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Recombinate (Antihemophilic Factor (Recombinant))
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Pharmacology
Clinical Pharmacology: AHF is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). Hemophilia A is a genetic bleeding disorder characterized by hemorrhages which may occur spontaneously or after minor trauma. The administration of antihemophilic factor (recombinant) provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect in these patients. Pharmacokinetic studies on 69patients revealed the circulating mean half-life for rAHF to be 14.6±4.9 hours (n=67), which was not statistically significantly different from plasma-derived antihemophilic factor (human), Hemofil M, (pdAHF). The mean half-life of Hemofil M was 14.7±5.1 hours (n=61). The actual baseline recovery observed with rAHF was 123.9±47.7 IU/dl (n=23) which is significantly higher than the actual Hemofil M baseline recovery of 101.7±31.6 IU/dL (n=61). However, the calculated ratio of actual to expected recovery with rAHF (121.2±48.9%) is similar to that of Hemofil M (123.4±16.4%).
The clinical study of rAHF in previously treated patients (individuals with hemophilia A who had been treated with plasma-derived AHF) was based on observations made on a study group of 69patients. These individuals received cumulative amounts of factor VIII ranging from 20914 to 1383063 IU over the 48-monthPatients were given a total of 17700 infusions totalling 28090769IU rAHF.
These patients were successfully treated for bleeding episodes on a demand basis and also for the prevention of bleeds (prophylaxis). Spontaneous bleeding episodes successfully managed include hemarthroses, soft tissue and muscle bleeds. Management of hemostasis was also evaluated in surgeries. A total of 24 procedures on 13patients were performed during this study. These included minor (e.g., tooth extraction) and major (e.g., bilateral osteotomies, thoracotomy and liver transplant) procedures. Hemostasis was maintained perioperatively and postoperatively with individualized rAHF replacement.
A study of rAHF in previously untreated patients was also performed as part of an ongoing study. The study group was comprised of 79 patients, of whom 76 had received at least 1 infusion of rAHF. To date, this cohort has been given 12209 infusions totalling over 11277043 IU rAHF. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
Clinical Pharmacology: AHF is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). Hemophilia A is a genetic bleeding disorder characterized by hemorrhages which may occur spontaneously or after minor trauma. The administration of antihemophilic factor (recombinant) provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect in these patients. Pharmacokinetic studies on 69patients revealed the circulating mean half-life for rAHF to be 14.6±4.9 hours (n=67), which was not statistically significantly different from plasma-derived antihemophilic factor (human), Hemofil M, (pdAHF). The mean half-life of Hemofil M was 14.7±5.1 hours (n=61). The actual baseline recovery observed with rAHF was 123.9±47.7 IU/dl (n=23) which is significantly higher than the actual Hemofil M baseline recovery of 101.7±31.6 IU/dL (n=61). However, the calculated ratio of actual to expected recovery with rAHF (121.2±48.9%) is similar to that of Hemofil M (123.4±16.4%).
The clinical study of rAHF in previously treated patients (individuals with hemophilia A who had been treated with plasma-derived AHF) was based on observations made on a study group of 69patients. These individuals received cumulative amounts of factor VIII ranging from 20914 to 1383063 IU over the 48-monthPatients were given a total of 17700 infusions totalling 28090769IU rAHF.
These patients were successfully treated for bleeding episodes on a demand basis and also for the prevention of bleeds (prophylaxis). Spontaneous bleeding episodes successfully managed include hemarthroses, soft tissue and muscle bleeds. Management of hemostasis was also evaluated in surgeries. A total of 24 procedures on 13patients were performed during this study. These included minor (e.g., tooth extraction) and major (e.g., bilateral osteotomies, thoracotomy and liver transplant) procedures. Hemostasis was maintained perioperatively and postoperatively with individualized rAHF replacement.
A study of rAHF in previously untreated patients was also performed as part of an ongoing study. The study group was comprised of 79 patients, of whom 76 had received at least 1 infusion of rAHF. To date, this cohort has been given 12209 infusions totalling over 11277043 IU rAHF. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
Indications
Clinical Pharmacology: AHF Is The Specific Clotting Factor Deficient In Patients With Hemophilia A (classical Hemophilia). Hemophilia A Is A Genetic Bleeding Disorder Characterized By Hemorrhages Which May Occur Spontaneously Or After Minor Trauma. The Administration Of Antihemophilic Factor (recombinant) Provides An Increase In Plasma Levels Of AHF And Can Temporarily Correct The Coagulation Defect In These Patients. Pharmacokinetic Studies On 69patients Revealed The Circulating Mean Half-life For RAHF To Be 14.6±4.9 Hours (n=67), Which Was Not Statistically Significantly Different From Plasma-derived Antihemophilic Factor (human), Hemofil M, (pdAHF). The Mean Half-life Of Hemofil M Was 14.7±5.1 Hours (n=61). The Actual Baseline Recovery Observed With RAHF Was 123.9±47.7 IU/dl (n=23) Which Is Significantly Higher Than The Actual Hemofil M Baseline Recovery Of 101.7±31.6 IU/dL (n=61). However, The Calculated Ratio Of Actual To Expected Recovery With RAHF (121.2±48.9%) Is Similar To That Of Hemofil M (123.4±16.4%).
The Clinical Study Of RAHF In Previously Treated Patients (individuals With Hemophilia A Who Had Been Treated With Plasma-derived AHF) Was Based On Observations Made On A Study Group Of 69patients. These Individuals Received Cumulative Amounts Of Factor VIII Ranging From 20914 To 1383063 IU Over The 48-monthPatients Were Given A Total Of 17700 Infusions Totalling 28090769IU RAHF.
These Patients Were Successfully Treated For Bleeding Episodes On A Demand Basis And Also For The Prevention Of Bleeds (prophylaxis). Spontaneous Bleeding Episodes Successfully Managed Include Hemarthroses, Soft Tissue And Muscle Bleeds. Management Of Hemostasis Was Also Evaluated In Surgeries. A Total Of 24 Procedures On 13patients Were Performed During This Study. These Included Minor (e.g., Tooth Extraction) And Major (e.g., Bilateral Osteotomies, Thoracotomy And Liver Transplant) Procedures. Hemostasis Was Maintained Perioperatively And Postoperatively With Individualized RAHF Replacement.
A Study Of RAHF In Previously Untreated Patients Was Also Performed As Part Of An Ongoing Study. The Study Group Was Comprised Of 79 Patients, Of Whom 76 Had Received At Least 1 Infusion Of RAHF. To Date, This Cohort Has Been Given 12209 Infusions Totalling Over 11277043 IU RAHF. Hemostasis Was Appropriately Managed In Spontaneous Bleeding Episodes, Intracranial Hemorrhage And Surgical Procedures.
Clinical Pharmacology: AHF Is The Specific Clotting Factor Deficient In Patients With Hemophilia A (classical Hemophilia). Hemophilia A Is A Genetic Bleeding Disorder Characterized By Hemorrhages Which May Occur Spontaneously Or After Minor Trauma. The Administration Of Antihemophilic Factor (recombinant) Provides An Increase In Plasma Levels Of AHF And Can Temporarily Correct The Coagulation Defect In These Patients. Pharmacokinetic Studies On 69patients Revealed The Circulating Mean Half-life For RAHF To Be 14.6±4.9 Hours (n=67), Which Was Not Statistically Significantly Different From Plasma-derived Antihemophilic Factor (human), Hemofil M, (pdAHF). The Mean Half-life Of Hemofil M Was 14.7±5.1 Hours (n=61). The Actual Baseline Recovery Observed With RAHF Was 123.9±47.7 IU/dl (n=23) Which Is Significantly Higher Than The Actual Hemofil M Baseline Recovery Of 101.7±31.6 IU/dL (n=61). However, The Calculated Ratio Of Actual To Expected Recovery With RAHF (121.2±48.9%) Is Similar To That Of Hemofil M (123.4±16.4%).
The Clinical Study Of RAHF In Previously Treated Patients (individuals With Hemophilia A Who Had Been Treated With Plasma-derived AHF) Was Based On Observations Made On A Study Group Of 69patients. These Individuals Received Cumulative Amounts Of Factor VIII Ranging From 20914 To 1383063 IU Over The 48-monthPatients Were Given A Total Of 17700 Infusions Totalling 28090769IU RAHF.
These Patients Were Successfully Treated For Bleeding Episodes On A Demand Basis And Also For The Prevention Of Bleeds (prophylaxis). Spontaneous Bleeding Episodes Successfully Managed Include Hemarthroses, Soft Tissue And Muscle Bleeds. Management Of Hemostasis Was Also Evaluated In Surgeries. A Total Of 24 Procedures On 13patients Were Performed During This Study. These Included Minor (e.g., Tooth Extraction) And Major (e.g., Bilateral Osteotomies, Thoracotomy And Liver Transplant) Procedures. Hemostasis Was Maintained Perioperatively And Postoperatively With Individualized RAHF Replacement.
A Study Of RAHF In Previously Untreated Patients Was Also Performed As Part Of An Ongoing Study. The Study Group Was Comprised Of 79 Patients, Of Whom 76 Had Received At Least 1 Infusion Of RAHF. To Date, This Cohort Has Been Given 12209 Infusions Totalling Over 11277043 IU RAHF. Hemostasis Was Appropriately Managed In Spontaneous Bleeding Episodes, Intracranial Hemorrhage And Surgical Procedures.
Contraindications
Known hypersensitivity to mouse, hamster or bovine protein may be a contraindication to the use of antihemophilic factor (recombinant).
Known hypersensitivity to mouse, hamster or bovine protein may be a contraindication to the use of antihemophilic factor (recombinant).
Precautions
General: Certain components used in the packaging of this product contain natural rubber latex.
Identification of the clotting defect as a factor VIII deficiency is essential before the administration of antihemophilic factor (recombinant), antihemophilic factor (recombinant) is initiated. No benefit may be expected from this product in treating other deficiencies.
The formation of neutralizing antibodies, inhibitors to factor VIII, is a known complication in the management of individuals with hemophilia A. The reported prevalence of these antibodies in patients receiving plasma derived AHF is 10 to 20%. These inhibitors are invariably IgG immunoglobulins, the factor VIII procoagulant inhibitory activity of which is expressed as Bethesda Units (BU)/mL of plasma or serum. Over the investigational period, none of the 69previously treated individuals, without an inhibitor at entry into the study, developed an inhibitor. In the previously untreated patient group there were 76 patients with factor VIII levels less thanequal to 2% who were tested for inhibitor after treatmentantihemophilic factor (recombinant) rAHF. Of this group 23individuals developed detectable inhibitor and of these, 8patients showed a titer greater than 10 BU Patients treated with rAHF should be carefully monitored for the development of antibodies to rAHF by appropriate clinical observations and laboratory tests.
Formation of Antibodies to Mouse, Hamster or Bovine Protein: As antihemophilic factor (recombinant) contains trace amounts of mouse protein (maximum of 0.1 ng/IU rAHF), hamster protein (maximum of 1 ng CHO protein/IU rAHF), and bovine protein (maximum of 1ng BSA/IU rAHF), the remote possibility exists that patients treated with this product may develop hypersensitivity to these nonhuman mammalian proteins.
Information to Be Provided to the Patient: Although allergic type hypersensitivity reactions were not observed in any patient receiving antihemophilic factor (recombinant) on study, such reactions are theoretically possible. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician if these symptoms occur.
Laboratory Tests: Although dosage can be estimated by the calculations which follow, it is strongly recommended that whenever possible, appropriate laboratory tests be performed on the patient's plasma at suitable intervals to assure that adequate AHF levels have been reached and are maintained.
If the patient's plasma AHF fails to reach expected levels or if bleeding is not controlled after adequate dosage, the presence of inhibitor should be suspected. By performing appropriate laboratory procedures, the presence of an inhibitor can be demonstrated and quantified in terms of AHF IU neutralized by each mL of plasma or by the total estimated plasma volume. If the inhibitor is present at levels less than 10 Bethesda Units/mL, administration of additional AHF may neutralize the inhibitor. Thereafter, the administration of additional AHF IU should elicit the predicted response. The control of AHF levels by laboratory assay is necessary in this situation.
Inhibitor titers above 10 Bethesda Units/mL may make hemostasis control with AHF either impossible or impractical because of the very large dose required. In addition, the inhibitor titer may rise following AHF infusion because of an anamnestic response to the AHF antigen.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Antihemophilic factor (recombinant) was tested for mutagenicity at doses considerably exceeding plasma concentrations of rAHF in vitro and at doses up to 10 times the expected maximum clinical dose in vivo. Antihemophilic factor (recombinant) did not cause reverse mutations, chromosomal aberrations, or an increase in micronuclei in bone marrow polychromatic erythrocytes. Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Children: Antihemophilic factor (recombinant) is appropriate for use in children of all ages, including the newborn. Safety and efficacy studies have been performed in both previously treated (n=23) and previously untreated (n=76) children (see Pharmacology and Precautions).
Pregnancy: Category C. Animal reproduction studies have not been conducted with antihemophilic factor (recombinant). It is not known whether antihemophilic factor (recombinant) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Antihemophilic factor (recombinant) should be given to a pregnant woman only if clearly needed.
General: Certain components used in the packaging of this product contain natural rubber latex.
Identification of the clotting defect as a factor VIII deficiency is essential before the administration of antihemophilic factor (recombinant), antihemophilic factor (recombinant) is initiated. No benefit may be expected from this product in treating other deficiencies.
The formation of neutralizing antibodies, inhibitors to factor VIII, is a known complication in the management of individuals with hemophilia A. The reported prevalence of these antibodies in patients receiving plasma derived AHF is 10 to 20%. These inhibitors are invariably IgG immunoglobulins, the factor VIII procoagulant inhibitory activity of which is expressed as Bethesda Units (BU)/mL of plasma or serum. Over the investigational period, none of the 69previously treated individuals, without an inhibitor at entry into the study, developed an inhibitor. In the previously untreated patient group there were 76 patients with factor VIII levels less thanequal to 2% who were tested for inhibitor after treatmentantihemophilic factor (recombinant) rAHF. Of this group 23individuals developed detectable inhibitor and of these, 8patients showed a titer greater than 10 BU Patients treated with rAHF should be carefully monitored for the development of antibodies to rAHF by appropriate clinical observations and laboratory tests.
Formation of Antibodies to Mouse, Hamster or Bovine Protein: As antihemophilic factor (recombinant) contains trace amounts of mouse protein (maximum of 0.1 ng/IU rAHF), hamster protein (maximum of 1 ng CHO protein/IU rAHF), and bovine protein (maximum of 1ng BSA/IU rAHF), the remote possibility exists that patients treated with this product may develop hypersensitivity to these nonhuman mammalian proteins.
Information to Be Provided to the Patient: Although allergic type hypersensitivity reactions were not observed in any patient receiving antihemophilic factor (recombinant) on study, such reactions are theoretically possible. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician if these symptoms occur.
Laboratory Tests: Although dosage can be estimated by the calculations which follow, it is strongly recommended that whenever possible, appropriate laboratory tests be performed on the patient's plasma at suitable intervals to assure that adequate AHF levels have been reached and are maintained.
If the patient's plasma AHF fails to reach expected levels or if bleeding is not controlled after adequate dosage, the presence of inhibitor should be suspected. By performing appropriate laboratory procedures, the presence of an inhibitor can be demonstrated and quantified in terms of AHF IU neutralized by each mL of plasma or by the total estimated plasma volume. If the inhibitor is present at levels less than 10 Bethesda Units/mL, administration of additional AHF may neutralize the inhibitor. Thereafter, the administration of additional AHF IU should elicit the predicted response. The control of AHF levels by laboratory assay is necessary in this situation.
Inhibitor titers above 10 Bethesda Units/mL may make hemostasis control with AHF either impossible or impractical because of the very large dose required. In addition, the inhibitor titer may rise following AHF infusion because of an anamnestic response to the AHF antigen.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Antihemophilic factor (recombinant) was tested for mutagenicity at doses considerably exceeding plasma concentrations of rAHF in vitro and at doses up to 10 times the expected maximum clinical dose in vivo. Antihemophilic factor (recombinant) did not cause reverse mutations, chromosomal aberrations, or an increase in micronuclei in bone marrow polychromatic erythrocytes. Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Children: Antihemophilic factor (recombinant) is appropriate for use in children of all ages, including the newborn. Safety and efficacy studies have been performed in both previously treated (n=23) and previously untreated (n=76) children (see Pharmacology and Precautions).
Pregnancy: Category C. Animal reproduction studies have not been conducted with antihemophilic factor (recombinant). It is not known whether antihemophilic factor (recombinant) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Antihemophilic factor (recombinant) should be given to a pregnant woman only if clearly needed.
Side Effects / Adverse Effects
During the clinical studies conducted in the previously treated patient group, there were 13infusion related minor adverse reactions reported out of 10446 infusions (0.12%) Onepatient experienced flushing and nausea during his first rAHF infusion which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and a third patient had a series of 11 nose bleeds with a periodicity associated with the infusions.
The protein in greatest concentration in antihemophilic factor (recombinant) is albumin (human). Reactions associated with i.v. administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could theoretically be encountered in the use of this antihemophilic factor preparation.
During the clinical studies conducted in the previously treated patient group, there were 13infusion related minor adverse reactions reported out of 10446 infusions (0.12%) Onepatient experienced flushing and nausea during his first rAHF infusion which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and a third patient had a series of 11 nose bleeds with a periodicity associated with the infusions.
The protein in greatest concentration in antihemophilic factor (recombinant) is albumin (human). Reactions associated with i.v. administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could theoretically be encountered in the use of this antihemophilic factor preparation.
Overdose
Information not available
Information not available
Recommended Dosage
Other dosage regimens have been proposed such as that of Schimpf, et al, which describes continuous maintenance therapy.
Reconstitution: Use aseptic technique: 1.Bring antihemophilic factor (recombinant), (dry concentrate) and sterile water for injection, USP,(diluent) to room temperature. 2.Remove caps from concentrate and diluent bottles. 3.Cleanse stoppers with germicidal solution and allow to dry prior to use. 4.Remove protective covering from one end of double-ended needle and insert exposed needle through the center of the stopper. 5.Remove protective covering from other end of double-ended needle. Invert diluent bottle over the upright antihemophilic factor (recombinant) bottle, then rapidly insert free end of the needle through the antihemophilic factor (recombinant) bottle stopper at its center. The vacuum in the bottle will draw in the diluent. 6.Disconnect the 2 bottles by removing needle from diluent bottle stopper, then remove needle from antihemophilic factor (recombinant) bottle. Swirl gently until all material is dissolved. Be sure that antihemophilic factor (recombinant) is completely dissolved, otherwise active material will be removed by the filter needle. Note: Do not refrigerate after reconstitution.
I.V. Administration: Use aseptic technique: Administer at room temperature. Antihemophilic factor (recombinant) should be administered not more than 3 hours after reconstitution.
Syringe Injection: Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. A colorless to faint yellow appearance is acceptable for antihemophilic factor (recombinant).
Plastic syringes are recommended for use with this product since proteins such as AHF tend to stick to the surface of all-glass syringes. 1.Attach filter needle to a disposable syringe and draw back plunger to admit air into the syringe. 2.Insert needle into reconstituted antihemophilic factor (recombinant). 3.Inject air into bottle and then withdraw the reconstituted material into the syringe. 4.Remove and discard the filter needle from the syringe; attach a suitable needle and inject i.v. as instructed under Rate of Administration. 5.If a patient is to receive more than one bottle of antihemophilic factor (recombinant), the contents of multiple bottles may be drawn into the same syringe by drawing up each bottle through a separate unused filter needle. Filter needles are intended to filter the contents of a single bottle of Antihemophilic factor (recombinant) only.
Rate of Administration: Preparations of antihemophilic factor (recombinant) can be administered at a rate of up to 10 mL/min with no significant reactions.
The pulse rate should be determined before and during administration of antihemophilic factor (recombinant). Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
Each bottle of Recombinate is labeled with the AHF activity expressed in IU/bottle. This potency assignment is referenced to the World Health Organization International Standard for Factor VIII:C Concentrate and is evaluated by appropriate methodology to ensure accuracy of the results.
The expected in vivo peak increase in AHF level expressed as IU/dL of plasma or % (percent) of normal can be estimated by multiplying the dose administered/kg body weight (IU/kg) by 2. This calculation is based on the clinical findings of Abildgaard et al and is supported by the data generated by 419 clinical pharmacokinetic studies with rAHF in 67 patients over time. This pharmacokinetic data demonstrated a peak recovery point above the preinfusion baseline of approximately 2.0 IU/dL per IU/kg body weight.
Example (assuming patient's baseline AHF level is at <1%): 1.A dose of 1750 IU AHF administered to a 70 kg patient, i.e., 25 IU/kg (1750/70), should be expected to cause a peak postinfusion AHF increase of 25 x 2 = 50 IU/dL (50% of normal).
2.A peak level of 70% is required in a 40 kg child. In this situation the dose would be 70/2 ´ 40=1400 IU.
Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.
Other dosage regimens have been proposed such as that of Schimpf, et al, which describes continuous maintenance therapy.
Reconstitution: Use aseptic technique: 1.Bring antihemophilic factor (recombinant), (dry concentrate) and sterile water for injection, USP,(diluent) to room temperature. 2.Remove caps from concentrate and diluent bottles. 3.Cleanse stoppers with germicidal solution and allow to dry prior to use. 4.Remove protective covering from one end of double-ended needle and insert exposed needle through the center of the stopper. 5.Remove protective covering from other end of double-ended needle. Invert diluent bottle over the upright antihemophilic factor (recombinant) bottle, then rapidly insert free end of the needle through the antihemophilic factor (recombinant) bottle stopper at its center. The vacuum in the bottle will draw in the diluent. 6.Disconnect the 2 bottles by removing needle from diluent bottle stopper, then remove needle from antihemophilic factor (recombinant) bottle. Swirl gently until all material is dissolved. Be sure that antihemophilic factor (recombinant) is completely dissolved, otherwise active material will be removed by the filter needle. Note: Do not refrigerate after reconstitution.
I.V. Administration: Use aseptic technique: Administer at room temperature. Antihemophilic factor (recombinant) should be administered not more than 3 hours after reconstitution.
Syringe Injection: Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. A colorless to faint yellow appearance is acceptable for antihemophilic factor (recombinant).
Plastic syringes are recommended for use with this product since proteins such as AHF tend to stick to the surface of all-glass syringes. 1.Attach filter needle to a disposable syringe and draw back plunger to admit air into the syringe. 2.Insert needle into reconstituted antihemophilic factor (recombinant). 3.Inject air into bottle and then withdraw the reconstituted material into the syringe. 4.Remove and discard the filter needle from the syringe; attach a suitable needle and inject i.v. as instructed under Rate of Administration. 5.If a patient is to receive more than one bottle of antihemophilic factor (recombinant), the contents of multiple bottles may be drawn into the same syringe by drawing up each bottle through a separate unused filter needle. Filter needles are intended to filter the contents of a single bottle of Antihemophilic factor (recombinant) only.
Rate of Administration: Preparations of antihemophilic factor (recombinant) can be administered at a rate of up to 10 mL/min with no significant reactions.
The pulse rate should be determined before and during administration of antihemophilic factor (recombinant). Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
Supplied / Packaging
Description: Antihemophilic factor (recombinant), Recombinate, is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to factor VIII, is utilized to selectively isolate the rAHF in the medium. The synthesized rAHF produced by the CHO cells has the same biological effects as antihemophilic factor (human) [AHF (Human)]. Structurally, the protein has a similar combination of heterogenous heavy and light chains as found in AHF (human).
Recombinate is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for i.v. injection. Recombinate is available in single-dose bottles which contain nominally 250, 500 and 1000 IU/bottle. Packaged with 10 mL of sterile water for injection, USP, a double-ended needle, a filter needle, and a package insert. Each bottle of Recombinate is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate. When reconstituted withappropriate volume of diluent, the product contains the following stabilizers in maximum amounts: 12.5 mg/mL albumin
(human), 0.20mg/mL calcium, 1.5 mg/mL polyethylene glycol (3350), 180mEq/L sodium, 55 mM histidine, and 1.5 µg/AHF IU polysorbate-80. Von Willebrand Factor (vWF) is coexpressed with the antihemophilic factor (recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrand's disease. Preservative-free.
Manufacturing of Recombinate is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces antihemophilic factor concentrate (recombinant) (for further manufacturing use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Store under refrigeration 2 to 8°C or at room temperature, not to exceed 30°C. Avoid freezing to prevent damage to the diluent bottle. Do not use beyond the expiration date printed on the bottle.
Description: Antihemophilic factor (recombinant), Recombinate, is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to factor VIII, is utilized to selectively isolate the rAHF in the medium. The synthesized rAHF produced by the CHO cells has the same biological effects as antihemophilic factor (human) [AHF (Human)]. Structurally, the protein has a similar combination of heterogenous heavy and light chains as found in AHF (human).
Recombinate is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for i.v. injection. Recombinate is available in single-dose bottles which contain nominally 250, 500 and 1000 IU/bottle. Packaged with 10 mL of sterile water for injection, USP, a double-ended needle, a filter needle, and a package insert. Each bottle of Recombinate is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate. When reconstituted withappropriate volume of diluent, the product contains the following stabilizers in maximum amounts: 12.5 mg/mL albumin
(human), 0.20mg/mL calcium, 1.5 mg/mL polyethylene glycol (3350), 180mEq/L sodium, 55 mM histidine, and 1.5 µg/AHF IU polysorbate-80. Von Willebrand Factor (vWF) is coexpressed with the antihemophilic factor (recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrand's disease. Preservative-free.
Manufacturing of Recombinate is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces antihemophilic factor concentrate (recombinant) (for further manufacturing use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Store under refrigeration 2 to 8°C or at room temperature, not to exceed 30°C. Avoid freezing to prevent damage to the diluent bottle. Do not use beyond the expiration date printed on the bottle.
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Brand Name
Recombinate
Recombinate
Generic Name
Antihemophilic Factor (Recombinant)
Antihemophilic Factor (Recombinant)
General Indications
Antihemophilic Coagulation Factor
Antihemophilic Coagulation Factor
