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Uses
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is an Antihemophilic Factor (Recombinant) indicated for control and prevention of bleeding episodes in adults and children (0-16 years) with Hemophilia A.
ADVATE is indicated in the perioperative management in adults and children (0-16 years) with Hemophilia A.
ADVATE is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with Hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with Hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand disease.
History
There is currently no drug history available for this drug.
Other Information
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered CHO cell line. In culture, the CHO cell line expresses rAHF into the cell culture medium. The rAHF is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against Factor VIII is employed to selectively isolate the rAHF from the medium. The cell culture and purification processes used in the manufacture of ADVATE employ no additives of human or animal origin. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The rAHF synthesized by the CHO cells has the same biological effects on clotting as human Antihemophilic Factor (Human) [hAHF ]. Structurally the recombinant protein has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
ADVATE is formulated as a sterile, non-pyrogenic, white to off-white powder for intravenous injection. When reconstituted with the provided Sterile Water for Injection, USP, the product contains the following stabilizers and excipients in targeted amounts:
Stabilizer and Excipient | 5 mL Reconstitution (for 250, 500, 1000, 1500, 2000, 3000, 4000 IU) Target |
2 mL Reconstitution (for 250, 500, 1000, 1500 IU) Target |
Tris (hydroxymethyl) aminomethane |
10 mM | 25 mM |
Calcium Chloride | 1.7 mM | 4.2 mM |
Mannitol | 3.2% (w/v) | 8 % (w/v) |
Sodium Chloride | 90mM | 225 mM |
α, α-Trehalose | 0.8% (w/v) | 2% (w/v) |
Histidine | 10 mM | 25 mM |
Glutathione (Reduced) | 0.08 mg/mL | 0.2 mg/mL |
Polysorbate 80 | 0.01% (w/v) | 0.025% (w/v) |
ADVATE is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000, 3000 or 4000 International Units (IU) per vial. The product contains the following stabilizers and excipients: mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate-80, and glutathione. VWF is co-expressed with Factor VIII and helps to stabilize it in culture. The final product contains no more than 2 ng VWF/IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease. The product contains no preservative.
Each vial of ADVATE is labeled with the rAHF activity expressed in International Units per vial. Biological potency is determined by an in vitro assay, which employs a Factor VIII concentrate standard that is referenced to a WHO International Standard for Factor VIII concentrates. One international unit, as defined by the WHO standard for blood coagulation Factor VIII, human, is approximately equal to the level of Factor VIII activity found in 1 mL of fresh pooled human plasma. The specific activity of ADVATE is 4000 to 10000 International Units per milligram of protein.
Sources
Advate Manufacturers
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Baxter Healthcare Corporation
Advate | Baxter Healthcare Corporation
For Intravenous Use after Reconstitution Only
Initiate treatment with ADVATE under the supervision of a physician experienced in the treatment of Hemophilia A. Each vial of ADVATE has the recombinant Factor VIII potency in International Units stated on the label. The expected in vivo peak increase in Factor VIII level expressed as IU/dL of plasma or percent normal can be estimated by multiplying the dose administered per kg body weight (IU/kg) by 2. The dosage and duration of treatment depend on the severity of Factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. [See Dosage and Administration (2.1) and (2.2)]The expected in vivo peak increase in Factor VIII level expressed as IU/dL (or % of normal) can be estimated using the following formulas:
IU/dL (or % of normal) = [Total Dose (IU)/body weight (kg)] × 2 [IU/dL]/[IU/kg]
OR
Dose (International Unit) = body weight (kg) × Desired Factor VIII Rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)
Examples (assuming patient's baseline Factor VIII level is < 1% of normal):
A dose of 1750 IU ADVATE administered to a 70 kg patient should be expected to result in a peak post-infusion Factor VIII increase of 1750 IU × {[2 IU/dL]/[IU/kg]}/[70 kg] = 50 IU/dL (50% of normal). A peak level of 70% is required in a 40 kg child. In this situation, the appropriate dose would be 40 kg × 70 IU/dL/{[2 IU/dL]/[IU/kg]} = 1400 IU.Base thedose and frequency on the individual clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to ADVATE. Although you can estimate the dose by the calculations above, whenever possible, perform appropriate laboratory tests including serial Factor VIII activity assays (see Warnings and Precautions [5.4] and Pharmacokinetics [12.3]).
2.1 Control and Prevention of Bleeding EpisodesA guide for dosing in the treatment of bleeding episodes is provided in Table 1. The careful control of treatment dose is especially important in cases of life-threatening bleeding episodes.
Table 1 ADVATE Dosing for Treatment of Bleeding Episodes in Adults and Children * Dose (IU/kg) = Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
Type of Bleeding Episodes Required Peak Post-infusion Factor VIII Activity in the Blood
(as % of Normal or IU/dL) Dosage and Frequency Necessary to Maintain the Therapeutic Plasma Level Minor
Early hemarthrosis, mild muscle bleeding, or mild oral bleeding episode. 20-40 10-20 International Units per kg* Repeat infusions every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for one to three days until the bleeding episode is resolved (as indicated by relief of pain) or healing is achieved. Moderate
Moderate bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma. 30-60 15-30 International Units per kg* Repeat infusions every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for three days or more until the bleeding episode is resolved (as indicated by relief of pain) or healing is achieved. Major
Significant gastrointestinal bleeding, intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces or iliopsoas sheath, fractures, head trauma. 60-100 Initial dose 30-50 International Units per kg*
Repeat dose 30-50 International Units per kg every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until resolution of the bleeding episode has occurred. 2.2 Perioperative ManagementA guide for dosing in perioperative management is provided in Table 2. The careful control of dose and duration of treatment is especially important in cases of major surgery.
Table 2 ADVATE Dosing for Perioperative Management in Adults and Children Type of Surgery Required Peak Post-infusion Factor VIII Activity in the Blood
(% of Normal or IU/dL) Frequency of Infusion * Dose (IU/kg) = Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)Minor
Including tooth extraction
60-100 A single bolus infusion (30-50 International Units/kg*) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding. For dental procedures, adjunctive therapy may be considered.Major
Examples include intracranial, intra-abdominal, or intrathoracic surgery, joint replacement surgery
80-120
(pre- and post-operative)Preoperative bolus infusion: 40-60 International Units/kg*. Verify 100% activity has been achieved prior to surgery.
Maintenance bolus infusion (40-60 International Unit/kg*) repeat infusions every 8 to 24 hours (6 to 24 hours for patients under the age of 6), depending on the desired level of Factor VIII and state of wound healing.
2.3 Routine ProphylaxisFor prevention of bleeding episodes, doses between 20 to 40 International Units of Factor VIII per kg body weight every other day (3 to 4 times weekly) may be utilized. Alternatively, an every third day dosing regimen targeted to maintain FVIII trough levels ≥ 1% may be employed. Adjust dose based on the patient’s clinical response.1,2
2.4 Instruction for UseAdminister ADVATE by intravenous (IV) injection after reconstitution. Ask patients to follow the specific preparation and administration procedures provided by their physicians.
For instructions, ask patients to follow the recommendations in the FDA-approved patient labeling (see FDA-approved patient labeling [17]).
Perform reconstitution, product administration, and handling of the administration set and needles with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted ADVATE, in an appropriate container.
2.5 Preparation and ReconstitutionThe procedures below are provided as general guidelines for the preparation and reconstitution of ADVATE. Always work on a clean surface and wash your hands before performing the following procedures:
Bring the ADVATE (dry factor concentrate) and Sterile Water for Injection, USP (diluent) to room temperature. Remove caps from the factor concentrate and diluent vials. Cleanse stoppers with germicidal solution and allow to dry prior to use. Place the vials on a flat surface. Open the BAXJECT II device package by peeling away the lid, without touching the inside (Figure A). Do not remove the device from the package. Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper (Figure B). Grip the BAXJECT II package at its edge and pull the package off the device (Figure C). Do not remove the blue cap from the BAXJECT II device. Do not touch the exposed white plastic spike. Turn the system over so that the diluent vial is on top. Quickly insert the white plastic spike fully into the ADVATE vial stopper by pushing straight down (Figure D). The vacuum will draw the diluent into the ADVATE vial. Swirl gently until ADVATE is completely dissolved. Do not refrigerate after reconstitution. 2.6 AdministrationADVATE is for intravenous use after reconstitution only.
Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear and colorless in appearance. If not, do not use the solution and notify Baxter immediately. Administer ADVATE at room temperature within 3 hours of reconstitution. Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes. Use aseptic technique. Remove the blue cap from the BAXJECT II device. Connect the syringe to the BAXJECT II device (Figure E). Do not inject air. Turn the system upside down (factor concentrate vial now on top). Draw the factor concentrate into the syringe by pulling the plunger back slowly (Figure F). Disconnect the syringe; attach a suitable needle and inject intravenously as instructed under Administration by Bolus Infusion. If a patient is to receive more than one vial of ADVATE, the contents of multiple vials may be drawn into the same syringe. Please note that the BAXJECT II device is intended for use with a single vial of ADVATE and Sterile Water for Injection, USP, only; therefore, reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device. Administer ADVATE over a period of ≤ 5 minutes (maximum infusion rate 10 mL/min). Determine the pulse rate before and during administration of ADVATE. Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly. Figure A Figure B Figure C
Figure D Figure E Figure F -
Baxter Healthcare Corporation
Advate | Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
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