Anfibra

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

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

Anfibra is an anticoagulant drug.

Release form and composition

Anfibra dosage form - injection solution: transparent, with a yellowish tinge or colorless (in ampoules of 0.2, 0.4, 0.6, 0.8 or 1 ml, in a cardboard box 2, 5, 10 ampoules included with an ampoule knife; in syringes of 0.2, 0.4, 0.6, 0.8 or 1 ml, 2 syringes in blisters, 1 or 5 packs in a cardboard box).

The composition of the injection solution in 1 ampoule / syringe:

active substance: enoxaparin sodium - 20, 40, 60, 80 or 100 mg (2000, 4000, 6000, 8000, 10,000 anti-Xa ME (international units));
auxiliary component (20/40/60/80/100 mg): water for injection - up to 0.2 / 0.4 / 0.6 / 0.8 / 1 ml.

Indications for use

venous thrombosis and thromboembolism in bed rest patients (decompensation of chronic heart failure (CHF) according to NYHA classification - III or IV class, acute heart / respiratory failure, infections or rheumatic diseases in acute course in combination with at least one of the conditions / diseases, which are a risk factor for venous thrombosis, namely: malignant neoplasms, age from 75 years, thromboembolism and thrombosis in history, obesity, heart failure, hormonal therapy, chronic respiratory failure) (for prevention);
venous thrombosis and thromboembolism during surgical procedures (especially during general surgical / orthopedic operations (for prevention);
deep vein thrombosis, including in combination with pulmonary embolism (for treatment);
thrombus formation in the artificial circulation system during hemodialysis for up to 4 hours (for prevention);
acute myocardial infarction with ST segment elevation in patients who are indicated for drug therapy or subsequent percutaneous coronary intervention (for treatment);
unstable angina and acute myocardial infarction without a Q wave on the ECG (combination therapy with acetylsalicylic acid (ASA)) (for treatment).

Contraindications

Absolute:

diseases / conditions accompanied by a high probability of bleeding: threatening abortion, dissecting aortic aneurysm or cerebral aneurysm (except for surgical interventions), suspected / established hemorrhagic stroke, uncontrolled bleeding, enoxaparin- / heparin-induced thrombocytopenia in severe course (for several last months);
age up to 18 years (the safety profile for this category of patients has not been studied);
pregnancy in women with an artificial heart valve (in other cases, it is necessary to assess the ratio of benefits to risks) and the period of breastfeeding;
the presence of hypersensitivity to the components of the drug, heparin or its derivatives, including fractionated heparins.

Relative (Anfibra is prescribed with caution in the following conditions / diseases):

disorders of the blood coagulation system, including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease, etc.;
conducting epidural / spinal anesthesia (due to the presence of a risk of hematoma);
recent ischemic stroke;
recent childbirth;
subacute / acute bacterial endocarditis;
diabetes mellitus in severe course;
intrauterine contraception;
peptic ulcer of the stomach or duodenum or other erosive and ulcerative lesions of the gastrointestinal tract;
pericardial effusion, pericarditis;
suspected / recently postponed neurological or ophthalmic operations;
renal / hepatic impairment;
recent radiation therapy;
lumbar puncture, transferred recently;
hemorrhagic / diabetic retinopathy;
open wounds on large areas of the skin;
severe trauma (especially the central nervous system);
active tuberculosis;
arterial hypertension (uncontrolled);
severe vasculitis;
active diseases of the respiratory and urinary system;
combined use with drugs that affect hemostasis.

Method of administration and dosage

Anfibra is injected subcutaneously, in the inferolateral / superior lateral parts of the anterior abdominal wall (alternately in the left or right). Intramuscular administration is contraindicated. The patient must lie down during the injection. The needle should be directed vertically, it should be inserted its entire length into the skin, which is clamped in a crease between two (index and thumb) fingers. Until the end of the injection, the skin fold is not straightened. Do not rub the injection site after the procedure.

The recommended dosage regimen for the prevention of venous thrombosis and thromboembolism (determined by the degree of risk of their development):

moderate risk (general surgical, orthopedic operations): 1 time a day, 20-40 mg (first injection - 2 hours before surgery);
high risk (orthopedic surgery): 1 time per day, 40 mg (first injection - 12 hours before surgery) or 2 times a day, 30 mg (first injection - 12-24 hours before surgery). Duration of use - 7-10 days (while maintaining the risk of thrombosis and thromboembolism, longer use is possible; in orthopedics - for 5 weeks (40 mg 1 time per day)).

For percutaneous coronary angioplasty, epidural / spinal anesthesia, in order to reduce the likelihood of bleeding, it is better to install / remove a catheter with a low anticoagulant efficacy of enoxaparin sodium.

For the prevention of deep vein thrombosis, a catheter is installed / removed 10-12 hours after the administration of Anfibra in prophylactic doses. In cases where the patient receives the drug in higher doses (2 times a day at 1 mg / kg or once a day at 1.5 mg / kg), these procedures should be postponed for 24 hours. The subsequent introduction of Anfibra is carried out no earlier than 2 hours after the removal of the catheter.

When prescribing the drug during epidural / spinal anesthesia, constant careful monitoring of the condition is required in order to identify any symptoms of a neurological nature (in the form of back pain, impaired motor / sensory functions, functional disorders of the intestine / bladder). In cases of the appearance of signs of a hematoma of the brain stem, urgent diagnosis and treatment is required, including, if necessary, spinal decompression.

For the prevention of venous thrombosis and thromboembolism in bed rest patients, Anfibra is prescribed 1 time per day, 40 mg for 6-14 days.

Treatment of deep vein thrombosis (with / without pulmonary embolism): once a day at 1.5 mg / kg or 2 times a day at 1 mg / kg, with complicated thromboembolic disorders - 2 times a day at 1 mg / kg. Duration of use - 10 days. Therapy should be carried out in combination with oral anticoagulants until the desired effect is achieved (INR (international normalized ratio) - 2-3).

In the treatment of unstable angina pectoris and myocardial infarction without Q wave, Anfibra is administered 2 times a day (with an interval of 12 hours) at 1 mg / kg in combination with ASA (1 time per day at 100-325 mg). The average duration of the course is 2-8 days (therapy is carried out until the condition is stabilized).

Treatment of ST-segment elevation myocardial infarction (medically or with the help of percutaneous coronary intervention) should begin with an intravenous bolus of 30 mg of enoxaparin sodium, followed by subcutaneous administration of 1 mg / kg of enoxaparin sodium (within 15 minutes) (maximum for the first two subcutaneous injection can be administered at 100 mg of Anfibra). Then the drug is injected subcutaneously at 1 mg / kg 2 times a day at regular intervals.

Patients over 75 years of age do not receive an initial IV bolus. Enoxaparin sodium is injected every 12 hours subcutaneously at a dose of 0.75 mg / kg (maximum 75 mg of Anfibra can be administered during the first two subcutaneous injections). Then the drug is administered subcutaneously at 0.75 mg / kg 2 times a day at regular intervals.

When combined with thrombolytics (fibrin-specific / nonspecific), enoxaparin sodium should be administered in the interval from 15 minutes before the start of thrombolytic therapy and up to 30 minutes after it. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, ASA is simultaneously prescribed (therapy, in the absence of contraindications, is carried out for at least 30 days, daily at 75-325 mg).

The recommended course duration is 8 days. The bolus solution is injected through a catheter inserted into the vein. It is impossible to mix / inject Anfibra simultaneously with other drugs (the catheter must be washed with 0.9% sodium chloride solution or 5% dextrose solution before and after the administration of enoxaparin sodium, the administration of Anfibra with these solutions is allowed).

In the treatment of acute myocardial infarction with ST segment elevation for bolus administration of the drug in a dose of 30 mg from large-volume glass syringes, the excess amount of solution is removed so that the required dose remains in them. It can be administered intravenously.

With intravenous bolus administration of Anfibra through a venous catheter, it is possible to use larger syringes (60/80/100 mg each). The use of 60 mg syringes is recommended. In this case, syringes of 20 mg are not used due to insufficient volume of the drug, 40 mg - due to the lack of division and the inability to correctly dose the drug.

When carrying out percutaneous coronary intervention, in cases where the last subcutaneous injection was performed less than 8 hours before the balloon catheter inserted into the narrowing of the coronary artery was inflated, additional Anfibra injection is not required. With a longer break, an intravenous bolus is additionally administered at a dose of 0.3 mg / kg.

In order to increase the accuracy of small volumes for bolus injection into a venous catheter, it is recommended to dilute the drug to a concentration of 3 mg / ml immediately before administration - using a pre-filled 60 mg syringe, use a container with 0.9% sodium chloride solution or 5% dextrose solution with a volume of 50 ml. From it, using a conventional syringe, remove and remove 30 ml of solution. Enoxaparin sodium is added to the 20 ml of infusion solution remaining in the container and mixed gently. The required volume of Anfibra must be removed with a syringe. The calculation is carried out as follows: volume of the diluted drug = patient weight (kg) x 0.1.

In the prevention of thrombus formation in the cardiopulmonary bypass system during hemodialysis, the drug is prescribed at the rate of 1 mg per 1 kg of patient weight. In cases where there is a high probability of bleeding, the dose is reduced: with a double vascular access - by 50%, with a single access - by 25%. In hemodialysis, Anfibra should be injected at the beginning of the hemodialysis session into the arterial site of the shunt. As a rule, one dose is sufficient for a 4-hour session, however, in cases of detection of fibrin rings with a longer hemodialysis, an additional dose of 0.5-1 mg / kg is possible.

For patients with severe renal failure, the dose is adjusted: with creatinine clearance less than 30 ml / min: treatment - 1 mg / kg once a day, prophylaxis - 20 mg once a day (the dosage regimen does not apply to hemodialysis cases). No dose adjustment is required for mild / moderate renal impairment.

In elderly patients without impaired renal function, the dosage regimen is not adjusted except for the treatment of myocardial infarction with ST segment elevation.

Dosing features with endogenous creatinine clearance less than 30 ml / min (subcutaneous administration): 1 mg / kg 2 times a day or 1.5 mg / kg 1 time per day (normal regimen) / 1 mg / kg 1 time per day (regimen with renal failure in severe course).

Acute ST-segment elevation myocardial infarction (treatment of patients depending on age):

under 75 years of age: intravenous bolus 30 mg and subcutaneously 1 mg / kg, followed by subcutaneous administration of 1 mg / kg 2 times (normal regimen) or 1 time (regimen for severe renal failure) per day;
over 75 years of age: subcutaneously 0.75 mg / kg 2 times a day (normal regimen) or 1 mg / kg 1 time per day (regimen for severe renal failure) without the initial bolus.

For prophylaxis, the following dosage regimen is indicated: 20 or 40 mg 1 time per day (usual regimen) / 20 mg 1 time per day (regimen for severe renal failure).

Side effects

Possible violations (≥1 / 10 - very often; ≥1 / 100- <1/10 - often; ≥1 / 1000- <1/100 - infrequently; ≥1 / 10,000- <1/1000 - rarely; <1 / 10,000 - very rare):

bleeding (the most common disorder, especially in cases of risk factors): very often - in the treatment of deep vein thrombosis with / without thromboembolism and prevention of venous thrombosis in surgical patients; often - in the prevention of venous thrombosis in bed rest patients and in the treatment of angina pectoris, myocardial infarction without Q wave / with ST segment elevation; infrequently - retroperitoneal / intracranial in the treatment of deep vein thrombosis with / without thromboembolism, myocardial infarction with ST segment elevation; rarely - retroperitoneal in the prevention of venous thrombosis in surgical patients, in the treatment of myocardial infarction without Q wave, angina pectoris;in rare cases (with epidural / spinal anesthesia and the use of penetrating catheters in the postoperative period) - the formation of neuraxial hematomas (development of neurological disorders that differ in severity, including irreversible / long-lasting paralysis, is possible);
thrombocytosis and thrombocytopenia: very often - thrombocytosis in the prevention of venous thrombosis in surgical patients and in the treatment of deep vein thrombosis with / without thromboembolism; often - thrombocytopenia in the prevention of venous thrombosis in surgical patients and in the treatment of deep vein thrombosis with / without thromboembolism, in ST-segment elevation myocardial infarction; infrequently - thrombocytopenia in the prevention of venous thrombosis in bed rest patients and in the treatment of angina pectoris, myocardial infarction without Q wave; very rarely - thrombocytopenia of autoimmune genesis in myocardial infarction with ST segment elevation; in some cases - autoimmune thrombocytopenia in combination with thrombosis (thrombosis can be complicated by limb ischemia or organ infarction);
others: very often - an increase in hepatic transaminases; often - allergic reactions, itching, urticaria, redness of the skin, pain / hematoma at the injection site; infrequently - bullous rashes, reactions at the injection site (inflammation / necrosis of the skin); rarely - anaphylactoid / anaphylactic reactions, hyperkalemia; in cases of development of skin necrosis (after the appearance of purpura or erythematous painful papules), treatment is canceled. Inflammatory solid nodules-infiltrates at the injection site disappear on their own after a few days, they are not grounds for canceling therapy.

special instructions

The risk of heparin-induced thrombocytopenia may persist for several years. If there is an indication of a history of thrombocytopenia, the appointment of Anfibra is possible only after consulting a specialist. Developing thrombocytopenia, as a rule, is detected in the period from 5 to 21 days from the start of treatment (it is recommended to regularly monitor the number of platelets before / during treatment). With a confirmed significant decrease in the number of platelets (by 30-50% in comparison with the baseline), therapy is canceled.

To reduce the likelihood of bleeding associated with invasive vascular manipulation in the treatment of unstable angina pectoris and myocardial infarction without a Q wave, the catheter should not be removed for 6-8 hours after subcutaneous administration of the drug. The next dose can be administered after a break of 6-8 hours from the moment the catheter is removed (observation of the injection site of Anfibra is shown in order to timely detect signs of bleeding and hematoma formation).

There is evidence of rare cases of spinal cord hematoma with the subsequent occurrence of irreversible / persistent paralysis when using the drug during epidural / spinal anesthesia. The likelihood of these phenomena decreases with the use of Anfibra in a dose of up to 40 mg, increases with an increase in the dose, as well as due to the use of penetrating epidural catheters in the postoperative period or when combined with drugs that affect hemostasis. When symptoms typical of a brain stem hematoma appear, diagnosis and treatment are prescribed.

The prophylactic appointment of Anfibra is justified in cases of the development of an acute infection only when the prolongation of the activated partial thromboplastin time and clotting time is combined with such diseases / conditions as: hormonal therapy, age from 75 years, obesity, malignant neoplasms, anamnestic data on thromboembolism / thrombosis, cardiac / chronic respiratory failure.

It is not necessary to alternate the use of Anfibra and other low molecular weight heparins.

Drug interactions

It is impossible to mix Anfibra in one syringe with other substances / medicines.

When combined with drugs such as salicylates of systemic action, ASA, non-steroidal anti-inflammatory drugs, dextrin with a molecular weight of 40 kDa, clopidogrel, ticlopidine, systemic glucocorticosteroids, thrombolytics or anticoagulants, other antiplatelet drugs, there is an increase in the likelihood of bleeding.

Analogs

Analogues of Anfibra are: Clexan, Gemapaksan, Eniksum.

Terms and conditions of storage

Store at temperatures up to 25 ° C, protected from light and out of reach of children.

Shelf life is 2 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!