Coagil-VII (Lyophilisate) Instructions for Use

ATC Code

B02BD08 (Eptacog alfa activated (blood coagulation factor VIIa))

Active Substance

Eptacog alfa (activated)

Eptacog alfa (activated) (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Blood coagulation factor VIIa preparation

Pharmacotherapeutic Group

Hemostatic agents; vitamin K and other hemostatic agents; blood coagulation factors

Pharmacological Action

Recombinant blood coagulation factor VIIa. In therapeutic doses, it binds to a large amount of tissue factor, forming a complex that enhances the initial activation of factor X.

In the presence of calcium ions and anionic phospholipids, it is capable of activating factor X on the surface of activated platelets, acting “bypassing” the coagulation cascade system.

It acts only at the site of injury and does not cause systemic activation of the coagulation process.

Pharmacokinetics

Pharmacokinetic profiles indicate a directly proportional dose-dependent relationship.

The V_d at steady state ranged from 130 to 165 ml/kg, mean clearance values ranged from 33.3 to 37.2 ml/h x kg, and the mean T_1/2 ranged from 3.9 to 6.0 hours.

Indications

Bleeding and prevention of massive bleeding during surgical operations in patients with hereditary or acquired hemophilia with inhibitors to coagulation factor VIII and coagulation factor IX; hereditary factor VII deficiency; in patients with Glanzmann’s thrombasthenia and refractoriness (current or past) to platelet transfusions in the presence or absence of platelet antibodies or when platelet concentrate is unavailable.

ICD codes

Dosage Regimen

Administer intravenously as a bolus injection over 2-5 minutes.

Reconstitute the lyophilisate only with the provided sterile water for injection.

Determine the dosage individually based on body weight, indication, severity of hemorrhage, and clinical response.

For hemophilia A or B with inhibitors, the initial recommended dose is 90 mcg/kg body weight.

Repeat dosing at 2-3 hour intervals until hemostasis is achieved.

For minor bleeding episodes, administer additional doses as needed.

For major bleeding and surgical interventions, continue dosing at 2-4 hour intervals for the entire duration of the hemostatic challenge.

In surgical settings, administer a bolus dose immediately pre-operatively.

Follow with repeat doses at 2-hour intervals for the first 48 hours.

Subsequently, administer doses at 2-6 hour intervals until wound healing is complete.

For congenital Factor VII deficiency, the recommended dose is 15-30 mcg/kg every 4-6 hours.

Adjust the dose and interval based on clinical response and Factor VII activity levels.

For Glanzmann’s thrombasthenia, the recommended dose is 90 mcg/kg.

Repeat dosing at 1.5-2 hour intervals until hemostasis is achieved.

Do not exceed single doses of 120 mcg/kg unless specifically indicated.

Monitor patients for signs of thrombotic events or disseminated intravascular coagulation during therapy.

Discontinue use immediately if signs of hypersensitivity or anaphylaxis occur.

Adverse Reactions

From the blood coagulation system: disseminated intravascular coagulation and associated changes in laboratory parameters (increased D-dimer content and decreased antithrombin III activity, coagulopathy).

From the immune system: hypersensitivity reactions, anaphylactic reactions.

From the nervous system: headache.

From the cardiovascular system: arterial thromboembolism (myocardial infarction, cerebral infarction, cerebral ischemia, cerebral artery occlusion, cerebrovascular complications, renal artery thrombosis, peripheral vascular ischemia, peripheral artery thrombosis, and intestinal ischemia), angina pectoris, thromboembolism (deep vein thrombosis, injection site vein thrombosis, pulmonary thromboembolism, hepatic thromboembolism, including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial vein thrombophlebitis, and intestinal ischemia), intracardiac thrombus.

From the digestive system: nausea.

From the skin and subcutaneous tissues: skin rash (including allergic dermatitis and erythematous rash), skin itching and urticarial rash, skin redness, angioedema.

From laboratory parameters: increased fibrin degradation products, increased ALT activity, ALP, LDH and prothrombin concentration.

Other: fever, reactions at the injection site, including pain.

Contraindications

Hypersensitivity to mouse, hamster, and cow proteins.

Use in Pregnancy and Lactation

Use during pregnancy should be avoided.

It is not known whether the active substance is excreted in breast milk.

Use with caution during breastfeeding, only if the expected benefit to the mother outweighs the potential risk to the infant.

Use in Hepatic Impairment

Should be used with caution in patients with liver diseases.

Pediatric Use

Can be used in children according to indications, in recommended doses and regimens.

Should be used with caution in newborns.

When used in pediatric practice, higher doses may be required to achieve a plasma concentration of eptacog alfa similar to the plasma concentration in adult patients.

Special Precautions

In pathological conditions accompanied by increased release of tissue factor, the use of eptacog alfa may be associated with a potential risk of thrombotic complications or DIC syndrome.

Such conditions include severe atherosclerosis, crush injuries, septicemia, or DIC syndrome.

Eptacog alfa should be prescribed with caution to patients with an increased risk of thrombotic complications or DIC syndrome, patients with a history of coronary artery disease and liver diseases, as well as patients in the postoperative period and newborns.

In each case, the potential benefit of using eptacog alfa for treating patients with the listed conditions must be carefully weighed against the risk of developing the described complications.

Such patients require careful medical supervision.

In patients with blood coagulation factor VII deficiency, prothrombin time and blood coagulation factor VII activity should be monitored before and after administration of eptacog alfa.

If the activity of blood coagulation factor VIIa does not reach the expected value, or bleeding continues despite the use of eptacog alfa in recommended doses, antibody formation can be suspected.

In this case, an analysis for the presence of antibodies should be performed.

Cases of thrombosis have been reported with the use of eptacog alfa during surgical interventions in patients with blood coagulation factor VII deficiency, but data on the risk of thrombosis in patients with blood coagulation factor VII deficiency during treatment with eptacog alfa are not available.

Drug Interactions

Eptacog alfa should not be mixed with infusion solutions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.