OKTAPLEX - Instructions For Use, Price, Analogues, Reviews

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

OCTAPLEX

OKTAPLEX: 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: Octaplex

ATX code: B02BD01

Active ingredient: prothrombin complex - coagulation factors II, VII, IX and X in combination (Prothrombin complex - Coagulation Factor II, VII, IX and X in combination)

Manufacturer: Octapharma (France)

Description and photo update: 2019-08-10

OCTAPLEX is a hemostatic drug that includes a combination of plasma coagulation factors II, VII, IX and X.

Release form and composition

OCTAPLEX is produced in the form of a lyophilisate for the preparation of a solution for intravenous (iv) administration: a powdery or loose mass of bluish or white color, has a high hygroscopicity; after recovery, a pale blue or colorless solution is formed, transparent or slightly opalescent [lyophilisate - in glass vials without color, sealed with a rubber stopper, sealed with an aluminum cap, on the side of which the identification number of the lyophilisate series is applied, and covered with a plastic cap (it can be rotated), in a cardboard box 1 bottle; solvent (water for injection) - 20 ml each in colorless glass vials, sealed with a rubber stopper, sealed with an aluminum cap, on the side of which the identification number of the solvent series is applied,and covered with a plastic cover (you can scroll it); set for dissolution and injection - 1 disposable syringe with a volume of 20 ml, 1 double-ended needle, 1 filter needle (filter pore size 20 μm), 1 injection system (butterfly needle), 2 disinfectant wipes in individual sealed packages, in a plastic bag 1 set; in a cardboard box 1 bottle with solvent and 1 package with a set for dissolution and administration; 1 cardboard box with lyophilisate and 1 cardboard box with solvent and a set for dissolution and administration are sealed with plastic tape. Each pack also contains instructions for the use of OCTAPLEX].1 injection system (butterfly needle), 2 disinfectant wipes in individual sealed packages, in a plastic bag 1 set; in a cardboard box 1 bottle with solvent and 1 package with a set for dissolution and administration; 1 cardboard box with lyophilisate and 1 cardboard box with solvent and a set for dissolution and administration are sealed with plastic tape. Each pack also contains instructions for the use of OCTAPLEX].1 injection system (butterfly needle), 2 disinfectant wipes in individual sealed packages, in a plastic bag 1 set; in a cardboard box 1 bottle with solvent and 1 package with a set for dissolution and administration; 1 cardboard box with lyophilisate and 1 cardboard box with solvent and a kit for dissolution and administration are sealed with plastic tape. Each pack also contains instructions for the use of OCTAPLEX]. Each pack also contains instructions for the use of OCTAPLEX]. Each pack also contains instructions for the use of OCTAPLEX].

1 bottle with lyophilisate contains:

• active ingredients: coagulation factor II (prothrombin) - 280-760 ME (international unit), coagulation factor VII - 180-480 ME, coagulation factor IX - 500 ME, coagulation factor X - 360-600 ME, protein C - 260–620 ME, protein S - 240–640 ME (total protein content is 260–820 mg);
• auxiliary components: heparin (sodium heparin), sodium citrate.

Pharmacological properties

Pharmacodynamics

OCTAPLEX is a hemostatic drug that is a prothrombin complex that includes a combination of plasma coagulation factors II, VII, IX and X, which are synthesized in the liver with the participation of vitamin K.

Factor VII is a proenzyme of active serine protease factor VIIa, which initiates the endogenous blood coagulation pathway. Complex "tissue factor - factor VIIa" activating factors X and IX, promotes the formation of factors Xa and IXa. This is followed by the activation of the coagulation cascade with the activation of prothrombin (factor II) and its conversion to thrombin, which ensures the formation of fibrin from fibrinogen and the formation of a clot. In addition, in primary hemostasis, normal thrombin synthesis contributes to platelet function.

In the case of isolated severe factor VII deficiency, thrombin formation is reduced, which leads to impaired fibrin formation, impaired primary hemostasis and increased bleeding. Isolated factor IX deficiency results in the development of hemophilia B, a type of classic hemophilia. Isolated factor II or X deficiency is extremely rare, and severe cases can cause bleeding similar to classical hemophilia.

Treatment with vitamin K antagonists can cause deficiencies in vitamin K-dependent clotting factors. Severe deficiency is accompanied by the development of severe bleeding, which is characterized by retroperitoneal or cerebral bleeding, but not bleeding into muscles and joints. A significant decrease in the level of vitamin K-dependent clotting factors and clinical symptoms of increased bleeding may also be a consequence of severe liver failure. At the same time, the reason for the development of severe hepatic failure is most often the following complex of disorders: simultaneously occurring mild intravascular coagulation, low platelet count, deficiency of coagulation inhibitors and impaired fibrinolysis.

In case of insufficiency of one or several plasma coagulation factors, the use of OCTAPLEX promotes an increase in the level of vitamin K-dependent coagulation factors in plasma and a temporary correction of coagulation disorders.

Pharmacokinetics

After intravenous administration of a solution of the prothrombin complex, the half-life (T _1/2) for its active components is: factor II - 48-60 hours; factor VII - 1.5-6 hours; factor IX - 20-24 hours; factor X - 24-48 hours

Indications for use

OCTAPLEX is used for the treatment of bleeding and perioperative prevention of bleeding during surgery in patients with the following clinical indications:

• acquired deficiency of prothrombin complex factors, developing against the background of treatment with vitamin K antagonists or their overdose - in order to quickly correct the deficiency;
• congenital deficiency of vitamin K-dependent coagulation factors II and X - in cases of unavailability of the preparation of a purified specific coagulation factor.

Contraindications

Absolute:

• an allergic reaction to heparin;
• a history of heparin-induced thrombocytopenia;
• IgA deficiency (immunoglobulin A) - if patients have antibodies to IgA;
• hypersensitivity to the components of the drug.

Relative contraindications for the use of OCTAPLEX, when the drug is used with caution, are pregnancy and the period of breastfeeding.

OCTAPLEX, instructions for use: method and dosage

The finished solution of OCTAPLEX is administered intravenously.

It is required to use the drug as directed and under the supervision of a physician with experience in the treatment of blood coagulation disorders.

The solution should be prepared and the procedure for its administration should be carried out under conditions of aseptic rules.

If necessary, the lyophilisate and the solvent (water for injection) in closed vials are brought to room temperature, including using a water bath to warm the solvent (water temperature not exceeding 37 ° C), avoiding contact of water with the cork or bottle cap. After removing the protective caps from the vials with lyophilisate and solvent, the rubber stoppers of the vials are disinfected using a disinfectant napkin from the supplied kit.

By freeing the short end of the double-ended needle from the plastic packaging, without touching the needle itself. Then, keeping the needle strictly vertical, pierce the cork of the solvent bottle in the center so that only its end is visible in the bottle. Having freed the long end of the double-ended needle from the plastic packaging, without touching the needle itself, inverting the bottle with the solvent, pierce the cork of the bottle with the lyophilisate in the center with the long end of the needle. Water for injection from the solvent vial will be drawn into the lyophilized vial by vacuum.

After separating the empty bottle from the solvent together with the needle from the bottle with the lyophilisate, the bottle is gently rotated in order to more quickly and completely dissolve the lyophilisate, the dissolution time should not exceed 10 minutes. The finished solution should have a transparent or slightly opalescent structure and be colorless or pale blue. Do not use a solution if it is cloudy, contains sediment or suspended particles.

OCTAPLEX must be administered immediately after dissolution. Before starting the injection, the physician should determine the patient's heart rate (HR), continuing to monitor it throughout the procedure. In case of a pronounced increase in heart rate, the rate of administration is recommended to be reduced or interrupted.

Always use a filter needle to draw solution into the syringe. After removing the coating from the filter needle, the rubber stopper of the vial with the obtained preparation is pierced with it, and its opposite end is connected to a disposable syringe. Turning the bottle over, the solution is drawn into a syringe. The skin at the injection site is treated with a disinfectant wipe. After disconnecting the filter needle from the syringe (it is intended for single use only), attach the butterfly needle.

The initial injection rate should not exceed 1 ml per minute (ml / min), then OCTAPLEX is administered at a rate of 2-3 ml / min. Do not allow blood to enter the syringe - this can cause the formation of a fibrin clot.

Unused solution must be disposed of in accordance with existing regulations.

When opening the bottle, it is necessary to register the name of the drug and its batch number.

The doctor prescribes the dose, frequency of administration and duration of treatment individually, taking into account the clinical condition of the patient, the severity and localization of bleeding, the severity of the disorders.

The selection of an individual dose is made on the basis of regular monitoring of the level of concentration in the blood plasma of specific coagulation factors, the indicator of prothrombin time and the international normalized ratio (INR). Evaluating the dynamics of changes and the patient's condition, the therapy is corrected.

It is necessary to determine the interval between the injections of OCTAPLEX taking into account the duration T _{1/2 of} each of the coagulation factors, which is part of the prothrombin complex.

With extensive surgical intervention, careful monitoring of substitution therapy is required. It is produced using the method of coagulation tests, determining the levels of specific clotting factors and / or performing general tests to assess the prothrombin complex.

For patients taking vitamin K antagonist drugs, the dose is determined at the rate of 1 ml of the finished solution per 1 kg of body weight (ml / kg) based on the initial (before the start of OCTAPLEX application) and the target INR value.

The recommended dosage for the treatment and perioperative prevention of bleeding for patients taking vitamin K antagonist drugs, required to normalize the MHO value (less than 1.2 within 1 hour), depending on the following initial INR values:

• INR 2–2.5: dose 0.9–1.3 ml / kg;
• INR 2.5–3: dose 1.3–1.6 ml / kg;
• INR 3–3.5: dose 1.6–1.9 ml / kg;
• INR greater than 3.5: dose greater than 1.9 ml / kg.

The maximum single dose is not more than 3000 ME or 120 ml of ready-made OCTAPLEX solution.

The INR value should be determined after the administration of each dose, if it has not reached the required value, the introduction of repeated doses of the drug is allowed.

The therapeutic effect of correcting hemostasis disorders in patients of this group can persist for 6–8 hours. When OCTAPLEX is used together with vitamin K, there is practically no need for re-administration of the prothrombin complex. Careful monitoring of INR is required, since the severity and duration of drug action are largely individual and can vary.

The calculation of the dose of OCTAPLEX for the treatment of bleeding and perioperative prevention of bleeding in patients with congenital deficiency of K-dependent coagulation factors II and X (if a purified specific coagulation factor preparation is unavailable) is carried out taking into account that the dose is approximately 1 IU per 1 kg of body weight (IU / kg) of factor II or X, provides an increase in their activity by 0.02 and 0.017 IU per 1 ml (IU / ml), respectively. The dose of each specific factor administered is expressed in IU, which are defined by the WHO standard. Plasma coagulation factor II or X activity can be expressed as a percentage relative to normal plasma, or in terms of ME relative to the international standard for a specific coagulation factor.

When calculating the required dose of OCTAPLEX, it should be borne in mind that 1 IU of coagulation factor is equivalent to its content in 1 ml of normal plasma.

Doses for clotting factors II or X are calculated using the following formula:

Dose required = body weight in kilograms (kg) × desired factor II or X increase (IU / ml) × inverse of the recovery target * (ml / kg)

* the inverse value of the established recovery index: for factor II = 50, for factor X = 59

Patients with an established individual recovery rate should use it to calculate the dose.

Side effects

Possible negative side reactions caused by the use of OCTAPLEX:

• on the part of the immune system: rarely - hypersensitivity, the manifestations of which may be allergic reactions at the injection site, nausea, vomiting, chills, rash, hyperemia, anxiety, headache, increased sweating, tachycardia, arterial pressure disorders, shortness of breath or bronchospasm, angioedema, up to cases of severe anaphylaxis;
• on the part of laboratory parameters: rarely - a transient increase in hepatic transaminases.

Undesirable phenomena of OCTAPLEX registered in post-marketing observations, the frequency of occurrence of which cannot be reliably estimated due to the uncertain population size of the patients interviewed and the voluntary (optional) research format:

• from the nervous system: tremor;
• on the part of the cardiovascular system: tachycardia, hypertension, hypotension, vascular insufficiency, thromboembolic episodes (including peripheral vascular thrombosis, pulmonary embolism, deep vein thrombosis, myocardial infarction or ischemic stroke), cardiac arrest;
• from the immune system: anaphylactic reaction, anaphylactic shock;
• from the respiratory system: respiratory failure; dyspnea;
• from the gastrointestinal tract: nausea;
• dermatological reactions: rash, urticaria;
• general disorders: chills, fever.

Overdose

Symptoms of an overdose of prothrombin complex preparations are myocardial infarction, disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, in case of complications - DIC syndrome, aggravation of thromboembolic pathologies.

special instructions

The presence of heparin in OCTAPLEX suggests the development of type II thrombocytopenia against the background of a sudden decrease in the number of allergic platelets by 50% from the initial value. A decrease in the number of platelets, as a result of the development of hypersensitivity to heparin, can be observed 6-14 days after the first injection of the lyophilisate solution. Care should be taken and caution should be exercised when treating patients with known hypersensitivity to heparin, since such a decrease can occur in them within a few hours from the start of drug administration. In this case, an immediate termination of the procedure is required and in the future such patients cannot be prescribed drugs containing heparin.

In rare cases, replacement therapy can lead to the formation of circulating antibodies that inhibit one or more factors of the prothrombin complex, which can reduce the clinical effect of OCTAPLEX.

Recommendations for the appointment of a prothrombin complex should be given by a specialist in the treatment of blood coagulation disorders. With an acquired deficiency of vitamin K-dependent blood coagulation factors, the use of the drug is indicated only if an urgent correction of the level of the prothrombin complex is necessary - massive bleeding or urgent surgical interventions. In all other cases, reducing the dose of the vitamin K antagonist or prescribing vitamin K preparations is usually sufficient.

In patients with a tendency to hypercoagulability, the simultaneous use of vitamin K antagonists and OCTAPLEX can aggravate this pathology of the homeostasis system. In the case of congenital deficiency of only one vitamin K-dependent clotting factor, a factor-specific drug should be prescribed, if available.

In case of shock, the administration of OCTAPLEX should be stopped immediately and the conventional anti-shock therapy should be started.

In the process of using drugs made from human blood or plasma, there is a risk of transmission of infectious agents, including unknown or recently identified viruses and pathogenic microorganisms. This applies to the following viruses: HIV (Human Immunodeficiency Virus), hepatitis B, hepatitis C, hepatitis A, and to a lesser extent parvovirus B19.

Parvovirus B19 is especially dangerous for pregnant women (intrauterine infection of the fetus), people with immunodeficiency and patients with increased production of red blood cells (including hemolytic anemia).

If there is a need for constant or repeated use of prothrombin complex preparations made from human blood or plasma, patients are advised to undergo appropriate vaccination against hepatitis A and B.

During treatment with drugs of the prothrombin complex, care should be taken in connection with the possible development of thrombosis or disseminated intravascular coagulation (DIC). Patients in the pre- and postoperative periods, with a history of ischemic heart disease, with liver pathologies, patients with a risk of thromboembolic complications and DIC, and newborns require special attention. When prescribing OCTAPLEX in this category of patients, it is necessary to carefully compare the potential benefits of the drug administration and the possible risk of thrombosis in them.

Under certain conditions, in patients with DIC, it may be necessary to replace the coagulation factors of the prothrombin complex, which should be carried out only after stopping the coagulopathy of exhaustion.

It is important to take into account that the abolition of concomitant therapy with vitamin K antagonists can cause thromboembolic complications in the patient, therefore, the resumption of anticoagulant therapy is required as soon as possible.

There is no experience of using OCTAPLEX for the treatment of bleeding in newborns with vitamin K deficiency.

When treating patients on a sodium-restricted diet, it should be borne in mind that one vial of lyophilisate contains up to 125 mg of sodium.

Influence on the ability to drive vehicles and complex mechanisms

Studies on the effect of OCTAPLEX on human psychomotor functions have not been conducted.

Application during pregnancy and lactation

The use of OCTAPLEX during pregnancy or breastfeeding is possible only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.

Drug interactions

Against the background of concomitant therapy with OCTAPLEX, the effect of vitamin K antagonists is neutralized.

When conducting heparin-sensitive blood clotting tests and using high doses of OCTAPLEX at the same time, the presence of heparin in its composition should be taken into account.

Do not mix other medicines with lyophilisate solution.

Analogs

Analogs of OCTAPLEX are: VILATE, Ditsinon, Immunat, Coaplex, OCTANAT, Gemate P, Protromplex 600, Eltrombopah, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures from 2 ° C to 25 ° C, protected from light. Avoid freezing.

Shelf life is 2 years.

The reconstituted solution under sterile conditions is stable for 8 hours at a storage temperature of 20 to 25 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about OCTAPLEX

OCTAPLEX is one of the three CPK (prothrombin complex concentrates) preparations registered in the Russian Federation. Scientific studies confirm the importance of its use in clinical practice for the urgent correction of hemostasis pathologies associated with a lack of vitamin K of various origins, post-traumatic and hepatic coagulopathies, and for the correction of perioperative hemostasis.

There are practically no reliable reviews from patients about OCTAPLEX, which is probably due to the inability to assess the effect of an individual drug in complex treatment.

A case in gynecological practice is described when OCTAPLEX, as part of intensive complex therapy, which also includes surgical intervention, transfusion of donor blood and plasma, helped to save the life of a young woman.

Price for OCTAPLEX in pharmacies

The price for OCTAPLEX for 1 set, including a cardboard box with a lyophilisate, a cardboard box with a solvent, and a set for dissolution and administration, can range from 13,546 rubles.

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!