Prothromplex TOTAL is licensed for the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin K antagonists or in case of overdose with vitamin K antagonists, when rapid correction of the deficiency is required.
Treatment and perioperative prophylaxis of haemorrhages in congenital deficiency of vitamin K-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.
Prothromplex TOTAL is indicated in adults. There are insufficient paediatric data to recommend the administration of Prothromplex TOTAL in children.
Watch our video demonstrating product reconstitution and explore our library, featuring Prothromplex TOTAL 500 IU formulary and guideline support documents.
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In response to valuable feedback from healthcare professionals (HCPs) like yourself, we have made significant enhancements to Prothromplex TOTAL.
Single-use, sterile Mix2Vial® Transfer Device and needle-free reconstitution
Prothromplex TOTAL 500 IU Mix2Vial presentation provides a more simplified, needle-free reconstitution and more rapid preparation vs the previous Prothromplex TOTAL presentation1,2
500 IU allows ease of dosing1
Prothromplex TOTAL 500 IU Mix2Vial allows ease of dosing, increasing HCP and health system choice within existing clinical protocols based on multiples of 500 IU prothrombin complex concentrates (PCCs)3,4
Number 1 Tender Ranking5
Prothromplex TOTAL continues to maintain its position as the Most Economically Advantageous Tender (MEAT) position in comparison to alternative PCCs, based on cost, ease of use and security of supply.5
*100% of patients (n=59) achieved normalisation of INR (≤1.3) with 30 minutes of a single dose of Prothromplex TOTAL.6
†Based on one clinical study (n=61) and post-marketing study (n=142).6,10
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Prothromplex TOTAL is licensed for the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin K antagonists or in case of overdose with vitamin K antagonists, when rapid correction of the deficiency is required.
Treatment and perioperative prophylaxis of haemorrhages in congenital deficiency of vitamin K-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.
Prothromplex TOTAL is indicated in adults. There are insufficient paediatric data to recommend the administration of Prothromplex TOTAL in children.
Primary Outcome: Proportion of subjects who achieved normalisation of international normaIised ratio (INR) to ≤ 1.3 within 30 minutes ± 5 minutes after INR reading
*n=59 included in the full analysis set, normal INR defined as ≤1.3 (2/61 subjects were excluded from the full analysis set, 1 due to blood draw outside of the 30±5 minutes time window, 1 due to lack of central laboratory assessment for primary endpoint).
Graph adapted from Altorjay A, 20151
* n=59 included in the full analysis set, normal INR defined as ≤1.3 (2/61 subjects were excluded from the full analysis set, 1 due to blood draw outside of the 30±5 minutes time window, 1 due to lack of central laboratory assessment for primary endpoint).
Graph adapted from Altorjay A, 20151
Coagulation factors
Prothrombin time
*n=59 included in the full analysis set, normal INR defined as ≤1.3 (2/61 subjects were excluded from the full analysis set, 1 due to blood draw outside of the 30±5 minutes time window, 1 due to lack of central laboratory assessment for primary endpoint).
Graphs adapted from Altorjay A, 20151
Overall haemostatic efficacy of Prothromplex TOTAL was rated “excellent” for 60 of 61 subjects1*
* The overall haemostatic efficacy of Prothromplex TOTAL was assessed in all 61 subjects.
Graphs adapted from Altorjay A, 20151
The safety profile of Prothromplex TOTAL was confirmed in a phase IV study1*
Safety outcome measures included the incidence of treatment-emergent adverse events (TEAEs) and levels of coagulation markers1
Incidence of TEAEs
Levels of coagulation factors markers
*Safety outcome measures were assessed in all 61 subjects.
† One 89-year-old subject died of septic shock (following perforation of the sigmoid colon and subsequent peritonitis) 13 days after the infusion; and one 83-year-old subject died of ventricular fibrillation 14 days after the infusion.
Click on the button below to find out about the details of the phase IV study design
Primary Outcome: INR
Secondary Outcome: Blood loss
Secondary Outcome: Transfused blood
Exploratory Outcome:
Activated partial thromboplastin time
*Based on a retrospective, single-centre (Spain) study performed between January 2009 and December 2012, including analysis of 142 patients treated with Prothromplex TOTAL (69% for reversing the anticoagulant effects of VKA). The median dose was 1,200 (900–1,500) IU per patient (≈15 IU/kg).
Graphs adapted from Leal-Noval S, 20132
Adverse Events
* Based on a retrospective, single-centre (Spain) study performed between January 2009 and December 2012, including analysis of 142 patients treated with Prothromplex TOTAL (69% for reversing the anticoagulant effects of VKA). The median dose was 1,200 (900–1,500) IU per patient (≈15 IU/kg).
Prothromplex TOTAL: Common adverse events3
Prothromplex TOTAL: Other safety considerations3
Thromboembolism, disseminated intravascular coagulation, fibrinolysis
There is a risk of thromboembolic episodes, following the administration of human prothrombin complex. In each situation, the potential benefit of treatment should be weighed against the risk of complications.
Particularly close monitoring should be exercised when administering PCCs to:
Virus Safety
When medicinal products prepared from human blood or plasma are administered, infectious diseases due to transmission of infective agents cannot be totally excluded.
Inhibitory antibodies
Replacement therapy with human PCCs, including therapy with Prothromplex TOTAL, may result in 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.
Class reactions
Sodium
This medicinal product contains 68 mg sodium per vial or 0.14 mg sodium per International Unit equivalent to 3.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Heparin
Heparin may cause allergic reactions and reduced blood cell counts, which may affect the blood clotting system. Patients with a history of heparin-induced allergic reactions should avoid the use of heparin-containing medicines.
Paediatric population
There are insufficient data to recommend the administration of Prothromplex TOTAL in children.
For full details please see the Summary of Product Characteristics
Preparation
Monitoring of international normalised ratio (INR) during treatment is mandatory
Refer to the Summary of Product Characteristics before use
For reconstitution only the enclosed reconstitution set should be used
Mixing
Withdrawal
For full details please see the Summary of Product Characteristics
Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment
If Prothromplex TOTAL administration is based on the INR measurement, the dose will depend on the INR before treatment and the targeted INR.1
The dosage and duration of the substitution therapy depend on the severity of the coagulation disorder, on the location and extent of the bleeding and on the patient’s clinical condition. Dosage and frequency of administration must be calculated on an individual patient basis. 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 the global test of the prothrombin complex level (e.g., Quick's time value, INR, prothrombin time) and continuous monitoring of the patient’s clinical condition.1
Monitoring of INR during treatment is mandatory.1
Bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin K-dependent coagulation factors when specific coagulation factor product is not available:1
Required units = body weight (kg) x desired factor X rise (IU/ml) x 60
Hereditary combined vitamin K-dependent clotting factors deficiency is a rare inherited coagulation defect that forms part of a wider group of rare disorders named Familial Multiple Coagulation Factor Deficiencies.5
Replacement therapy with Prothromplex TOTAL, may result in 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.1
Allergic or anaphylactic-type reactions have been commonly observed.1
Increase in body temperature has been commonly observed.1
There is a risk of thromboembolic episodes, following the administration of human prothrombin complex.1
For full details please see the Summary of Product Characteristics
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Phase IV Study Design
Primary Outcome
Secondary Outcomes
Safety Outcomes
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Takeda UK Ltd. at: AE.GBR-IRL@takeda.com
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