Reviews Xyntha


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Xyntha Drug Description
XYNTHA™
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]
For Intravenous Use, Freeze-Dried Powder
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient
in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant
DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is a purified glycoprotein
with an approximate molecular mass of 170 kDa consisting of 1438 amino acids,
which does not contain the B-domain.13 The amino acid sequence of
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is comparable
to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is secreted
by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell
line is grown in a chemically defined cell culture medium that contains recombinant
insulin, but does not contain any materials derived from human or animal sources.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is purified
by a process that uses a series of chromatography steps, one of which is based
on affinity chromatography using a patented synthetic peptide affinity ligand.14
The process also includes a solvent-detergent viral inactivation step and a
virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5500 to 9900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried
powder preparation for intravenous (IV) injection. Each single-use vial contains
nominally 250, 500, 1000 or 2000 IU of XYNTHA. Upon reconstitution, the product
is a clear to slightly opalescent, colorless solution that contains sodium chloride,
sucrose, L-histidine, calcium chloride and polysorbate 80.
REFERENCES
13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et
al. Structural and Functional Characterization of B-Domain Deleted Recombinant
Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.
14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and
Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP
Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.
Last reviewed on RxList: 3/18/2008




Xyntha Drug Description
XYNTHA™
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]
For Intravenous Use, Freeze-Dried Powder
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient
in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant
DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is a purified glycoprotein
with an approximate molecular mass of 170 kDa consisting of 1438 amino acids,
which does not contain the B-domain.13 The amino acid sequence of
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is comparable
to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is secreted
by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell
line is grown in a chemically defined cell culture medium that contains recombinant
insulin, but does not contain any materials derived from human or animal sources.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is purified
by a process that uses a series of chromatography steps, one of which is based
on affinity chromatography using a patented synthetic peptide affinity ligand.14
The process also includes a solvent-detergent viral inactivation step and a
virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5500 to 9900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried
powder preparation for intravenous (IV) injection. Each single-use vial contains
nominally 250, 500, 1000 or 2000 IU of XYNTHA. Upon reconstitution, the product
is a clear to slightly opalescent, colorless solution that contains sodium chloride,
sucrose, L-histidine, calcium chloride and polysorbate 80.
REFERENCES
13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et
al. Structural and Functional Characterization of B-Domain Deleted Recombinant
Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.
14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and
Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP
Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.
Last reviewed on RxList: 3/18/2008




Xyntha Drug Description
XYNTHA™
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]
For Intravenous Use, Freeze-Dried Powder
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient
in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant
DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is a purified glycoprotein
with an approximate molecular mass of 170 kDa consisting of 1438 amino acids,
which does not contain the B-domain.13 The amino acid sequence of
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is comparable
to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is secreted
by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell
line is grown in a chemically defined cell culture medium that contains recombinant
insulin, but does not contain any materials derived from human or animal sources.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is purified
by a process that uses a series of chromatography steps, one of which is based
on affinity chromatography using a patented synthetic peptide affinity ligand.14
The process also includes a solvent-detergent viral inactivation step and a
virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5500 to 9900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried
powder preparation for intravenous (IV) injection. Each single-use vial contains
nominally 250, 500, 1000 or 2000 IU of XYNTHA. Upon reconstitution, the product
is a clear to slightly opalescent, colorless solution that contains sodium chloride,
sucrose, L-histidine, calcium chloride and polysorbate 80.
REFERENCES
13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et
al. Structural and Functional Characterization of B-Domain Deleted Recombinant
Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.
14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and
Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP
Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.
Last reviewed on RxList: 3/18/2008




Xyntha Drug Description
XYNTHA™
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]
For Intravenous Use, Freeze-Dried Powder
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient
in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant
DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is a purified glycoprotein
with an approximate molecular mass of 170 kDa consisting of 1438 amino acids,
which does not contain the B-domain.13 The amino acid sequence of
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is comparable
to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is secreted
by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell
line is grown in a chemically defined cell culture medium that contains recombinant
insulin, but does not contain any materials derived from human or animal sources.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is purified
by a process that uses a series of chromatography steps, one of which is based
on affinity chromatography using a patented synthetic peptide affinity ligand.14
The process also includes a solvent-detergent viral inactivation step and a
virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5500 to 9900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried
powder preparation for intravenous (IV) injection. Each single-use vial contains
nominally 250, 500, 1000 or 2000 IU of XYNTHA. Upon reconstitution, the product
is a clear to slightly opalescent, colorless solution that contains sodium chloride,
sucrose, L-histidine, calcium chloride and polysorbate 80.
REFERENCES
13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et
al. Structural and Functional Characterization of B-Domain Deleted Recombinant
Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.
14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and
Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP
Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.
Last reviewed on RxList: 3/18/2008




Xyntha Drug Description
XYNTHA™
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]
For Intravenous Use, Freeze-Dried Powder
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient
in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant
DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is a purified glycoprotein
with an approximate molecular mass of 170 kDa consisting of 1438 amino acids,
which does not contain the B-domain.13 The amino acid sequence of
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is comparable
to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is secreted
by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell
line is grown in a chemically defined cell culture medium that contains recombinant
insulin, but does not contain any materials derived from human or animal sources.
The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA is purified
by a process that uses a series of chromatography steps, one of which is based
on affinity chromatography using a patented synthetic peptide affinity ligand.14
The process also includes a solvent-detergent viral inactivation step and a
virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5500 to 9900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried
powder preparation for intravenous (IV) injection. Each single-use vial contains
nominally 250, 500, 1000 or 2000 IU of XYNTHA. Upon reconstitution, the product
is a clear to slightly opalescent, colorless solution that contains sodium chloride,
sucrose, L-histidine, calcium chloride and polysorbate 80.
REFERENCES
13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et
al. Structural and Functional Characterization of B-Domain Deleted Recombinant
Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.
14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and
Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP
Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.
Last reviewed on RxList: 3/18/2008





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Other reviews about Xyntha on web:

An albumin-free recombinant factor VIII product that uses a state-of-the-art purification process.* Xyntha


Xyntha (antihemophilic factor) is used to treat or prevent bleeding episodes in adults and children with hemophilia A. Includes Xyntha side effects, interactions and indications. Xyntha Information from Drugs.com


Learn about the prescription medication Xyntha (Antihemophilic Factor), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling. Xyntha (Antihemophilic Factor) Drug Information: Uses, Side ...


All about Xyntha. View complete and up to date Xyntha information - part of the Drugs.com trusted medication database. Xyntha Facts and Comparisons at Drugs.com


XYNTHA is a completely albumin-free recombinant factor VIII product that uses a state-of-the-art purification process. This process is entirely free Xyntha


Xyntha is a new albumin free recombinant factor VIII product for patients with hemophilia A XYNTHA Albumin Free Recombinant Factor VIII For Hemophilia A


XYNTHA-uses a next-generation purification process that's free of added human and animal materials. XYNTHA is completely albumin-free, plus 1*: Health Care Professionals Log In


XYNTHA. Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Tradename: XYNTHA Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003 XYNTHA


1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XYNTHA™ safely and effectively. See full prescribing information for XYNTHA XYNTHA™ [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]


CBER XYNTHA Product Approval Information ... March 7, 2008 Corrected Approval Letter - XYNTHA. Our STN: BL 125264/0. Wyeth Pharmaceuticals, Inc. March 7, 2008 Corrected Approval Letter - XYNTHA





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