 ± 0.4% of normal activity. The required dose is determined using the following formula:

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

The dose and frequency of administration should be adjusted according to the patient's clinical response.

In the case of bleeding episodes as described below, factor VIII activity should not fall below the established plasma activity level (in % of normal plasma or IU/dl) during the corresponding period. The following table may be used as a guide for dosing in bleeding episodes and surgery:

Prophylaxis

For long-term prophylaxis to prevent bleeding in patients with severe hemophilia A, doses of 20 to 40 IU of FVIII/kg body weight should be administered every 2 to 3 days. In some cases, especially in younger patients, it may be necessary to shorten the dosing intervals or use higher doses.

von Willebrand Disease (vWD)

Generally, 1 IU of VWF:RCo/kg increases circulating levels by approximately 2%. Target levels should be VWF:RCo > 0.6 IU/ml (60%) and FVIII:C > 0.4 IU/ml (40%).

Typically, 40–80 IU/kg of von Willebrand factor (VWF:RCo) and 20–40 IU/kg of FVIII:C are recommended to achieve hemostasis.

An initial dose of 80 IU/kg of von Willebrand factor may be required, especially in patients with type 3 von Willebrand disease, where maintaining adequate levels may require higher doses than in other types of von Willebrand disease.

Appropriate re-dosing should be administered every 12–24 hours. The dose and duration of treatment depend on the patient's clinical condition, the type and severity of bleeding, and the levels of VWF:RCo and FVIII:C.

When using a von Willebrand factor preparation containing factor VIII, the treating physician must consider that continued treatment may cause excessive increases in FVIII:C. After 24–48 hours of treatment, to avoid excessive elevation of FVIII:C, dose reduction and/or prolongation of the dosing interval should be considered, or alternatively, products containing von Willebrand factor with low levels of factor VIII should be considered.

Pediatric population

The safety and efficacy of Fanhdi in children under 6 years of age have not been established for the approved indications.

Dosing in children aged 6 years and older is not considered different from that in adults, as it is based on body weight and adjusted according to the clinical response to the conditions described above.