Is Bebulin discontinued?
Is Bebulin discontinued?
Shire is discontinuing the manufacture and distribution of BEBULIN®, the company’s factor IX human plasma-derived prothrombin complex concentrate product. BEBULIN® is indicated for the prevention and control of bleeding episodes in adult patients with hemophilia B.
What is Bebulin?
Bebulin is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting. Bebulin is used to treat or prevent bleeding episodes in people with factor IX deficiency (hemophilia B).
How is factor9 administered?
Factor IX is generally administered as a slow IV push (bolus injection). Continuous infusion of Factor IX is indicated for patients requiring admission for severe bleeds or surgical procedures. Factor IX replacement for such patients should be managed in consultation with Clinical Haematology.
How long do the effects of Kcentra last?
*Effective hemostasis measured up to 24 hours for the Acute Major Bleeding trial and until the end of procedure (up to 24 hours) for the Urgent Surgery/Invasive Procedures trial. Rapid INR reduction to ≤1.3 at 0.5 hours after end of infusion.
What is the cost of factor VIII?
In that year, the price of factor VIII averaged 2.53 U.S. dollars in the United States. Factor VIII is a drug used, for example, to treat patients with hemophilia A….Average prices of factor VIII in selected countries in 2017 (in U.S. dollars)*
| Characteristic | Average price in U.S. dollars |
|---|---|
| United States | 2.53 |
Does Kcentra work without vitamin K?
Why must vitamin K be used with Kcentra? The administration of vitamin K is expected to maintain factor levels once the effects of Kcentra have diminished. The dose of vitamin K is not specified in the prescribing information.
When can I check INR after Kcentra?
- Recheck INR 30 minutes after Kcentra® dose. Kcentra®=4-Factor PCC.
- Time elapsed: Immediate. Protamine 1–1.5 mg slow IV.
- Time elapsed: 30 – 60 minutes. Protamine 0.5–0.75 mg slow IV.
- Time elapsed: >2 hours. Protamine 0.25– 0.375 mg slow IV.
- Enoxaparin (Lovenox ®)
- 0.5 mg Protamine per.
- Time elapsed: < 8 hours.
How much is clotting factor?
The average annual cost of clotting factor therapies for a person with severe hemophilia is roughly $300,000. Medical expenses for a person with severe hemophilia, the most common form of hemophilia, can be twice that.
What is the clinical pharmacology of bebulin?
Bebulin – Clinical Pharmacology. Bebulin is a combination of vitamin K-dependent clotting factors found in normal plasma. The administration of Bebulin provides an increase in plasma levels of Factor IX and can temporarily correct the coagulation defect of patients with Factor IX deficiency. Plasma levels of Factors II and X will also be increased.
How is bebulin supplied?
How is Bebulin Supplied. Bebulin is supplied in single dose vials (NDC 64193-445-02) with Sterile Water for Injection, U.S.P., double-ended needle, and filter needle for reconstitution and withdrawal. The vial stopper of the 20 mL Sterile Water for Injection may contain Dry Natural Rubber Latex.
Is bebulin effective in the treatment of hemophilia B deficiency?
Bebulin is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients. Bebulin is not indicated for use in the treatment of Factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency. None known.
How much Heparin is in bebulin?
In addition, the product contains small amounts of heparin (≤ 0.15 IU heparin per IU Factor IX). Bebulin is standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU).
