Gleevec

Gleevec

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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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

1.1 Control and Prevention of Bleeding Episodes in Hemophilia B

BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease).

1.2 Peri-operative Management in Patients with Hemophilia B

BeneFIX, Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B.

BeneFIX, Coagulation Factor IX (Recombinant), is NOT indicated for:

  1. treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X),
  2. treatment of hemophilia A patients with inhibitors to factor VIII,
  3. reversal of coumarin-induced anticoagulation,
  4. treatment of bleeding due to low levels of liver-dependent coagulation factors.

History

There is currently no drug history available for this drug.

Other Information

BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA. It has a primary amino acid sequence that is identical to the Ala148 allelic form of plasma-derived factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No human or animal proteins are added during the purification and formulation processes of BeneFIX.

BeneFIX is not derived from human blood and contains no preservatives, and the manufacture of BeneFIX includes no added animal or human components. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain any proteins derived from animal or human sources, and the recombinant factor IX is purified by a chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation. The potency (in International Units, IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One International Unit is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein.

BeneFIX is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. BeneFIX is intended for intravenous (IV) injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of Coagulation Factor IX (Recombinant). After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. All dosage strengths yield a clear, colorless solution upon reconstitution.

Gleevec Manufacturers


  • Novartis Pharmaceuticals Corporation
    Gleevec (Imatinib Mesylate) Tablet [Novartis Pharmaceuticals Corporation]

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