Mononine (Lyophilisate) Instructions for Use

ATC Code

B02BD04 (Blood coagulation factor IX)

Active Substance

Human coagulation factor IX

Human coagulation factor IX (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Blood coagulation factor IX preparation

Pharmacotherapeutic Group

Hemostatic agent

Pharmacological Action

Hemostatic agent used in hemophilia B. In the process of blood coagulation, coagulation factor IX is activated by factor XIa.

The active form of coagulation factor IX – factor IXa – in combination with coagulation factor VIII activates factor X, which, in turn, promotes the conversion of prothrombin to thrombin and the formation of a fibrin clot.

Pharmacokinetics

In patients with hemophilia B, T_1/2 is 1 day.

Indications

Prophylaxis and treatment of bleeding in hemophilia B, acquired deficiency of coagulation factor IX.

ICD codes

Dosage Regimen

Determine the dose individually based on the severity of hemorrhage, body weight, and the patient’s clinical condition.

Calculate the required dose in International Units (IU) using the formula: Body Weight (kg) x Desired Factor IX Increase (% of normal) x 1.0 IU/kg.

For minor spontaneous bleeding or prophylaxis, administer intravenously at a dose of 20-30 IU/kg. Target a factor IX level of 20-30% of normal.

For moderate bleeding (e.g., hematomas, minor trauma), administer a dose of 30-50 IU/kg. Target a factor IX level of 30-50% of normal.

For major bleeding, extensive trauma, or major surgical interventions, administer a dose of 60-75 IU/kg. Target a factor IX level of 60-100% of normal. Repeat doses as necessary.

Adjust the dosage and frequency based on regular monitoring of plasma factor IX activity. Maintain levels above 5% for prophylaxis and tailor peak levels for specific bleeding episodes or surgical procedures.

Administer by slow intravenous infusion. Do not exceed an infusion rate of 3 mL per minute. Monitor pulse rate before and during administration.

Reduce the infusion rate or stop administration immediately if a significant increase in pulse rate occurs or if signs of an allergic reaction develop.

Adverse Reactions

Allergic reactions: chills, fever, urticaria are possible.

From the digestive system: nausea, vomiting are possible.

From the blood coagulation system: cases of intravascular coagulation and development of thrombosis during surgical interventions and in patients with liver diseases have been reported.

Other: headache, feeling of heat are possible.

Contraindications

Hypersensitivity to coagulation factor IX.

Use in Pregnancy and Lactation

Currently, there is insufficient experience with the use of coagulation factor IX during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in patients with liver diseases.

Pediatric Use

Use with caution in newborn infants.

Special Precautions

Use with caution in patients with liver diseases, in the postoperative period, in newborns, and in other cases of increased risk of thrombosis and DIC.

If DIC syndrome is suspected or present, administration can be carried out only after this process has been stopped, preferably in combination with antithrombin III.

A thorough justification for the use of coagulation factor IX is necessary in patients with hemophilia B with recent thrombosis or acute myocardial infarction in cases where they develop bleeding.

During administration, it is necessary to monitor the degree of increase in coagulation factor IX values, which should average 25% and should not exceed 50%; pulse rate before and during the administration of coagulation factor IX.

If the pulse rate increases significantly, it is necessary to slow down the infusion rate of the drug or stop its administration.

Patients with allergic diseases are recommended to receive prophylactic corticosteroids and antihistamines.

In case of allergic or anaphylactic reactions, administration should be stopped immediately and appropriate therapy should be prescribed.

When using drugs made from human blood or plasma, the possibility of contracting infectious diseases cannot be completely excluded.

Drug Interactions

Coagulation factor IX eliminates excessive anticoagulant effect and bleeding caused by warfarin.

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.