Arixtra
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Arixtra is an antithrombotic drug; synthetic selective inhibitor of activated factor X (Xa).
Release form and composition
Arixtra is available in the form of a solution for intravenous and subcutaneous or only subcutaneous administration: colorless, transparent or almost transparent liquid (0.5 ml in glass syringes, 5 syringes in plastic trays, 2 trays in a cardboard box).
The composition of the solution for 1 syringe:
- active substance: fondaparinux sodium - 2.5 mg;
- auxiliary components: sodium chloride, 0.01M hydrochloric acid solution / 0.005M sodium hydroxide solution, water for injection.
Indications for use
Arixtra is used to treat the following diseases:
- deep vein thrombosis in the acute stage;
- acute symptomatic thrombosis of the superficial veins of the lower extremities in the absence of deep vein thrombosis;
- acute coronary syndrome with myocardial infarction without ST-segment elevation or unstable angina (to prevent refractory ischemia, myocardial infarction, or cardiovascular death);
- acute coronary syndrome with ST-segment elevation myocardial infarction (to prevent re-infarction and death in persons receiving thrombolytic therapy or patients who did not initially receive reperfusion treatment);
- pulmonary embolism.
For the purpose of prophylaxis, the drug is used in the following cases:
- venous thromboembolic complications in persons undergoing abdominal surgery and are at risk of such complications;
- venous thromboembolic complications in patients undergoing "major" surgical orthopedic operations on the lower extremities (hip replacement, knee replacement, fracture of the hip joint, including long-term prevention in the postoperative period);
- venous thromboembolic complications in non-surgical individuals in the presence of risk factors for such complications with limited mobility in the acute period of the disease.
Contraindications
Absolute:
- severe renal failure (creatinine clearance less than 20 ml / min);
- acute bacterial endocarditis;
- clinically significant active bleeding;
- hypersensitivity to any component of the drug.
Reception is not recommended:
- performing the procedure of primary PCI (percutaneous coronary intervention) in persons with ST-segment elevation myocardial infarction (immediately before and during the procedure);
- non-primary PCI in patients with myocardial infarction without elevation and elevation of the ST segment.
Relative (the drug Arixtra is used with caution):
- exacerbation of peptic ulcer of the duodenum and stomach;
- severe liver dysfunction;
- recently transferred intracranial hemorrhage;
- acquired or congenital disorders of the blood coagulation system (in the form of bleeding);
- recent surgery on the spinal cord or brain;
- recently transferred ophthalmic operations;
- moderate renal failure (creatinine clearance less than 50 ml / min);
- the patient's body weight is less than 50 kg (due to the high risk of bleeding);
- advanced age over 75 years (due to the high risk of bleeding);
- simultaneous use with drugs that increase the risk of bleeding.
The use of the drug during pregnancy is allowed only if the expected benefit to the mother significantly outweighs the potential risk to the fetus.
During lactation (breastfeeding), the use of Arixtra is not recommended.
Method of administration and dosage
The drug Arixtra is administered subcutaneously (s / c) or intravenously (i / v) under the supervision of a physician.
Subcutaneous injections are performed alternately into the left and right anterolateral surface of the anterior abdominal wall. The needle is inserted all the way into the fold of skin, which is clamped with the thumb and forefinger and is not unclenched during insertion.
For intravenous administration, Arixtra solution is injected into a catheter or mini-containers of 25 or 50 ml with 0.9% sodium chloride solution are used, in which the drug is previously diluted. After injection, the catheter should be flushed with a sufficient amount of isotonic sodium chloride solution in order to ensure delivery of the full dose of the drug. If mini-containers are used for administration, the duration of the infusion should be 1-2 minutes.
Recommended doses and duration of treatment with Arixtra in adult patients:
- deep vein thrombosis and pulmonary embolism: s.c. 5 mg (patients weighing less than 50 kg), 7.5 mg (patients weighing 50-100 kg) or 10 mg (patients weighing more than 100 kg) once a day. Vitamin K antagonists should be added to therapy not later than 72 hours from the start of treatment. Duration of treatment is 5-9 days;
- superficial vein thrombosis: s / c 2.5 mg once a day. Treatment begins as early as possible and continues for 45 days;
- unstable angina pectoris or myocardial infarction without ST segment elevation: s / c 2.5 mg once a day. Treatment begins as early as possible and continues for 8 days, and in the case of an earlier discharge of the patient, until the moment of discharge. When performing PCI during treatment with Arixtra, the patient should also receive unfractionated heparin. With CABG (coronary artery bypass grafting), it is undesirable to administer fondaparinux sodium during the day before the operation; the drug is resumed two days after CABG;
- ST-segment elevation myocardial infarction: 2.5 mg once a day. The first dose should be administered intravenously, all subsequent doses should be administered subcutaneously. Treatment begins as early as possible and continues for 8 days, and in the case of an earlier discharge of the patient - until the moment of discharge. When performing PCI during treatment with Arixtra, the patient should also receive unfractionated heparin. With CABG, fondaparinux sodium is undesirable to administer within 24 hours before surgery; the drug is resumed two days after CABG;
- prevention of venous thromboembolic complications: s / c 2.5 mg once a day after surgery. The first dose of the drug is administered no earlier than 6 hours after the end of the operation, and also under the condition of independent hemostasis. Duration of treatment is at least 5-9 days. In patients with a fracture of the hip joint, after surgery, therapy can be continued for up to 24 days. In non-surgical patients with risk factors for thromboembolic complications, the duration of the drug is 6-14 days.
Special studies on the use of Arixtra in children and adolescents under 17 years of age have not been conducted.
Prescribing fondaparinux sodium to children for the treatment of pulmonary embolism and deep vein thrombosis is carried out in doses similar to those used in adult patients - s / c 0.1 mg / kg / body weight 1 time per day.
Side effects
- nervous system: sometimes - headaches; rarely - drowsiness, dizziness, anxiety, loss or confusion;
- digestive system: sometimes - vomiting and nausea; rarely - gastritis, diarrhea or constipation, dyspepsia, abdominal pain;
- liver and biliary tract: sometimes - an increase in the concentration of liver enzymes in the blood, abnormal results of liver function tests; rarely - an increase in the concentration of bilirubin;
- cardiovascular system: rarely - lowering blood pressure;
- hematopoietic system: often - purpura, various bleeding, anemia; sometimes - thrombocythemia, coagulation disorder, thrombocytopenia, platelet abnormality;
- respiratory system: rarely - cough, shortness of breath;
- metabolism: rarely - hypokalemia;
- skin and subcutaneous fat: sometimes - itching, rash, discharge from the wound;
- other reactions: often - edema; sometimes fever; rarely - pain in the chest and lower extremities, facial flushing, allergic reactions, infection of a postoperative wound, fatigue, syncope, reactions at the injection site.
special instructions
The drug Arixtra is prohibited to be administered intramuscularly.
Medicines that increase the likelihood of bleeding should not be used concomitantly with fondaparinux sodium. An exception is vitamin K antagonists, which are used in the treatment of pulmonary embolism and venous thrombosis. If necessary, the use of such combinations, therapy is carried out under the strict supervision of a physician.
With the simultaneous lumbar puncture or epidural / spinal anesthesia and the use of Arixtra, spinal or epidural hematomas may appear, sometimes leading to prolonged or permanent paralysis. The risk of such rare events is increased with the simultaneous administration of other drugs that affect hemostasis, and with the postoperative use of indwelling epidural catheters.
Studies on the effect of the drug Arixtra on the speed of psychomotor reactions and concentration have not been conducted.
Drug interactions
With simultaneous use with antiplatelet agents (acetylsalicylic acid), cardiac glycosides (digoxin), oral anticoagulants (warfarin) and non-steroidal anti-inflammatory drugs (piroxicam), the pharmacodynamics or pharmacokinetics of fondaparinux sodium did not change. The drug also did not affect the pharmacodynamic and pharmacokinetic parameters of the listed drugs.
Arixtra solution is not recommended to be mixed in the same syringe with other means.
Analogs
The analogue of Arkistra is Fondaparinux sodium.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C out of reach of children. The drug must not be frozen.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
