Obizur
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Uses
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.
Limitations of Use:
- •
- Safety and efficacy of OBIZUR has not been established in patients with baseline anti- porcine factor VIII inhibitor titer greater than 20 BU.
- •
- OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in OBIZUR is a recombinant (r) analogue of porcine factor VIII (pFVIII) with an approximate molecular weight of 170 kDa. The rpFVIII molecule in OBIZUR is a glycoprotein containing a 90 kDa heavy chain and a 80 kDa light chain. The B-domain normally present in naturally occurring porcine factor VIII has been replaced with a twenty-four amino acid linker. Once activated, the resulting rpFVIIIa has a comparable activity to the endogenous human FVIIIa.
OBIZUR is expressed in a genetically engineered baby hamster kidney (BHK) cell line which secretes rpFVIII into the cell culture medium, and the rpFVIII protein is purified using a series of chromatography and filtration steps. The production process includes two dedicated viral clearance steps - a solvent/detergent treatment step for viral inactivation and a nanofiltration step through a series of two 15-nm filters for removal of viruses. No additives of human or animal origin are used in the formulation of OBIZUR.
OBIZUR is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (Sterile Water for Injections). OBIZUR is available in single-use vials that nominally contain 500 units (U) per vial. When reconstituted with the diluent, the product contains the following components per mL: 8.8 mg sodium chloride, 0.04 mg Tris-base, 0.73 mg Tris-HCl, 1.47 mg tri-sodium citrate dehydrate, 0.15 mg calcium chloride dehydrate, 1.9 mg sucrose, and 0.05 mg polysorbate 80.
Each vial of OBIZUR is labeled with the actual rpFVIII activity expressed in units determined by a one-stage clotting assay, using a reference rpFVIII material calibrated against the World Health Organization (WHO) 8th International Standard for human FVIII concentrates. The specific activity of OBIZUR is in the range of 11000 - 18000 U per milligram of protein. The potency values of OBIZUR determined by the chromogenic assay vary and are approximately 20-50 % lower than those of the one-stage clotting assay.
Sources
Obizur Manufacturers
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Baxter Healthcare Corporation
![Obizur (Antihemophilic Factor Porcine, B-domain Truncated Recombinant) Kit [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Obizur | Baxter Healthcare Corporation
For intravenous use after reconstitution only
2.1 Dose • Dose, dosing frequency, and duration of treatment with OBIZUR depend on the location and severity of bleeding episode, target factor VIII levels, and the patient’s clinical condition. Monitor replacement therapy in cases of major surgery or life-threatening bleeding episodes. • Each vial of OBIZUR has the recombinant porcine factor VIII potency in units stated on the vial. • Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Titrate dose and frequency based on factor VIII recovery levels and individual clinical response.A guide for dosing OBIZUR for the treatment and prevention of bleeding episodes is provided in Table 1. Maintain the factor VIII activity within the target range. Plasma levels of factor VIII should not exceed 200% of normal or 200 units per dL.
Table 1 Dosing for Treatment of Bleeding EpisodesType of Bleeding
Factor VIII Level Required (Units per dL or % of normal)
Initial Dose (Units per kg)
Subsequent Dose
Frequency and Duration of Subsequent Dosing
Minor and Moderate Superficial muscle/no neurovascular compromise, and joint
50-100
200
Titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical response
Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII levels
Major
Moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, intracranial
100-200 (To treat an acute bleed)
50-100 (After acute bleed is controlled, if required)
2.2 Reconstitution • Use aseptic technique during the reconstitution procedure. • If the patient needs more than one vial of OBIZUR per injection, reconstitute each vial according to the following instructions: 1. Bring the OBIZUR vial and the pre-filled diluent syringe to room temperature. 2. Remove the plastic cap from the OBIZUR vial (Figure A). 3. Wipe the rubber stopper with an alcohol swab (not supplied) and allow it to dry prior to use. 4. Peel back the cover of the vial adapter package (Figure B). Do not to touch the luer-lock (tip) in the center of the vial adapter. Do not remove the vial adapter from the plastic package. 5. Place the vial adapter package on a clean surface with the luer-lock pointing up. 6. Snap off the tamper resistant cap of the pre-filled syringe (Figure C). 7. While firmly holding the vial adapter package, connect the pre-filled syringe to the vial adapter by pushing the syringe tip down onto the luer lock in the center of the vial adapter, and turning it clockwise until the syringe is secured. Do not over tighten (Figure D). 8. Remove the plastic package (Figure E). 9. Place the OBIZUR vial on a clean, flat, hard surface. Place the vial adapter over the OBIZUR vial and firmly push the filter spike of the vial adapter through the center of the OBIZUR vial’s rubber circle until the clear plastic cap snaps onto the vial (Figure F). 10. Push the plunger down to slowly inject all of the diluent from the syringe into the OBIZUR vial. 11. Gently swirl (in a circular motion) the OBIZUR vial without removing the syringe until all of the powder is fully dissolved (Figure G). The reconstituted solution should be inspected visually for particulate matter before administration. Do not use if particulate matter or discoloration is observed. 12. With one hand hold the vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H). 13. Use OBIZUR within 3 hours after reconstitution when stored at room temperature. 2.3 AdministrationFor intravenous injection only
• Inspect the reconstituted OBIZUR solution for particulate matter and discoloration prior to administration. The solution should be clear and colorless in appearance. Do not administer if particulate matter or discoloration is observed. • Do not administer OBIZUR in the same tubing or container with other medicinal products for infusion. 1. Once all vials have been reconstituted, connect a large syringe to the vial adapter by gently pushing the syringe tip down onto the luer lock in the center of the vial adapter, and turning clockwise until the syringe is secured. 2. Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted OBIZUR into the syringe (Figure I).Figure I
3. Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials of OBIZUR until the total volume to be administered is reached. 4. Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 mL per minute. 2.1 Dose • Dose, dosing frequency, and duration of treatment with OBIZUR depend on the location and severity of bleeding episode, target factor VIII levels, and the patient’s clinical condition. Monitor replacement therapy in cases of major surgery or life-threatening bleeding episodes. • Each vial of OBIZUR has the recombinant porcine factor VIII potency in units stated on the vial. • Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Titrate dose and frequency based on factor VIII recovery levels and individual clinical response.A guide for dosing OBIZUR for the treatment and prevention of bleeding episodes is provided in Table 1. Maintain the factor VIII activity within the target range. Plasma levels of factor VIII should not exceed 200% of normal or 200 units per dL.
Table 1 Dosing for Treatment of Bleeding EpisodesType of Bleeding
Factor VIII Level Required (Units per dL or % of normal)
Initial Dose (Units per kg)
Subsequent Dose
Frequency and Duration of Subsequent Dosing
Minor and Moderate Superficial muscle/no neurovascular compromise, and joint
50-100
200
Titrate subsequent doses to maintain recommended factor VIII trough levels and individual clinical response
Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII levels
Major
Moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, intracranial
100-200 (To treat an acute bleed)
50-100 (After acute bleed is controlled, if required)
2.2 Reconstitution • Use aseptic technique during the reconstitution procedure. • If the patient needs more than one vial of OBIZUR per injection, reconstitute each vial according to the following instructions: 1. Bring the OBIZUR vial and the pre-filled diluent syringe to room temperature. 2. Remove the plastic cap from the OBIZUR vial (Figure A). 3. Wipe the rubber stopper with an alcohol swab (not supplied) and allow it to dry prior to use. 4. Peel back the cover of the vial adapter package (Figure B). Do not to touch the luer-lock (tip) in the center of the vial adapter. Do not remove the vial adapter from the plastic package. 5. Place the vial adapter package on a clean surface with the luer-lock pointing up. 6. Snap off the tamper resistant cap of the pre-filled syringe (Figure C). 7. While firmly holding the vial adapter package, connect the pre-filled syringe to the vial adapter by pushing the syringe tip down onto the luer lock in the center of the vial adapter, and turning it clockwise until the syringe is secured. Do not over tighten (Figure D). 8. Remove the plastic package (Figure E). 9. Place the OBIZUR vial on a clean, flat, hard surface. Place the vial adapter over the OBIZUR vial and firmly push the filter spike of the vial adapter through the center of the OBIZUR vial’s rubber circle until the clear plastic cap snaps onto the vial (Figure F). 10. Push the plunger down to slowly inject all of the diluent from the syringe into the OBIZUR vial. 11. Gently swirl (in a circular motion) the OBIZUR vial without removing the syringe until all of the powder is fully dissolved (Figure G). The reconstituted solution should be inspected visually for particulate matter before administration. Do not use if particulate matter or discoloration is observed. 12. With one hand hold the vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H). 13. Use OBIZUR within 3 hours after reconstitution when stored at room temperature. 2.3 AdministrationFor intravenous injection only
• Inspect the reconstituted OBIZUR solution for particulate matter and discoloration prior to administration. The solution should be clear and colorless in appearance. Do not administer if particulate matter or discoloration is observed. • Do not administer OBIZUR in the same tubing or container with other medicinal products for infusion. 1. Once all vials have been reconstituted, connect a large syringe to the vial adapter by gently pushing the syringe tip down onto the luer lock in the center of the vial adapter, and turning clockwise until the syringe is secured. 2. Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted OBIZUR into the syringe (Figure I).Figure I
3. Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials of OBIZUR until the total volume to be administered is reached. 4. Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 mL per minute.
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