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Elocta is a brand name for Efmoroctocog Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ELOCTA can be used for all age groups.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting or chromogenic assays) is advised to guide the dose to be administered and the frequency of repeated injections.
Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight and overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly affected by both the type of the aPTT reagent and the reference standard used in the assay.
Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagent used in the assay.
Posology The dose 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. The number of units of factor VIII administered is expressed in 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 IU (relative to an International Standard for factor VIII in plasma). 4 One IU of recombinant factor VIII Fc activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
On-demand treatment The calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL. 5 (IU/kg per IU/dL) The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Summary of the safety profile 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 rarely and may in some cases progress to severe anaphylaxis (including shock).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ELOCTA. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
In such cases, it is recommended that a specialised haemophilia centre be contacted. Tabulated list of adverse reactions The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies of adverse reactions are based on clinical studies with a total of 379 patients with severe haemophilia A, of which 276 were previously treated patients (PTPs) and 103 were previously untreated patients (PUPs). 1 for additional details on the clinical studies.
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 2: Adverse reactions reported for ELOCTA in clinical trials1 MedDRA System Organ Class Adverse reactions Frequency category1 Blood and lymphatic system disorders FVIII inhibition Uncommon (PTPs)2 Very common (PUPs)2 Nervous system disorders Headache Uncommon Dizziness Uncommon Dysgeusia Uncommon Cardiac disorders Bradycardia Uncommon Vascular disorders Hypertension Uncommon Hot flush Uncommon Angiopathy4 Uncommon Respiratory, thoracic, and mediastinal disorders Cough Uncommon Gastrointestinal disorders Abdominal pain, lower Uncommon Skin and subcutaneous tissue disorders Papular rash Common (PUPs)3 Rash Uncommon Musculoskeletal and connective tissue disorders Arthralgia Uncommon Myalgia Uncommon Back pain Uncommon Joint swelling Uncommon General disorders and administration site conditions Device related thrombosis Common (PUPs)3 Malaise Uncommon Chest pain Uncommon Feeling cold Uncommon Feeling hot Uncommon Injury, poisoning, and procedural complications Procedural hypotension Uncommon PTPs = previously treated patients, PUPs = previously untreated patients.
Hypersensitivity Allergic type hypersensitivity reactions are possible with ELOCTA. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Patients should be informed of the signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. In case of shock, standard medical treatment for shock should be implemented.
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 correlated 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 of a risk of insufficient clinical response than high titre inhibitors. In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence 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. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Table 1 can be used to guide dosing in bleeding episodes and surgery:
Table 1: Guide to ELOCTA dosing for treatment of 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 injection every 12 to 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
1 More extensive haemarthrosis, muscle bleeding or haematoma 30-60 Repeat injection every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved. 1 Life threatening haemorrhages 60-100 Repeat injection every 8 to 24 hours until threat is resolved.
Surgery Minor surgery including tooth extraction 30-60 Repeat injection every 24 hours, for at least 1 day, until healing is achieved. Major surgery 80-100 (pre- and post- operative) Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
1 In some patients and circumstances the dosing interval can be prolonged up to 36 hours. 2 for pharmacokinetic data. Prophylaxis For long term prophylaxis, the recommended dose is 50 IU of factor VIII per kg body weight at intervals of 3 to 5 days.
2). In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. Elderly There is limited experience in patients ≥65 years. 1). For adolescents of 12 years of age and above, the dose recommendations are the same as for adults.
Method of administration ELOCTA is for intravenous use. ELOCTA should be injected intravenously over several minutes. The rate of administration should be determined by the patient’s comfort level and should not exceed 10 mL/min. 6.
1 ADRs and frequency are based on occurrence in PTPs only, unless otherwise noted. 2 Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. 3 ADRs and frequency are based on occurrence in PUPs only.
4 Investigator term: vascular pain after injection of ELOCTA. Paediatric population No age-specific differences in adverse reactions were observed between paediatric and adult subjects. Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 the national reporting system listed in Appendix V.
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. Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
6 Paediatric population The listed warnings and precautions apply both to adults, children and adolescents. Excipient related considerations Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
However, depending on the body weight and posology, the patient could receive more than one vial (see section 2 for information on content per vial). This should be taken into consideration by patients on a controlled sodium diet. 4 mg of polysorbate 20 in each vial.
Polysorbates may cause allergic reactions.