Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Arixtra 5 mg/0.4 ml solution for injection

Arixtra 7.5 mg/0.6 ml solution for injection

Arixtra 10 mg/0.8 ml solution for injection

fondaparinux sodium

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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.

Leaflet contents:

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 used to treat or help prevent the formation of blood clots in blood vessels (an antithrombotic agent). Arixtra contains a synthetic substance called fondaparinux sodium. This substance blocks the action of coagulation factor Xa ("ten-A") in the blood, thereby preventing the formation of unwanted blood clots (thrombi) in blood vessels.

Arixtra is used to treat adults who have a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).

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 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 causing a decrease in blood 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, spinal105 or eye surgery;

• if you have severe liver disease

• if you have kidney disease

• if you are 75 years of age or older.

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

Children and adolescents

Arixtra has not been studied in children and 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; therefore, it is considered essentially “sodium-free”.

The Arixtra syringe contains latex

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

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

3. How to use Arixtra

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Must be injected at approximately the same time each day.

How to administer Arixtra

• Arixtra is administered by subcutaneous injection into a skin fold formed in the lower abdominal area. The syringes are pre-filled with the exact dose you need. Different syringes are available for the 5 mg, 7.5 mg, and 10 mg doses. For a detailed description of how to use Arixtra, see the end of this leaflet.
• Do not inject Arixtra into a muscle (intramuscularly).

How long you should use Arixtra

You should use Arixtra for the length of time prescribed by your doctor, as Arixtra protects you from a serious medical 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 forgotten doses.
• If you are unsure, contact your doctor or pharmacist.

If you stop using Arixtra

If you stop treatment before your doctor has advised you to do so, the blood clot may not have been adequately treated, and you may be at risk of developing a new blood clot in a leg vein or in the 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 everybody gets them.

Symptoms to watch for

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

• swelling, sometimes of the face or mouth (angioedema), causing difficulty in 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, eye bleeding, bleeding into joints, internal bleeding in the uterus)
• localized accumulation of blood (in any organ or body tissue)
• anaemia (decrease 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)
• headache
• pain
• chest pain
• difficulty breathing
• skin rash or itching
• discharge from the surgical wound
• fever
• feeling dizzy (nausea or vomiting)
• 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
• internal bleeding in the brain, liver, or abdomen
• anxiety or confusion
• fainting or dizziness, low blood pressure
• drowsiness or fatigue
• flushing
• cough
• pain and inflammation at the injection site
• wound infection
• increased blood levels of non-protein nitrogen
• leg pain or stomach pain
• indigestion
• diarrhoea or constipation
• increased bilirubin (a substance produced by the liver) in the blood
• decreased potassium levels in the blood
• pain around the upper abdomen or heartburn

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 the presence of particles or a change in the solution's colour.
• if you observe that the syringe is damaged.
• if the syringe has been opened and will not be used immediately.

Disposal of syringes

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

6. Contents of the pack and other information

Composition of Arixtra

The active substance:

• 5 mg of fondaparinux sodium in 0.4 ml of injectable solution
• 7.5 mg of fondaparinux sodium in 0.6 ml of injectable solution
• 10 mg of fondaparinux sodium in 0.8 ml of injectable solution

The other components are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust pH (see section 2).

Arixtra does not contain any animal-derived substances.

Appearance of the product and contents of the pack

Arixtra is a clear, colourless or slightly yellowish injectable solution. It is supplied in a single-use pre-filled syringe equipped with a safety system designed to help prevent accidental needlestick injuries after use.

It is available in packs containing 2, 7, 10 and 20 pre-filled syringes. However, only certain pack sizes may be marketed.

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 obtained by contacting the local representative of the Marketing Authorisation Holder.

Drawing 3. Syringe with a manual needle protection system, with the safety cap covering the needle AFTER

USE

Types of safety syringes:

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

Components of the syringes:

• Needle protector
  ? Plunger
  ? Gripping area (for fingers)
• Needle safety cap

Drawing 1. Syringe with an automatic needle protection system

Syringe with a manual needle protection system

Drawing 2. 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 and manual needle protection systems).

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

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

• Remove the syringe from its packaging and check that:

• the expiration date has not passed

• the solution is clear, colorless, and free of particles

• the syringe has not been opened or damaged

• Sit or lie down in a comfortable position. Select a site in the lower abdominal area at least 5 cm below the navel (drawing A).

For each injection, alternate between the left and right sides of the lower abdomen. This will help reduce discomfort at the injection site.

If injection in the lower abdomen is not possible, consult your doctor.

Drawing A

1. Clean the injection site with an alcohol swab or alcohol-soaked cotton ball.

2. Remove the needle protector: first by twisting it (drawing B1) and then by pulling it straight off the syringe barrel (drawing B2).

Discard the needle protector.

Important note

1. Do not touch the needle and avoid contact with any surface before the injection.

2. A small air bubble in the syringe is normal. Do not attempt to remove this air bubble before administering the injection, as this may result in loss of some medication.

3. Gently pinch the previously cleaned skin to form a skin fold. Hold the skin fold between your thumb and index finger throughout the injection (drawing C).

4. Firmly hold the syringe by the gripping area. Insert the needle fully into the skin fold at a right angle (drawing D).

Drawing B1

Drawing B

Drawing C

Drawing D

• Inject ALL the contents of the syringe by fully depressing the plunger downward (drawing E).

Drawing E

Syringe with automatic system

1. Release the plunger, and the needle will automatically retract from the skin into a safety cap, where it will be permanently locked (drawing F).

Drawing F

Syringe with manual system

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

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