Agemfil B (Lyophilisate) Instructions for Use

Marketing Authorization Holder

FSBI Hematology Research Center Of Roszdrav (Russia)

ATC Code

B02BD04 (Blood coagulation factor IX)

Active Substance

Human coagulation factor IX

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

Dosage Form

Agemfil B

Lyophilisate for preparation of solution for infusion 250 IU: vial 1 pc.

Dosage Form, Packaging, and Composition

Blood substitute vials (1) – cardboard packs.

Clinical-Pharmacological Group

Hemostatic agent. Blood clotting factors (VIII and von Willebrand) preparation

Pharmacotherapeutic Group

Hemostatic agent

Pharmacological Action

Agemfil B contains a purified concentrate of blood coagulation factor IX, which is obtained from a pool of fresh frozen donor plasma.

Control for the absence of hepatitis B virus surface antigen (HBsAg), antibodies to hepatitis C virus (anti-HCV) and to human immunodeficiency virus – HIV-1/HIV-2 is carried out by enzyme immunoassay.

Blood coagulation factor IX has a hemostatic effect; it increases the content of factor IX in plasma and restores hemostasis in patients with its deficiency.

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

It increases the level of vitamin K-dependent coagulation factors (II, VII, IX, and X) in plasma.

When the plasma level of factor IX decreases below 5% of normal, the risk of spontaneous hemorrhage increases sharply, while a content above 20% of normal provides satisfactory hemostasis.

Pharmacokinetics

About 40% of factor IX is determined in the blood immediately after intravenous infusion, then the hemostatic activity gradually decreases T_1/2 – 20 hours.

Indications

• Treatment and prevention of bleeding in patients with hemophilia B, including during emergency or planned surgical intervention.

ICD codes

Dosage Regimen

The drug is used only intravenously after complete dissolution in 20 ml of water for injections. The recommended rate of administration is 100 IU/min.

Preparation of the solution Agemfil B should be diluted only in sterile water for injections.

Before dilution, the vial with the drug and sterile water for injections should be brought to a temperature of 20-30°C (-22°F).

Using a sterile disposable needle and syringe, draw up the required volume of sterile water for injections (20 ml) and inject it into the vial with the drug.

To completely dissolve, gently swirl the vial without shaking.

After 3-5 minutes, a clear or slightly opalescent solution should be obtained.

The diluted drug should be used within 1 hour after preparation.

If a gel or clot forms in the vial, the resulting solution should not be used.

The dose of Agemfil B for hemostasis restoration is selected individually, depending on the degree of bleeding and the required level of factor IX.

The introduction of one unit of activity (IU) of factor IX per kg of body weight increases the level of factor IX in blood plasma by an average of 1% and the following formula can be recommended for dose calculation.

Required dose = required increase in factor IX activity (%) x body weight (kg)/1(%/IU/kg)

To achieve a satisfactory clinical result, it is necessary to correlate the therapeutic effect with the data from measurements of the factor IX level in the patient’s plasma.

The required dose of the drug for a single administration and the duration of treatment depend on the severity of factor IX deficiency, as well as on the location and volume of bleeding and the clinical condition of the patient.

Mild bleeding. To treat superficial or beginning bleeding for 2-3 days, a dose of Agemfil B is administered to maintain the concentration of factor IX in blood plasma at a level of 30%.

Moderate bleeding. To treat moderate bleeding, the level of factor IX should be raised to 30-50% by administering Agemfil B for 3-4 days at intervals of 12-14 hours.

Severe bleeding. In patients with life-threatening bleeding or bleeding into vital organs (central nervous system, retropharyngeal or retroperitoneal space, iliopsoas muscle), the level of factor IX in blood plasma must be increased to 80-100% by administering Agemfil B for 10-14 days at intervals of 12-14 hours.

Surgery. The intensity of replacement therapy with Agemfil B depends on the type of surgical operation and the subsequent postoperative regimen.

During extensive surgical interventions, the level of factor IX should be maintained at a level of at least 50%.

For this purpose, transfusions of Agemfil B can be repeated every 6-12 hours for 10-14 days.

Prophylaxis. The prophylactic treatment regimen should be adjusted according to the individual needs of the patient.

As a rule, for maintenance therapy in patients with a severe form of hemophilia, a dose of 20-30 IU/kg of Agemfil B, administered 3 times a week, is effective to maintain a 3-5% level of factor IX in blood plasma.

Adverse Reactions

Too rapid administration of the drug can sometimes cause a short-term increase in body temperature, chills, headache.

In some cases, nausea, tachycardia, a tingling sensation in the body, back pain, postoperative thrombosis, allergic reactions (urticaria, anaphylactic reaction), and decreased resistance to infectious diseases may occur.

Contraindications

• DIC syndrome;
• Acute thrombosis;
• Acute myocardial infarction;
• Factor VII deficiency;
• Acute hepatic failure;
• Individual hypersensitivity to the drug,

Use in Pregnancy and Lactation

Studies of the effect of Agemfil B on animal reproductive capacity have not been conducted.

It is not known whether Agemfil B can cause fetal harm or affect reproductive capacity when administered to a pregnant woman.

Agemfil B should be prescribed to women only if the expected benefit outweighs the possible risk for both the woman and the fetus/child.

Use in Hepatic Impairment

Contraindicated in acute hepatic failure.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

There are no indications that Agemfil B can reduce the ability to drive a car or operate machinery.

Overdose

Symptoms of Agemfil B overdose are unknown.

Drug Interactions

Unknown. Agemfil B should not be administered in the same syringe with any other medications.

Storage Conditions

Store in a dark place out of the reach of children (2-6°C (21.2°F)). List B.

Shelf Life

Shelf life – 1 year.

Dispensing Status

By prescription.

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.