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REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

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About the medicine

How to use REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introduction
  2. What is Refixia and what is it used for
  3. What you need to know before you use Refixia
  4. How to use Refixia
  5. Possible side effects
  6. Storage of Refixia
  7. Container Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Refixia500UI powder and solvent for solution for injection

Refixia 1000UI powder and solvent for solution for injection

Refixia 2000UI powder and solvent for solution for injection

Refixia 3000UI powder and solvent for solution for injection

nonacog beta pegol

This medicinal product is subject to additional monitoring, which will allow for 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.
  • 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Refixia and what is it used for
  2. What you need to know before you use Refixia
  3. How to use Refixia
  4. Possible side effects
  5. Storage of Refixia
  6. Contents of the pack and other information

1. What is Refixia and what is it used for

What is Refixia

Refixia contains the active substance nonacog beta pegol. It is a long-acting factor IX. Factor IX is a protein that is naturally found in the blood and helps to stop bleeding.

What Refixia is used for

Refixia is used to treat and prevent bleeding episodes in patients of all ages with haemophilia B (congenital factor IX deficiency).

In patients with haemophilia B, factor IX is missing or does not work properly. Refixia replaces the missing or non-functioning factor IX and helps the blood to form clots at the site of bleeding.

Doctor consultation

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2. What you need to know before you use Refixia

Do not use Refixia

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to hamster proteins.

If you are in any of these situations or are not sure, consult your doctor before using this medicine.

Warnings and precautions

Traceability

In order to improve the tracing of any adverse reactions, it is important to keep a record of the batch number of Refixia. Therefore, each time you get a new pack of Refixia, note the batch number (which is printed on the carton after the word ‘Batch’) and the date you got it, and keep this information in a safe place.

Allergic reactions and development of inhibitors

There is a small risk that you may develop an allergic reaction to Refixia. Stop the injection and contact your doctor or emergency services immediately if you get any signs of an allergic reaction, such as rash, hives, itching over large areas of the body, 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 you promptly for these reactions. Your doctor may also do a blood test to check if you have developed inhibitors (neutralising antibodies) to your medicine, as inhibitors can develop together with allergic reactions. If you develop such inhibitors, you may have a higher risk of getting severe allergic reactions (e.g. anaphylactic reactions) during future treatment with factor IX.

Because of the risk of allergic reactions with factor IX, your initial treatment with Refixia should be carried out in a hospital or in the presence of a healthcare professional who can provide you with appropriate medical care in case of an allergic reaction.

Tell your doctor immediately if bleeding does not stop as expected or if you need to increase significantly the amount of Refixia you need to stop a bleed. Your doctor will do a blood test to check if you have developed inhibitors (neutralising antibodies) to Refixia. The risk of developing inhibitors is higher in people who have not been treated before with factor IX medicines, usually in young children.

Blood clots

Tell your doctor if you have any of the following, as the risk of blood clots increases during treatment with Refixia:

  • you have recently had surgery
  • you have other serious illnesses, such as liver disease, heart disease or cancer
  • you have risk factors for developing heart disease, such as high blood pressure, obesity or smoking.

Kidney disease (nephrotic syndrome)

There is a small risk of developing a specific kidney disease called “nephrotic syndrome” after administration of high doses of factor IX in patients with haemophilia B and factor IX inhibitors, as well as a history of allergic reactions.

Catheter-related complications

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

Other medicines and Refixia

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Refixia.

Driving and using machines

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

Refixia contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially ‘sodium-free’. In case of treatment with multiple vials, the total sodium content should be taken into account.

3. How to use Refixia

Treatment with Refixia should be started by a doctor who has experience in the treatment of patients with haemophilia B. Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, ask your doctor again how to use Refixia.

Your doctor will calculate the dose you need based on your weight and what the medicine is being used for.

Bleeding prevention

The usual dose of Refixia is 40 international units (IU) per kg body weight. It is given by injection once a week. Your doctor may choose a different dose or change how often you get injections, based on your needs.

Bleeding treatment

The usual dose of Refixia is 40 international units (IU) per kg body weight. Depending on the location and severity of the bleed, you may need a higher dose (80 IU per kg) or additional injections. Ask 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 Refixia is given

Refixia is available as powder and solvent for solution for injection (reconstitution) and should be injected into a vein. See “Instructions for using Refixia” for further information.

If you use more Refixia than you should

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

If you need to increase significantly the amount of Refixia you need to stop a bleed, tell your doctor immediately. For more information, see section 2 “Allergic reactions and development of inhibitors”.

If you forget to use Refixia

If you forget a dose, inject the missed dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose. If you are not sure, ask your doctor.

If you stop using Refixia

If you stop using Refixia, you will no longer be protected against bleeding or a bleed that is already happening may not stop. Do not stop using Refixia without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions can occur with this medicine.

If severe allergic reactions (e.g. anaphylactic reactions) occur, the injection must be stopped immediately. If you get any of the following early signs of a severe allergic reaction (anaphylactic reaction), contact your doctor or emergency services immediately:

  • difficulty swallowing or breathing
  • shortness of breath or wheezing
  • chest tightness
  • redness and/or swelling of the lips, tongue, face or hands
  • rash, hives, itching or prickling sensation
  • pale and cold skin, palpitations and/or dizziness (low blood pressure).

For previously untreated children with factor IX medicines, the development of inhibitors (see section 2) is common (up to 1 in 10 patients). If this happens, the medicine may stop working properly and your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.

The following side effects have been observed with Refixia:

Common side effects(may affect up to 1 in 10 people)

  • allergic reactions (hypersensitivity). This can be severe and may be life-threatening (anaphylactic reactions)
  • itching (pruritus)
  • skin reactions at the injection site
  • nausea
  • feeling very tired
  • rash
  • previously untreated children with factor IX medicines: neutralising antibodies (inhibitors), anaphylactic reactions.

Uncommon side effects(may affect up to 1 in 100 people)

  • palpitations
  • flushing.

Reporting of side effects

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

5. Storage of Refixia

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

Do not use Refixia after the expiry date which is stated on the carton and on the labels of the vial and the pre-filled syringe after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

Refixia can be stored at room temperature (up to 30°C) for a maximum of 1 year. Note the date you removed Refixia from the refrigerator and the new expiry date on the carton. The new expiry date should never be later than the one printed on the carton. Discard this medicine if you have not used it after the new expiry date. After storage at room temperature, do not put it back in the refrigerator.

Use the injection immediately after reconstitution. If you cannot use it immediately, it can be used within 24 hours if stored in a refrigerator (2°C - 8°C) or within 4 hours if stored at room temperature (up to 30°C).

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

The reconstituted solution is clear and colourless to slightly yellow. Do not use the reconstituted solution if you notice it contains particles or discolouration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container Contents and Additional Information

Composition of Refixia

  • The active substance is nonacog beta pegol (human coagulation factor IX [rDNA] pegylated). Each vial of Refixia contains 500 IU, 1,000 IU, 2,000 IU, or 3,000 IU of nonacog beta pegol, which corresponds to approximately 125 IU/ml, 250 IU/ml, 500 IU/ml, or 750 IU/ml, respectively, after reconstitution with the histidine solvent.
  • The other components of the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, and hydrochloric acid. See section 2 "Refixia contains sodium".
  • The components of the sterilized solvent are histidine, water for injectable preparations, sodium hydroxide, and hydrochloric acid.

Appearance of Refixia and Container Contents

  • Refixia is supplied as a powder and solvent for solution for injection (500 IU, 1,000 IU, 2,000 IU, or 3,000 IU of powder in a vial and 4 ml of solvent in a pre-filled syringe, a plunger rod with a vial adapter; package size of 1).
  • The powder is white to off-white and the solvent is transparent and colorless.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

Date of Last Revision of this Leaflet:

Other Sources of Information

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

Instructions for UseRefixia

Read these instructions carefully before using Refixia.

Refixia is supplied as a powder. Before injection, a solution (reconstituted) must be prepared with the supplied solvent in the syringe. The solvent is a histidine solution. The reconstituted solution must be injected into a vein (intravenous [IV] injection). The components of this package are designed to reconstitute and inject Refixia.

You will also need an intravenous infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze, and bandages. These materials are not included in the Refixia package.

Do not use the equipment without having received proper training from your doctor or nurse.

Always wash your hands and ensure the area around you is clean.

When preparing and injecting the medication directly into the veins, it is essential to use a clean and germ-free (aseptic) technique.Incorrect technique can introduce germs that can infect the blood.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped or is damaged.Use a new package instead.

Do not use the equipment if it has expired.Use a new package instead. The expiration date is printed on the outer packaging, the vial, the vial adapter, and the pre-filled syringe.

Do not use the equipment if you suspect it is contaminated.Use a new package instead.

Do not discard any components until the reconstituted solution has been injected.

The equipment is for single use.

Contents

The package contains:

  • 1 vial with Refixia powder
  • 1 vial adapter
  • 1 pre-filled syringe with solvent
  • 1 plunger rod (located under the syringe)

Glass vial with blue plastic cap and rubber stopper indicated with arrows and labels

Vial adapter with transparent protective cover and visible spike under white protective paper

Pre-filled syringe with plunger and graduated scale showing the syringe cap and tip under the cap

Plunger rod with thread on one end and wide end with visible inner and outer cylinder

  1. Prepare the vial and syringe
  • Prepare the number of Refixia packages you need.
  • Check the expiration date.
  • Check the name, concentration, and color of the package to ensure it contains the correct product.
  • Wash your hands and dry them properly with a clean towel or air.
  • Remove the vial, vial adapter, and pre-filled syringe from the package. Leave the plunger rod untouched in the package.
  • Bring the vial and pre-filled syringe to room temperature. You can do this by holding both in your hands until you feel they are at the same temperature as your hands.
  • Do not use any other system to heat the vial and pre-filled syringe.

Hands holding two components of an auto-injector, preparing to assemble them for use

  • Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial.
  • Clean the rubber stopper with a sterile alcohol swab and let it air dry for a few seconds before using it to ensure it is as germ-free as possible.
  • Do not touch the rubber stopper with your fingers, as this can transfer germs.

Hand holding a vial of medication with a needle inserted into the top stopper and an arrow indicating the direction of withdrawal

  1. Place the vial adapter
  • Remove the protective paper from the vial adapter.

If the protective paper is not fully sealed or is broken, do not use the vial adapter.

Do not remove the vial adapter from the protective cover with your fingers.If you touch the spike of the vial adapter, you can transfer germs from your fingers.

Hands holding an applicator with a visible needle and a blue arrow indicating the direction of insertion

  • Place the vial on a flat, hard surface.
  • Place the protective cover upside down and press the vial adapter firmly onto the vial.

Once attached, do not remove the vial adapter from the vial.

Hand holding an auto-injector pressing against the skin with an arrow indicating the direction and a vial underneath

  • Slightly compress the protective cover between your thumb and index finger, as shown.

Remove the protective coverfrom the vial adapter.

Do not remove the vial adapter from the vialwhen removing the protective cover.

Hand holding an auto-injector with a transparent needle downward on a flat surface with a blue arrow indicating the direction

  1. Assemble the plunger rod and syringe
  • Hold the plunger rod by the wide end and remove it from the package. Do not touch the sides or thread of the plunger rod. If you touch the sides or thread, you can transfer germs from your fingers.
  • Immediately connect the plunger rod to the syringe by turning it clockwise inside the plunger in the pre-filled syringe until you feel resistance.

Hands holding a syringe with a transparent needle and a curved arrow indicating the direction of plunger withdrawal

  • Remove the syringe cap by folding it downward until the perforation breaks.
  • Do not touch the tip of the syringe under the syringe cap. If you touch the tip of the syringe, you can transfer germs from your fingers.

If thesyringe capis loose or missing, do not use the pre-filled syringe.

Two hands holding the ends of a pre-filled injection device with an arrow indicating connection

  • Tightly screw the pre-filled syringe onto the vial adapter until you feel resistance.

Hands holding a pre-filled injection device with a blue arrow indicating the direction of rotation

  1. Reconstitute the powder with the solvent
  • Hold the pre-filled syringe slightly inclined with the vial pointing downward.
  • Press the plunger rod to inject all the solvent into the vial.

Hand holding a syringe with a needle inserted, blue arrow indicating the direction of injection, and details of the syringe parts

  • Keep the plunger rod pressed and gently swirl the vial until the powder is dissolved.

Do not shake the vial, as this would produce foam.

  • Check the reconstituted solution. It should be transparent and colorless to slightly yellow and should not have visible particles. If you observe particles or a color change, do not use it. Use a new package instead.

Auto-injector device with gray button and transparent cylinder showing a curved arrow indicating rotation to activate

It is recommended to use Refixia immediately after reconstitution,as, if left, the medication may lose sterility and could cause infections.

If you cannot use the reconstituted Refixia solution immediately,you must use it within 4 hours if stored at room temperature (up to 30°C) and within 24 hours if stored in the refrigerator (between 2°C and 8°C). Store the reconstituted product in the vial.

Do not freeze the reconstituted Refixia solution or store it in syringes.

Store the reconstituted Refixia solution away from direct light.

If your dose requires more than one vial, repeat steps Ato Jwith additional vials, vial adapters, and pre-filled syringes until the required dose is reached.

  • Keep the plunger rod fully pressed inward.
  • Turn the syringe upside down with the vial pointing downward.
  • Release the pressure on the plunger rod and let it move back by itself as the reconstituted solution fills the syringe.
  • Pull the plunger rod slightly downward to move the reconstituted solution into the syringe.
  • If you only need part of the vial, use the syringe scale to see the amount of reconstituted solution you have withdrawn, as instructed by your doctor or nurse.

If there is air in the syringe at any time, inject the air back into the vial.

  • While holding the vial upside down, gently tap the syringe to make any bubbles rise to the top.
  • Slowly press the plunger rod until all bubbles are removed.

Hand holding a pre-filled syringe transparent and blue with an arrow indicating the direction of injection downward

  • Unscrew the adapter with the vial.
  • Do not touch the tip of the syringe. If you touch the tip of the syringe, you can transfer germs from your fingers.

Hand holding an auto-injector connecting to a medication vial with curved arrows indicating connection

  1. Inject the reconstituted solution

Refixia is now ready to be injected into a vein.

  • Inject the reconstituted solution following the instructions of your doctor or nurse.
  • Inject slowly over 1 to 3 minutes.
  • Do not mix Refixia with any other infusion solution or intravenous medication.

Injection of Refixia through needle-free connectors for intravenous (IV) catheters

Precaution:the pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needle-free connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility can prevent administration of the medication and/or damage the needle-free connector.

Injection of the solution through a central venous access device (CVAD) such as a central venous catheter or subcutaneous port:

  • Use a clean and germ-free (aseptic) technique. Follow the instructions for the proper use of your connector and CVAD with the advice of your doctor or nurse.
  • Injection into a CVAD may require using a sterile 10 ml plastic syringe to withdraw the reconstituted solution. This should be done immediately after step J.
  • If it is necessary to flush the CVAD line before or after the injection of Refixia, use a sodium chloride 9 mg/ml injectable solution.

Disposal

  • After injection, safely discard any unused Refixia solution, the syringe with the intravenous infusion set, the vial with the vial adapter, and other waste following the instructions of your pharmacist.

Do not throw it away in household trash.

Vial with rubber stopper crossed by lines, needle inserting, and arrow indicating direction toward a small transparent vial

Do not disassemble the equipment before disposing of it.

Do not reuse the equipment.

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5.0 (112)
Doctor

Roman Raevskii

General medicine 7 years exp.

Dr. Roman Raevskii is a licensed general practitioner in Spain, offering online medical consultations with a strong focus on prevention, early diagnosis, and personalized care. He combines evidence-based clinical expertise with a patient-centered approach to deliver comprehensive support.

Dr. Raevskii provides medical care in the following areas:

  • Diagnosis and management of common conditions: hypertension, diabetes, respiratory and digestive disorders.
  • Oncological consultations: early cancer detection, risk evaluation, and treatment navigation.
  • Supportive care for oncology patients – pain control, symptom relief, and side effect management.
  • Preventive medicine and health screenings.
  • Development of tailored treatment plans based on clinical guidelines.

With a patient-centred approach, Dr. Raevskii helps individuals manage both chronic illnesses and complex oncological cases. His consultations are guided by current medical standards and adapted to each patient’s needs.
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€55
5.0 (21)
Doctor

Jonathan Marshall Ben Ami

Family medicine 9 years exp.

Dr. Jonathan Marshall Ben Ami is a licensed family medicine doctor in Spain. He provides comprehensive care for adults and children, combining general medicine with emergency care expertise to address both acute and chronic health concerns.

Dr. Ben Ami offers expert diagnosis, treatment, and follow-up for:

  • Respiratory infections (cold, flu, bronchitis, pneumonia).
  • ENT conditions such as sinusitis, ear infections, and tonsillitis.
  • Digestive issues including gastritis, acid reflux, and irritable bowel syndrome (IBS).
  • Urinary tract infections and other common infections.
  • Management of chronic diseases: high blood pressure, diabetes, thyroid disorders.
  • Acute conditions requiring urgent medical attention.
  • Headaches, migraines, and minor injuries.
  • Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.
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€55
1

Frequently Asked Questions

Is a prescription required for REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
The active ingredient in REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION is coagulation factor IX. This information helps identify medicines with the same composition but different brand names.
Who manufactures REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION is manufactured by Novo Nordisk A/S. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to REFIXIA 500 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
Other medicines with the same active substance (coagulation factor IX) include ALPROLIX 1,000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION, ALPROLIX 2,000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION, ALPROLIX 250 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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