Arixtra (fondaparinux natrium) 2.5 mg/0.5 ml. №10

Description

Ingredients:

active ingredient:  fondaparinux sodium;

1 syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium;

excipients: sodium chloride, water for injections, hydrochloric acid or sodium hydroxide.

Medicinal form.  Solution for injections.

Pharmacotherapeutic group.  Antithrombotic agents. PBX code В01А Х05.

Indications.

• Prevention of venous thromboembolism in patients after major orthopedic operations on the lower extremities, including hip fracture (including extended prophylaxis), and hip and knee joint replacement operations.
• Prevention of venous thromboembolism in patients after operations on abdominal organs who have a risk of thromboembolic complications.
• Prevention of venous thromboembolism in patients at risk of such complications due to long-term mobility limitation during the acute phase of the disease.
• Unstable angina or non-ST-segment elevation myocardial infarction to prevent fatal events, myocardial infarction, and refractory ischemia.
• ST-Elevation Myocardial Infarction to prevent fatal, recurrent myocardial infarction in patients treated with thrombolytic agents or in those naïve to other forms of reperfusion therapy.

Contraindications.

Established allergy to the active substance or to any of the auxiliary substances of the drug. Active clinically significant bleeding. Acute bacterial endocarditis. Severe renal failure (creatinine clearance < 20 ml/min).

Dosage and Administration.

Application method.

Arixtra  is intended for subcutaneous or intravenous injection. Do not use intramuscularly.

Subcutaneous injection.

When Arixtra   is used in the form of a deep subcutaneous injection, the patient should be in a supine position. The injection sites should be alternately left and right anterolateral or left and right posterolateral abdominal wall. To avoid the loss of the drug, do not remove the air bubble from the pre-filled syringe before injection. The needle should be inserted along its entire length perpendicularly into the fold of skin, pinched between the thumb and forefinger; during the introduction, the skin fold must be held tight.

Arixtra  is intended only for use under the supervision of a physician.

Subcutaneous injection should be administered in the same way as in the case of using a classic syringe.

Intravenous injection (only the first dose in the treatment of patients with ST-segment elevation myocardial infarction).

It is administered intravenously through the existing intravenous system directly without dilution or with dilution in a small volume (25 or 50 ml) of 0.9% sodium chloride. To avoid the loss of the drug, do not remove the air bubble from the pre-filled syringe before injection. After injection, the system or catheter should be thoroughly flushed with 0.9% sodium chloride solution to ensure that the drug has been completely injected. When diluting Arixtra  with a 0.9% sodium chloride solution, the injection should be carried out within 1-2 minutes.

Before using the solution for injections, it is necessary to visually control the absence of visible particles and a change in color.

^{Arixtra Ò} pre-filled syringes have been designed with an automatic needle protection system to prevent damage after drug injection.

Any unused product or material must be disposed of in accordance with legal regulations.

Step-by-step instructions for using the drug Arikstra 

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

2. Remove the syringe from the packaging and make sure that:

· the expiration date of the drug has not expired,

· the solution is transparent and colorless, and also does not contain particles,

· the syringe was not opened or damaged.

3. Take a comfortable position while sitting or lying down.

Choose a spot in the lower abdomen (stomach), at least 5 cm below the navel.

Use the left and right sides of the lower abdomen alternately with each injection. This will help reduce discomfort at the injection site.

If it is not possible to inject into the lower part of the abdomen, ask a nurse or doctor for help.

4. Clean the injection site with an alcohol wipe.

5. Remove the needle cap by first turning it (Figure B1) and then pulling it in a straight line away from the syringe body.

Discard the needle cap.

An important note

Do not touch the needle or allow the needle to touch any surface before the injection.

It is normal if you see small air bubbles in this syringe. Do not try to remove these air bubbles before giving the injection – you may lose some of the medicine if you do.

6. Gently squeeze the cleansed skin to form a fold. Hold the crease between your thumb and index finger throughout the injection.

7. Hold the syringe firmly with your fingertips.

Insert the needle full length at a right angle into the skin fold.

8. Inject ALL of the contents of the syringe by pushing the plunger all the way in.

9. Release the plunger and the needle will automatically exit the skin and return to the safety cap where it will be permanently sealed.
Do not throw away the used syringe in household waste. Dispose of it according to the instructions given to you by your doctor or pharmacist.

Prevention of venous thromboembolism.

Extensive orthopedic and abdominal interventions.

The recommended dose of Arixtra for adults is 2.5 mg once a day after surgery in the form of a subcutaneous injection.

The initial dose should be administered no earlier than 6 hours after the end of the operation, provided hemostasis is achieved.

Treatment should be carried out before reducing the risk of developing thromboembolism, usually before transferring the patient to outpatient treatment, at least 5-9 days after the operation. Experience shows that there is a risk of venous thromboembolism in patients who have undergone hip fracture surgery for more than 9 days. Additional prophylactic use of Arixtra  for a period of up to 24 days is recommended for such patients.

Patients with a high risk of thromboembolic complications based on the results of an individual risk assessment.

The recommended dose of Arixtra  is 2.5 mg once a day as a subcutaneous injection. The duration of treatment in this case is from 6 to 14 days.

Unstable angina/myocardial infarction without ST segment elevation.

The recommended dose of Arixtra  is 2.5 mg once a day as a subcutaneous injection. Treatment should be initiated as soon as possible after diagnosis and continued for a maximum of 8 days or until the patient is discharged from the hospital, whichever occurs first.

Patients who are to undergo percutaneous coronary intervention while on Arixtra  should use unfractionated heparin during such intervention, taking into account the potential risk of bleeding in the patient, including the time after administration of the last dose of fondaparinux. The time to resume subcutaneous use of Arixtra  after removal of the catheter is determined based on the patient’s clinical condition. In a clinical trial in unstable angina/non-ST-segment elevation myocardial infarction, resumption of treatment with Arixtra  was initiated no earlier than 2 hours after catheter removal.

ST segment elevation myocardial infarction.

The recommended dose of Arixtra  is 2.5 mg once a day. The first dose of Arixtra (fondaparinux sodium) is administered intravenously, subsequent doses are given by subcutaneous injection. Treatment should be initiated as soon as possible after diagnosis and continued for a maximum of 8 days or until the patient is discharged from the hospital, whichever occurs first.

Patients who are to undergo non-primary percutaneous coronary intervention during treatment with Arixtra  should use unfractionated heparin during such intervention, taking into account the potential risk of bleeding in the patient, including the time after administration of the last dose of fondaparinux. The time to resume subcutaneous use of Arixtra  after catheter removal should be determined based on the patient’s clinical condition. In a clinical trial in unstable angina/ST-segment elevation myocardial infarction, resumption of treatment with Arixtra  was initiated no earlier than 3 hours after catheter removal.

Patients who are scheduled for coronary artery bypass grafting (CABG).

In patients with ST-segment elevation myocardial infarction or patients with unstable angina/non-ST-segment elevation myocardial infarction who are scheduled for coronary artery bypass grafting (CABG), fondaparinux should be withheld for 24 hours before surgery if possible, and fondaparinux can be restarted 48 hours later after surgery.

Special groups of patients.

Children.

The safety and efficacy of Arixtra (fondaparinux sodium) in children have not been established.

Prevention of venous thromboembolism after surgery.

In the case of surgery, the timing of the first fondaparinux injection should be strictly observed in patients aged ≥ 75 years and/or body weight < 50 kg, and/or with impaired renal function with creatinine clearance in the range of 20 to 50 mL/min.

The first dose of fondaparinux should be administered no earlier than 6 hours after closing the surgical wound. The injection should not be made until hemostasis is established.

Elderly patients (over 75 years old).

Arixtra  should be used with caution in elderly patients, as kidney function deteriorates with age.

Patients with a body weight of less than 50 kg.

Prevention of venous thromboembolism and treatment of unstable angina/non-ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction. Patients with a body weight of less than 50 kg have an increased risk of bleeding. Elimination of fondaparinux decreases with decreasing body weight. Fondaparinux should be used with caution in such patients.

Kidney failure.

Prevention of venous thromboembolism. Patients with mild renal impairment (creatinine clearance > 50 ml/min) do not need to change the dose.

Patients with a creatinine clearance of 20-50 ml/min are recommended to use the drug in a dose of 1.5 mg per day as prescribed by a doctor.

Arixtra (fondaparinux sodium) is not recommended for patients with creatinine clearance below 20 ml/min.

Unstable angina/non-ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction. Arixtra  is contraindicated for the treatment of patients with creatinine clearance less than 20 ml/min. It is not necessary to adjust the dose for the treatment of patients with a creatinine clearance of 20 ml/min or more.

Violation of liver function.

Prevention of venous thromboembolism and treatment of unstable angina/non-ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction. It is not necessary to adjust the dosage for patients with mild and moderate hepatic insufficiency. Arixtra should be used with caution in patients with severe hepatic insufficiency, as this group of patients has not been studied.