Fraxodi

Package leaflet: Information for the patient

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 the medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any undesirable effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 condition 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 hemorrhagic 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
When using 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 recently underwent surgery on the brain, spinal cord, or eye,
  • the patient has high blood pressure (hypertension);
• the patient has severe liver dysfunction;
• the patient has impaired kidney function;
• 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 hemorrhages or hard, painful redness of the skin, discontinue the medicine immediately and contact a doctor.
Use of Fraxodi may lead to increased potassium levels in the blood.
If the patient has conditions in which elevated potassium levels may occur, such as: diabetes, severe kidney disease, prior 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 is undergoing epidural or spinal anaesthesia, or lumbar puncture (spinal tap) while receiving 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 Fraxodi.
The needle cap of the pre-filled syringe may contain latex [see section: "Packaging contains latex (natural rubber)"].

Fraxodi with other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Concurrent use of Fraxodi with the following medicines is not recommended due to the risk of bleeding. If co-administration cannot be avoided, the doctor will closely monitor the patient's condition. These include:

• acetylsalicylic acid (e.g. aspirin),
• non-steroidal anti-inflammatory drugs – NSAIDs (medicines used to relieve pain, such as ibuprofen),
• antiplatelet drugs (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),
• glucocorticosteroids (steroid medicines used, among others, in asthma treatment),
• 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Fraxodi may be used during pregnancy only if the doctor considers the expected benefits to outweigh the potential risks.
It is unknown whether Fraxodi components 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 effects of Fraxodi on the ability to drive or operate machinery.

Packaging may contain latex (natural rubber)
The packaging of the medicine (needle cap) may contain latex rubber, which may cause severe allergic reactions.

3. How to use Fraxodi

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Method of administration
Fraxodi should be administered by subcutaneous injection.
Fraxodi must not be administered by intramuscular injection.
Pre-filled syringes with graduation markings facilitate the administration of appropriate doses, especially when dose adjustment according to the patient's body weight is required.
When administering the injection subcutaneously, the preferred site is usually the anterior-lateral abdominal wall, alternating between the right and left side. Alternatively, the thigh may be used as an injection site.
Detailed instructions for performing the subcutaneous injection 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, the doctor may recommend kidney function tests and adjust the dose of Fraxodi accordingly.
Renal impairment
The 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 a higher than recommended dose is administered, contact your doctor immediately. The main symptom of overdose is bleeding.
Missed dose of Fraxodi
Continue treatment with Fraxodi as prescribed; do not increase 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
Fraxodi should be used for as long as your doctor recommends. Do not stop using Fraxodi without consulting your doctor.
If a patient wishes to discontinue treatment with Fraxodi, this should first be discussed with the doctor or pharmacist.
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 everybody will experience them.
Stop the medicine immediately and contact your doctor if any of the following occur:

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

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

• 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 within a few days.

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

• Skin reaction at the injection site,
• Increased liver enzyme activity (aminotransferases), usually transient (detected in blood tests).

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Decrease in platelet count (thrombocytopenia),
• Increase in 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 people):

• Hypersensitivity reactions, including angioedema and skin reactions,
• Pseudo-anaphylactic reaction (symptoms similar to anaphylactic – allergic reaction; see beginning of this section),
• Skin necrosis,
• Increase in eosinophil count (a type of white blood cell) – transient after discontinuation of treatment (detected in blood tests),
• Increased blood potassium levels,
• 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 estimated 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 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 provide more information on the safety of the medicine.

5. How to store the medicine Fraxodi

The medicine should be stored 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 stated month.
Medicines and syringes must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fraxodi contains

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

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

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.

SELF-INJECTION INSTRUCTIONS FOR SUBCUTANEOUS INJECTIONS OF FRAXODI

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

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 side. 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 or allow it to come into contact with 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 — doing so may result in loss of some of the medicine.

5. Gently pinch the cleaned skin with your fingers to create a skin fold. Hold the skin fold between your thumb and index finger throughout the entire 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 full contents of the pre-filled syringe by pressing the plunger down until resistance is felt.

8. Remove the syringe with the needle 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 cap over the needle to prevent needle-stick injury (Picture 6).
    Firmly hold the syringe grip with one hand, and with the other hand grasp the outer cap of the pre-filled syringe and slide it toward the needle. This will unlock the safety cap. Then continue sliding the cap forward until it locks into position, completely covering the needle. Resistance will be felt during the unlocking and locking process.

Picture 6

11. Appearance of the pre-filled syringe after deployment of the safety cap (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.