ADVATE 1000 IU/2 ML Powder and solvent for solution for injection: Proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań 250 j.m.

Summary of the safety profile Clinical studies with ADVATE included 418 patients with at least one exposure to ADVATE and reported a total of 93 adverse drug reactions (ADRs). The ADRs that occurred with the highest frequency were development of neutralising antibodies to factor VIII (inhibitors), headache and pyrexia. Allergic or hypersensitivity reactions (which may include ang

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known allergic reaction to mouse or hamster protein.

ADVATE 1000 IU/2 ML Powder and solvent for solution for injection

Q: Indications?

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ADVATE is indicated for all age groups.

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ADVATE 1000 IU/2 ML Powder and solvent for solution for injection — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: Antihemorrhagics: blood coagulation factor VIII.‍‍‍‍‍‍‍‍‍‍‍‍‍ ATC code: B02BD02. Mechanism of action ADVATE contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma. Octocog alfa is a glycoprotein consisting of 2,332 amino acids with an approximate molecular weight of 280 kD. 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 haemophilia patient, factor VIII binds to endogenous 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 to thrombin. Thrombin then converts fibrinogen to 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:C activity, resulting in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of factor deficiency and correction of bleeding tendencies. It should be noted that the annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies. Clinical efficacy and safety Data on immune tolerance induction (ITI) have been collected in patients with inhibitors. In a substudy of study 060103 in previously untreated patients (PUPs), ITI treatment interventions were documented in 11 PUPs. A retrospective chart review was performed for 30 paediatric subjects treated with ITI (in study 060703). In a non-interventional prospective registry (PASS-INT-004), 44 paediatric and adult subjects were documented, of whom 36 completed ITI treatment. Data demonstrate that immune tolerance can be achieved. Study 060201 compared two long-term prophylactic treatment regimens in 53 previously treated patients (PTPs) — a pharmacokinetically-guided, individualised dosing regimen (in the range of 20 to 80 IU factor VIII per kg body weight at intervals of 72 ± 6 hours, n = 23) and a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ± 6 hours, n = 30). The aim of the pharmacokinetically-guided dosing regimen (according to a specific formula) was to maintain factor VIII trough levels ≥ 1% at a dosing interval of 72 hours. Data from this study demonstrate that the reduction in bleeding is comparable between the two prophylactic dosing regimens. Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with ADVATE in all subsets of the paediatric population with haemophilia A (congenital factor VIII deficiency) in "immune tolerance induction in patients with haemophilia A (congenital factor VIII deficiency) who have developed factor VIII inhibitors" and "treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)" (see section 4.2 for information on paediatric use).

⚠️ Warnings

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity Allergic-type hypersensitivity reactions (including anaphylaxis) have been reported with ADVATE.‍‍‍‍‍‍‍‍‍‍‍‍‍ The product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including urticaria, generalised urticaria, tightness of chest, wheezing, hypotension and anaphylaxis. In case of shock, standard medical treatment for shock should be followed. In the event of a hypersensitivity reaction, there is less time to react, i.e. stop the injection, due to the reduced volume of ADVATE reconstituted in 2 ml water for injection. Therefore, caution is recommended during injection of ADVATE reconstituted in 2 ml water for injection, especially in children. Inhibitors The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is related to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon. The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less risk of insufficient clinical response than high-titre inhibitors. In general, all patients treated with coagulation factor VIII products must be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors. Incorrect administration of ADVATE With ADVATE reconstituted with 2 ml water for injection, incorrect administration (intra-arterial or paravenous) may lead to mild short-term reactions at the injection site, such as bruising and erythema. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk. Catheter-related complications If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered. Excipient-related considerations Sodium This medicinal product contains 10 mg sodium per vial, equivalent to 0.5% of the WHO recommended maximum daily sodium intake of 2 g for an adult. It is strongly recommended that every time ADVATE is administered to a patient, the name and batch number of the product are recorded in order to maintain a clear link between the patient and the batch of the product. Paediatric population The listed warnings and precautions apply to both adults and children.

ADVATE 1000 IU/2 ML Powder and solvent for solution for injection

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