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BERIPLEX P/N is a brand name for Factor IX. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. - Treatment and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Only general dosage guidelines are given below. Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. The dosage and duration of the substitution therapy depend on the indication for treatment, severity of the disorder, on the location and extent of bleeding and on the patient’s clinical condition.
The amount and the frequency of administration should be calculated on an individual patient basis. 2). Individual dosage requirements can only be identified on the basis of regular determinations of the individual plasma levels of the coagulation factors of interest, or on global tests of the prothrombin complex levels (INR, Quick’s test), and a continuous monitoring of the clinical condition of the patient.
In case of major surgical interventions, precise monitoring of the substitution therapy by means of coagulation assays is essential (specific coagulation factor assays and/or global tests for prothrombin complex levels). - Bleeding and perioperative prophylaxis of bleedings during vitamin K antagonist treatment.
The dose will depend on the INR before treatment and the targeted INR. The pre-treatment INR should be measured as close as possible to the time of dosing in order to calculate the appropriate dose of Beriplex. g. 3) at different initial INR levels are given.
4 2 Approximate dose IU (Factor IX)/kg body weight 25 35 50 Dose is based on body weight up to but not exceeding 100 kg. 0. The correction of the vitamin K antagonist-induced impairment of haemostasis is commonly reached approximately 30 minutes after the injection.
The simultaneous administration of vitamin K should be considered in patients receiving Beriplex for urgent reversal of vitamin K antagonists since vitamin K usually takes effect within 4 - 6 hours. Repeated dosing with Beriplex for patients requiring urgent reversal of vitamin K antagonist treatment is not supported by clinical data and therefore not recommended.
These recommendations are based on data from clinical studies with a limited number of subjects. Recovery and the duration of effect may vary, therefore monitoring of INR during treatment is mandatory. - Bleedings and perioperative prophylaxis in congenital deficiency of any of the vitamin K dependent coagulation factors when specific coagulation factor products are not available.
4). Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response. In such cases, it is recommended to contact a specialised haemophilia centre for guidance.
Anaphylactic reactions have been observed in patients with antibodies to factors contained in Beriplex. Increase in body temperature has been commonly observed. 4). Tabulated list of adverse drug reactions of Beriplex The following adverse reactions are based on clinical trial data, post marketing experience as well as scientific literature.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been based on clinical trial data, 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) or not known (cannot be estimated from the available data).
4. Paediatric population No data are available regarding the use of Beriplex in paediatric population. 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 reaction via the Yellow Card Scheme. uk/yellowcard
The advice of a specialist experienced in the management of coagulation disorders should be sought. g. as induced by treatment of vitamin K antagonists), Beriplex should only be used when rapid correction of the prothrombin complex levels is necessary, such as major bleedings or emergency surgery.
In other cases, reduction of the dose of the vitamin K antagonist and/or administration of vitamin K is usually sufficient. Patients receiving a vitamin K antagonist may have an underlying hypercoaguable state and infusion of human prothrombin complex may exacerbate this.
In congenital deficiency of any of the vitamin K-dependent factors, specific coagulation factor products should be used when available. g. discontinue injection) and an appropriate treatment has to be initiated. Therapeutic measures depend on the kind and severity of the undesirable effect.
The current medical standards for shock treatment are to be observed. There is a risk of thrombosis or disseminated intravascular coagulation when patients, with either congenital or acquired deficiency, are treated with human prothrombin complex particularly with repeated dosing.
The risk may be higher in treatment of isolated factor VII deficiency, since the other vitamin K- dependent coagulation factors, with longer half-lives, may accumulate to levels considerably higher than normal. Patients given human prothrombin complex should be observed closely for signs or symptoms of disseminated intravascular coagulation or thrombosis.
Because of the risk of thromboembolic complications, close monitoring should be exercised when administering Beriplex to patients with a history of coronary heart disease or myocardial infarction, to patients with liver disease, to patients per- or postoperatively, to neonates or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation or simultaneous inhibitor deficiency.
1. In the case of disseminated intravascular coagulation, prothrombin complex- preparations may only be applied after termination of the consumptive state. Known history of heparin-induced thrombocytopenia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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019 IU/ml) of normal. The dose of a specific factor administered is expressed in International Units (IU), which are related to the current WHO standard for each factor. The activity in the plasma of a specific coagulation factor is expressed either as a percentage (relative to normal plasma) or in International Units (relative to the international standard for the specific coagulation factor).
One International Unit (IU) of a coagulation factor activity is equivalent to the quantity in one ml of the normal human plasma. 019 IU/ml.
The required dosage is determined using the following formula:
Required units = body weight [kg] x desired factor X rise [IU/ml] x 53 where 53 (ml/kg) is the reciprocal of the estimated recovery. Note that the calculation is based upon data from patients receiving vitamin K antagonists. A calculation based upon data from healthy subjects would provide a lower estimate of the required dose.
If the individual recovery is known, that value should be used for calculation. 2). 4). Older population The posology and method of administration in older people (> 65 years) is equivalent to the general recommendations. 6. The reconstituted solution should be administered intravenously (not more than 8 ml/min*).
The solution should be clear or slightly opalescent.
In each of these situations, the potential benefit of treatment with Beriplex should be weighed against the potential risk of such complications. In patients with disseminated intravascular coagulation, it may, under certain circumstances, be necessary to substitute the coagulation factors of the prothrombin complex.
g. by treatment of the underlying cause, persistent normalization of the antithrombin III level). Reversing vitamin K antagonists exposes patients to the thromboembolic risk of the underlying disease. Resumption of anticoagulation should be carefully considered as soon as possible.
Undesirable reactions may include the development of heparin-induced thrombocytopenia, type II (HIT, type II). Characteristic signs of HIT are a platelet count drop > 50 per cent and/or the occurrence of new or unexplained thromboembolic complications during heparin therapy.
Onset is typically from 4 to 14 days after initiation of heparin therapy but may occur within 10 hours in patients recently exposed to heparin (within the previous 100 days). Nephrotic syndrome has been reported in single cases following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
No data are available regarding the use of Beriplex in case of perinatal bleeding due to vitamin K deficiency in neonates. Beriplex contains up to 343 mg sodium (approximately 15 mmol) per 100 ml. To be taken into consideration by patients on a controlled sodium diet.
Virus safety Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A and parvovirus B19 viruses. Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived prothrombin complex products.
It is strongly recommended that every time that Beriplex 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.