Fraxodi

Patient Information Leaflet

Fraxodi, 11,400 IU AXa/0.6 ml, solution for injection
Fraxodi, 15,200 IU AXa/0.8 ml, solution for injection
Fraxodi, 19,000 IU AXa/1 ml, solution for injection
(Nadroparinum calcicum)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Fraxodi is and what it is used for

Fraxodi is an anticoagulant medicine used in the treatment of deep vein thrombosis.
The medicine is administered by subcutaneous injection.
Indications for use:

• Treatment of venous thromboembolic disease.

2. Important information before using Fraxodi

When not to use Fraxodi:

• if the patient is allergic to the active substance, calcium nadroparin, heparin, or a similar product (such as enoxaparin, bemiparin, dalteparin), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient previously experienced a decrease in platelet count – blood cells involved in blood clotting (heparin-induced thrombocytopenia) after receiving Fraxodi;
• if the patient has active bleeding or any disease causing reduced blood clotting;
• if the patient has a medical condition associated with an increased risk of bleeding [e.g. active peptic ulcer of the stomach and/or duodenum];
• if the patient has recently had a haemorrhagic stroke;
• if the patient has acute infective endocarditis;
• if the patient has severe renal impairment and is being treated for thrombosis, e.g. in the lungs (pulmonary embolism) or in the leg (deep vein thrombosis);
• if the patient has severe renal impairment and is being treated for heart disease (e.g. unstable angina or non-Q-wave myocardial infarction).

Warnings and precautions
During treatment with Fraxodi, a decrease in platelet count may rarely occur, which can sometimes be severe. During treatment, the doctor will recommend blood tests to monitor for this effect.
Before using Fraxodi, the patient should inform the doctor if:

• the patient has conditions that increase the risk of bleeding, particularly if:
  • the patient has a peptic ulcer of the stomach and/or duodenum,
  • the patient has coagulation disorders,
  • the patient has recently undergone surgery involving the brain, spinal cord, or eye,
  • the patient has high blood pressure (hypertension);
• the patient has severe hepatic impairment;
• the patient has renal impairment;
• the patient has eye diseases affecting blood vessels (vascular disorders of the choroid and retina);
• the patient is taking other medicines affecting blood clotting (see section: "Fraxodi with other medicines").

In case of bleeding, contact a doctor immediately.
If skin necrosis occurs, which may be preceded by small subcutaneous haemorrhages or hard, painful redness of the skin, discontinue the medicine immediately and contact a doctor.
Treatment with Fraxodi may lead to increased potassium levels in the blood.
If the patient has conditions in which potassium levels may rise, such as: diabetes, severe kidney disease, previous metabolic acidosis, or if the patient is taking other medicines that increase blood potassium levels, the doctor may recommend regular blood tests. If the patient is unsure whether they are taking such medicines, they should consult their doctor.
If the patient receives epidural or spinal anaesthesia, or cerebrospinal fluid sampling from the space around the spinal cord (lumbar puncture) while being treated with Fraxodi, there is a risk of bleeding into the spinal canal at the puncture site, which may lead to serious consequences. During such procedures, the patient's condition will be monitored frequently to detect any concerning symptoms.
If the patient is elderly (over 65 years of age), the doctor may recommend blood tests before starting treatment with Fraxodi.
The needle cover of the pre-filled syringe may contain latex [see section: "Packaging contains latex (natural rubber)"].

Fraxodi with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Concomitant use of Fraxodi with the following medicines is not recommended due to the risk of bleeding. If such combination cannot be avoided, the doctor will closely monitor the patient's condition. This applies to the following medicines:

• acetylsalicylic acid (e.g. aspirin),
• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, such as ibuprofen),
• antiplatelet agents (medicines used to prevent blood clots, such as clopidogrel).

Fraxodi should be used with caution with:

• oral anticoagulants (medicines preventing blood clotting, such as warfarin),
• glucocorticoids (steroid medicines used, among others, in the treatment of bronchial asthma),
• dextran (a medicine administered intravenously to increase circulating blood volume).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Fraxodi may be used during pregnancy only if the doctor considers the expected benefits to outweigh the possible risks.
It is unknown whether the components of Fraxodi pass into human milk; therefore, breastfeeding should not be performed during treatment with Fraxodi.

Driving and operating machinery
There are no data available on the effect of Fraxodi on the ability to drive or operate machinery.

Packaging may contain latex (natural rubber)
The packaging of the medicine (needle cover) may contain latex rubber. It may cause severe allergic reactions.

3. How to use Fraxodi

This medicine should always be used exactly as your doctor has told you. If you are not sure,
please consult your doctor or pharmacist.
Method of administration
Fraxodi should be administered by subcutaneous injection.
Fraxodi must not be given by intramuscular injection.
Pre-filled syringes with dose markings make it easier to administer the appropriate doses, especially when dose adjustment according to body weight is required.
When administering Fraxodi by subcutaneous injection, the usual injection site is the anterior-lateral abdominal wall, alternating between the right and left side. The thigh may also be used as an alternative injection site.
Detailed instructions for performing subcutaneous injections are provided in the section: “Instructions for self-administration of subcutaneous injections of Fraxodi”.
Recommended dosage
The dosage is determined individually by the doctor for each patient, depending on the indication, clinical condition, and body weight.
Use in children and adolescents
Fraxodi must not be used in children and adolescents.
Elderly patients (over 65 years of age)
Renal function may be impaired in these patients. Therefore, your doctor may recommend kidney function tests and adjust the dose of Fraxodi accordingly.
Renal impairment
Your doctor will adjust the dose of Fraxodi according to the severity of renal impairment.
Fraxodi is contraindicated in patients with severe renal impairment.
Use of a higher than recommended dose of Fraxodi
If you use more Fraxodi than you should, contact your doctor immediately. The main symptom of overdose is bleeding.
Missing a dose of Fraxodi
Continue using the medicine as prescribed, without increasing the next dose. Do not shorten the interval between doses.
Do not use a double dose to make up for a missed dose.
Stopping Fraxodi
Continue using Fraxodi for as long as your doctor recommends. Do not stop using Fraxodi without consulting your doctor.
If you wish to discontinue treatment with Fraxodi, discuss this with your doctor or pharmacist first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop the medicine immediately and contact your doctor if any of the following occur:

• allergic reaction presenting as: urticaria (bright pink, itchy blisters on the skin), angioedema (swelling of the face or lips causing breathing difficulties),
• skin necrosis at the injection site – preceded by subcutaneous haemorrhages or hard or painful redness of the skin, with or without accompanying general symptoms.

Very common adverse reactions (may affect more than 1 in 10 patients):

• bleeding at various sites, more frequent in patients with other risk factors,
• small bruises at the injection site. In some cases, hard lumps may appear, which do not indicate heparin crystallization and should disappear after a few days.

Common adverse reactions (may affect up to 1 in 10 patients):

• skin reaction at the injection site,
• increased liver enzyme activity (aminotransferases), usually transient (visible in blood test results).

Uncommon adverse reactions (may affect up to 1 in 1000 patients):

• decreased platelet count (thrombocytopenia),
• increased platelet count (thrombocytosis),
• rash, urticaria, redness, itching of the skin,
• subcutaneous calcification at the injection site.

Rare adverse reactions (may affect up to 1 in 10,000 patients):

• allergic reactions, including angioedema and skin reactions,
• pseudo-anaphylactic reaction (symptoms similar to anaphylactic – allergic reaction; see beginning of this section),
• skin necrosis,
• increased eosinophil count (a type of white blood cells) – transient after discontinuation of treatment (visible in blood test results),
• increased potassium levels in blood,
• prolonged, painful penile erection (priapism) – if this occurs, urgent medical advice must be sought, as treatment may be required to avoid serious complications.

Not known (frequency cannot be determined from available data):

• headache,
• migraine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Fraxodi

Keep the medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines and syringes must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fraxodi contains

• The active substance is: 11,400 IU AXa of calcium nadroparin in 0.6 ml solution for injection, 15,200 IU AXa of calcium nadroparin in 0.8 ml solution for injection, 19,000 IU AXa of calcium nadroparin in 1 ml solution for injection.
• The other ingredients are: calcium hydroxide solution or diluted hydrochloric acid for pH adjustment, water for injections.

What Fraxodi looks like and contents of the pack
Fraxodi is a solution for injection. The pre-filled syringe contains a clear to slightly opalescent, colourless or slightly coloured solution. The medicine is supplied in pre-filled syringes with a needle safety guard to prevent needlestick injury after administration.
The pack contains 2, 6 or 10 pre-filled syringes with a needle safety guard, individually blister-packed in a cardboard box.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Tel: 22 546 64 00

Manufacturer
Aspen Notre Dame de Bondeville
1, rue de l’Abbaye
76960 Notre-Dame de Bondeville
France
or
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznań
Poland

Information for healthcare professionals
Detailed dosage and administration instructions are provided in section 4.2 of the approved Product Characteristics.

INSTRUCTIONS FOR SELF-ADMINISTRATION OF SUBCUTANEOUS INJECTIONS OF FRAXODI

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

2. Sit or lie down in a comfortable position. Choose an injection site on the side of the abdomen (Picture 1). Alternate injections between the left and right sides. Picture 1
3. Clean the injection site with an alcohol swab.
4. Remove the needle cap. Discard the needle cap.

Important notes

• Do not touch the needle and avoid contact between the needle and any surface before injection.
• The presence of a small air bubble in the pre-filled syringe is normal. Do not remove the air bubble before injecting – this may result in loss of some of the medicine.

5. Gently pinch the cleaned skin between your fingers to create a skin fold. Hold the skin fold firmly between your thumb and index finger throughout the injection (Picture 2).

Picture 2

6. Hold the pre-filled syringe firmly by the grip. Insert the entire length of the needle perpendicularly into the skin fold (Picture 3).

Picture 3

7. Inject the entire contents of the pre-filled syringe by pressing the plunger down until resistance is felt.

8. Remove the needle and syringe from the skin (Picture 4). Do not rub the injection site.

Picture 4

9. Appearance of the pre-filled syringe after injection (Picture 5).

Safety cap
Syringe grip
Picture 5

10. After completing the injection, slide the protective needle shield forward

on the pre-filled syringe to protect against needlestick injury (Picture 6).
While firmly holding the syringe grip with one hand, grasp the outer cap of the pre-filled syringe with the other hand and slide it toward the needle. This will unlock the cap. Then slide the cap forward until it locks into position, completely covering the needle. Resistance will be felt during unlocking and locking of the cap.

Picture 6

11. Appearance of the pre-filled syringe after sliding the safety cap into place (Picture 7).

Safety cap
Syringe grip
Picture 7

12. Do not dispose of used pre-filled syringes in household waste. Dispose of them according to your doctor’s or pharmacist’s instructions.