Coagadex 500 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Coagadex 250 IU powder and solvent for solution for injection

Coagadex 500 IU powder and solvent for solution for injection

human coagulation factor X

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, ask your doctor.
• 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 could 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 Coagadex is and what it is used for
2. What you need to know before using Coagadex
3. How to use Coagadex
4. Possible side effects
5. How to store Coagadex
6. Contents of the pack and other information

1. What Coagadex is and what it is used for

Coagadex is a human coagulation factor X concentrate, a protein necessary for blood to clot. The factor X in Coagadex is derived from human plasma (the liquid part of blood). It is used to treat and prevent bleeding in patients with hereditary factor X deficiency, including during surgery.

Patients with hereditary factor X deficiency do not have enough factor X in their blood for normal blood clotting, which can lead to excessive bleeding. Coagadex replaces the missing factor X and allows blood to clot normally.

2. What you need to know before using Coagadex

Do not use Coagadex:

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

Check with your doctor if this applies to you.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Coagadex:

• if you experience bleeding that is more severe or lasts longer than usual, or if bleeding does not stop after injection of Coagadex;
• if you are taking a medication to prevent blood clots that works by blocking coagulation factor Xa. These medications may prevent Coagadex from working properly.

Some patients with deficient factor X may develop inhibitors (antibodies) against factor X during treatment, which could prevent this medicine from working correctly. Your doctor will regularly check for the presence of these antibodies, especially before surgery. Before and after treatment with this medicine, particularly during the first treatment cycle, your doctor will likely perform tests to monitor your blood factor X levels.

Viral safety

When medicines derived from human blood or plasma are administered, certain measures are applied to prevent the transmission of infections to recipients. These measures include:

• careful selection of blood and plasma donors to exclude those who might transmit infections,
• testing donated plasma for viruses/infections,
• inclusion of manufacturing steps that inactivate or remove viruses during the processing of blood or plasma.

The measures applied are considered effective against the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus, and parvovirus B19. Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This also includes unknown or emerging viruses and other types of infections.

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

If you regularly or repeatedly receive factor X products derived from human plasma, your doctor may recommend that you consider vaccination against hepatitis A and B.

Children and adolescents

The warnings and precautions mentioned for adults also apply to children (aged 2 to 11 years) and adolescents (aged 12 to 18 years).

Using Coagadex with other medicines

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

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 or pharmacist before using this medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed.

Coagadex contains sodium

This medicine contains up to 9.2 mg of sodium (a main component of table/cooking salt) per millilitre of solution. This corresponds to 0.0046% of the maximum daily recommended sodium intake for an adult.

3. How to use Coagadex

Treatment should be initiated by a physician experienced in the treatment of coagulation disorders.

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Coagadex must be injected directly into a vein. Before injecting this product at home, a healthcare professional must have provided you with training on how to do so.

Your doctor will explain how much to use, when to use it, and for how long. Generally, the dose prescribed by your doctor will be the number of complete vials containing the appropriate dose for you. Doses exceeding 60 IU/kg per day must not be administered in any age group.

Use in adults

How much Coagadex should be administered to treat bleeding or to prevent future bleeding?
Your doctor will tell you how much Coagadex to administer to treat bleeding and to prevent future bleeding; the required dose will depend on your normal blood levels of factor X.

How much should be administered before, during, and after major surgery?

Before: The dose of Coagadex used should be sufficient to increase factor X in the blood to a level between 70 and 90 IU/dL. The dose you require will depend on your normal blood factor X levels and will be calculated by your doctor.

After: During the first few days after surgery, plasma factor X concentration will be monitored regularly. It is recommended that your blood factor X level be maintained above 50 IU/dL. Your doctor will calculate the dose you require.

If your blood concentration of factor X is too low (this will be assessed by your doctor) or decreases faster than expected, this may be due to the presence of a factor X inhibitor that prevents the medicine from working properly. Your doctor will order appropriate laboratory tests to determine if this is the case.

How much should be administered regularly for long-term prevention of bleeding?
Your doctor will advise you whether this use is appropriate for your case and, if so, will determine the corresponding dose.

Use in children and adolescents

Your doctor will recommend an appropriate dose for you or your child. Doses for children under 12 years of age are generally higher than doses for adolescents and adults. Doses for adolescents will be similar to those for adults.

When to inject Coagadex

• The medicine should be injected at the first sign of bleeding.
• The injection should be repeated as necessary to stop the bleeding.
• The severity of each bleeding episode should be assessed individually.
• The first time you use this medicine, you will be supervised by your doctor.

Reconstitution of the medicine before use

Your medicine must only be reconstituted with the solvent provided with the product.

Coagadex is supplied together with the amount of solvent as shown in the table.

You may reconstitute this medicine using the Mix2Vial needle-free transfer device included in the package.

Allow the Coagadex vials to reach room temperature before mixing. Reconstitute the medicine as follows:

Do not use this medicine:

• if the solvent does not pass into the vial (this indicates loss of vacuum in the vial, in which case the powder must not be used).

• if the dissolved powder and solvent form a gel or a clot (if this occurs, inform your healthcare provider, reporting the batch number printed on the vial).

If you use more Coagadex than you should

If you administer more of this medicine than your doctor prescribed, you may develop a blood clot. If you think you are using too much product, stop the injections and consult your doctor, pharmacist, or nurse. If you know you have used too much, inform your doctor, pharmacist, or nurse as soon as possible.

If you forget to use Coagadex

Do not use a double dose to make up for forgotten doses. Inject your normal dose as soon as you remember, then continue with the administration schedule indicated by your doctor.

If you stop treatment with Coagadex

Always consult your doctor before deciding to stop your treatment.

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

4. Possible adverse effects

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

Allergic reactions (hypersensitivity reactions) have occurred rarely during treatment of coagulation disorders with similar medicines (may affect up to 1 in 1,000 people), and in some cases have progressed to shock. Signs of such reactions may include skin rash (such as hives), tingling, flushing, nausea, vomiting, headache, wheezing (whistling sounds when breathing), chest tightness, chills, rapid heartbeat, dizziness, lethargy, restlessness, facial swelling, throat tightness, and discomfort at the infusion site. If you experience any of these adverse effects, contact your doctor.

The following adverse effects have been reported with Coagadex.

Frequent (may affect up to 1 in 10 people):

• pain or redness at the infusion site
• fatigue
• back pain

Adverse effects in children and adolescents

Adverse effects 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 through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Coagadex

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

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

The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Do not freeze.

Keep the container in the outer packaging to protect it from light.

Do not use this medicine if you notice small particles in the reconstituted solution. Once reconstituted, Coagadex must be used within one hour.

Medicines must not be disposed of via wastewater or household waste. Your treatment centre will provide you with a special container to dispose of any leftover solution, used syringes, needles, and empty containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Coagadex

• The active substance is human coagulation factor X. One vial contains 250 IU or 500 IU nominal of human coagulation factor X.
• The other components are: citric acid, disodium phosphate dihydrate, sodium chloride, sodium hydroxide, and sucrose (see section 2 for more information about the components).

Solvent: water for injections.

Appearance of Coagadex and contents of the pack

Coagadex is a white or almost white powder, packed in 250 IU and 500 IU strengths. After reconstitution, the solution is colourless, clear or slightly opalescent. Before injection, inspect the solution. Do not use if it is cloudy or contains particles.

A Mix2Vial transfer device is also provided.

Contents of the 250 IU pack

1 vial containing 250 IU of powder

1 vial containing 2.5 ml of water for injections

1 transfer device (Mix2Vial)

Contents of the 500 IU pack

1 vial containing 500 IU of powder

1 vial containing 5 ml of water for injections

1 transfer device (Mix2Vial)

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kedrion S.p.A. Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca), Italy.

Manufacturer

PharmaKorell GmbH, Georges-Köhler-Str. 2, 79539 Lörrach, Germany

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu.