Riastap

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Riastap, 1 g
Powder for solution for injection / for infusion.
Human fibrinogen
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Riastap is and what it is used for

What Riastap is?
Riastap contains human fibrinogen, which is an important protein for blood clotting
(coagulation). A lack of fibrinogen means that blood does not clot as quickly as it should, leading to an increased tendency to bleed. Replacing human fibrinogen with Riastap helps restore normal clotting mechanisms.
What Riastap is used for?
Riastap is used in the treatment of bleeding in patients with congenital fibrinogen deficiency
(hypo- or afibrinogenemia) who have a tendency to bleed.

2. Important information before using Riastap

The information provided in this section should be taken into account by the physician before administering the Riastap medication.
When not to use Riastap:

• if the patient has an allergy to human fibrinogen or to any of the other components of this medicine (listed in section 6.). If the patient has an allergy to any medication or food, they must inform the physician.

Warnings and precautions:

• if the patient previously experienced allergic reactions to Riastap. In such cases, prophylactic administration of antihistamines and corticosteroids should be considered, if recommended by the physician.
• if allergic reactions or anaphylactic-type reactions (severe allergic reactions causing serious breathing difficulties or dizziness) occur. Administration of Riastap must be immediately discontinued (e.g. by stopping the injection).
• due to the increased risk of blood clot formation in blood vessels (thrombosis), particularly:
• when a high dose is administered or repeated dosing is required
• if the patient has a history of heart disease (coronary heart disease or myocardial infarction)
• in case of liver disease
• immediately after surgical procedures (postoperative patients)
• shortly before surgical procedures (preoperative patients)
• in newborn infants (neonates)
• if there is a higher-than-normal tendency to form blood clots (patients at risk of thromboembolic disorders or disseminated intravascular coagulation)

The physician will assess the benefit-risk ratio of therapy with Riastap versus the risks associated with the complications listed above.
Viral safety
For medicinal products derived from human blood or plasma, measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors to exclude infected individuals, and
• testing of individual donations and plasma pools for the presence of viruses/infections.

Manufacturers of these products also incorporate steps in the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, however, it cannot be completely excluded that infectious agents may be transmitted during administration of medicinal products derived from human blood or plasma. This includes unknown or newly emerging viruses and other types of infections.
These procedures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV, the virus causing AIDS), hepatitis B virus and hepatitis C virus (inflammatory conditions of the liver), as well as against non-enveloped viruses such as hepatitis A virus (inflammatory condition of the liver) and parvovirus B19.
The physician may recommend considering vaccination against hepatitis A and B in case of regular or repeated administration of products derived from human plasma.
It is recommended that the physician records the date of administration, batch number, and volume injected.
Riastap and other medicines

• Inform the physician or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
• Riastap must not be mixed with other medicinal products, except as described in the section “Information intended exclusively for healthcare professionals / Reconstitution”.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her physician or pharmacist before using this medicine.
• During pregnancy or breastfeeding, Riastap should be administered only if clearly needed.

Driving and operating machinery
Riastap has no effect or negligible effect on the ability to drive motor vehicles or operate machinery.
Important information about certain components of Riastap
Riastap contains up to 164 mg (7.1 mmol) of sodium per vial. This corresponds to 11.5 mg (0.5 mmol) of sodium per kg of body weight when the recommended initial dose of 70 mg/kg body weight is administered. This should be taken into consideration when treating patients on a sodium-controlled diet.

3. How to use Riastap

Treatment should be initiated and supervised by a physician experienced in the management of this
type of disorder.
Dosage
The required amount of human fibrinogen and duration of therapy depend on:

• severity of the disease
• location and intensity of bleeding
• clinical condition of the patient. Administration of a higher than recommended dose of Riastap The physician should regularly monitor the patient's coagulation status during therapy. In case of overdose, the risk of thromboembolic complications is increased.

Method of administration
If you have any questions regarding the use of this product, consult your
physician or pharmacist (see section "Information intended exclusively for healthcare professionals").

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not
everyone will experience them.
You should contact your doctor immediately:

• if any adverse reactions occur
• if any adverse reactions not listed in this leaflet occur.

The following adverse reactions have been observed very commonly (may occur in more than 1
in 10 people):

• Increased body temperature

The following adverse reactions have been observed uncommonly (in less than 1 in 100 people):

• Sudden allergic reaction (such as skin redness, generalized skin rash, drop in blood pressure, difficulty breathing).

The following adverse reactions have been observed commonly (in less than 1 in 10 people; however,
these events occur more frequently in patients not receiving fibrinogen):

• Risk of increased blood clot formation (see section 2, “Warnings and precautions”).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: ://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Riastap

• Keep the medicine out of the sight and reach of children.
• Do not use Riastap after the expiry date stated on the label and carton.
• Do not store above 25°C. Do not freeze.
• To protect from light, the vial should be stored in the outer packaging.
• The reconstituted solution should ideally be used immediately.
• If the prepared solution is not administered immediately, it may be stored for a maximum of 8 hours at room temperature (max. 25°C).
• The reconstituted solution must not be refrigerated.

6. Contents of the pack and other information

What Riastap contains
Active substance:
Human fibrinogen (1 g/vial; after reconstitution in 50 ml of water for injections approximately
20 mg/ml).
For more detailed information, see section "Information exclusively intended for medical personnel".
Other components:
Human albumin, sodium chloride, L-arginine hydrochloride, sodium citrate, sodium hydroxide
(for pH adjustment).
See the last section of part 2: "Important information about some components of Riastap".

What Riastap looks like and contents of the pack
Riastap is a white powder.
After reconstitution in water for injections, the resulting solution should be clear or slightly opalescent, i.e. it may shimmer when viewed under light, but must not contain any visible particles.

Packaging
Pack containing 1 g (Fig. 1)
One vial containing 1 g of human fibrinogen
Filter: Pall syringe filter
Dosing spike: Mini-Spike dosing spike

Fig. 1

Marketing Authorisation Holder and Manufacturer:
CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is registered in the European Economic Area (EEA) Member States
under the following names:
Riastap 1g, powder for solution for injection/infusion United Kingdom
Riastap 1g, poudre pour solution injectable/perfusion France
Riastap 1g, prašek za raztopino za injiciranje ali infundiranje Slovenia
Riastap 1g Germany, Ireland
Riastap Belgium, Cyprus, Denmark, Finland, Greece, Iceland, Italy, Luxembourg,
Malta, Norway, Poland, Slovakia, Spain, Sweden

Information intended exclusively for medical professionals

Dosage:
Fibrinogen (functional) levels should be measured to calculate the individual dosage, volume, and frequency of administered doses for each patient, through regular monitoring of plasma fibrinogen levels and continuous assessment of the patient's clinical status, taking into account other concomitant replacement therapies.
Normal plasma fibrinogen levels range between 1.5 – 4.5 g/l. The critical plasma fibrinogen level, below which bleeding may occur, is approximately 0.5 – 1 g/l. In cases of major surgical procedures, careful monitoring of replacement therapy with coagulation tests is required.

Initial dose
If the patient's fibrinogen level is unknown, the recommended intravenous dose is 70 mg per kg of body weight.

Subsequent doses
The target level (1 g/l) should be maintained for at least three days in cases of mild bleeding (e.g., epistaxis, intramuscular or menstrual bleeding). The target level (1.5 g/l) should be maintained for seven days in cases of severe bleeding (e.g., head trauma or intracranial hemorrhage).

Fibrinogen dose = [Target level (g/l) – measured level (g/l)]
(mg/kg body weight) 0.017 (g/l per mg/kg body weight)

Dosage in newborns, infants, and children
Clinical data on Riastap dosing in pediatric patients are limited. However, dosing recommendations in pediatric therapy are the same as in adults, based on available clinical studies and long-term clinical experience with fibrinogen products.

Administration instructions

General information

• Reconstitution and product withdrawal must be performed under aseptic conditions.
• Reconstituted solutions should be visually inspected prior to administration to exclude the presence of particles or discoloration.
• The solution should be nearly colorless to slightly yellowish, clear to slightly opalescent, with neutral pH. Do not use solutions that are cloudy or contain precipitates.

Reconstitution

• Warm both the solvent and the powder to room temperature or body temperature (not exceeding 37°C) without opening the vials.
• Reconstitute Riastap with Water for Injections (50 ml, not supplied).
• Wash hands or wear gloves before reconstitution.
• Remove the cap from the Riastap vial to expose the central portion of the stopper.
• Wipe the stopper surface with an antiseptic solution and allow it to dry.
• Introduce the solvent into the vial using appropriate equipment. Ensure that the powder is completely wetted.
• Gently swirl the vial until the powder is fully dissolved. Avoid vigorous shaking, which may cause foaming. Complete dissolution typically occurs within approximately 5 minutes. The entire process should not exceed 15 minutes.
• Open the plastic blister containing the provided Mini-Spike transfer device supplied with the Riastap medicinal product (Fig. 2).

Fig. 2

• Insert the provided Mini-Spike transfer device into the stopper of the vial containing the reconstituted product (Fig. 3).

Fig. 3

• After inserting the transfer device, remove the cap. Do not touch the exposed surface after cap removal.
• Open the blister containing the filter (Pall syringe filter) supplied with the Riastap medicinal product (Fig. 4).

Fig. 4
Screw the syringe onto the filter (Fig. 5).

Fig. 5

• Attach the syringe with the connected filter to the transfer device (Fig. 6).

Fig. 6

• Draw the reconstituted product into the syringe (Fig. 7).

Fig. 7

• After completion, detach the filter, transfer device, and empty vial from the syringe. Dispose of all components according to applicable regulations. Begin administration of the drug as recommended. The reconstituted solution should be administered immediately using a dedicated injection/infusion set.
• Take care to avoid aspirating blood into the syringe filled with the product.

Any unused portions of the medicinal product or waste materials should be disposed of
in accordance with local regulations.

Administration method
For intravenous administration, the reconstituted solution at room temperature should be administered using a standard infusion set. The reconstituted solution should be injected or infused slowly at a rate appropriate for patient comfort. The infusion or injection rate should not exceed approximately 5 ml per minute.