Arykstra, 2.5mg/0.5 ml 0.5 ml syringes 10 pcs

Antithrombotic drug. Synthetic selective inhibitor of activated factor X (Xa). Antithrombotic activity is the result of selective inhibition of factor Xa mediated by antithrombin III.

Indications

Active ingredient

Composition

1 syringe contains:

How to take, the dosage

The recommended dose of Arykstra is 2.5 mg once daily by mouth.

The initial dose is administered 6 hours after the completion of surgery if there is hemostasis.

The course of treatment should last 5-9 days. The efficacy and safety of Aricstra over 9 days has not been established.

If prolonged therapy with anticoagulants is necessary, the patient should be transferred to drugs with a history of long-term use.

The timing of the first injection of Arixtra in patients over 75 years of age, and/or with a body weight less than 50 kg, and/or with moderately impaired renal function (CK 30-50 ml/min) should be strictly adhered to: the drug should not be injected earlier than 6 hours after completion of surgery. The injection should not be given until final hemostasis.

Interaction

Peroral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin do not affect the pharmacokinetics of fondaparinux sodium. Fondaparinux sodium had no effect on either warfarin activity or bleeding time with acetylsalicylic acid or piroxicam or on the pharmacokinetics of digoxin in equilibrium.

Do not use concomitantly with fondaparinux sodium drugs that increase the risk of bleeding (desirudin, fibrinolytics, GP IIb/IIIa receptor antagonists, heparin, heparinoids or low molecular weight heparins).

The risk of bleeding is increased when co-administering Acrixtra with substances that may increase the risk of bleeding (acetylsalicylic acid, other NSAIDs, dipyridamole, sulfinpyrazone, ticlopidine, clopidogrel). If it is necessary to use such a combination, therapy should be carried out with caution and under strict control.

Special Instructions

If prophylactic use of heparin or low-molecular-weight heparins is necessary after Arykstra therapy, the first injection of heparins should be given one day after the last administration of Arykstra.

If maintenance therapy with vitamin K antagonists is necessary, the simultaneous administration of fondaparinux sodium should be continued until the target INR (international normalized ratio) is achieved.

When using Aricstra concomitantly with epidural anesthesia or spinal tap, the possibility of epidural or spinal hematomas that may lead to paralysis cannot be excluded. The risk of this rare complication may increase with the postoperative use of permanent epidural catheters or the simultaneous administration of other drugs that affect hemostasis.

The elderly have an increased risk of bleeding. Since renal function usually decreases with age, excretion of fondaparinux sodium may be reduced in elderly patients and thus the drug exposure is increased. Therefore, Arikstra should be used with caution in elderly patients.

Patients weighing less than 50 kg are at greater risk of bleeding because excretion of fondaparinux sodium is reduced in these patients. In these patients Arykstra should be used with caution.

The risk of bleeding is increased in patients with impaired renal function with a CKC less than 50 ml/min.

Arixtra should be administered with caution in moderate renal dysfunction.

When prescribing the drug in patients with hepatic impairment there is no need to adjust the dose of Arikstra. However, in patients with severe liver function impairment due to deficiency of clotting factors the risk of bleeding increases, therefore Arikstra should be used with caution.

Before starting therapy and at the end of therapy it is recommended to control the platelet count. This is particularly important if maintenance treatment with heparin or low molecular weight heparins is to be performed.

Contraindications

– Active, clinically significant bleeding;
– Acute bacterial endocarditis;
– Severe renal insufficiency (CK – conditions associated with the risk of bleeding (clotting disorders, including. Hemophilia, thrombocytopenia, hypocoagulation, Willebrand’s disease);
– Gastric and duodenal ulcer in acute phase;
– cerebral hemorrhage;
– cerebral aneurysm;
– uncontrolled arterial hypertension (increased risk of cerebral hemorrhage);
– dissecting aortic aneurysm;
– diabetic retinopathy;
– repeated neurological or ophthalmologic surgeries;
– spinal anesthesia (potential risk of hematoma development);
– threatening abortion;
– significant liver function disorders;
–
– simultaneous use with such drugs as fibrinolytic agents, heparin, heparinoids, GP IIb/IIIa receptor antagonists, antiplatelet agents, NSAIDs;
– hypersensitivity to the drug components.
It is administered with caution in patients with increased risk of bleeding, for example, with platelet count less than 50 000/μl, with peptic ulcer disease, after recent intracranial hemorrhage or surgical interventions on the brain or spinal cord, after ophthalmic operations.

Arixtra should be avoided in patients with heparin-induced thrombocytopenia type II (due to lack of clinical experience with the drug).

Side effects

The frequency of adverse reactions is presented according to the following grading: very frequently (>1/10), frequently (>1/100, <1/10); sometimes (>1/1000, <1/100); rarely (>1/10 000, <1/1000); very rarely (<1/10 000).

These adverse reactions should be considered in a surgical and therapeutic context depending on the indication.

Hematopoietic system disorders: frequent – anemia, bleeding (various localization, including rare cases of intracranial/intracerebral and retroperitoneal bleeding), purpura; sometimes – thrombocytopenia, thrombocythemia, platelet abnormality, coagulation disorders.

Mechanical disorders: rarely – hypokalemia.

Nervous system disorders: sometimes – headache; rarely – anxiety, confusion, dizziness, somnolence, loss of consciousness.

Cardiovascular system: rare – arterial hypotension.

Respiratory system: rarely – shortness of breath, cough.

The digestive system: sometimes – nausea, vomiting; rarely – abdominal pain, dyspepsia, gastritis, constipation, diarrhea.

Hepatic and biliary tract disorders: sometimes – abnormal results of liver tests, increased concentration of liver enzymes in blood; rarely – increased concentration of bilirubin in blood.

Skin and subcutaneous fat: sometimes – rash, itching, wound discharge.

Others: often – edema; sometimes – fever; rarely – infection of the postoperative wound, chest pain, pain in the lower extremities, fatigue, facial hyperemia (flushes), syncopal states, allergic reactions, reactions at the injection site.

Overdose

Symptoms: bleeding.

Treatment: withdrawal of the drug, examination of the patient.

The use of surgical hemostasis, replenishment of blood loss, transfusion of fresh plasma, plasmapheresis is possible.

Pregnancy use

Arquistra should not be administered in pregnancy unless the estimated benefit to the mother exceeds the potential risk to the fetus.

There is no clinical experience with the use of the drug in pregnancy. Experimental studies on the effects of fondaparinux sodium on the course of pregnancy, embryo/fetal development, as well as on labor and postnatal development are insufficient due to limited exposure.

Breastfeeding should be stopped during the use of the drug.

Sodium fondaparinux has been found to be excreted in rat milk, but there are no data on excretion with breast milk in women during lactation. Absorption of fondaparinux sodium in a breastfed infant is unlikely.