Feiba Nf
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Questions & Answers
Side Effects & Adverse Reactions
Allergic reactions, including severe anaphylactoid reactions, have been reported following the infusion of FEIBA. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA NF and provide appropriate supportive care. Epinephrine and other appropriate medications to treat allergic reactions should be available whenever FEIBA NF is administered.
Thrombotic and thromboembolic events [including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke] have been reported following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see ADVERSE REACTIONS). The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia. Thromboembolic events are well recognized potential complications of FEIBA infusion. Many of these events occurred with doses above 200 units/kg/day or in patients with other risk factors for thromboembolic events. A single dose of 100 units/kg body weight and a daily dose of 200 units/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. Patients receiving more than 100 units/kg of body weight of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding.
Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor (TF) or predisposing coagulopathy.
FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients:
- at risk of DIC, arterial or venous thrombosis.
- with existing thrombotic conditions (e.g., acute myocardial infarction, or venous thrombosis).
FEIBA NF should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. Infusion of FEIBA NF should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg body weight. Thrombotic events have been identified through post-marketing surveillance following FEIBA use for each of the approved indications. The incidence of thrombotic events cannot be determined from post-marketing data.
FEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor heated, is made from human plasma. Products made from plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non- B hepatitis. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
Anamnestic responses with rise in Factor VIII inhibitor titer have been observed in 20% of the cases (see CLINICAL STUDIES).
Allergic reactions, including severe anaphylactoid reactions, have been reported following the infusion of FEIBA. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA NF and provide appropriate supportive care. Epinephrine and other appropriate medications to treat allergic reactions should be available whenever FEIBA NF is administered.
Thrombotic and Thromboembolic EventsThrombotic and thromboembolic events [including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke] have been reported following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see ADVERSE REACTIONS). The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia. Thromboembolic events are well recognized potential complications of FEIBA infusion. Many of these events occurred with doses above 200 units/kg/day or in patients with other risk factors for thromboembolic events. A single dose of 100 units/kg body weight and a daily dose of 200 units/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. Patients receiving more than 100 units/kg of body weight of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding.
Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor (TF) or predisposing coagulopathy.
FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients:
- at risk of DIC, arterial or venous thrombosis.
- with existing thrombotic conditions (e.g., acute myocardial infarction, or venous thrombosis).
FEIBA NF should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. Infusion of FEIBA NF should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg body weight. Thrombotic events have been identified through post-marketing surveillance following FEIBA use for each of the approved indications. The incidence of thrombotic events cannot be determined from post-marketing data.
Transmission of Infectious AgentsFEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor heated, is made from human plasma. Products made from plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non- B hepatitis. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
Anamnestic ResponsesAnamnestic responses with rise in Factor VIII inhibitor titer have been observed in 20% of the cases (see CLINICAL STUDIES).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
FEIBA NF (Anti-Inhibitor Coagulant Complex) is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.
Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic Factor. Patients with titers ranging between 5 and 10 B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.
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| Patient’s Inhibitor | Clinical Situation | ||
| Titer | Minor Bleeding | Major Bleeding | Surgery (Emergency) |
| less than 5 B.U. | AHF* | AHF | AHF |
| 5 to 10 B.U. | AHF | AHF | AHF |
| FEIBA NF | FEIBA NF | FEIBA NF | |
| more than 10 B.U. | FEIBA NF | FEIBA NF | FEIBA NF |
Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function3-5 that were present before treatment with FEIBA NF, nanofiltered and vapor-heated.
History
There is currently no drug history available for this drug.
Other Information
FEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor heated, is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, FEIBA NF shortens the activated partial thromboplastin time (APTT) of plasma containing Factor VIII inhibitor. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA NF that shortens the APTT of a high titer Factor VIII inhibitor reference plasma to 50% of the blank value.
FEIBA NF contains Factors II, IX, and X, mainly non-activated, and Factor VII mainly in the activated form. The product contains approximately equal unitages of Factor VIII inhibitor bypassing activity and Prothrombin Complex Factors. In addition, 1–6 units of Factor VIII coagulant antigen (FVIII C:Ag) per mL are present. The preparation contains only traces of factors of the kinin generating system. It contains no heparin.
Reconstituted FEIBA NF contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL.
FEIBA NF is manufactured from large plasma pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of FEIBA NF is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with the U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative. In addition, two dedicated and independent virus removal/inactivation steps have been integrated into the manufacturing process, namely 35 nm nanofiltration and a vapor heat treatment process. In addition, the DEAE-Sephadex adsorption contributes to the virus safety profile of FEIBA NF. Despite these measures, such products can still potentially transmit disease (see WARNINGS ).
In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g. at minimum incubation times and temperatures below specifications for vapor-heat treatment). Virus clearance studies for FEIBA NF performed in accordance with good laboratory practices have demonstrated, that the manufacturing process of FEIBA NF ensures a high margin of safety with respect to adventitious viruses (Table 1).
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| Virus Type | Enveloped RNA | Enveloped DNA | Non-enveloped RNA | Non-enveloped DNA | |||
| Virus Family | Retroviridae | Flaviviridae | Herpesviridae | Picornaviridae | Parvoviridae | ||
| Virus* | HIV-1 | BVDV | WNV | PRV | HAV | B19V† | MMV |
| DEAE Sephadex Adsorption | 3.2 | 1.8 | n.d. | 2.5 | 1.5 | 1.7 | 1.2 |
| 35 nm Nanofiltration | > 5.3 | 2.1 | 4.7 | > 5.7 | 2.6 | 0.2‡ | 1.0 |
| Vapor-Heat Treatment | > 5.9 | > 5.6 | > 8.1 | > 6.7 | > 5.2 | 3.5 | 0.9‡ |
| Overall log reduction factor (ORF) | > 14.4 | > 9.5 | > 12.8 | > 14.9 | > 9.3 | 5.2 | 2.2 |
Sources
Feiba Nf Manufacturers
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Baxter Healthcare Corporation
![Feiba Nf (Anti-inhibitor Coagulant Complex) Kit [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Feiba Nf | Baxter Healthcare Corporation
(See under Intravenous Injection or Infusion:).
Clinical trials1,2 demonstrated that the response to treatment with FEIBA may differ from patient to patient with no correlation to the patient’s inhibitor titer. Response may also vary between different types of hemorrhage (e.g. joint hemorrhage vs. CNS hemorrhage). As a general guideline, a dosage range of 50 to 100 Units of FEIBA NF per kg of body weight is recommended. However, care should be taken to distinguish between the following four indications, all of which have undergone careful clinical evaluation:
Joint HemorrhageIn joint hemorrhage, a dose of 50 units per kg of body weight is recommended at 12-hour intervals, which may be increased to doses of 100 units per kg of body weight at 12-hour intervals.
Treatment should be continued until clear signs of clinical improvement appear, such as relief of pain, reduction of swelling or mobilization of the joint.
Mucous Membrane BleedingA dose of 50 units per kg of body weight is recommended to be given at 6-hour intervals under careful monitoring (visible bleeding site, repeated measurements of the patient’s hematocrit). If hemorrhage does not stop, the dose may be increased to 100 units per kg of body weight at 6-hour intervals. Two such administrations or 200 units per kg of body weight a day should not be exceeded.
Soft Tissue HemorrhageFor serious soft tissue bleeding, such as retroperitoneal bleeding, doses of 100 units per kg of body weight at 12-hour intervals are recommended. A daily dosage of 200 units per kg of body weight should not be exceeded.
Other Severe HemorrhagesSevere hemorrhages, such as CNS bleedings have been effectively treated with doses of 100 units per kg of body weight at 12-hour intervals. Sometimes, FEIBA NF may be indicated at 6-hour intervals until clear clinical improvement is achieved.
Reconstitution: Allow the unopened vials of FEIBA NF (concentrate) and Sterile Water for Injection (diluent) to reach room temperature (not above 37ºC, 98ºF). Remove the caps from the concentrate and diluent vials to expose central portions of the rubber stoppers. Disinfect the rubber stoppers of both vials using a germicidal solution. Place the vials on an even surface and allow them to dry. Open the package of the BAXJECT II Hi-Flow device by peeling away the lid without touching the inside contents (Fig. A). Do not remove the transfer system from the package. Do not touch the clear spike. (Fig. B). Grip the BAXJECT II Hi-Flow device package at the edges and pull the package off the device (Fig. C). Do not remove the blue protective cap from the BAXJECT II Hi-Flow device. Do not touch the purple spike. Turn the system over so that the vial is on top. Press the purple spike of the BAXJECT II Hi-Flow device fully into the FEIBA NF vial. The vacuum will draw the diluent into the FEIBA NF vial (Fig. D). Swirl the entire system gently until the powder is dissolved. Make sure that the FEIBA NF has been dissolved completely.Fig A
Fig B
Fig C
Fig D
Do not refrigerate after reconstitution!
After complete reconstitution of FEIBA NF, its injection or infusion should be commenced as promptly as practicable, but must be completed within three hours following reconstitution. The solution must be given by intravenous injection or intravenous drip infusion.
Intravenous Injection/Infusion:Inspect for particulate matter and discoloration after reconstituting the concentrate as described under Reconstitution prior to administration. The appearance of the solution should be colorless to slightly yellowish and essentially free of visible particles.
Plastic Luer lock syringes are recommended for use with this product since protein such as FEIBA NF tends to stick to the surface of all-glass syringes.
Remove the blue protective cap from the BAXJECT II Hi-Flow device. Connect the syringe to the BAXJECT II Hi-Flow device (DO NOT DRAW AIR INTO THE SYRINGE) (Fig. E). (Fig. F). Disconnect the syringe, attach a suitable needle and inject or infuse intravenously as instructed under Rate of Administration.Fig E
Fig F
Rate of Administration:The maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. For a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5-7.5 mL per minute depending on the number of units per vial (see label on vial).
Rate of Administration:The maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. For a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5-7.5 mL per minute depending on the number of units per vial (see label on vial).
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Baxter Healthcare Corporation
Feiba Nf | Baxter Healthcare Corporation
Treatment should be initiated and supervised by a physician experienced in the management of hemophilia.
Clinical trials 1, 2 demonstrated that the response to treatment with FEIBA may differ from patient to patient with no correlation to the patient’s inhibitor titer. Response may also vary between different types of hemorrhage (e.g. joint hemorrhage vs. CNS hemorrhage). As a general guideline, a dosage range of 50 to 100 Units of FEIBA NF, per kg of body weight is recommended. However, care should be taken to distinguish between the following four indications:
Dosing Guidelines by Type of Hemorrhage * Begin treatment with 50 units/kg. Dose may be increased to 100 units/kg if hemorrhage does not stop. † Patients receiving more than 100 units/kg of body weight of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding. Indication Units/kg of Body Weight Recommended Dosing Interval Additional Information Joint Hemorrhage 50 - 100* 12 hoursContinue treatment until clear signs of clinical improvement appear (e.g., relief of pain, reduction of swelling or mobilization of the joint).
Two administrations of 100 units/kg a day or a daily total dose of 200 units/kg should not normally be exceeded†. Mucous Membrane Bleeding 50 – 100* 6 hoursCarefully monitor patient (i.e., examine for cecessation of visible bleeding) and perform repeated measurements of the patient’s hemoglobin/hematocrit.
Two administrations of 100 units/kg a day or a daily total dose of 200 units/kg should not be exceeded†. Soft Tissue Hemorrhage
(e.g., retroperitoneal bleeding) 100 12 hours A daily total dose of 200 units/kg should not be exceeded†. Other Severe Hemorrhage
(e.g., CNS bleeds) 100 6-12 hoursMay be indicated at 6-hour intervals until clear clinical improvement is achieved.
Single doses of 100 units/kg body weight and a daily dose of 200 units/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses†.Reconstitution
FEIBA NF contains no preservatives. Aseptic technique should be used throughout the entire reconstitution process and the solution should then be used immediately.
Allow the unopened vials of FEIBA NF (concentrate) and Sterile Water for Injection (diluent) to reach room temperature (not above 37°C, 98°F). Remove caps from the concentrate and diluent vials to expose central portions of the rubber stoppers. Disinfect the rubber stoppers of both vials using a germicidal solution. Place the vials on an even surface and allow them to dry. Open the package of BAXJECT device by peeling away the lid without touching the inside (Fig. A). Do not remove the device from the package. Turn the package over and insert the plastic spike through diluent stopper. (Fig. B). Grip the package at its edge and pull the package off the device (Fig. B). Turn the system over, so that the vial is on top. Quickly insert the other plastic spike into the FEIBA NF stopper (Fig. C). The vacuum will draw the diluent into the FEIBA NF vial. Please make sure that the connection of the two vials should be done expeditiously to close the open fluid pathway created by the first insertion of the spike to the diluent vial. Swirl gently until FEIBA NF is completely dissolved. Make sure that FEIBA NF has been dissolved completely; otherwise, active material will not pass through the device filter.Fig A
Fig B
Fig C
Do not refrigerate after reconstitution!
After complete reconstitution of FEIBA NF its injection or infusion should be commenced as promptly as practicable, but must be completed within three hours following reconstitution. The solution must be given by intravenous injection or intravenous drip infusion.
Rate of Administration:
The maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. For a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5 - 7.5 mL per minute depending on the number of units per vial (see label on vial).
Intravenous Injection or Infusion:
Inspect for particulate matter and discoloration after reconstituting the concentrate as described under Reconstitution prior to administration. The appearance of the solution should be colorless to slightly yellowish and essentially free of visible particles. Do not use solutions that are cloudy or have deposits. Mixing of FEIBA NF with other products or substances must be avoided. It is advisable to flush venous access lines with isotonic saline prior to and after infusion of FEIBA NF. If devices other than those supplied with FEIBA NF are used, ensure use of an adequate filter. Plastic Luer lock syringes are recommended for use with this product since protein such as FEIBA NF tends to stick to the surface of all-glass syringes. Turn the BAXJECT device handle down towards the FEIBA NF concentrate vial and remove the cap attached to the syringe connection of the BAXJECT device (Fig. D). Draw air into the syringe, connect the syringe to the BAXJECT device, inject air into the concentrate vial (Fig. E). While keeping the syringe plunger in place, turn the system upside down (concentrate vial now on top). Draw the concentrate into the syringe by pulling the plunger back slowly (Fig. F). Turn the BAXJECT handle to its original position (facing side way). Disconnect the syringe, attach a suitable needle and inject or infuse intravenously as instructed under Rate of Administration..
Fig D
Fig E
Fig F
![Feiba Nf (Anti-inhibitor Coagulant Complex) Kit [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=70a31431-1a44-4415-84ec-c91897ffac17&name=3bdffc8e-b908-4827-b941-31a1f7063125-07.jpg)
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