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Antihemophilic Factor (recombinant), PEGylated-aucl

Class: Hemostatics
Brands: Jivi

Medically reviewed by Drugs.com. Last updated on Sep 24, 2018.

Introduction

Antihemophilic factor (recombinant), PEGylated-aucl is a hemostatic.

Uses for Antihemophilic Factor (recombinant), PEGylated-aucl

Antihemophilic factor (recombinant), PEGylated-aucl has the following uses:

Antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.1

Antihemophilic factor (recombinant), PEGylated-aucl has the following limitations of use:

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in children < 12 years of age due to a greater risk for hypersensitivity reactions.1 Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in previously untreated patients (PUPs).1

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for the treatment of von Willebrand disease.1

Antihemophilic Factor (recombinant), PEGylated-aucl Dosage and Administration

General

Antihemophilic factor (recombinant), PEGylated-aucl is available in the following dosage form(s) and strength(s):

  • Lyophilized powder in single-use vials containing nominally 500, 1000, 2000, or 3000 IU.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Pediatric Patients

For intravenous use after reconstitution only.1

Dose
  • Each vial label of antihemophilic factor (recombinant), PEGylated-aucl states the Factor VIII potency in international units (IU). One IU is defined by the current WHO (World Health Organization) international standard for Factor VIII concentrate.1

  • Dosage 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. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.1

  • Potency assignment for antihemophilic factor (recombinant), PEGylated-aucl is determined using a chromogenic substrate assay.1

  • Monitor the Factor VIII activity of antihemophilic factor (recombinant), PEGylated-aucl in plasma using either a validated chromogenic substrate assay or a validated one-stage clotting assay.1

  • Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU of Factor VIII per kilogram body weight increases the plasma Factor VIII level by 2 IU/dL.1

  • Estimate the required dose for on-demand treatment and control of bleeding and perioperative management using the following formula: 1

Required dose (IU) = body weight (kg) × desired Factor VIII rise (% of normal or IU/dL) × reciprocal of expected recovery (or observed recovery, if available) (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg)1

  • Estimate the expected in vivo peak increase using the following formula:1

Estimated increment of Factor VIII (IU/dL or % of normal) = [Total dose (IU)/body weight (kg)] × 2 (IU/dL per IU/kg)1

  • Adjust dose and frequency to the patient’s clinical response. Patients may vary in their pharmacokinetic [e.g., half-life, incremental recovery and AUC (area under the curve)] and clinical responses to antihemophilic factor (recombinant), PEGylated-aucl.1

  • The total recommended maximum dose per infusion is approximately 6000 IU (rounded to vial size).1

On-demand Treatment and Control of Bleeding Episodes: A guide for dosing antihemophilic factor (recombinant), PEGylated-aucl for the on-demand treatment and control of bleeding episodes is provided in Table 1. The goal of treatment is to maintain a plasma Factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.1

Table 1: Dosing for Control of Bleeding Episodes

Degree of Bleeding

Hemorrhage/Hemorrhagic Event

Factor VIII Level Required

(IU/dL or % of normal)

Dose

(IU/kg)

Frequency of Doses (hours)

Duration of Treatment

Minor (e.g., early hemarthrosis, minor muscle bleeding, oral bleeds)

20–40

10–20

Repeat every 24–48 hours

Until bleeding is resolved

Moderate (e.g., more extensive hemarthrosis, muscle bleeding, or hematoma)

30–60

15–30

Repeat every 24–48 hours

Until bleeding is resolved

Major (e.g., intracranial, intra-abdominal or intrathoracic hemorrhages, gastrointestinal bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath, life- or limb- threatening hemorrhage)

60–100

30–50

Repeat every 8–24 hours

Until bleeding is resolved

Perioperative Management of Bleeding: A guide for dosing antihemophilic factor (recombinant), PEGylated-aucl during surgery (perioperative management) is provided in Table 2. The goal of treatment is to maintain a plasma Factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 2. During major surgery, monitoring with appropriate laboratory tests, including serial Factor VIII activity assays, is highly recommended.1

Table 2: Dosing for Perioperative Management

Type of Surgery

Factor VIII Level Required (IU/dL or % of normal)

Dose (IU/kg)

Frequency of Doses (hours)

Duration of Treatment (days)

Minor (e.g., tooth extraction)

30–60 (pre- and post-operative)

15-30

Repeat every 24 hours

At least 1 day until healing is achieved

Major (e.g., intracranial, intra-abdominal, intrathoracic, or joint replacement surgery)

80–100 (pre- and post-operative)

40-50

Repeat every 12–24 hours

Until adequate wound healing is complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of 30–60% (IU/dL)

Routine Prophylaxis:

  • The recommended initial regimen is 30–40 IU/kg twice weekly.1

  • Based on the bleeding episodes, the regimen may be adjusted to 45–60 IU/kg every 5 days. A regimen may be further individually adjusted to less or more frequent dosing.1

Preparation and Reconstitution

Reconstitute and administer antihemophilic factor (recombinant), PEGylated-aucl with the components provided with each package. If any component of the package is opened or damaged, do not use this component.1

Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.1

    Reconstitution:
  • Warm both unopened antihemophilic factor (recombinant), PEGylated-aucl vial and prefilled diluent syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).

  • Remove the protective cap from the vial. Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.

  • Place the product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down. The adapter will snap over the vial cap. Do not remove the adapter housing at this step.

  • Holding the syringe by the barrel, snap the syringe cap off the tip. Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.

  • Now remove and discard the adapter plastic housing.

  • Attach the prefilled syringe to the vial adapter thread by turning clockwise.

  • Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe.

  • Inject the diluent slowly by pushing down on the plunger rod.

  • Swirl vial gently until all powder on all sides of the vial is dissolved. Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.

  • Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe. Pooling: If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. Use a larger plastic syringe (not provided) to combine the contents of the vials into the syringe.

  • Filter the reconstituted product to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter. Withdraw all the solution through the vial adapter into the syringe by pulling the plunger rod back slowly and smoothly. Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.

  • Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the infusion set provided and inject the reconstituted product intravenously.

  • Note: follow instructions for infusion set provided.

Administration
    For intravenous use only.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.1

  • Do not use if you notice any particulate matter or discoloration and immediately contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).1

  • Administer reconstituted antihemophilic factor (recombinant), PEGylated-aucl as soon as possible. If not, store at room temperature for no longer than 3 hours.1

  • Infuse antihemophilic factor (recombinant), PEGylated-aucl intravenously over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient (maximum infusion rate 2.5 mL/min).1

Adults

For intravenous use after reconstitution only.1

Dose
  • Each vial label of antihemophilic factor (recombinant), PEGylated-aucl states the Factor VIII potency in international units (IU). One IU is defined by the current WHO (World Health Organization) international standard for Factor VIII concentrate.1

  • Dosage 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. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.1

  • Potency assignment for antihemophilic factor (recombinant), PEGylated-aucl is determined using a chromogenic substrate assay.1

  • Monitor the Factor VIII activity of antihemophilic factor (recombinant), PEGylated-aucl in plasma using either a validated chromogenic substrate assay or a validated one-stage clotting assay.1

  • Calculation of the required dose of Factor VIII is based on the empirical finding that 1 IU of Factor VIII per kilogram body weight increases the plasma Factor VIII level by 2 IU/dL.1

  • Estimate the required dose for on-demand treatment and control of bleeding and perioperative management using the following formula: 1

Required dose (IU) = body weight (kg) × desired Factor VIII rise (% of normal or IU/dL) × reciprocal of expected recovery (or observed recovery, if available) (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg)1

  • Estimate the expected in vivo peak increase using the following formula:1

Estimated increment of Factor VIII (IU/dL or % of normal) = [Total dose (IU)/body weight (kg)] × 2 (IU/dL per IU/kg)1

  • Adjust dose and frequency to the patient’s clinical response. Patients may vary in their pharmacokinetic [e.g., half-life, incremental recovery and AUC (area under the curve)] and clinical responses to antihemophilic factor (recombinant), PEGylated-aucl.1

  • The total recommended maximum dose per infusion is approximately 6000 IU (rounded to vial size).1

On-demand Treatment and Control of Bleeding Episodes: A guide for dosing antihemophilic factor (recombinant), PEGylated-aucl for the on-demand treatment and control of bleeding episodes is provided in Table 3. The goal of treatment is to maintain a plasma Factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 3.1

Table 3: Dosing for Control of Bleeding Episodes

Degree of Bleeding

Hemorrhage/Hemorrhagic Event

Factor VIII Level Required

(IU/dL or % of normal)

Dose

(IU/kg)

Frequency of Doses (hours)

Duration of Treatment

Minor (e.g., early hemarthrosis, minor muscle bleeding, oral bleeds)

20–40

10–20

Repeat every 24–48 hours

Until bleeding is resolved

Moderate (e.g., more extensive hemarthrosis, muscle bleeding, or hematoma)

30–60

15–30

Repeat every 24–48 hours

Until bleeding is resolved

Major (e.g., intracranial, intra-abdominal or intrathoracic hemorrhages, gastrointestinal bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath, life- or limb- threatening hemorrhage)

60–100

30–50

Repeat every 8–24 hours

Until bleeding is resolved

Perioperative Management of Bleeding: A guide for dosing antihemophilic factor (recombinant), PEGylated-aucl during surgery (perioperative management) is provided in Table 4. The goal of treatment is to maintain a plasma Factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 4. During major surgery, monitoring with appropriate laboratory tests, including serial Factor VIII activity assays, is highly recommended.1

Table 4: Dosing for Perioperative Management

Type of Surgery

Factor VIII Level Required (IU/dL or % of normal)

Dose (IU/kg)

Frequency of Doses (hours)

Duration of Treatment (days)

Minor (e.g., tooth extraction)

30–60 (pre- and post-operative)

15-30

Repeat every 24 hours

At least 1 day until healing is achieved

Major (e.g., intracranial, intra-abdominal, intrathoracic, or joint replacement surgery)

80–100 (pre- and post-operative)

40-50

Repeat every 12–24 hours

Until adequate wound healing is complete, then continue therapy for at least another 7 days to maintain Factor VIII activity of 30–60% (IU/dL)

Routine Prophylaxis:

  • The recommended initial regimen is 30–40 IU/kg twice weekly.1

  • Based on the bleeding episodes, the regimen may be adjusted to 45–60 IU/kg every 5 days. A regimen may be further individually adjusted to less or more frequent dosing.1

Preparation and Reconstitution

Reconstitute and administer antihemophilic factor (recombinant), PEGylated-aucl with the components provided with each package. If any component of the package is opened or damaged, do not use this component.1

Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.1

    Reconstitution:
  • Warm both unopened antihemophilic factor (recombinant), PEGylated-aucl vial and prefilled diluent syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).

  • Remove the protective cap from the vial. Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.

  • Place the product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down. The adapter will snap over the vial cap. Do not remove the adapter housing at this step.

  • Holding the syringe by the barrel, snap the syringe cap off the tip. Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.

  • Now remove and discard the adapter plastic housing.

  • Attach the prefilled syringe to the vial adapter thread by turning clockwise.

  • Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe.

  • Inject the diluent slowly by pushing down on the plunger rod.

  • Swirl vial gently until all powder on all sides of the vial is dissolved. Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.

  • Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe. Pooling: If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. Use a larger plastic syringe (not provided) to combine the contents of the vials into the syringe.

  • Filter the reconstituted product to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter. Withdraw all the solution through the vial adapter into the syringe by pulling the plunger rod back slowly and smoothly. Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.

  • Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the infusion set provided and inject the reconstituted product intravenously.

  • Note: follow instructions for infusion set provided.

Administration
    For intravenous use only.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.1

  • Do not use if you notice any particulate matter or discoloration and immediately contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).1

  • Administer reconstituted antihemophilic factor (recombinant), PEGylated-aucl as soon as possible. If not, store at room temperature for no longer than 3 hours.1

  • Infuse antihemophilic factor (recombinant), PEGylated-aucl intravenously over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient (maximum infusion rate 2.5 mL/min).1

Cautions for Antihemophilic Factor (recombinant), PEGylated-aucl

Contraindications

Do not use in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.1

Warnings/Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including severe allergic reactions, have occurred with antihemophilic factor (recombinant), PEGylated-aucl. Monitor patients for hypersensitivity symptoms. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension, and nausea. If hypersensitivity reactions occur, immediately discontinue administration and initiate appropriate treatment.1

Antihemophilic factor (recombinant), PEGylated-aucl may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.1

Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG).1

Neutralizing Antibodies

Neutralizing antibody (inhibitor) formation can occur following administration of antihemophilic factor (recombinant), PEGylated-aucl. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody).1

Immune Response To PEG

A clinical immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in patients <6 years of age. The symptoms of the clinical immune response were transient. Anti-PEG IgM titers decreased over time to undetectable levels. No immunoglobulin class switching was observed.1

In case of clinical suspicion of loss of drug effect, conduct testing for Factor VIII inhibitors and Factor VIII recovery.1

A low post-infusion Factor VIII level in the absence of detectable Factor VIII inhibitors indicates that loss of drug effect is likely due to anti-PEG antibodies. Discontinue antihemophilic factor (recombinant), PEGylated-aucl and switch patients to a previously effective Factor VIII product.1

Monitoring Laboratory Tests

If monitoring of Factor VIII activity is performed, use a validated chromogenic assay or a selected validated one-stage clotting assay.1

Laboratories intending to measure the Factor VIII activity of antihemophilic factor (recombinant), PEGylated-aucl should check their procedures for accuracy. For antihemophilic factor (recombinant), PEGylated-aucl, select silica-based one-stage assays may underestimate the Factor VIII activity of antihemophilic factor (recombinant), PEGylated-aucl in plasma samples; some reagents, e.g., with kaolin-based activators, have the potential for overestimation. Therefore, the suitability of the assay must be ascertained. If a validated one-stage clotting or chromogenic assay is not available locally, then use of a reference laboratory is recommended.1

Monitor for development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained or if bleeding is not controlled with the expected dose of antihemophilic factor (recombinant), PEGylated-aucl. Use Bethesda Units (BU) to report inhibitor titers.1

Specific Populations

Pregnancy

There are no data with antihemophilic factor (recombinant), PEGylated-aucl use in pregnant women to inform on drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with antihemophilic factor (recombinant), PEGylated-aucl. It is not known whether antihemophilic factor (recombinant), PEGylated-aucl can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.1

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.1

Lactation

There is no information regarding the presence of antihemophilic factor (recombinant), PEGylated-aucl in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for antihemophilic factor (recombinant), PEGylated-aucl and any potential adverse effects on the breastfed infant from antihemophilic factor (recombinant), PEGylated-aucl or from the underlying maternal condition.1

Pediatric Use

The safety and effectiveness in patients below the age of 12 have not been established.1

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in previously untreated patients.1

Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in children below 12 years of age.1

In completed clinical studies with 73 pediatric previously treated patients (PTPs) <12 years of age (44 PTPs <6 years, 29 PTPs 6 to <12 years), adverse reactions due to immune response to PEG were observed in children less than 6 years of age. In 23% of subjects in the age group <6 years of age, loss of drug effect due to neutralizing anti-PEG IgM antibodies during the first 4 exposure days (EDs) was observed. In 7% of the subjects < 6 years of age, loss of drug effect was combined with hypersensitivity reactions.1

Geriatric Use

Clinical studies of antihemophilic factor (recombinant), PEGylated-aucl did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease and other drug therapy.1

Common Adverse Effects

The most frequently reported adverse reactions in clinical trials in previously treated patients (PTPs) ≥12 years of age (≥5%) were headache, cough, nausea, and fever.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Antihemophilic factor (recombinant), PEGylated-aucl, a site-specific PEGylated recombinant antihemophilic factor, temporarily replaces the missing coagulation Factor VIII. The site-specific PEGylation in the A3 domain reduces binding to the physiological Factor VIII clearance receptors resulting in an extended half-life and increased AUC.1

Advice to Patients

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).1

  • Hypersensitivity reactions are possible with antihemophilic factor (recombinant), PEGylated-aucl. Warn patients of the early signs of hypersensitivity reactions (including tightness of the chest or throat, dizziness, mild hypotension, and nausea during infusion) which can progress to anaphylaxis. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment with resuscitative measures such as the administration of epinephrine and oxygen.1

  • Inhibitor formation may occur at any time in the treatment of a patient with hemophilia A. Advise patients to contact their physician or treatment center for further treatment and/or assessment, if they experience a lack of clinical response to Factor VIII replacement therapy, as this may be a manifestation of an inhibitor.1

  • Allergic reactions to polyethylene glycol (PEG), a component of antihemophilic factor (recombinant), PEGylated-aucl, are possible. Advise patients to contact their physician or treatment center if they experience a lack of clinical response from their usual dose.1

  • Advise patients to discard all equipment, including any unused product, in an appropriate container.1

  • Advise patients to consult with their healthcare provider prior to travel. Advise patients to bring an adequate supply of antihemophilic factor (recombinant), PEGylated-aucl while traveling based on their current regimen of treatment.1

Additional Information

AHFSfirstRelease. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Antihemophilic Factor (recombinant), PEGylated-aucl

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV use only

500 IU

Jivi (with 2.5 mL sterile water for injection prefilled diluent syringe; available with vial adapter)

Bayer HealthCare LLC

1000 IU

Jivi (with 2.5 mL sterile water for injection prefilled diluent syringe; available with vial adapter)

Bayer HealthCare LLC

2000 IU

Jivi (with 2.5 mL sterile water for injection prefilled diluent syringe; available with vial adapter)

Bayer HealthCare LLC

3000 IU

Jivi (with 2.5 mL sterile water for injection prefilled diluent syringe; available with vial adapter)

Bayer HealthCare LLC

AHFS Drug Information. © Copyright 2019, Selected Revisions September 24, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Bayer HealthCare LLC. Jivi (Antihemophilic Factor (Recombinant) PEGylated-aucl) prescribing information. 2018 Aug. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f04e5bd5-d7e2-453b-a407-2616d81a695d

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