Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Arixtra 1.5 mg/0.3 ml injection solution

fondaparinux sodium

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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Arixtra is and what it is used for

Arixtra is a medicine that helps prevent blood clots from forming in blood vessels (an antithrombotic agent).

Arixtra contains a synthetic substance called fondaparinux sodium. This substance inhibits the action of coagulation factor Xa ("ten-A") in the blood and thereby prevents the formation of unwanted blood clots (thrombi) in blood vessels.

Arixtra is used to:

• prevent the formation of blood clots in the blood vessels of the legs or lungs following orthopedic surgery, such as hip or knee surgery, or abdominal surgery
• prevent the formation of blood clots during and shortly after a period of restricted mobility due to an acute illness

treat blood clots in the blood vessels close to the skin surface in the legs (superficial venous thrombosis).

2. What you need to know before using Arixtra

Do not use Arixtra:

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

• if you are experiencing significant bleeding

• if you have a bacterial infection of the heart

• if you have severe kidney disease.

• Tell your doctor if you think any of these situations apply to you. If so, you must not use
  Arixtra.

Warnings and precautions

Talk to your doctor or pharmacist before using Arixtra:

• if you have previously experienced complications during treatment with heparin or heparin-like medicines that caused a decrease in platelet count (heparin-induced thrombocytopenia)

• if you are at risk of uncontrolled bleeding (hemorrhage), such as:

  • gastric ulcer
  • bleeding disorders
  • recent bleeding in the brain (intracranial hemorrhage)
  • recent brain, spinal, or eye surgery

• if you have severe liver disease

• if you have kidney disease

• if you are 75 years of age or older

• if you weigh less than 50 kg

• Tell your doctor if any of these situations apply to you.

Children and adolescents

Arixtra has not been studied in children or adolescents under 17 years of age.

Using Arixtra with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Taking other medicines may affect how Arixtra works or may be affected by Arixtra.

Pregnancy and breastfeeding

Arixtra should not be prescribed to pregnant women unless strictly necessary. Breastfeeding is not recommended during treatment with Arixtra. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Arixtra contains sodium

This medicine contains less than 23 mg of sodium per dose and is therefore considered essentially “sodium-free”.

The Arixtra syringe contains latex

The needle cover of the syringe contains latex, which may cause allergic reactions in latex-sensitive individuals.

• Tell your doctor if you are allergic to latex before being treated with Arixtra.

3. How to use Arixtra

Follow exactly the instructions for using this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 2.5 mg once daily, injected at approximately the same time each day.

If you have a kidney disease, the dose may be reduced to 1.5 mg once daily. How to administer Arixtra

• Arixtra is administered by subcutaneous injection (under the skin) into a skin fold formed in the lower abdominal area. The syringes are prefilled with the exact dose you require. Different syringes are available for the 2.5 mg and 1.5 mg doses. For a detailed description of how to use Arixtra, see the end of this leaflet.
• Do not inject Arixtra into a muscle.

How long you should use Arixtra

You should use Arixtra for the length of time prescribed by your doctor, as Arixtra helps prevent you from developing a serious condition.

If you inject more Arixtra than you should

Contact your doctor or pharmacist immediately, as there is an increased risk of bleeding. If you forget to use Arixtra

• Take the missed dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose.
• If in doubt, contact your doctor or pharmacist.

If you stop using Arixtra

If you stop treatment before your doctor has instructed you to do so, you may be at risk of developing a blood clot in a vein in your leg or in your lung. Before stopping treatment, contact your doctor or pharmacist.

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

4. Possible adverse effects

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

Symptoms to watch for

Severe allergic reactions (anaphylaxis): these are very rare (up to 1 in 10,000) in patients using Arixtra. Symptoms include:

• swelling, sometimes of the face or mouth (angioedema), causing difficulty swallowing or breathing

• collapse.

• Contact a doctor immediately if you experience these symptoms. Stop using Arixtra.

Frequent adverse effects

These may affect more than 1 in every 100 patients treated with Arixtra.

• bleeding (e.g. from the surgical site, from an existing stomach ulcer, or from the nose, gums, blood in urine, coughing up blood, ocular bleeding, bleeding into joint spaces, internal bleeding in the uterus)
• localized accumulation of blood (in any organ or body tissue)
• anaemia (a reduction in the number of red blood cells)
• bruising

Uncommon adverse effects

These may affect up to 1 in every 100 patients treated with Arixtra.

• swelling (edema)
• feeling dizzy (nausea or vomiting)
• headache
• pain
• chest pain
• difficulty breathing
• skin rash or itching
• discharge from the surgical wound
• fever
• decrease or increase in the number of platelets (blood cells necessary for clotting)
• increase in certain chemical substances (enzymes) produced by the liver.

Rare adverse effects

These may affect up to 1 in every 1,000 patients treated with Arixtra.

• allergic reaction (including itching, swelling, rash)
• internal bleeding in the brain, liver, or abdomen
• anxiety or confusion
• fainting or dizziness, low blood pressure
• drowsiness or fatigue
• flushing
• cough
• leg pain or stomach pain
• diarrhoea or constipation
• indigestion
• pain and inflammation at the injection site
• wound infection
• increased bilirubin (a substance produced by the liver) in the blood
• increased non-protein nitrogen in the blood
• reduced potassium levels in the blood
• pain or burning sensation around the upper abdomen

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arixtra

• Keep this medicine out of the sight and reach of children.
• Store below 25°C. Do not freeze.
• It is not necessary to store Arixtra in the refrigerator.

Do not use this medicine:

• after the expiry date stated on the label and carton
• if you notice particles in the solution, or if the solution is discolored
• if the syringe appears damaged
• if you have opened the syringe and do not intend to use it immediately.

Disposal of syringes:

Medicines or syringes must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of syringes and medicines you no longer require. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arixtra

• The active substance is 1.5 mg of fondaparinux sodium in 0.3 ml of injectable solution.
• The other components are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).

Arixtra does not contain any animal-derived products.

Appearance of the product and contents of the pack

Arixtra is a clear, colourless injectable solution. It is supplied in a single-use pre-filled syringe equipped with a safety system designed to help prevent accidental needle sticks after use. Packs containing 2, 7, 10 and 20 pre-filled syringes are available. However, not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer:

Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.

Date of the most recent revision of this leaflet:

Other sources of information

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

Further information on this medicine can be requested from the local representative of the Marketing Authorisation Holder.

Types of safety syringes:

There are two types of safety syringes for Arixtra, designed to protect against accidental needlestick injuries after use. One type of syringe has an automatic needle protection system and the other has a manual system.

Components of the syringes:

• Needle protector
  ? Plunger
  ? Grip area (for fingers)
• Safety needle cap

Figure 1. Syringe with an automatic needle protection system

Syringe with a manual needle protection system

DESCRIPTION OF THE METHOD OF USE OF ARIXTRA
Instructions for Use

These instructions apply to both types of syringes (with automatic needle protection system and with manual needle protection system).

When there is a difference between the syringes, it will be clearly specified.

1. Wash your hands thoroughly with water and soap and dry them with a towel.

2. Remove the syringe from the packaging and check that:

   • the expiry date has not been exceeded
   • the solution is clear, colorless, and free of particles
   • the syringe has not been opened or damaged

1. Clean the injection site with an alcohol wipe or cotton ball soaked in alcohol.

Syringe with manual system

1. After injection, hold the syringe by the needle safety cap with the fingers of one hand, grasp the gripping area with the fingers of the other hand, and pull backward. This action releases the cap. Slide the cap along the barrel of the syringe until it is locked in a position covering the needle, as shown in drawing 3.

Do not dispose of the used needle in the trash can. Discard it according to the instructions provided by your doctor or pharmacist.