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OCTAPLEX is a brand name for Protein C, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: octaplex® (Human Prothrombin Complex) is indicated for: • The treatment of bleeding and perioperative prophylaxis of bleeding 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Classical dose-response studies were not performed due to the human origin of the product. Dose recommendations for single factor deficiencies are based on the required level, on the body weight (BW) of the patient, and the activity increase per unit of the respective factor administered.
For acquired deficiencies, dosing should also be individualised and preferably be accompanied by laboratory analysis of global and single coagulation parameters. Because of the risk of thromboembolic complications, close monitoring should be exercised when administering human prothrombin complex to patients with a history of coronary heart disease, myocardial infarction, to patients with liver disease, to peri- or post-operative patients, to neonates, or to patients at risk of thromboembolic events or disseminated intravascular coagulation (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment 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 severity of the disorder, on the location and extent of the bleeding and on the patient’s clinical condition.
The amount and the frequency of administration should be calculated on an individual patient basis. Dosage intervals must be adapted to the different circulating half-life of the different coagulation factors in the prothrombin complex.
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 (prothrombin time, INR), and 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). Acquired deficiencies Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment: The dose will depend on the INR before treatment and the targeted INR.
2 within 1 hour) at different initial INR levels are given. 000 IU (120 mL octaplex®). The correction of the vitamin K antagonist induced impairment of haemostasis persists for approximately 6-8 hours. However, the effects of vitamin K, if administered simultaneously, are usually achieved within 4-6 hours.
3% (3/90) in clinical trials. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 for details on the clinical trials. In total, 90 patients have been enrolled and the patients received a total of about 569,000 IU of octaplex®.
, headache occurring twice in 1 individual, a transient increase in liver transaminases (Alanin aminotransferase (ALAT), Aspartate aminotransferase (ASAT)), 3 parvovirus B19 seroconversions, an injection site burning, and an aggravation of arterial hypertension.
Table 4 Clinical Trial Adverse Reactions MedDRA Standard System Organ Class Adverse event Severity / Causality No. of episodes No. of episodes/ no. 3%) In LEX-201, no viral seroconversion was observed in all ten patients that were assessed for viral markers.
Viral markers were measured at baseline, after 3 and 6 months and 6-12 weeks after the last administration of octaplex®. In total, 5 deaths have been reported during clinical trials, and all cases were unrelated to octaplex® treatment, as assessed by the responsible investigators.
octaplex® Human Prothrombin Complex, freeze dried Page 19 of 30 Unclassified / Non classifié Relative Frequency of Adverse Drug Reactions Due to the small number of patients enrolled in clinical trials and the low number of ADRs no meaningful statement on the relative frequency can be made for each potential ADR.
3 Less Common Clinical Trial Adverse Reactions Due to the small number of patients enrolled in clinical trials and the low number of ADRs no meaningful statement on the relative frequency can be made for each potential ADR. , prothrombin fragment F1+2, thrombin- antithrombin III complex, fibrin monomers, d-dimers plasma levels, Prothrombin time (PT) and Activated partial thromboplastin time (aPTT)).
). This product is prepared from large pools of human plasma, which may contain the causative agents of hepatitis and other viral diseases. The physician should discuss the risks and benefits of this product with the patient before prescribing or administering to the patient (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations Classical dose-response studies were not performed due to the human origin of the product. Dose recommendations for single factor deficiencies are based on the required level, on the body weight (BW) of the patient, and the activity increase per unit of the respective factor administered.
For acquired deficiencies, dosing should also be individualised and preferably be accompanied by laboratory analysis of global and single coagulation parameters. Because of the risk of thromboembolic complications, close monitoring should be exercised when administering human prothrombin complex to patients with a history of coronary heart disease, myocardial infarction, to patients with liver disease, to peri- or post-operative patients, to neonates, or to patients at risk of thromboembolic events or disseminated intravascular coagulation (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment 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 severity of the disorder, on the location and extent of the bleeding and on the patient’s clinical condition.
The amount and the frequency of administration should be calculated on an individual patient basis. Dosage intervals must be adapted to the different circulating half-life of the different coagulation factors in the prothrombin complex.
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 (prothrombin time, INR), and continuous monitoring of the clinical condition of the patient.
• octaplex® is contraindicated for patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Since octaplex® contains up to 310 IU of heparin, it should not be given to patients suffering from heparin-induced thrombocytopenia type II or with known allergies to heparin. Even if the antibody against the heparin-protein complex cannot be demonstrated, the administration of octaplex® may cause a booster effect with an immediate generation of the antibody.
• octaplex® is contraindicated in those rare cases where an individual has an immunoglobulin A (IgA) deficiency, with known antibodies against IgA. • octaplex® should not be used in patients with recent myocardial infarction, with a high risk of thrombosis, or with angina pectoris with the exception of life-threatening bleeds due to overdose of oral anticoagulants, or when an emergency surgical procedure is indicated in patients on vitamin K antagonists and an INR (International normalised ratio) > 3.
octaplex® Human Prothrombin Complex, freeze dried Page 5 of 30 Unclassified / Non classifié • In patients suffering from disseminated intravascular coagulation (DIC), the administration of octaplex® is principally not recommended because of the pro-coagulant capacity of the product.
However, for life-threatening events when the substitution by FFP is not sufficient enough or if FFP cannot be given because of a threat of hypervolaemia, octaplex® might be used after interrupting the cause of DIC. Under these circumstances, it is important to administer antithrombin (AT) and heparin before the administration of a PCC.
• In patients treated for coagulation disorders because of chronic liver disease or because of liver transplantation, AT levels should be monitored and an AT concentrate should be given concomitantly if an AT deficiency is present.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Thus, repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered. As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR treatment is mandatory.
Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Table 2 Parenteral Products Strength Vial Size Volume of Solvent to be Added to Vial Approximate Available Volume Concentration per mL 500 IU 30 mL 20 mL 20 mL 25 IU/mL FIX 1000 IU 50 mL 40 mL 40 mL IU = International units; FIX = Human Coagulation Factor IX octaplex® Human Prothrombin Complex, freeze dried Page 7 of 30 Unclassified / Non classifié octaplex® is provided with a transfer device for reconstitution of the lyophilized powder in solvent (sterile Water for Injection (sWFI)).
octaplex® is for single use only. Do not re-use any of the components. Inspect all components for physical integrity prior to use. Do not use products or components that appear damaged or broken. Reconstitute octaplex® using aseptic technique for the procedure described below.
The product reconstitutes quickly (1 to 5 minutes) at room temperature (20°C to 25°C). As octaplex® contains no preservatives, the solution should be administered immediately after reconstitution, or within 8 hours, provided sterility is maintained.
The reconstituted solution can be stored for up to 8 hours at room temperature (20°C to 25°C). The reconstituted solution should be clear, colourless or slightly blue. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
A blue colour is not interpreted as discolouration. Instructions for preparation and reconstitution: 1. Ensure that the lyophilized powder and solvent vials are at room temperature (20°C to 25°C). This temperature should be maintained during reconstitution.
If the octaplex® powder and water for injection (WFI) are not already at room temperature, warm up the closed vials to room temperature. This temperature should be maintained during reconstitution. If a water bath is used to warm the WFI, care should be taken to ensure the water does not come into contact with the rubber stopper or closure system of the vials or warming beyond 30°C.
Figure 1 2. Remove the flip caps of the lyophilized powder and solvent vials and disinfect the rubber stoppers with an alcohol swab and allow to dry. 3. Open the transfer device package by peeling off the lid (Figure 1). To maintain sterility, do not remove the transfer device from the blister package and do not touch the spike.
octaplex® Human Prothrombin Complex, freeze dried Page 8 of 30 Unclassified / Non classifié Figure 2 4. Place the solvent vial on a flat, even, clean surface and hold it firmly. Without removing the blister package, place the blue part of the transfer device on top of the solvent vial and press straight and firmly down, in one […]
No pattern of elevated markers was seen that could have been induced by the administration of octaplex®. In LEX-202, one patient had transient increases of ALAT and ASAT 12 hours after the last octaplex® infusion. Five days after infusion the laboratory tests were back to normal.
Otherwise, safety laboratory findings were not altered by octaplex® injections. In LEX-203, a slight decrease over time could be seen for haematological parameters (haematocrit, haemoglobin, blood cell count). Due to the main inclusion criteria for this study being the preparation of a surgical intervention or to control bleedings and the patient population studied (patients under oral anticoagulant therapy), almost all patients showed abnormal haematological values at baseline and during the subsequent sampling period.
None of the clinical chemistry parameters seemed to be affected by the study medication. 5 Post-Market Adverse Reactions The following adverse reactions have been reported during the global post-marketing use of octaplex®. The frequency of such adverse reactions cannot be reliably estimated due to the voluntary nature of such reports and causality of which cannot be clearly established.
Adverse Reactions Reported During the global Post-Marketing Use of octaplex® Immune system disorders Anaphylactic shock, anaphylactic reaction, hypersensitivity Nervous system disorders Tremor Cardiac disorders Cardiac arrest, tachycardia Vascular disorders Thromboembolic event, circulatory collapse, hypotension, hypertension Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory failure octaplex® Human Prothrombin Complex, freeze dried Page 20 of 30 Unclassified / Non classifié Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Urticaria, rash General disorders and administration site conditions Pyrexia, chills Lack of efficacy is mentioned as a listed/expected adverse experience.
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). Acquired deficiencies Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment: The dose will depend on the INR before treatment and the targeted INR.
2 within 1 hour) at different initial INR levels are given. 000 IU (120 mL octaplex®). The correction of the vitamin K antagonist induced impairment of haemostasis persists for approximately 6-8 hours. However, the effects of vitamin K, if administered simultaneously, are usually achieved within 4-6 hours.
Thus, repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered. As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR treatment is mandatory.
Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Table 2 Parenteral Products Strength Vial Size Volume of Solvent to be Added to Vial Approximate Available Volume Concentration per mL 500 IU 30 mL 20 mL 20 mL 25 IU/mL FIX 1000 IU 50 mL 40 mL 40 mL IU = International units; FIX = Human Coagulation Factor IX octaplex® Human Prothrombin Complex, freeze dried Page 7 of 30 Unclassified / Non classifié octaplex® is provided with a transfer device for reconstitution of the lyophilized powder in solvent (sterile Water for Injection (sWFI)).
octaplex® is for single use only. Do not re-use any of the components. Inspect all components for physical integrity prior to use. Do not use products or components that appear damaged or broken. Reconstitute octaplex® using aseptic technique for the procedure described below.
The product reconstitutes quickly (1 to 5 minutes) at room temperature (20°C to 25°C). As octaplex® contains no preservatives, the solution should be administered immediately after reconstitution, or within 8 hours, provided sterility is maintained.
The reconstituted solution can be stored for up to 8 hours at room temperature (20°C to 25°C). The reconstituted solution should be clear, colourless or slightly blue. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
A blue colour is not interpreted as discolouration. Instructions for preparation and reconstitution: 1. Ensure that the lyophilized powder and solvent vials are at room temperature (20°C to 25°C). This temperature should be maintained during reconstitution.
If the octaplex® powder and water for injection (WFI) are not already at room temperature, warm up the closed vials to room temperature. This temperature should be maintained during reconstitution. If a water bath is used to warm the WFI, care should be taken to ensure the water does not come into contact with the rubber stopper or closure system of the vials or warming beyond 30°C.
Figure 1 2. Remove the flip caps of the lyophilized powder and solvent vials and disinfect the rubber stoppers with an alcohol swab and allow to dry. 3. Open the transfer device package by peeling off the lid (Figure 1). To maintain sterility, do not remove the transfer device from the blister package and do not touch […]
No clinical data are available for octaplex® for the treatment of bleeding disorders because of liver parenchymal disorders or oesophageal varices or because of major liver surgery therefore octaplex® cannot be recommended in these patients.