"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Antihemophilic Factor, Recombinant
ReFacto® Antihemophilic Factor (Recombinant) is a purified protein produced by recombinant DNA technology for use in therapy of factor VIII deficiency. ReFacto (antihemophilic factor) is a glycoprotein with an approximate molecular mass of 170 kDa consisting of 1438 amino acids. It has an amino acid sequence that is comparable to the 90 + 80 kDa form of factor VIII, and post-translational modifications that are similar to those of the plasma-derived molecule. ReFacto (antihemophilic factor) has in vitro functional characteristics comparable to those of endogenous factor VIII.
ReFacto (antihemophilic factor) is produced by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes B-domain deleted recombinant factor VIII into a defined cell culture medium that contains human serum albumin and recombinant insulin, but does not contain any proteins derived from animal sources. The protein is purified by a chromatography purification process that yields a high-purity, active product. The potency expressed in international units (IU) is determined using the European Pharmacopoeial chromogenic assay against the WHO standard. The specific activity of ReFacto (antihemophilic factor) is 9110-13700 IU per milligram of protein. ReFacto (antihemophilic factor) is not purified from human blood and contains no preservatives or added human or animal components in the final formulation.
ReFacto (antihemophilic factor) is formulated as a sterile, nonpyrogenic, lyophilized powder preparation for intravenous (IV) injection. It is available in single-use vials containing the labeled amount of factor VIII activity (IU). Each vial contains nominally 250, 500, 1000 or 2000 IU of ReFacto (antihemophilic factor) per vial. The formulated product is a clear colorless solution upon reconstitution and contains sodium chloride, sucrose, L-histidine, calcium chloride, and polysorbate 80.
What are the possible side effects of recombinant antihemophilic factor?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:
- chest pain;
- easy bruising, increased bleeding episodes; or
- bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
- sore throat, cough, runny nose;
- fever or...
Last reviewed on RxList: 2/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Refacto Information
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