OBIZUR

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OBIZUR

Classes

Blood Coagulation Factors

Administration

Factor VIII activity is expressed in units. Potency values are determined by a 1-stage clotting assay.
Each single-use vial nominally contains 500 units per vial. The exact recombinant porcine factor VIII potency in units is stated on each vial.
Plasma factor VIII concentrations can be monitored using a 1-stage clotting assay.[58255]

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be clear and colorless. Do not administer if particulate matter or discoloration are observed.

Intravenous Administration

Reconstitution
Use aseptic technique throughout the entire reconstitution process.
Allow vial of antihemophilic factor porcine sequence and prefilled diluent syringe (provided) to reach room temperature.
Peel back the cover of the vial adapter package, taking care not to touch the Luer-lock (tip) in the center of the vial adapter. Do not remove the vial adapter from the plastic package.
Place the vial adapter package on a clean surface with the Luer-lock pointing up.
Snap off the tamper-resistant cap of the prefilled syringe.
While firmly holding the vial adapter package, connect the prefilled syringe to the vial adapter by pushing the syringe tip down onto the Luer-lock in the center of the vial adapter. Turn clockwise until the syringe is secured. Do not over tighten.
Remove plastic package.
Place the antihemophilic factor porcine sequence vial on a clean, flat, hard surface. Place the vial adapter over the vial and firmly push the filter spike of the vial adapter through the center of the antihemophilic factor porcine sequence vial's rubber circle until the clear plastic cap snaps onto the vial.
Push the plunger down to slowly inject all the diluent from the syringe into the vial.
Gently swirl, in a circular motion, the antihemophilic factor porcine sequence vial without removing the syringe until all of the powder is fully dissolved.
With 1 hand, hold the vial and adapter, and with the other hand firmly grasp the barrel of the prefilled syringe and in a counterclockwise motion, unscrew the syringe from the vial adapter.
Storage: Use the reconstituted solution within 3 hours after reconstitution when stored at room temperature.[58255]
 
Intermittent IV infusion
Once all vials have been reconstituted, attach 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, turning clockwise until it is securely in place.
Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted solution into the syringe.
Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials until the total volume to be administered is reached.
Do not administer in the same tubing with other medications.
Administer intravenously at a rate of 1 to 2 mL/minute.[58255]

Adverse Reactions
Severe

anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

Moderate

antibody formation / Delayed / 26.0-62.5
hypotension / Rapid / Incidence not known
dyspnea / Early / Incidence not known
wheezing / Rapid / Incidence not known

Mild

pruritus / Rapid / Incidence not known
urticaria / Rapid / Incidence not known

Common Brand Names

OBIZUR

Dea Class

Rx

Description

Antihemophilic factor
Used for the treatment of bleeding episodes in adults with acquired hemophilia A
Porcine factor VIII antibodies can develop and may result in lack of efficacy

Dosage And Indications
For the treatment of bleeding episodes in adults with acquired hemophilia A.
NOTE: The FDA has granted orphan drug status to antihemophilic factor, porcine sequence, recombinant for this indication.
Intravenous dosage Adults

200 units/kg IV initially; initial dosing less than 200 units/kg has been associated with lack of efficacy. The subsequent dose, frequency, and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses may be administered every 4 to 12 hours based on clinical response and measured factor VIII concentration. For minor and moderate bleeding (e.g., superficial muscle without neurovascular compromise, and joint), the circulating factor VIII concentration required is 50% to 100% of normal. For major bleeding (e.g., moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, intracranial), the circulating factor VIII concentration required is 100% to 200% of normal to treat an acute bleed and 50% to 100% of normal after the acute bleed is controlled, if needed. Plasma concentration of factor VIII should not exceed 200% of normal or 200 units/dL. Safety and efficacy has not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of more than 20 Bethesda Units (BU).

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Antihemophilic Factor, Porcine Sequence, Recombinant products.

How Supplied

OBIZUR Intravenous Inj Pwd F/Sol

Maximum Dosage
Adults

Specific maximum dosage information is not available. Individualize dosage based on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.

Geriatric

Specific maximum dosage information is not available. Individualize dosage based on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Patients with acquired hemophilia A have normal factor VIII genes but develop autoantibodies (i.e., inhibitors) against endogenous factor VIII. The autoantibodies neutralize circulating human factor VIII, resulting in a deficiency of this procoagulant protein. Patients with acquired hemophilia A have a prolonged clotting time, measured by aPTT, a conventional in vitro test for biological activity of factor VIII. Administration of recombinant antihemophilic factor, porcine sequence temporarily replaces the inhibited factor VIII needed for effective hemostasis and normalizes the aPTT over the effective dosing period. However, factor VIII activity, not aPTT, should not be used as a measure of efficacy during treatment.

Pharmacokinetics

Antihemophilic factor, porcine sequence, recombinant is administered intravenously. Formal pharmacokinetic studies have not been conducted. The pharmacokinetics were studied in 3 patients with hemophilia A and a history of human factor VIII inhibitors receiving a single antihemophilic factor, porcine sequence, recombinant dose of 100 units/kg. Utilizing the one-stage clotting assay, the mean (standard deviation) for Cmax was 176 (88) units/dL, Tmax was 0.6 (0.03) hours, and half-life was 10.63 (0.77) hours.
 
Affected CYP450 isoenzymes or drug transporters: none

Pregnancy And Lactation
Pregnancy

There are no data with antihemophilic factor, porcine sequence, recombinant use in pregnant patients to inform a drug-associated risk. Is it not known if antihemophilic factor, porcine sequence, recombinant can cause fetal harm if given during pregnancy or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with antihemophilic factor, porcine sequence, recombinant.

There is no data regarding the presence of antihemophilic factor, porcine sequence, recombinant in human milk, the effect on the breast-fed child, or its effect on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for antihemophilic factor, porcine sequence, recombinant and any potential adverse effects on the breast-fed child from antihemophilic factor, porcine sequence, recombinant or the underlying maternal condition.