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FIBRYGA 1G POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): HUMAN FIBRINOGEN / HUMAN FIBRINOGEN

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B.000.000.UK

B.000.000.UK

B.000.000.UK

B.000.000.UK

Package leaflet: Information for the user
FIBRYGA, 1g
Powder for solution for injection / infusion
Human fibrinogen



if you have experienced allergic reactions to FIBRYGA in the
past.

Please inform your doctor if you are allergic to any
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using FIBRYGA.

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can help by
reporting any side effects you may get. See the end of section 4 for
how to report side effects.
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 further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1. What FIBRYGA is and what it is used for

Risk of clots in blood vessels
Your doctor should evaluate the benefits of this medicine against
the risk of clots in blood vessels, in particular if:


you have received high dose or repeated dosing of this
medicine



you have had a heart attack (history of coronary heart
disease or myocardial infarction)



you have liver disease



you have just had surgery (patients postoperatively)



you are having surgery (patients perioperatively)



in newborn infants (neonates)



you are likely to suffer of clots or clotting problems in
blood vessels (patients at risk of thromboembolic events or
disseminated intravascular coagulation).

Your doctor may ask you to have additional clotting tests done in
order to monitor the risk.



the testing of each donation and pools of plasma for signs
of virus/infections

FIBRYGA is given as an intravenous infusion (infusion into a vein) by
healthcare personnel.



the inclusion of steps in the processing of the blood or
plasma that can inactivate or remove viruses.

The dose and dosage regimen depends on:

Despite these measures, when medicines prepared from human
blood or plasma are administered, the possibility of passing on
infection cannot be totally excluded. This also applies to any
unknown or emerging viruses or other types of infections.



your weight



the severity of your disease



the location of the bleeding or



the nature of your operation and



your health status

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

Use in children and adolescents

Parvovirus B19 infection may be serious for pregnant women
(infection of the unborn baby) and for individuals whose immune
system is depressed or who have some types of anaemia (e.g. sickle
cell disease or abnormal breakdown of red blood cells).

If you use more FIBRYGA than you should

It is strongly recommended that every time you receive a dose
of FIBRYGA the name and the batch number of the product are
recorded in order to maintain a record of the batches used.
Your doctor may recommend that you consider vaccination against
hepatitis A and B if you regularly/repeatedly receive human plasmaderived fibrinogen products.

The administration of FIBRYGA in children and adolescents
(intravenously) does not differ from the administration in adults.

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 clots in your blood vessels
may become increased.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
Method of administration

Children and adolescents
There are no specific or additional warnings or precautions applicable
for children and adolescents.

This medicine should be injected or infused into the veins. If you
have any further questions on the use of this product, ask your
doctor or pharmacist.

2. What you need to know before you use FIBRYGA
3. How to use FIBRYGA

Allergic or anaphylactic-type reactions

4. Possible side effects

Any medicine, such as FIBRYGA, which is prepared from human blood
(containing proteins) and which is injected into a vein (administered
intravenously) can cause allergic reactions. If you have experienced
allergic reactions to FIBRYGA in the past, your doctor will advise you
whether anti-allergy medication is needed.

5. How to store FIBRYGA
6. Contents of the pack and other information

1. What FIBRYGA is and what it is used for
What FIBRYGA is
FIBRYGA contains human fibrinogen which is a protein important
for blood clotting (coagulation). Lack of fibrinogen means that
the blood does not clot as well as it should, which results in an
increased tendency to bleed. The replacement of human fibrinogen
with FIBRYGA will correct the coagulation defect.
What FIBRYGA is used for
FIBRYGA is used for:


treatment of bleeding in patients with congenital lack of
fibrinogen (hypo- or afibrinogenaemia) with a bleeding
tendency.

2. What you need to know before you use FIBRYGA
Do NOT use FIBRYGA:


if you are allergic to human fibrinogen or any of the other
ingredients of this medicine (listed in section 6).

Your doctor will explain to you the warning signs of allergic or
anaphylactic-type reactions.

Other medicines and FIBRYGA
Tell your doctor or pharmacist if you are using, have recently used,
or might use any other medicines.
FIBRYGA must not be mixed with other medicines except those
mentioned in section “The following information is intended for
healthcare professionals only / Reconstitution”.
Pregnancy, breast-feeding and fertility

Please pay attention to early signs of allergic reactions
(hypersensitivity), such as:

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. This product should only be used
during pregnancy or breast-feeding after consultation with your
doctor or pharmacist.



hives



skin rash



tightness of the chest



wheezing

Driving and using machines



low blood pressure,

FIBRYGA has no influence on the ability to drive and use machines.



or anaphylaxis (when any or all of the above symptoms
develop rapidly and are intense).

If they occur, the injection / infusion of FIBRYGA should be stopped
immediately (i.e. discontinue injection).



careful selection of blood and plasma donors to make sure
those at risk of carrying infections are excluded

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Please contact your doctor immediately:


if any of the side effects occur



if you notice any side effects not listed in this leaflet

The following side effects have been reported for FIBRYGA and
other fibrinogen products (the frequency of the listed side effects is
not known):


Allergic or anaphylactic-type reactions:skin reactions)(see
section 2 “Warnings and precautions”)



Cardiovascular: thromboembolism, pulmonary embolism,
thrombophlebitis (see section 2 “Warnings and
precautions”)



increase in body temperature

FYBRINA contains sodium
This medicine contains up to 132 mg (5.8 mmol) sodium per bottle.
Please take this into account if you are on a controlled sodium diet.

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

Virus safety
When medicines are made from human blood or plasma, certain
measures are put in place to prevent infections being passed on to
patients. These include:

4. Possible side effects

3. How to use FIBRYGA
Reporting of side effects
Always use this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You

can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

Manufacturers

Elderly patients

Octapharma Pharmazeutika Produktionsges.m.b.H.

Clinical studies of FIBRYGA did not include patients age 65 and over
to provide conclusive evidence as to whether or not they respond
differently than younger patients.

Oberlaaer Strasse 235, 1100 Vienna, Austria

B.000.000.UK

2. Treatment of bleeding
Bleeding in patients with congenital hypo- or afibrinogenaemia

5. How to store FIBRYGA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Keep the bottle in the outer
carton to protect from light.
The powder should be dissolved only directly before injection/
infusion. The stability of the solution has been demonstrated for 24
hours at room temperature. Nevertheless, to prevent contamination,
the solution should be used immediately and on one occasion only.
The reconstituted product must not be stored in the refrigerator or
freezer.

This medicinal product is authorised in the Member States
of the EEA under the following names:
Fibryga: Austria, Belgium, Czech Republic, Denmark, Hungary,
Finland, Germany, Luxembourg, Norway, Poland, Portugal,
Slovakia, Sweden, United Kingdom

Method of Administration

Fibrema: Slovenia



This leaflet was last revised in 06/2017.

Reconstitution

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

The following information is intended for healthcare
professionals only:

6. Contents of the pack and other information

Posology

What FIBRYGA contains




The active substance is human fibrinogen. FIBRYGA
contains 1 g human fibrinogen per bottle or 20 mg/ mL
human fibrinogen after reconstitution with 50 mL water for
injection.
The other ingredients are L-arginine hydrochloride, glycine,
sodium chloride and sodium citrate dihydrate.

The dosage and duration of the substitution therapy depend on the
severity of the disorder, location and extent of bleeding and the
patient’s clinical condition.
The (functional) fibrinogen level should be determined in order
to calculate individual dosage and the amount and frequency of
administration should be determined on an individual patient basis
by regular measurement of plasma fibrinogen level and continuous
monitoring of the clinical condition of the patient and other
replacement therapies used.

What FIBRYGA looks like and contents of the pack

Normal plasma fibrinogen level is in the range of 1.5-4.5 g/l. The
critical plasma fibrinogen level below which haemorrhages may
occur is approximately 0.5 – 1.0 g/l.

FIBRYGA is a powder for solution for injection/ infusion and is
available in bottles.

In case of major surgical intervention, precise monitoring of
replacement therapy by coagulation assays is essential.

FIBRYGA is a white or pale yellow, hygroscopic powder or friable
solid. The reconstituted solution is almost colourless and slightly
opalescent.

1. Prophylaxis in patients with congenital hypo- or
afibrinogenaemia and known bleeding tendency.

FIBRYGA is sold in one carton containing:


1 bottle with powder for solution for injection/ infusion



1 Octajet transfer device



To prevent excessive bleeding during surgical procedures,
prophylactic treatment is recommended to raise fibrinogen levels
to 1 g/l and maintain fibrinogen at this level until haemostasis is
secured and above 0.5 g/l until wound healing is complete.
In case of surgical procedure or treatment of a bleeding episode, the
dose should be calculated as follows:

1 particle filter

Bleeding should be treated to achieve a recommended target
fibrinogen plasma level of 1 g/l. This level should be maintained until
haemostasis is secured.

General Instructions
The reconstituted solution should be almost colourless and
slightly opalescent. Do not use solutions that are cloudy or
have deposits.

1. Warm both the powder and a vial of 50ml water for
injection (WFI, not provided) in unopened bottles up to room
temperature. This temperature should be maintained during
reconstitution. If a water bath is used for warming, care must
be taken to avoid water coming into contact with the rubber
stoppers or the caps of the bottles. The temperature of the
water bath should not exceed +37°C (98°F).
2. Remove the cap from the concentrate (FIBRYGA) bottle and
the WFI to expose the central portion of the infusion stopper.
Clean the rubber stopper with an alcohol swab and allow the
rubber stopper of the bottles to dry.
3. Peel away the lid of the outer package of the Octajet transfer
device. To maintain sterility, leave the Octajet device in the
clear outer packaging.
4. Take the Octajet in its outer package and invert it over the
concentrate (FIBRYGA) bottle. Place device while in the outer
package onto the center of the FIBRYGA bottle until the clips
of the product spike (colorless) are locked. While holding onto
the concentrate bottle, carefully remove the outer package
from the Octajet, being careful to not touch the water spike
(blue) and leave the Octajet attached firmly to the concentrate
bottle. (Fig. 1)

7. When transfer of the WFI is complete, gently swirl the product
bottle until the powder is fully dissolved. Do not shake
the bottle to avoid foam formation. The powder should be
dissolved completely within approximately 5 minutes. It should
not take longer than 30 minutes to dissolve the powder. If the
powder is not dissolved within 30 minutes the product should
be discarded.
8. Turn the blue WFI bottle connector (both directions possible)
to bring position markers together and remove WFI bottle
together with the water spike. (Fig. 5)

Fig. 5
9. Attach a syringe to the provided filter (Fig. 6) and connect the
filter to the Octajet Luer Lock on the concentrate bottle (Fig. 7).
Withdraw the solution through the filter into the syringe. (Fig. 8)

Fig. 6

Fig. 7

Fig. 8

10. Detach the filled syringe from the filter and discard the empty
bottle.
A standard infusion set is recommended for intravenous application
of the reconstituted solution at room temperature.
Any unused medicinal product or waste material should be disposed
of in accordance with local requirements.
Method of administration
Intravenous infusion or injection.
FIBRYGA should be administered slowly intravenously at a
recommended maximum rate of 5 mL per minute.

Fig. 1
5. With the concentrate (FIBRYGA) bottle held firmly on a level
surface, invert the WFI bottle and place it at the center of the
water spike. Push the blue plastic cannula of the Octajet firmly
through the rubber stopper of the WFI bottle. (Fig. 2)

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

Incompatibilities
This medicinal product must not be mixed with other medicinal
products.

0.018 (g/L per mg/kg body weight)
Marketing Authorisation Holder and Manufacturer

Subsequent posology (doses and frequency of injections) should be
adapted based on the patient’s clinical status and laboratory results.

Marketing Authorization Holder

The biological half-life of fibrinogen is 3-4 days. Thus, in the absence
of consumption, repeated treatment with human fibrinogen is not
usually required. Given the accumulation that occurs in case of
repeated administration for a prophylactic use, the dose and the
frequency should be determined according to the therapeutic goals
of the physician for a given patient.

Octapharma Ltd.
The Zenith Building
26 Spring Gardens

Fig. 2
6. Remove the distance ring (Fig. 3) and press the WFI bottle
down (Fig. 4). WFI will flow into the concentrate (FIBRYGA)
bottle.

M2 1AB Manchester
Posology in specific populations

United Kingdom

Fig. 3

Paediatric Patients

Fig. 4

Currently available data are described in section 4.8. and 5.1. of
the SmPC but no recommendation on a posology can be made in
children.

5

6

B.000.000.UK

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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