Octanate - Instructions For Use, 500 IU, 1000 IU, Price, Analogues

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

Octanate

Octanate: 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. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Octanat

ATX code: B02BD02

Active ingredient: blood coagulation factor VIII (Coagulation Factor VIII)

Manufacturer: Octapharma, AB (Sweden); Octapharma, S. A. S. (Octapharma, SAS) (France); Octapharma Pharmazeutika Produktionsges.mbH (Austria)

Description and photo update: 2019-08-10

Octanate is a hemostatic agent.

Release form and composition

The drug is produced in the form of a lyophilisate for the preparation of a solution for intravenous (iv) administration: an amorphous mass or powder from white to pale yellow [250, 500 or 1000 International Units (ME) in a glass vial sealed with a rubber stopper covered with aluminum cap for running-in and a plastic cap, in a cardboard box 1 bottle and instructions for use of Octanate. Solvent: 5 ml (for a dose of 250 ME) or 10 ml (for a dose of 500 and 1000 ME Octanate) water for injection in a glass vial, sealed with a rubber stopper, covered with an aluminum cap and a plastic cap, in a cardboard box 1 bottle. Set for dissolution and intravenous administration, in a plastic bag: 1 disposable syringe, 1 double-ended needle, 1 filter needle, 1 butterfly needle, 2 disinfecting wipes in individual sealed packages. Plastic tape fastened 1 cardboard box with a bottle of lyophilisate, 1 cardboard box with a bottle of solvent and 1 bag with a kit for dissolution and IV administration].

The composition of the lyophilisate, which is in 1 bottle, includes:

• active ingredient: human blood coagulation factor VIII - 250, 500 or 1000 IU, which is equivalent to a protein content of 5.5; 11 or 22 mg, respectively;
• additional ingredients: sodium citrate, sodium chloride, calcium chloride, glycine.

Pharmacological properties

Pharmacodynamics

Octanate is a hemostatic drug used in hemophilia A. Blood coagulation factor VIII - the active component of the drug, provides the transition of prothrombin to thrombin and promotes the formation of a fibrin clot.

Pharmacokinetics

In patients with hemophilia A, the half-life (T _1/2) is 12 hours. The activity of blood coagulation factor VIII (antihemophilic globulin) decreases by 15% over 12 hours.

Since antihemophilic globulin is thermolabile and rapidly degrades when the temperature rises, this causes a reduction in T _1/2.

Indications for use

Octanate is recommended for the treatment and prevention of bleeding in patients (including children under 6 years of age) with congenital hemophilia A or acquired deficiency of blood coagulation factor VIII, including inhibitory forms (using the method of induction of immune tolerance).

Contraindications

A contraindication to the use of Octanate is the presence of hypersensitivity to any of its ingredients.

Octanate, instructions for use: method and dosage

The Octanate solution prepared from the lyophilisate is intended for intravenous administration. To dilute the lyophilized powder, use the included solvent - water for injection.

The dose of Octanate and the duration of replacement therapy are determined taking into account the degree of deficiency of coagulation factor VIII, the duration and localization of bleeding, and the patient's condition.

The amount of hemostatic agent is expressed in ME, which corresponds to the accepted standards of the World Health Organization (WHO) for factor VIII (FVIII). The activity of the latter in plasma is expressed as a percentage - relative to the normal concentration of the factor in human plasma) or in IU - relative to the International Standard for FVIII.

One IU of FVIII is equivalent to its concentration in 1 ml of normal human plasma. The required dose is calculated on the basis of empirical data, according to which 1 IU / kg FVIII increases the plasma factor level by 1.5–2% of the norm. The dose required for the patient is calculated by setting the initial level of FVIII and determining the amount by which this activity should be increased, according to the formula:

required dose = body weight (kg) × desired increase in FVIII level (%) (IU / dl) × 0.5

The amount and frequency of administration of Octanate should in each case correspond to the clinical effectiveness. With the development of subsequent bleeding, the activity of FVIII should not be lower than the initial plasma level (in% of the normal level) in the corresponding period.

The list below can be used to determine the dose of FVIII and the frequency of injections for bleeding of varying severity and different types of surgical interventions (the required level of FVIII is indicated):

• intramuscular (i / m) bleeding, early hemarthrosis, bleeding in the oral cavity: FVIII - 20–40%; inject every 12-24 hours, for at least 1 day until the pain is relieved or the source of bleeding heals;
• more common hemarthrosis, intramuscular bleeding or hematoma: FVIII - 30-60%; enter every 12-24 hours for 3-4 days until relief of pain symptoms and restoration of working capacity;
• life-threatening bleeding: FVIII - 60-100%; enter every 8-24 hours until the threat to life is completely removed;
• minor surgical interventions, including tooth extraction: FVIII - 30-60%; every 24 hours for at least 1 day until healing is observed;
• major surgical interventions: FVIII (pre- and postoperative) - 80-100%; inject every 8-24 hours until adequate wound healing is observed, then continue therapy for at least 7 days to maintain FVIII activity within 30-60%.

In the course of treatment with Octanate, the level of FVIII should be determined to adjust the dose used and the frequency of administrations, since patients respond to the drug individually. As a consequence, different levels of in vivo recovery and different T1 _{/ 2} clotting factor can be observed. The most careful monitoring of the activity of this factor is required during replacement therapy, especially during major surgical operations. The doses indicated in the list are indicative, in each case the required dose and the frequency of administration are set individually by the doctor.

For use of Octanate in persons with severe hemophilia A for long-term prevention of bleeding, the recommended doses of antihemophilic globulin are 20-40 IU / kg every 2-3 days. Sometimes, mainly in young patients, an increase in the dose or a decrease in the interval between injections may be required.

After therapy, some patients may develop inhibitory antibodies to FVIII, which can affect the result of further treatment. If during the course of therapy the expected increase in the activity of FVIII is not achieved or the necessary hemostatic effect is absent, you should consult a specialized hematological / hemophilic center with the Bethesda test (a specific blood test for the presence of an inhibitor). To eliminate the inhibitor to FVIII, it is possible to use therapy for the induction of immune tolerance, which is based on daily administration of FVIII at a concentration that exceeds the inhibitor's blocking ability (in a daily dose of 100-200 IU / kg, taking into account the inhibitor titer). Performing the function of an antigen,Octanate causes an increase in the inhibitor titer until tolerance develops - a decrease and further elimination of the inhibitor. Treatment is continuous and lasts for 10–18 months and should only be carried out by a specialist experienced in the management of patients with hemophilia.

Instructions for dissolving the lyophilisate:

1. The preparation contained in closed vials and the accompanying solvent (water for injection) should be brought to room temperature. If a water bath is used for warming, its temperature should not exceed 37 ° C, in addition, it is required not to allow water to come into contact with the bottle caps or rubber stoppers.
2. After removing the protective caps from the vials with lyophilizate and solvent, it is necessary to wipe the rubber stoppers of both vials with one of the disinfecting wipes.
3. After removing the plastic packaging from the short end of the double-ended needle, you need to pierce the cork of the solvent bottle with it and push it down until it stops, and then turn the bottle over and hold it upside down with the needle.
4. Having freed the other, long end of the double-ended needle from the package, it is required to pierce the cork of the vial with the drug with it and push it down until it stops. The vacuum inside the lyophilisate vial will draw in the solvent.
5. Having separated the bottle with the solvent together with the needle from the bottle with the drug, you should slowly shake the bottle with the lyophilisate until it is completely diluted. The prepared solution should be colorless, transparent or slightly opalescent, without sediment.

After dissolving the lyophilisate, it is required to remove the protective coating from the filter needle and then pierce the rubber cap of the bottle with the prepared solution with it. After removing the cap from the filter needle, you need to attach a syringe to it, and holding the bottle with the fixed syringe upside down, draw in the last solution. When making an injection, it is necessary to follow the rules of asepsis and antiseptics. After disconnecting the needle with the filter from the syringe, attach a butterfly needle instead. The solution must be injected slowly intravenously, the rate of administration is 2-3 ml / min.

Before and during the administration of Octanate, as a precaution, it is necessary to monitor the heart rate (HR). If there is a pronounced acceleration of the pulse, you should reduce the rate of intravenous infusion of the drug or stop the injection.

If more than one bottle of Octanate is used in one treatment procedure, the syringe and butterfly needle can be reused. The filter needle is intended for single use only. It is always recommended to use a filter needle to draw the solution obtained after dissolving the lyophilisate into the syringe.

Side effects

Against the background of treatment with Octanate, in rare cases, hypersensitivity reactions may occur, which can manifest as a burning sensation at the injection site, hot flashes, anxiety, lethargy, a feeling of trembling, chills, urticaria (including generalized), a decrease in blood pressure (BP), headache, vomiting, nausea, shortness of breath, chest tightness, tachycardia, fever, angioedema.

Very rarely, these symptoms can progress to a severe anaphylactic reaction, including shock.

Overdose

Despite the fact that there are no reports of symptoms of Octanate overdose, the recommended dose should not be exceeded.

special instructions

Against the background of treatment with Octanate, as with the use of other drugs of protein origin for parenteral administration, hypersensitivity reactions may occur. Due to the fact that, in addition to FVIII, Octanate contains trace amounts of other blood proteins, it is necessary to take into account possible early signs of hypersensitivity reactions, such as a feeling of tightness in the chest, urticaria, shortness of breath, decreased blood pressure, anaphylaxis. If these symptoms appear, it is required to immediately stop the administration of the solution, and if shock develops, it is necessary to resort to modern methods of anti-shock therapy.

When using medicinal products made from human blood or plasma, the risk of transmission of pathogenic agents cannot be completely excluded, this also applies to pathogens of unknown diseases. However, the threat of transmission of infections is reduced as a result of the following measures:

• selection of donors through medical examination and survey; screening of individual plasma pools for antibodies to human immunodeficiency virus (HIV) and hepatitis C (HCV), hepatitis B virus (HBV) antigens;
• analysis of plasma pools to identify HCV genetic material;
• inactivation / elimination procedures that have been validated in a viral model and incorporated into the manufacturing process; these procedures are effective for HIV, HBV, HCV and hepatitis A virus (HAV), but may show limited effect against non-enveloped viruses, including parvovirus B19, the latter can lead to fetal infection in seronegative pregnant women, and also have serious consequences for patients with immunodeficiency or increased production of red blood cells, for example, with hemolytic anemia.

Patients receiving F VIII concentrate made from blood plasma are recommended to be vaccinated against hepatitis A and B.

With the development of allergic reactions, it is necessary to examine the patient for the presence of an FVIII inhibitor, since in the presence of the latter, in the course of further drug therapy, the risk of anaphylactic reactions may increase. As a result, the first administration of Octanate should be carried out according to the prescription of the attending physician under the supervision of physicians in conditions that allow the provision of the necessary qualified assistance in case of allergic reactions.

When introducing a solution prepared from a lyophilisate Octanate, only the injection devices that are included in the package should be used. In the case of using other devices, due to the possible adsorption of FVIII on the inner surface of some of them, a decrease in the effectiveness of the drug may be noted.

Application during pregnancy and lactation

Therapy with the drug Octanate during pregnancy and lactation is possible only if the expected benefit outweighs the risk to the health of the fetus and child.

Pediatric use

The use of Octanate in children is possible according to the dosage regimen.

Drug interactions

There are no data on the interaction of coagulation factor VIII with drugs / agents.

During the administration of Octanate, other medicines should not be used.

Analogs

Octanate analogues are Beriate, Hemophil M, Nuvik, Agemfil A, LongEit, Cryoprecipitate, Hemoktin, Immunat, Coate-DVI, Fundy, etc.

Terms and conditions of storage

Store out of the reach of children, protected from light, at a temperature of 2–25 ° C, without freezing.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Octanate

The few reviews about Octanate found on medical sites are usually positive. They note the effectiveness of the drug in the treatment and prevention of bleeding due to congenital hemophilia A or acquired deficiency of coagulation factor VIII. After the course use of Octanate, bleeding stops, and the general condition is significantly improved, which significantly improves the quality of life. Octanate injections, according to patients, are not very painful. There are no complaints about the development of undesirable phenomena.

Price for Octanate in pharmacies

The price of Octanate, a lyophilisate for preparing a solution for intravenous administration, depends on the dosage: Octanate 500 IU - 4800–5600 rubles, Octanate 1000 IU - 7500–8500 rubles. for 1 bottle with a solvent and a set for dissolution and intravenous administration.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!