Coagil-VII - Instructions For Use, Price, Analogues, Reviews

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

Coagil-VII

Coagil-VII: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Drug interactions
11. 11. Analogs
12. 12. Terms and conditions of storage
13. 13. Terms of dispensing from pharmacies
14. 14. Reviews
15. 15. Price in pharmacies

Latin name: Coagil-VII

ATX code: B02BD08

Active ingredient: eptacog alfa (activated)

Manufacturer: Generium CJSC (Russia)

Description and photo updated: 2018-29-11

Coagil-VII is a hemostatic agent.

Release form and composition

Produce the drug in the form of a lyophilisate for the preparation of a solution for intravenous (i / v) administration: amorphous white mass [lyophilisate: 1.2; 2.4 or 4.8 mg in a glass vial, sealed with a rubber stopper and an aluminum-plastic cap for running-in, with first opening control; solvent - water for injection (water for injection): 5 ml in a glass ampoule with a ring or break point or 2, 4, 5, 8 or 10 ml in a glass bottle sealed with a combined cap containing elastomeric elements; 1 vial with lyophilisate and 1 ampoule with solvent (for 1.2 and 2.4 mg) or 2 ampoules with solvent (for 4.8 mg), or 1 vial with lyophilisate and 1 vial with solvent in a blister strip or without it, complete with 1 or 2 dilution needles, syringe without needle, peripheral vein catheter,an injection filter and 2 alcohol wipes in a cardboard box with labels to control the first opening at the junction of the bottom and the lid with the front and rear edges; each pack also contains instructions for the use of Coagil-VII].

1 bottle with the drug contains:

• active substance: eptacog alpha (activated) - 1.2 mg [60 KED / 60 thousand international units (ME)]; 2.4 mg (120 KED / 120 thousand IU); 4.8 mg (240 KED / 240 thousand IU);
• additional components: calcium chloride dihydrate, sodium chloride, polysorbate 80, glycylglycine, mannitol.

1 ml of the prepared solution contains eptacog alpha (activated) in an amount of 0.6 mg.

Pharmacological properties

Eptacog alpha (activated) is a recombinant coagulation factor VIIa, derived from hamster kidney cells (BHK cells) through genetic engineering. The molecular weight is approximately 50,000 daltons (Da).

Pharmacodynamics

The mechanism of action of Coagil-VII determines the binding of the blood coagulation factor VIIa to the tissue released factor at the site of injury. The formed complex stimulates the process of converting blood coagulation factors IX and X into the active form IXa and Xa, which results in the initiation of the initial reactions of the conversion of prothrombin (II) into thrombin. Through the conversion of fibrinogen to fibrin, thrombin leads to the appearance of a hemostatic plug and the activation of platelets and coagulation factors V and VIII, localized at the site of injury.

In pharmacological doses, Coagil-VII directly, without the effect of tissue factor, converts on the surface of activated platelets located at the site of injury, the clotting factor X into the active form Xa, which causes the formation of a large amount of thrombin from prothrombin. The pharmacodynamic effect of eptacog alpha (activated) is thus manifested in the intensive local formation of the blood coagulation factor Xa with further accelerated production of thrombin and fibrin.

During the period of use of recombinant blood coagulation factor VIIa in patients with diseases that contribute to the development of disseminated intravascular coagulation syndrome (DIC), the threat of systemic activation of blood coagulation cannot be completely excluded.

Pharmacokinetics

According to published data, in adults, the half-life (T _1/2) of recombinant coagulation factor VIIa varies from 2 to 2.5 hours, in children this period is shorter.

The average clearance of eptacog alfa is 31.8 ml / h / kg, in children, the value of this indicator is about 2 times higher

Indications for use

Coagil-VII is recommended for use in order to stop bleeding and prevent the development of the latter during surgical interventions and procedures in the presence of the following diseases / conditions:

• congenital deficiency of blood coagulation factor VII;
• hemophilia (hereditary / acquired) with a high titer of an inhibitor to coagulation factors VIII or IX;
• Glanzman's thrombastenia with existing antibodies to glycoproteins IIb-IIIa and refractoriness (past or present) to platelet transfusions.

Contraindications

The use of Coagil-VII is contraindicated in cases of diagnosed hypersensitivity to proteins from hamsters, mice or cows, as well as to any component of the drug.

With extreme caution, it is required to use a hemostatic agent for the following conditions / diseases:

• widespread atherosclerosis;
• crushed wounds;
• sepsis;
• thrombotic complications;
• recent surgery due to a possible aggravation of the risk of thrombotic complications or disseminated intravascular coagulation (DIC).

Coagil-VII, instructions for use: method and dosage

Coagil-VII solution is intended for intravenous administration.

Recommended dosage regimen:

• bleeding of mild and moderate severity (including in outpatient treatment): I treatment regimen - the initial dose is 90 mcg / kg; to ensure hemostasis before stopping bleeding, 1–3 doses are prescribed with intervals between injections of 3 hours; to maintain the therapeutic effect, it is possible to introduce another dose; II treatment regimen - the drug is used once at a dose of 270 μg / kg; the duration of outpatient treatment should not exceed 24 hours; early administration of the solution makes it possible to more effectively control bleeding of mild to moderate severity into the skin, joints, muscles and mucous membranes;
• severe bleeding: the dose is 90 μg / kg, Coagil-VII can be administered during the patient's transportation to the clinic, the subsequent therapy regimen depends on the severity and type of bleeding, the solution is injected every 2 hours until the bleeding stops; if it is necessary to continue the treatment, the intervals between injections for 1–2 days can be increased to 3 hours, and subsequently, throughout the course, the intervals can be sequentially increased to 4, 6, 8 or 12 hours; duration of treatment - 2-3 weeks or more (taking into account clinical indications);
• inhibitory hemophilia A or B, or acquired hemophilia: if bleeding occurs, the solution must be administered as early as possible, the dose is set individually, the agent is administered for 2-5 minutes IV bolus, the initial dose in most cases is 90 μg / kg injection until hemostasis is achieved, injections may be repeated every 2-3 hours; with the available indications for continuing therapy, the time between injections can be increased to 4, 6, 8 or 12 hours; the course depends on the severity of bleeding, the nature of invasive interventions or surgical treatment;
• factor VII deficiency: to stop bleeding and prevent its occurrence during surgery and procedures, Coagil-VII is administered every 4–6 hours at a dose of 15–30 μg / kg until hemostasis is achieved;
• Glanzman's thrombastenia: to control bleeding and prevent its occurrence against the background of invasive interventions or surgical operations, Coagil-VII is administered every 2 hours at a dose of 90 mcg (80-120 mcg), injections are performed at least 3 times; in the presence of Glanzman's thrombasthenia without refractoriness, the use of platelet mass is the main method of therapy;
• invasive interventions / surgical operations: Coagil-VII at a dose of 90 mcg / kg is administered immediately before the intervention or surgery, then after 2 hours and then during the first 24–48 hours at intervals of 2–3 hours; in large operations, therapy lasts 6–7 days with intervals between injections of 2–4 hours; in the next 2 weeks, the intervals can be increased to 6–8 hours, the general course is 2–3 weeks.

Rules for the preparation and administration of the Coagil-VII injection solution (subject to strict adherence to the rules of asepsis):

1. Heat the vial with the lyophilizate and (depending on the configuration) the ampoule (s) or the vial with the solvent - water d / and (for example, holding it in your hands) to room temperature, but not higher than 37 ° C.
2. Remove the protective cap from the lyophilisate vial and from the solvent vial, if the latter is included in the kit.
3. Treat the rubber stopper of the vial with the drug and the vial with the solvent or the neck of the ampoule (s) with the solvent with alcohol wipes, let them dry before use.
4. Open the syringe package and then open the needle package by peeling back the paper cover.
5. Put a sterile needle on the syringe without removing the protective cap and without touching the tip of the syringe to your hand or other surfaces. Open the ampoule (s) with water d / and (when equipped with a solvent in ampoules), observing the rules of asepsis and precautions. Release the needle from the protective cap.
6. Draw up the solvent from the opened ampoule (s) or from the bottle into the syringe by inserting the needle into its rubber stopper, in the required amount for injection: for 1.2 mg - 2 ml; for 2.4 mg - 4 ml; for 4.8 mg - 8 ml.
7. Set aside the syringe when filling water d / and in the vial, without removing the needle from its cork, and then, opening the blister pack of the second sterile needle, disconnect the syringe from the first needle, leaving it in the cork of the vial, and without removing the protective cap, put it on the syringe with water d / and the second needle, then remove the cap from it.
8. Introduce the required volume of water d / i into the vial with the drug, slowly pressing on the piston rod of the syringe. At the same time, the syringe should be slightly tilted; it is necessary not to hit the lyophilisate directly with a stream of water, as this can lead to its foaming.
9. Gently shake the bottle without shaking it until the drug is completely dissolved.
10. Draw the solution from the vial, holding it in a slightly tilted position, into the syringe, gradually raising the plunger. After making sure that all the prepared solution is in the syringe, set aside the last one, without removing the needle from the bottle cap, until the next manipulation.
11. Open the packaging of the peripheral vein catheter and the packaging of the injection filter.
12. Remove the syringe from the needle after removing air from it without changing the position of the piston, put the injection filter on the syringe with its open end, preventing the latter from contacting foreign surfaces.
13. Remove the protective plug from the catheter tube and attach the free end of the filter to the tube by turning it clockwise until it stops.
14. Remove the cap from the catheter needle, removing air from the syringe and the attached system for intravenous administration, inject the prepared solution into / into a jet (bolus) for 2–5 minutes.

If the administration of Coagil-VII is prescribed in an amount exceeding the dose contained in one vial, the solution must be prepared in the same way in the second vial with lyophilisate, using the supplied water for injection. Then the resulting solutions should be combined in a larger syringe (not included in the kit) and injected as usual. It is recommended to administer Coagil-VII solution immediately after preparation.

Side effects

• cardiovascular system: in some cases (especially in predisposed patients with concomitant risk factors): venous thrombosis - deep vein thrombosis and related complications, thrombophlebitis, pulmonary embolism; arterial thrombosis - angina pectoris, cerebrovascular circulation disorders (cerebral ischemia, cerebral infarction), intestinal infarction, myocardial infarction;
• blood coagulation system: rarely - a decrease in the number of platelets and a decrease in the level of fibrinogen, an increase in the concentration of D-dimer, prothrombin;
• allergic reactions: rarely - skin redness, itching, skin rash;
• digestive system: rarely - vomiting, nausea, increased levels of alkaline phosphatase (ALP), alanine aminotransferase (ALT), lactate dehydrogenase (LDH);
• others: fever, chills, weakness, headache, sweating, pain (including at the injection site).

Isolated cases of antibodies to factor VII have been reported after the use of eptacog alpha (activated) in patients with factor VII deficiency. In the past, these patients were transfused with human plasma and / or plasma factor VII.

Overdose

With the introduction of Coagil-VII in doses exceeding the recommended 10–20 times, the threat of arterial and / or venous thrombosis is aggravated. As a result, if an overdose is suspected, it is necessary to carefully monitor the clinical condition of the patient and monitor the coagulogram parameters.

special instructions

In the case of using Coagil-VII at home, the patient must be informed about each administration of a hemostatic agent to the attending physician or clinic. If it is not possible to stop the bleeding, the patient must be hospitalized without fail. The course of therapy on an outpatient basis should not exceed 24 hours.

In the presence of an increased risk of developing DIC syndrome, the patient's condition must be strictly monitored, and the coagulogram indicators must also be monitored.

Before and after injections of Coagil-VII, patients with a deficiency of coagulation factor VII should monitor the activity of this coagulation factor and prothrombin time. If, despite treatment with the drug in the prescribed doses, the activity of the coagulation factor does not reach an adequate level or bleeding continues, it can be assumed that antibody formation is taking place. In such cases, it is necessary to test for the presence and determine the level of antibodies.

If there is a threat of venous thrombosis due to concomitant diseases, a history of thrombosis, vein catheterization or immobilization during the period after surgery, patients need to be closely monitored.

If foreign inclusions are found in the prepared solution, it must not be used.

Application during pregnancy and lactation

During pregnancy and lactation, the use of Coagil-VII is allowed only on strict indications.

Drug interactions

Coagil-VII should not be mixed with any other drug in the same syringe.

Do not use the drug simultaneously with activated or non-activated prothrombin complex concentrates.

In patients with hemophilia, with the introduction of antifibrinolytics, intraoperative blood loss is reduced, especially against the background of orthopedic operations or operations performed on tissues with high fibrinolytic activity, for example, in the oral cavity. However, the possibility of the combined use of Coagil-VII and antifibrinolytics has not been studied.

Analogs

Analogs of Coagil-VII are NovoSeven, Adveit, Aimfix, Hemoktin, Ditsinon, Cryoprecipitate, Octofactor, Refacto AF, Troxaminate, Etamzilat, etc.

Terms and conditions of storage

Store at 2-8 ° C (do not freeze), out of reach of children.

Shelf life: lyophilisate - 2 years; solvent in vials - 2.5 years; solvent in ampoules - 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Coagil-VII

According to the few reviews of Coagil-VII, the drug effectively stopped bleeding and prevented their development during surgical interventions, a deficiency in the body of coagulation factors, increased bleeding, and also effectively corrected hemostasis disorders.

The disadvantages of Coagil-VII include the development of allergic reactions when using it (skin rash, urticaria) and high cost.

Price for Coagil-VII in pharmacies

The price for Coagil-VII can be for 1 bottle with a lyophilisate for preparing a solution for intravenous administration:

• dosage 1.2 mg - 30,400 rubles;
• dosage 2.4 mg - 63,900 rubles;
• dosage 4.8 mg - 118 600 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!