Refixia 3000 ui polvo y disolvente para solucion inyectable

Product Information for the User

Refixia500UI Powder and Solvent for Injectable Solution

Refixia 1000UI Powder and Solvent for Injectable Solution

Refixia 2000UI Powder and Solvent for Injectable Solution

Refixia 3000UI Powder and Solvent for Injectable Solution

nonacog beta pegol

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4includes information on how to report these adverse effects.

Read this entire prospectus carefully before starting to use this medicine, as it contains important information for you.

•Keep this prospectus, as you may need to refer to it again.

•If you have any doubts, consult your doctor.

•This medicine has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

•If you experience adverse effects, consult your doctor, even if they are not listed in this prospectus. See section4.

1.What is Refixia and what is it used for

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

3.How to use Refixia

4.Possible adverse effects

5.Storage of Refixia

6.Contents of the package and additional information

What is Refixia

Refixiacontains the active ingredientnonacog beta pegol. It is a prolonged-action version of the factorIX. FactorIX is a protein that is naturally found in the blood and helps to stop bleeding.

What Refixia is used forRefixia

Refixia is used to treat and prevent bleeding episodes in patients of all age groups with hemophiliaB (congenital deficiency of factorIX).

In patients with hemophiliaB, factorIX is either lacking or does not function correctly. Refixia replacesthis missing or non-functioning factorIX and helps the blood to form clots at the site of bleeding.

No use Refixia

•If you are allergic to the active ingredient or to any of the other components of this medication (listed in section6).

•If you are allergic to hamster proteins.

If you find yourself in any of the above situations or are unsure, consult your doctor before using this medication.

Warnings and Precautions

Traceability

It is essential to maintain a record of the batch number of Refixia. Therefore, each time you obtain a new box of Refixia, you must note the date and batch number (which appears on the packaging after Lot) and store this information in a safe place.

Allergic Reactions and Inhibitor Development

A minimal risk exists of a sudden and severe allergic reaction (e.g., anaphylactic reaction) to Refixia. Stop the injection and contact your doctor or emergency services immediately if you experience signs of an allergic reaction, such as:

•Rash, hives, itching in large areas of the skin, redness, and/or swelling of the lips, tongue, face, or hands

•Difficulty swallowing or breathing, shortness of breath, wheezing, chest tightness, pale and cold skin, palpitations, and/or dizziness

Your doctor may need to treat these reactions quickly. Your doctor may also perform a blood test to check if you have developed inhibitors of factorIX (neutralizing antibodies) against your medication, as inhibitors can develop along with allergic reactions. If you develop these inhibitors, you may be at a higher risk of experiencing sudden and severe allergic reactions (e.g., anaphylactic reaction) during future treatment with factorIX.

Due to the risk of experiencing allergic reactions with factorIX, your initial treatment with Refixia should be carried out in a healthcare setting or in the presence of a healthcare professional who can provide appropriate medical attention if necessary.

Inform your doctor immediately if bleeding does not stop as expected or if you need to significantly increase the amount of Refixia to stop bleeding. Your doctor will perform a blood test to check if you have developed inhibitors (neutralizing antibodies) against Refixia. The risk of developing inhibitors is higher in individuals who have not been treated with factorIX medications before, generally in young children.

Blood Clots

Inform your doctor if you experience any of the following circumstances, as the risk of blood clot formation increases during Refixia treatment:

•You have recently undergone surgery

•You have any other serious illness, such as liver disease, heart disease, or cancer

•You have risk factors for developing heart disease, such as high blood pressure, obesity, or smoking.

Renal Disease (Nephrotic Syndrome)

A minimal risk exists of developing a specific renal disease called “nephrotic syndrome” after administration of high doses of factorIX in patients with hemophiliaB and inhibitors of factorIX, as well as a history of allergic reactions.

Complications Related to the Catheter

If you have a central venous access device (DAVC), you may develop infections or blood clots at the catheter insertion site.

Other Medications and Refixia

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using Refixia.

Driving and Operating Machines

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

Refixia Contains Sodium

This medication contains less than 1mmol of sodium (23mg) per vial; it is essentially “sodium-free.” In the case of treatment with multiple vials, the total sodium content should be considered.

A doctor with experience in treating patients with hemophilia will initiate treatment with Refixia. Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor again on how to use Refixia.

Your doctor will calculate your suitable dose based on your weight and the purpose for which the medication is being used.

Prevention of bleeding

The normal dose of Refixia is40units per kilogram of body weight. It is administered via injection once a week. Your doctor may choose another dose or change the frequency of injections according to your needs.

Treatment of bleeding

The normal dose of Refixia is40units per kilogram of body weight. It may be necessary to administer a higher dose (80units per kilogram) or additional injections depending on the location and severity of the bleeding. Consult with your doctor about the dose and number of injections you need.

Use in children and adolescents

Refixia can be used in children and adolescents of all ages. The dose in children and adolescents is also calculated based on body weight and is the same dose as for adults.

How to administer Refixia

Refixia is available in powder and solvent to prepare a solution (reconstitution) and should be injected into a vein.See “Instructions for using Refixia” for more information.

If you use more Refixia than you should

If you use more Refixia than you should, contact your doctor.

If you need to significantly increase the amount of Refixia you need to stop bleeding, inform your doctor immediately. For more information, see section2“Allergic reactions and development of inhibitors”.

If you forgot to use Refixia

If you forgot a dose, inject the missed dose as soon as you remember. Do not administer a double dose to compensate for the missed dose. If you have any doubts, contact your doctor.

If you interrupt treatment with Refixia

If you interrupt treatment with Refixia, you will no longer be protected against bleeding or it may be possible that an existing bleeding will not stop. Do not interrupt treatment with Refixia without first talking to your doctor.

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

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

It is possible to experience allergic reactions with this medicine.

If severe and sudden allergic reactions (anaphylactic reactions) occur, the injection must be stopped immediately. If you experience any of the following early symptoms of a severe allergic reaction (anaphylaxis), contact your doctor or emergency services immediately:

•Difficulty swallowing or breathing

•Lack of air or wheezing

•Chest tightness

•Redness and/or swelling of the lips, tongue, face, or hands

•Rashes, hives, itching, or prickling

•Pale and cold skin, palpitations, and/or dizziness (low blood pressure).

For children not previously treated with factor IX medications, the generation of inhibitors (see section 2) is common (up to 1 in 10 patients). If this occurs, the medication may not work properly and your child may experience persistent bleeding. If this occurs, you must contact your doctor immediately.

The following side effects have been observed with Refixia:

Frequent side effects(may affect up to1in10people)

•Allergic reactions (hypersensitivity). This can be severe and life-threatening (anaphylactic reactions)

•Itching (pruritus)

•Skin reactions at the injection site

•Nausea

•Feeling extremely tired

•Hives

•Children not previously treated with factor IX medications: neutralizing antibodies (inhibitors), anaphylactic reactions.

Rare side effects(may affect up to1in100people)

•Palpitations

•Headaches.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use Refixia after the expiration date that appears on the packaging and on the vial and preloaded syringe labels after “CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze. Store the vial in the outer packaging to protect it from light.

Refixia can be out of the refrigerator for a maximum period of 1 year and stored at room temperature (up to 30°C). Note on the packaging the date when you removed Refixia from the refrigerator and put it at room temperature. The new expiration date should never be later than the one on the carton. Discard this medication if you have not used it before the new expiration date. After storing the medication at room temperature, do not put it back in the refrigerator.

Use the injection immediately after preparing the solution (reconstitution). If you cannot use it immediately, you must use it within 24 hours if you store it in the refrigerator between 2°C and 8°C or within 4 hours if you store it out of the refrigerator at a maximum temperature of 30°C.

The powder in the vial is a white to off-white powder. Do not use it if the color of the powder has changed.

The reconstituted solution is transparent and colorless to slightly yellow. Do not use the reconstituted solution if you observe that it contains particles or discoloration.

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

Composition of Refixia

•The active principle is nonacog beta pegol (human coagulation factor IX [ADNr] pegylated). Each vial of Refixia contains 500 UI, 1,000 UI, 2,000 UI or 3,000 UI of nonacog beta pegol, which correspond to approximately 125 UI/ml, 250 UI/ml, 500 UI/ml or 750 UI/ml respectively after reconstitution with histidine solvent.

•The other components of the powder are sodium chloride, histidine, sucrose, polisorbate 80, mannitol, sodium hydroxide and hydrochloric acid. See section 2 “Refixia contains sodium”.

•The components of the sterilized solvent are histidine, water for injection, sodium hydroxide and hydrochloric acid.

Appearance of Refixia and contents of the package

•Refixia is supplied as a powder and solvent for injectable solution (500 UI, 1,000 UI, 2,000 UI or 3,000 UI of powder in a vial and 4 ml of solvent in a pre-filled syringe, a plunger rod with a vial adapter; package size 1).

•The powder is white to off-white and the solvent is transparent and colourless.

Holder of the marketing authorisation and manufacturer responsible

Novo Nordisk A/S

Novo Allé

DK-2880Bagsværd, Denmark

Date of the last review of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.