Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Arixtra 2.5 mg/0.5 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 could 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 adverse 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 after 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 certain types of heart attack and severe angina (pain caused by narrowing of the heart arteries)
• 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 bacterial infection of the heart (endocarditis)

• 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 had complications during treatment with heparin or heparin-like medicines causing 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 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 or 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 may contain latex

The needle cap of the syringe may contain latex, which can cause allergic reactions in people 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 instructions for using this medicine as given 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 into a skin fold formed in the lower abdominal area. The syringes are pre-filled with the exact dose you need. There are different syringes for the 2.5 mg and 1.5 mg doses. For a detailed description of how to use Arixtra, see the end of the leaflet**. To treat certain types of heart attacks, a healthcare professional may administer the first dose intravenously (intravenous route).**
• 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 illness.

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

• Administer the missed dose as soon as you remember. Do not inject a double dose to make up for forgotten doses.
• 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 are at risk of developing a blood clot in a vein in your leg or 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 be aware of

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 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 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 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 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
• reduction in blood potassium
• pain around the upper abdomen or heartburn

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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 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 discoloured
• if the syringe appears damaged
• if you have opened the syringe and do not intend to use it immediately.

Disposal of syringes:

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

6. Contents of the pack and other information

Composition of Arixtra

• The active substance is 2.5 mg of fondaparinux sodium in 0.3 ml of injectable solution.
• The other components are sodium chloride, water for injectable preparations, 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 needlestick injuries after use. It is available in packs of 2, 7, 10 and 20 pre-filled syringes. Only certain 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

You can request further information about this medicine 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
  ? Grip 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 in instructions between the syringes, it will be clearly specified.

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

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

• the expiration date has not passed
• the solution is clear and colorless and contains no particles
• the syringe has not been previously opened or damaged

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

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

If injection into the lower abdominal area is not possible, consult your doctor.

Drawing A

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

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

Discard the needle protector.

Important note

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

• It is normal to see a small air bubble in the syringe. Do not attempt to remove this air bubble before administering the injection, as some of the medication may be lost.

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

2. Hold the syringe firmly by the grip area. Insert the needle fully into the skin fold at a 90-degree angle (drawing D).

Drawing B1

Drawing B2

Drawing C

Drawing D

1. Inject ALL of 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 the 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, grasp the grip area with the fingers of the other hand, and 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.