Xyntha
Loading...Xyntha Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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
XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:
- Control and prevention of bleeding episodes
- Perioperative management
XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It 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 rAHF in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain.13 The amino acid sequence of the rAHF is comparable to the 90 + 80 kDa form of human coagulation factor VIII.
The purification process 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 5,500 to 9,900 IU per milligram of protein.
XYNTHA is formulated as a sterile, nonpyrogenic, no preservative, lyophilized powder preparation for intravenous injection. Each single-use prefilled dual-chamber syringe (named XYNTHA SOLOFUSE) contains nominally 250, 500, 1000, 2000, or 3000 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.
Sources
Xyntha Manufacturers
-
Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
![Xyntha (Antihemophilic Factor (Recombinant, Plasma/albumin-free)) Kit [Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Xyntha | Mallinckrodt Inc.
GeneralAs with all radiopaque contrast agents, only the lowest dose necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of Optiray. The combination of volume and concentration of Optiray to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.
It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected.
If during administration a reaction occurs, the injection should be stopped until the reaction has subsided.
Patients should be well hydrated prior to and following Optiray (ioversol injection) administration.
As with all contrast media, other drugs should not be mixed with ioversol solutions because of the potential for chemical incompatibility.
Sterile technique must be used in all vascular injections involving contrast media.
If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and should not be used if particulates are observed or marked discoloration has occurred.
The Optiray formulations are supplied in single dose containers. Discard unused portion.
Login To Your Free Account