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
(Nadroparin calcium)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Fraxodi and what is it 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 is Fraxodi and what is it used for

Fraxodi is an anticoagulant medicine used to treat 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 you are allergic to the active substance nadroparin calcium, 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 you have previously experienced a decrease in platelet count (thrombocytopenia) after using Fraxodi;
• if you have bleeding or any disease that affects blood clotting;
• if you have a medical condition that increases the risk of bleeding [e.g. active peptic ulcer disease of the stomach and/or duodenum];
• if you have recently had a hemorrhagic stroke;
• if you have acute infectious endocarditis;
• if you have severe kidney dysfunction and are taking anticoagulant medications, e.g. for pulmonary embolism or deep vein thrombosis;
• if you have severe kidney dysfunction and are taking medications for heart disease (e.g. unstable angina or myocardial infarction without Q-wave).

Warnings and precautions

During treatment with Fraxodi, a decrease in platelet count may rarely occur, which can sometimes be severe. During treatment, your doctor will recommend blood tests to check for this side effect.
Before using Fraxodi, you should tell your doctor if:

• you have conditions that increase the risk of bleeding, in particular, if:
• you have peptic ulcer disease of the stomach and/or duodenum,
• you have coagulation disorders,
• you have recently undergone surgery in the brain, spinal cord, or eye,
• you have high blood pressure;
• you have severe liver dysfunction;
• you have kidney dysfunction;
• you have eye diseases affecting blood vessels (vascular disorders of the retina and choroid);
• you are taking other medications that affect blood clotting (see "Fraxodi and other medicines").

In case of bleeding, you should immediately contact your doctor.
In case of skin necrosis, which may be preceded by small subcutaneous hemorrhages or hard or painful redness of the skin, you should immediately stop using the medicine and contact your doctor.
Using Fraxodi may cause an increase in blood potassium levels.
If you have diseases that may cause an increase in potassium levels, such as diabetes, severe kidney disease, previous metabolic acidosis, or if you are taking other medications that increase potassium levels in the blood, your doctor may recommend regular blood tests. If you are unsure whether you are taking such medications, you should ask your doctor.
If you are undergoing spinal or epidural anesthesia, or lumbar puncture, there is a risk of bleeding into the spinal cord at the injection site, which can lead to serious consequences. During such procedures, your condition will be closely monitored to check for worrying symptoms.
If you are elderly (over 65 years old), your doctor may recommend blood tests before starting treatment with Fraxodi.

Fraxodi and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
It is not recommended to use Fraxodi with the following medicines due to the risk of bleeding. If this cannot be avoided, your doctor will closely monitor your condition. This applies to the following medicines:

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

Fraxodi should be used with caution with:

• oral anticoagulants (medicines that prevent blood clotting, e.g. warfarin),
• glucocorticosteroids (steroid medicines used to treat e.g. asthma),
• dextran (a medicine given intravenously to increase blood volume).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Fraxodi may only be used during pregnancy if your doctor considers that the expected benefits of using the medicine outweigh the possible risks.
It is not known whether the ingredients of Fraxodi pass into breast milk, so you should not breastfeed during treatment with Fraxodi.

Driving and using machines

There is no data on the effect of Fraxodi on the ability to drive and use machines.

The packaging of the medicine may contain latex (natural rubber)

The packaging of the medicine (needle shield) may contain latex. This can 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, ask your doctor or pharmacist.
Method of administration
Fraxodi should be administered by subcutaneous injection.
Fraxodi should not be administered by intramuscular injection.
The graduated syringe makes it easy to administer the correct dose if dose adjustment is necessary based on the patient's body weight.
When administering the medicine by subcutaneous injection, the anterior abdominal wall is usually chosen as the injection site, alternating between the right and left sides. Another injection site may be the thigh.

Detailed instructions for self-administering subcutaneous injections of Fraxodi can be found in the section "Instructions for self-administering subcutaneous injections of Fraxodi".

Recommended dosage

The dosage is determined by your doctor, individually for each patient, depending on the indication, clinical condition, and patient's body weight.

Use in children and adolescents
Fraxodi should not be used in children and adolescents.
Patients over 65 years old (elderly patients)
In these patients, kidney function may be impaired. Therefore, your doctor may recommend kidney function tests and adjust the dose of Fraxodi accordingly.
Kidney dysfunction
Your doctor will adjust the dose of Fraxodi according to the severity of kidney dysfunction.
Fraxodi is contraindicated in patients with severe kidney dysfunction.

Using a higher dose of Fraxodi than recommended

If a higher dose of Fraxodi than recommended is used, you should immediately contact your doctor. The main symptom of overdose is bleeding.

Missing a dose of Fraxodi

You should continue using the medicine without increasing the next dose. You should not shorten the time interval between injections.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Fraxodi

Fraxodi should be used for as long as your doctor recommends. You should not stop using Fraxodi without consulting your doctor.
If you want to stop using Fraxodi, you should discuss this with your doctor or pharmacist first.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fraxodi can cause side effects, although not everybody gets them.
You should immediately stop using the medicine and contact your doctor if you experience:

• allergic reactioncharacterized by: hives (light red, itchy blisters on the skin), angioedema (swelling of the face or lips that can make breathing difficult),
• skin necrosis at the injection site -this is preceded by subcutaneous hemorrhages or hard or painful redness of the skin with or without accompanying general symptoms.

Very common side effects(may affect more than 1 in 10 people):

• bleeding at various sites, more common in patients with other risk factors,
• small hematomas 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 side effects(may affect up to 1 in 10 people):

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

Rare side effects(may affect up to 1 in 1000 people):

• decrease in platelet count (thrombocytopenia),
• increase in platelet count (thrombocytosis),
• rash, hives, redness, itching of the skin,
• calcification under the skin at the injection site.

Very rare side effects(may affect up to 1 in 10,000 people):

• allergic reactions, including angioedema and skin reactions,
• pseudo-anaphylactic reaction (symptoms are similar to anaphylaxis -allergic reaction
• see the beginning of this section),
• skin necrosis,
• increase in eosinophil count (a type of white blood cell) - transient after treatment (visible in blood test results),
• increase in blood potassium levels,
• prolonged, painful erection of the penis (priapism) - if this occurs, you should immediately contact your doctor, as you may need treatment to avoid serious complications.

Unknown(frequency cannot be estimated from available data)

• headache,
• migraine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fraxodi

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 given month.
Medicines and syringes should not be disposed of in the sewage system or household waste containers.
Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fraxodi contains

• The active substance of the medicine is: 11,400 IU AXa nadroparin calcium in 0.6 ml solution for injection, 15,200 IU AXa nadroparin calcium in 0.8 ml solution for injection, 19,000 IU AXa nadroparin calcium in 1 ml solution for injection
• The other ingredients are: calcium hydroxide solution or diluted hydrochloric acid to adjust pH, 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, colorless or slightly colored solution. The medicine is packaged in pre-filled syringes with a protective needle shield.
The pack contains 2, 6, or 10 pre-filled syringes with a protective needle shield, in individual blisters, in a cardboard box.

Marketing authorization 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

Date of last revision of the leaflet: 02/2024

Information for healthcare professionals

Detailed dosage and administration instructions can be found in section 4.2 of the approved Summary of Product Characteristics.

INSTRUCTIONS FOR SELF-ADMINISTERING SUBCUTANEOUS INJECTIONS OF FRAXODI

FRAXODI

• 1. Wash your hands thoroughly with soap and water and dry them with a towel.
• 2. Sit or lie down in a comfortable position. Choose an injection site on the side of your abdomen (Figure 1). Injections should be administered alternately on the left and right sides.

Figure 1

• 3. Clean the injection site with a swab soaked in spirit.
• 4. Remove the needle shield. The needle shield should be discarded.

Important notes

• Do not touch the needle and do not allow the needle to come into contact with other surfaces before injection.
• The presence of a small air bubble in the pre-filled syringe is normal. Do not remove the air bubble before administering the injection - this may lead to loss of part of the medicine.
• 5. Hold the previously cleaned skin with your fingers, creating a skin fold. Hold the skin fold between your thumb and index finger during the entire injection process (Figure 2).

Figure 2

• 6. Hold the pre-filled syringe with your fingers on the handle in a firm manner. Insert the entire length of the needle into the skin fold at a right angle (Figure 3).

Figure 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 pre-filled syringe from the skin (Figure 4). Do not rub the injection site.

Figure 4

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

Protective needle shield
Pre-filled syringe handle
Figure 5

• 10. After injection, slide the protective shield over the pre-filled syringe to protect against needle stick injury (Figure 6). Holding the pre-filled syringe handle firmly with one hand, use the other hand to grasp the outer shield of the pre-filled syringe and slide it towards the needle. The shield will unlock. Then, slide the shield to the position where it will block the entire needle. When releasing and locking the shield, resistance is felt.

Figure 6

• 11. Appearance of the pre-filled syringe after sliding the protective shield (Figure 7).

Protective needle shield
Pre-filled syringe handle
Figure 7

• 12. Used pre-filled syringes should not be disposed of in household waste containers. They should be disposed of in accordance with the doctor's or pharmacist's instructions.