BeneFIX Dosage

Generic name: coagulation factor IX (recombinant)
Dosage form: injection

This dosage information does not include all the information needed to use BeneFIX safely and effectively. See full prescribing information for BeneFIX.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

General Considerations for Administration

For Intravenous Use after Reconstitution

  • Treatment with BeneFIX, Coagulation Factor IX (Recombinant), should be initiated under the supervision of a physician experienced in the treatment of hemophilia B.
  • Each vial of BeneFIX has the rFIX potency in the International Units (IU) stated on the vial.
  • Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

To ensure that the desired factor IX activity level has been achieved, precise monitoring using the factor IX activity assay is advised. Doses should be titrated using the factor IX activity, pharmacokinetic parameters, such as half-life and recovery, as well as taking the clinical situation into consideration in order to adjust the dose as appropriate.

Dosing of BeneFIX may differ from that of plasma-derived factor IX products [see Clinical Pharmacology (12)]. Subjects at the low end of the observed factor IX recovery may require upward dosage adjustment of BeneFIX to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity.

The safety and efficacy of BeneFIX administration by continuous infusion have not been established [see Warnings and Precautions (5)].

Method of Calculating Initial Estimated Dose

The method of calculating the factor IX dose is shown in Table 1.

Table 1

number of factor IX IU required (IU)

=

body weight (kg)

x

desired factor IX increase (% or IU/dL)

x

reciprocal of observed recovery (IU/kg per IU/dL)

Average Recovery Adult Patients in Clinical Trial

In adult PTPs, on average, one International Unit (IU) of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.8 ± 0.2 IU/dL (range 0.4 to 1.2 IU/dL). The method of dose estimation is illustrated in Table 2. If you use 0.8 IU/dL average increase of factor IX per IU/kg body weight administered, then:

Table 2

number of factor IX IU required (IU)

=

body weight (kg)

x

desired factor IX increase (% or IU/dL)

x

1.3 (IU/kg per IU/dL)

Average Recovery Pediatric Patients (<15 years) in Clinical Trial

In pediatric patients, on average, one international unit of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.7 ± 0.3 IU/dL (range 0.2 to 2.1 IU/dL; median of 0.6 IU/dL per IU/kg). The method of dose estimation is illustrated in Table 3. If you use 0.7 IU/dL average increase of factor IX per IU/kg body weight administered, then:

Table 3

number of factor IX IU required (IU)

=

body weight (kg)

x

desired factor IX increase (% or IU/dL)

x

1.4 (IU/kg per IU/dL)

Doses administered should be titrated to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to BeneFIX. Although the dose can be estimated by the calculations above, it is highly recommended that, whenever possible, appropriate laboratory tests, including serial factor IX activity assays, be performed.

Dosing Guide for Control and Prevention of Bleeding Episodes and Peri-operative Management

Table 4

Type of Hemorrhage

Circulating Factor IX Activity Required [% or (IU/dL)]

Dosing Interval [hours]

Duration of Therapy [days]
Adapted from: Roberts and Eberst1

Minor
     
Uncomplicated hemarthroses, superficial
muscle, or soft tissue
20-30 12-24 1-2

Moderate
     
Intramuscle or soft tissue with dissection,
mucous membranes, dental extractions, or hematuria
25-50 12-24 Treat until bleeding stops and healing
begins, about 2 to 7 days

Major
     
Pharynx, retropharynx,
retroperitoneum, CNS, surgery
50-100 12-24 7-10

Instructions for Use

BeneFIX is administered by intravenous (IV) infusion after reconstitution of the lyophilized powder with the supplied pre-filled diluent (0.234% sodium chloride solution) syringe.

Patients should follow the specific reconstitution and administration procedures provided by their physicians.

For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling [see Patient Counseling Information (17.3)].

Reconstitution, product administration, and handling of the administration set must be done with caution. Discard all equipment, including any reconstituted BeneFIX product, in an appropriate container. Place needles used for venopuncture in a sharps container after single use. Percutaneous puncture with a needle contaminated with blood from an infected patient can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.

Preparation and Reconstitution

The procedures below are provided as general guidelines for the reconstitution and administration of BeneFIX.

Preparation

  1. Always wash your hands before performing the following procedures.
  2. Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
  3. Use all components in the reconstitution and administration of this product as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.

    Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted according to the following instructions. The diluent syringe should be removed leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted contents of each vial. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.

Reconstitution

  1. Allow the vial of lyophilized BeneFIX and the pre-filled diluent syringe to reach room temperature.
  2. Remove the plastic flip-top cap from the BeneFIX vial to expose the central portions of the rubber stopper.
    figure
  3. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
  4. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
  5. Place the vial on a flat surface. While holding the adapter in the package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper.
    figure
  6. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.
    figure
  7. Break off the tamper-resistant plastic-tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if not administering reconstituted BeneFIX immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated.
    figure
  8. Lift the package away from the adapter and discard the package.
    figure
  9. Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.
    figure
  10. Slowly depress the plunger rod to inject all the diluent into the BeneFIX vial.
    figure
  11. Without removing the syringe, gently swirl the contents of the vial until the powder is dissolved.

    Note: The final solution should be inspected visually for particulate matter before administration. The solution should appear clear and colorless. If it is not, the solution should be discarded and a new kit should be used.

  12. Invert the vial and slowly draw the solution into the syringe.
    figure
  13. Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. Discard the vial with the adapter attached.

    Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.

BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX, including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations for dosage and administration be followed closely [see Dosage and Administration (2)].

Administration (Intravenous Injection)

For Intravenous Use only after Reconstitution

BeneFIX is administered by intravenous (IV) infusion after reconstitution with the pre-filled diluent (0.234% sodium chloride solution) syringe.

  • BeneFIX should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • The reconstituted solution may be stored at room temperature prior to administration, but BeneFIX should be administered within 3 hours. BeneFIX should be administered using the tubing provided in this kit, and the pre-filled diluent syringe provided, or a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.
  • A dose of BeneFIX may be administered over a period of several minutes. The rate of administration, however, should be adapted to the comfort level of each individual patient.
  1. Attach the syringe to the luer end of the infusion set tubing provided.
  2. Apply a tourniquet and prepare the injections site by wiping the skin well with an alcohol swab provided in the kit.
    figure
  3. Perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. The reconstituted BeneFIX product should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level.
    figure

Reconstituted BeneFIX should not be administered in the same tubing or container with other medicinal products.

Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX. No adverse events have been reported in association with this observation. To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe. If red blood cell agglutination is observed in the tubing or syringe, discard all material (tubing, syringe and BeneFIX solution) and resume administration with a new package.

Following completion of BeneFIX treatment, remove the infusion set and discard. Dispose of all unused solution, empty vial(s), and used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

The safety and efficacy of administration by continuous infusion have not been established [see Warnings and Precautions (5)].

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