Obizur Dosage

Generic name: SUSOCTOCOG ALFA 500[USP'U] in 1mL;
Dosage form: injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Mar 23, 2023.

For intravenous use after reconstitution only.

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.
Initial dosing below the recommended 200 U/kg has been associated with lack of efficacy.

A guide for dosing OBIZUR for the on-demand treatment and control 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 On-Demand Treatment and Control of Bleeding Episodes
Type 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 to 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 to 200 (To treat an acute bleed) 50 to 100 (After acute bleed is controlled, if required)	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

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).

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 touch the luer-lock (tip) in the center of the vial adapter. Do not remove the vial adapter from the plastic package.

Figure B

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).

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).

Figure D

8.: Remove the vial adapter from the plastic package (Figure E).

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).

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.

Figure G

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).

Figure H

13.: Use OBIZUR within 3 hours after reconstitution when stored at room temperature.

Administration

For intravenous use after reconstitution 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.