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Components:
Coagulation Factor Viii
Method of action:
Antihemorrhagics, Hemostatic, Replenishing Deficiency Of Coagulation Factor Viii
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.05

Qualitative and quantitative composition

Coagulation Factor Viii

Pharmaceutical form

Lyophilizate for the preparation of a solution for intravenous administration

Therapeutic indications

The information provided in Therapeutic indications of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Koate-DVI® is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Despite the von Willebrand factor content and functionality of this product there are no data from clinical trials supporting use in von Willebrand disease.

This product may be used in the management of acquired factor VIII deficiency.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.

Posology

The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.

On demand treatment

The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).

One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. The calculation of the required dosage of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2.1 ± 0.4% of normal activity. The required dosage is determined using the following formula:

Required units = body weight (kg) × desired factor VIII rise (%) (IU/dl) × 0.5

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Degree of haemorrhage/ Type of surgical procedure

Factor VIII level required (%) (IU/dl)

Frequency of doses (hours)/ Duration of therapy (days)

Haemorrhage

Early haemarthrosis, muscle bleeding or oral bleeding

20 - 40

Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemarthrosis, muscle bleeding or haematoma

30 - 60

Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved.

Life threatening haemorrhages

60 - 100

Repeat infusion every 8 to 24 hours until threat is resolved.

Surgery

Minor

including tooth extraction

30 - 60

Every 24 hours, at least 1 day, until healing is achieved.

Major

80 - 100

(pre-and postoperative)

Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).

Prophylaxis

For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

Continuous infusion

During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.

Paediatric population

There are insufficient data from clinical trials to recommend the use of Koate-DVI® in children less than 6 years of age.

As the posology is adjusted to the clinical outcome of the above mentioned conditions, the posology in children, by body weight, is not considered to be different to that of adults.

Method of administration

< The product should be administered via the intravenous route. Koate-DVI® should be administered at a rate of no more than 10 ml/min.

Contraindications

The information provided in Contraindications of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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As with any intravenous protein product, allergic type hypersensitivity reactions are possible.

Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development. Therefore, it is recommended to monitor patients carefully for inhibitor occurrence following any product switch.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular receipt of human plasma-derived factor VIII products.

It is strongly recommended that every time that Koate-DVI® is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Sodium content

The residual content of sodium in Koate-DVI®, arising from the manufacturing process, does not exceed 23 mg per vial in the 250, 500 and 1000 IU presentations, and 34.5 mg per vial in the 1500 IU presentation. This is equivalent to 1.15% and 1.72% respectively of the recommended maximum daily intake of sodium for an adult. However, depending on the body weight of the patient and the posology, the patient may receive more than one vial.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Koate-DVI® has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to severe anaphylaxis (including shock).

On rare occasions, fever has been observed.

The adverse drug reactions reported are summarised and categorised according to the MedDRA system organ class in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing of seriousness. Frequency has been determined using the following criteria:

- very common: >1/10 infusions

- common: >1/100 to <1/10 infusions

- uncommon: >1/1,000 to <1/100 infusions

- rare: >1/10,000 to <1/1,000 infusions

- very rare: <1/10,000, not known (cannot be estimated from the available data.)

System Organ Class

Body System Preferred Term

ADR frequency evaluation

General disorders and administration site conditions

Pyrexia

Rare

Patients with haemophilia A may develop neutralising antibodies to factor VIII.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, website: https://yellowcard.mhra.gov.uk.

Overdose

The information provided in Overdose of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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No case of overdose has been reported.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic Group: Antihaemorrhagics: blood coagulation factor VIII. ATC code: B02BD02.

In Koate-DVI®, factor VIII is presented as a complex with von Willebrand factor.

The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.

When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.

Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed.

Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

In addition to its role as a factor VIII protecting protein, von Willebrand mediates platelet adhesion to sites of vascular injury and plays a role in platelet aggregation.

There are insufficient data from clinical trials in children less than 6 years of age.

Data on Immune Tolerance Induction (ITI) have been collected in paediatric and adult patients with haemophilia A who have developed inhibitors to FVIII. The 57 patients from a retrospective study and 14 patients from prospective studies included a broad spectrum of primary and rescue ITI patients with varying prognoses for achieving immune tolerance. Data show that Koate-DVI has been used to induce immune tolerance. In patients where tolerance was achieved, bleeding could be prevented or controlled on either prophylactic or on-demand therapy with a FVIII concentrate.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Plasma factor VIII activity decreases by a two-phase exponential decay.

The half-life of human factor VIII obtained in the clinical trial carried out with Koate-DVI® is 14.18 ± 2.55 hours and the "in vivo" recovery is 105.5 ± 18.5%, which is equivalent to approximately 2.1 ± 0.4 IU/dl per IU/kg administered (determinations performed following chromogenic method). Additional pharmacokinetic parameters are: mean residence time (MRT) 19.9 ± 4.1 h, area under curve (AUC) 19.3 ± 3.8 IU h/ml and clearance 2.6 ± 0.6 ml/h/kg.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Antihaemorrhagics: blood coagulation factor VIII. ATC code: B02BD02.

Preclinical safety data

The information provided in Preclinical safety data of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Human plasma coagulation factor VIII (active ingredient for Koate-DVI®) is a normal constituent of the human plasma and acts like the endogenous factor VIII. Single dose toxicity testing is of no relevance since higher doses result in overloading.

Repeated dose toxicity testing in animals is impracticable due to interference with developing antibodies to heterologous protein.

Incompatibilities

The information provided in Incompatibilities of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Koate-DVI® must not be mixed with other medicinal products.

Only the provided infusion set should be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surfaces of some infusion equipment.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Koate-DVI is based on data of another medicine with exactly the same composition as the Koate-DVI of the medicine (Coagulation Factor Viii). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Koate-DVI directly from the package or from the pharmacist at the pharmacy.
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Do not use after the expiry date shown on the label.

Left-over product must never be kept for later use, nor stored in a refrigerator.

To prepare the solution:

1. Warm the vial and syringe but not above 30°C.

2. Attach plunger to syringe containing diluent.

3. Remove filter from packaging. Remove cap from syringe tip and attach syringe to filter.

4. Remove vial adaptor from packaging and attach to syringe and filter.

5. Remove cap from vial and wipe stopper with swabs provided.

6. Pierce vial stopper with adaptor needle.

7. Transfer all diluent from syringe to vial.

8. Gently shake vial until all product is dissolved. As with other parenteral solutions, do not use if product is not properly dissolved or particles are visible.

9. Briefly separate the syringe/filter from vial/adaptor, to release the vacuum.

10. Invert vial and aspirate solution into syringe.

11. Prepare injection site, separate syringe and inject product using the butterfly needle provided. Injection rate should be 3 ml/min into a vein and never more than 10 ml/min to avoid vasomotor reactions.

Do not re-use administration sets.

Any unused product or waste material should be disposed of in accordance with local requirements.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.

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