Fibryga 1 g polvo y disolvente para solucion inyectable y para perfusion

Prospect: information for the user

Fibryga 1g

Powder and solvent for injectable solution and for infusion

Human fibrinogen

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1. What is Fibryga and how it is used

2. What you need to know before starting to use Fibryga

3. How to use Fibryga

4. Possible adverse effects

5.Storage of Fibryga

6. Contents of the package and additional information

Fibryga contains human fibrinogen, which is an important protein for blood clotting. A lack of fibrinogen means that the blood does not clot as well as it should, leading to a greater tendency to bleed. Human fibrinogen substitution with Fibryga will correct the clotting defect.

What is Fibryga used for

Fibryga is used for:

• the treatment of bleeding episodes and prophylaxis for surgery in patients with congenital fibrinogen deficiency (hypo or afibrinogenemia) with a tendency to bleed.
• the supplementation of fibrinogen in patients with uncontrolled severe bleeding accompanied by acquired fibrinogen deficiency during surgery.

.

Do not use Fibryga:

• if you are allergic to human fibrinogen or any of the other components of this medication (listed in section6).
• if you have had allergic reactions to Fibryga in the past.

Please inform your doctor if you are allergic to any medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fibryga.

Risk of blood clots

Your doctor must assess the benefits of this medication against the risk of blood clots, particularly if:

• you have received a high or repeated dose of this medication
• you have had a heart attack (history of coronary heart disease or myocardial infarction)
• you have liver disease
• you have recently been operated on (postoperative patients)
• you are about to be operated on (perioperative patients)
• you are a newborn (neonates)
• you are likely to develop blood clots or coagulation problems (patients at risk of thromboembolic events or disseminated intravascular coagulation).

Your doctor may ask you to have additional coagulation tests to monitor the risk.

Allergic reactions and anaphylactic reactions

Any medication, like Fibryga, that is prepared from human blood (containing proteins) and injected into a vein (administered intravenously) may cause allergic reactions. If you have had allergic reactions to Fibryga in the past, your doctor will advise you whether you need to take antiallergics.

Your doctor will explain the warning signs of allergic reactions or anaphylactic reactions.

Please be aware of the first symptoms of allergic reactions (hypersensitivity), such as:

• hives
• skin rash
• chest tightness
• shortness of breath
• hypotension,
• or anaphylaxis (when any or all of the above symptoms develop rapidly and are intense).

If these occur, the injection or infusion of Fibryga should be stopped immediately (i.e., interrupt the injection).

Viral safety

When medications are prepared from blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include:

• careful selection of blood and plasma donors to ensure that those at risk of being carriers of infections are excluded
• analysis of each donation and plasma mixture to detect signs of viruses or infections
• inclusion of steps in the processing of blood or plasma that can inactivate or eliminate viruses.

Despite these measures, when medications prepared from blood or plasma are administered, it cannot be ruled out that an infection may be transmitted. This also applies to any unknown or emerging viruses and other types of infections.

The measures taken are considered effective for encapsulated viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and for non-encapsulated hepatitis A virus. The measures taken may have limited value against non-encapsulated viruses such as parvovirus B19.

Parvovirus B19 infection can be severe in pregnant women (fetal infection) and for individuals with a weakened immune system or certain types of anemia (e.g., sickle cell anemia or abnormal red blood cell breakdown).

It is strongly recommended that each time you receive a dose of Fibryga, you record the name and batch number of the product to maintain a record of the batches used.

Your doctor may recommend that you consider getting vaccinated against hepatitis A and B if you regularly receive products containing human fibrinogen-derived plasma.

Children and adolescents

No specific or additional warnings or precautions apply to children and adolescents.

Use of Fibryga with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Fibryga should not be mixed with other medications, except those mentioned in the section“This information is intended solely for healthcare professionals / Reconstitution”.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should only be used during pregnancy or breastfeeding after consulting with your doctor or pharmacist.

Driving and operating machines

Fibryga has no influence on the ability to drive and operate machines.

Fibryga contains sodium

This medication contains 132mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 6.6% of the maximum daily sodium intake recommended for an adult. Please take this into account if you are following a low-sodium diet.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Fibryga is administered in the form of intravenous infusion (drip in a vein) by healthcare personnel.

The dose and posological regimen depend on:

• your weight
• the severity of your illness
• the location of the hemorrhage or
• the nature of your operation and
• your state of health

Use in children and adolescents

The administration of Fibryga in children and adolescents (intravenous route) does not differ from the administration in adults.

If you use more Fibryga than you should

To avoid the risk of overdose, your doctor will perform regular blood tests to measure your fibrinogen level.

In case of overdose, the risk of abnormal blood clots in the blood vessels may increase.

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

Administration form

This medication must be injected or infused into the veins after reconstitution with the solvent provided. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Please consult your doctor immediately:

• if any of the adverse effects occur
• if you observe any adverse effect not listed in this prospectus

The following adverse effects have been reported for Fibryga and other fibrinogen medications (the frequency of the adverse effects listed is unknown):

• Allergic and anaphylactic reactions: skin reactions such as skin rash or skin redness(see section2 “Warnings and Precautions”)
• Cardiovascular:inflammation of veins and blood clot formation(see section2 “Warnings and Precautions”)
• Increased body temperature

If you experience any of the above symptoms, consult your doctor as soon as possible.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and the box. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not freeze. Store the vial in the outer packaging to protect it from light.

The powder must be dissolved only immediately before injection or infusion. The stability of the reconstituted solution has been demonstrated for 24hours at room temperature (max. 25 ºC). However, to avoid contamination, the solution must be used immediately and only once.The reconstituted product must not be stored in the refrigerator or freezer.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Fibryga

• The active principle is human fibrinogen.
• Fibryga contains 1g of human fibrinogen per vial or 20mg/ml of human fibrinogen after reconstitution with the provided solvent (50ml of water for injectable preparations).
• The other components are L-arginine hydrochloride, glycine, sodium chloride, and sodium citrate dihydrate.

Appearance of the product and contents of the package

Fibryga is presented as a powder and solvent for injectable solution and for perfusion, and is available in glass vials.

The powder is white or pale yellow and hygroscopic, with a friable appearance.

The solvent is a transparent and colorless liquid.

The reconstituted solution is practically colorless and slightly opalescent.

Fibryga is supplied in a box containing:

• 1 vial with the powder for injectable solution and for perfusion
• 1 vial with the solvent (water for injectable preparations)
• 1 nextaro transfer device

Marketing Authorization Holder

Octapharma, S.A.

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

Ed. Dublín - 2nd Floor

28830 San Fernando de Henares

Madrid

Responsible for Manufacturing

Octapharma Pharmazeutika Produktionsges.m.b.H.,

Oberlaaer Strasse 235, 1100 Vienna, Austria

or

Octapharma AB,

Lars Forssells gata 23, 112 75 Stockholm, Sweden

or

Octapharma GmbH

Elisabeth-Selbert-Str. 11, 40764 Langenfeld, Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Fibryga®: Germany, Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Spain,Estonia, Finland, France, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden,

Fibrema®: Slovenia

Last review date of this leaflet: 11/2023

This information is intended solely for healthcare professionals:

Dosage

The dose and duration of treatment depend on the severity of the disorder, as well as the location and extent of the hemorrhages and the patient's clinical status.

The level of fibrinogen (functional) must be determined to calculate the individual dose, and the amount and frequency of administration must be determined for each patient by regular measurement of plasma fibrinogen levels and continuous monitoring of the patient's clinical status and other substitution treatments used.

In the case of major surgery, precise monitoring of substitution treatment by coagulation analysis is essential.

1. Prophylaxis in patients with congenital hypofibrinogenemia and known bleeding tendency.

To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to elevate fibrinogen levels to 1g/l and maintain fibrinogen at this level until hemostasis is assured and above 0.5g/l until wound healing is complete.

In the case of surgical procedure or treatment of a hemorrhagic episode, the dose must be calculated as follows:

Dose (mg/kg of body weight) =[Target level (g/l) - measured level (g/l)]

0.018 (g/l per mg/kg of body weight)

The subsequent dosing (dose and frequency of injections) must be adapted according to the patient's clinical status and laboratory results.

The biological half-life of fibrinogen is 3-4days. Therefore, in the absence of consumption, it is not usually necessary to repeat fibrinogen treatment. Given the accumulation that occurs with repeated administration for prophylactic use, the dose and frequency must be determined in accordance with the therapeutic objectives of the physician for each individual patient.

Pediatric population

In the case of surgical procedure or treatment of a hemorrhagic episode, the dose in adolescents must be calculated in accordance with the formula described above for adults, while the dose in children <12years of age must be calculated as follows:

Dose (mg/kg of body weight) =[Target level (g/l) – measured level (g/l)]

0.014(g/l per mg/kg of body weight)

The subsequent dosing must be adapted according to the patient's clinical status and laboratory results.

Geriatric population

Studies with Fibryga did not include patients aged 65years or older as to provide conclusive evidence that these patients respond differently to those younger patients.

2. Treatment of hemorrhages

Hemorrhage in patients with congenital hypofibrinogenemia

Bleeding episodes must be treatedin accordance with the formulas previously indicated for adults/adolescents and children, respectivelyuntil a plasma fibrinogen level target recommended of 1g/l is reached. This level must be maintained until hemostasis is assured.

Hemorrhage in patients with acquired fibrinogen deficiency

Adults

Generally, 1-2g are administered at the beginning, withperfusions subsequently as needed. In the case of severe bleeding, for example during major surgery, larger quantities (4-8g) of fibrinogen may be required.

Pediatric population

The dose must be determined according to body weight and clinical needs, although it is usually 20-30mg/kg.

Instructions for preparation and administration

General instructions

• The reconstituted solution must be practically colorless and slightly opalescent. Do not use turbid or sediment-containing solutions.
• Fibryga is valid only for single use. Do not reuse any of the components.
• For microbiological safety reasons, the solution must be administered immediately after reconstitution. The chemical and physical stability of the reconstituted solution has been demonstrated under conditions of use for 24hours at room temperature (max. 25°C). After reconstitution, do not refrigerate or freeze the Fibryga solution.

Reconstitution

1. Ensure that the powder vial (Fibryga) and the solvent vial are at room temperature. This temperature must be maintained during reconstitution. If a water bath is used to heat, care must be taken to avoid the water coming into contact with the rubber stoppers or the flip-off closure capsules of the containers.The water temperature must not exceed +37°C.
2. Remove the flip-off closure capsule from the powder vial (Fibryga) and the solvent vial to expose the central part of the perfusion stopper. Clean the rubber stoppers with an alcohol wipe and allow them to dry.
3. Remove the cap from the container of the transfer device (nextaro) (Fig.1). To maintain sterility, do not remove the transfer device from the transparent blister.Do not touch the needle.

1. Place the solvent vial on a flat and clean surface and hold it firmly in place. Without removing the blister, place the blue part of the transfer device over the solvent vial. Press firmly downwards in a straight line until it fits into place (Fig.2).Do not rotate it when attaching.

Note:
The transfer device must be attached first to the solvent vial and then to the lyophilized powder vial.Otherwise, the vacuum will be lost and the transfer of the solvent will not take place.

1. While holding the solvent vial, carefully remove the blister from the transfer device (nextaro) by pulling it upwards in a vertical direction. Ensure that the transfer device remains firmly attached to the solvent vial (Fig. 3).

1. Place the powder vial (Fibryga) on a flat and clean surface and hold it firmly in place. Take the solvent vial with the transfer device attached and invert it. Place the white part of the connector of the transfer device over the powder vial (Fibryga) and press firmly downwards until it fits into place (Fig.4). Do not rotate it when attaching. The solvent will flow automatically into the powder vial (Fibryga).

1. With the solvent vial still attached, gently rotate the Fibryga vial until the powder is completely dissolved. To avoid foam formation, do not shake the vial. The powder should be completely dissolved in about 5minutes. The powder should not take longer than 20minutes to dissolve. If it does not dissolve in 20minutes, the product must be discarded.
2. In rare cases where undissolved powder is observed floating during the transfer of water for injectable preparations or where the reconstitution time is unexpectedly prolonged, the process of dissolution can be facilitated by agitating the vial horizontally with more force.
3. Once reconstitution is complete, unscrew the transfer device (blue part) in a counterclockwise direction in two parts (Fig.5). Do not touch the Luer connector of the white part of the transfer device.

1. Discard the empty solvent vial along with the blue part of the transfer device.

Administration

1. Attach a syringe to the Luer connector of the white part of the transfer device (Fig.6).
2. Invert the Fibryga vial and withdraw the solution into the syringe (Fig.7).

1. Once the solution has been transferred, hold the syringe body firmly (keeping the syringe plunger oriented downwards) and remove the syringe from the transfer device (Fig.8).

1. Discard the white part of the transfer device along with the empty Fibryga vial.

It is recommended to use a standard infusion set for the intravenous administration of the reconstituted solution at room temperature.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Administration route

Infusion or intravenous injection.

Fibryga must be administered slowly by intravenous route at a maximum recommended rate of 5ml per minute in patients with congenital hypofibrinogenemia, and at a maximum recommended rate of 10ml per minute in patients with acquired fibrinogen deficiency.

Incompatibilities

This medicinal product must not be mixed with others.