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Benefix

Benefix

INDICATIONS

BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFIX®, Coagulation Factor IX (Recombinant), is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

DOSAGE AND ADMINISTRATION

The safety and efficacy of BeneFIX® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see WARNINGS).

Treatment with BeneFIX®, Coagulation Factor IX (Recombinant), should be initiated under the supervision of a physician experienced in the treatment of hemophilia B.

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.

In an eleven subject, crossover, randomized PK evaluation of BeneFIX® (coagulation factor ix recombinant) and a single lot of highpurity plasma-derived factor IX, the recovery was lower for BeneFIX® (see CLINICAL PHARMACOLOGY). In the clinical efficacy studies, subjects were initially administered the same dose previously used for plasma-derived factor IX. Even in the absence of factor IX inhibitor, approximately half of the subjects increased their dose in these studies. Titrate the initial dose upward if necessary to achieve the desired clinical response. As with some plasmaderived factor IX products, subjects at the low end of the observed factor IX recovery may require upward dosage adjustment to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity.

BeneFIX® (coagulation factor ix recombinant) is administered by IV infusion over several minutes after reconstitution of the lyophilized powder with Sterile Water for Injection (USP).

Method of Calculating

Dose The method of calculating the factor IX dose is shown in the following equation:

number of factor IXIU required (IU) = body weight (kg) x Desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)

In the presence of an inhibitor, higher doses may be required.

Adult Patients

In adult PTPs, on average, one international unit of BeneFIX® (coagulation factor ix recombinant) per kilogram of body weight increased the circulating activity of factor IX by 0.8 ± 0.2 (range 0.4 to 1.4) IU/dL. The method of dose estimation is illustrated in the following example. If you use 0.8 IU/dL average increase of factor IX per IU/kg body weight administered, then:

number of factor IXIU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.2 (IU/kg per IU/dL)

Pediatric Patients (<15 years)

In pediatric patients, on average, one international unit of BeneFIX® (coagulation factor ix recombinant) per kilogram of body weight increased the circulating activity of factor IX by 0.7 ± 0.3 (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 the following example. If you use 0.7 IU/dL average increase of factor IX per IU/kg body weight administered, then:

number of factor IXIU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg per IU/dL)

The following chart3 may be used to guide dosing in bleeding episodes and surgery:

Type of Hemorrhage Circulating Factor IX Activity Required [% or(IU/dL)] Dosing Interval [hours] Durationof Therapy [days]
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
  Phary nx, retropharynx, retroperitoneum, CNS, surgery 50-100 12-24 7-10
Adapted from: Roberts and Eberst3

Instruction For use

The procedures below are provided as general guidelines for the reconstitution and administration of BeneFIX® (coagulation factor ix recombinant) . Patients should follow the specific reconstitution and administration procedures provided by their physicians.

Reconstitution

Always wash your hands before performing the following procedures. Aseptic technique should be used during the reconstitution procedure. BeneFIX®, Coagulation Factor IX (Recombinant), will be administered by intravenous (IV) infusion after reconstitution with Sterile Water for Injection (diluent).

  1. Allow the vials of lyophilized BeneFIX® (coagulation factor ix recombinant) and diluent to reach room temperature.
  2. Remove the plastic flip-top caps from the BeneFIX® (coagulation factor ix recombinant) vial and the diluent vial to expose the central portions of the rubber stoppers.
  3. Wipe the tops of both vials with the alcohol swab provided, or use another antiseptic solution, and allow to dry.
  4. 4. Remove the protective cover from the short end of the sterile double-ended needle and insert the short end into the diluent vial at the center of the stopper.
  5. 5. Remove the protective cover from the long end of the needle. Invert the solvent vial and, to minimize leakage, quickly insert the long end of the needle through the center of the stopper of the upright BeneFIX® (coagulation factor ix recombinant) vial.
    Note: Point the double-ended needle toward the wall of the BeneFIX® (coagulation factor ix recombinant) vial to prevent excessive foaming.
  6. The vacuum will draw the diluent into the BeneFIX® (coagulation factor ix recombinant) vial.
  7. Once the transfer is complete, remove the long end of the needle from the BeneFIX® (coagulation factor ix recombinant) vial, and properly discard the needle with the diluent vial.
    Note: If the diluent does not transfer completely into the BeneFIX® (coagulation factor ix recombinant) vial, DO NOT USE the contents of the vial. Note that it is acceptable for a small amount of fluid to remain in the diluent vial after transfer.
  8. Gently rotate the vial to dissolve the powder.
  9. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted BeneFIX® (coagulation factor ix recombinant) should appear clear and colorless.

BeneFIX® (coagulation factor ix recombinant) should be administered within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.

BeneFIX® (coagulation factor ix recombinant) , 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® (coagulation factor ix recombinant) , including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

Administration (Intravenous Injection)

BeneFIX®, Coagulation Factor IX (Recombinant), should be administered using a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the sterile filter spike.

  1. Using aseptic technique, attach the sterile filter spike to the sterile disposable syringe.
    Note: Do NOT inject air into the BeneFIX® (coagulation factor ix recombinant) vial. This may cause partial loss of product.
  2. Insert the filter spike end into the stopper of the BeneFIX® (coagulation factor ix recombinant) vial.
  3. Invert the vial and withdraw the reconstituted solution into the syringe.
  4. Remove and discard the filter spike. Note: If you use more than one vial of BeneFIX® (coagulation factor ix recombinant) , the contents of multiple vials may be drawn into the same syringe through a separate, unused filter spike.
  5. Attach the syringe to the Luer end of the infusion set tubing and perform venipuncture as instructed by your physician.
    Note: Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX® (coagulation factor ix recombinant) . 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® (coagulation factor ix recombinant) solution) and resume administration with a new package.

After reconstitution, BeneFIX® (coagulation factor ix recombinant) should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level (see ADVERSE REACTIONS). The safety and efficacy of administration by continuous infusion have not been established (see WARNINGS and ADVERSE REACTIONS, Post-marketing Experience).

Dispose of all unused solution, empty vials, and used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

Storage

Product as packaged for sale: BeneFIX®, Coagulation Factor IX (Recombinant), should be stored under refrigeration at a temperature of 2 to 8°C (36 to 46°F). Prior to the expiration date, BeneFIX® (coagulation factor ix recombinant) may also be stored at room temperature not to exceed 25°C (77°F) for up to 6 months. The patient should make note of the date the product was placed at room temperature in the space provided on the outer carton. Freezing should be avoided to prevent damage to the diluent vial. Do not use BeneFIX® (coagulation factor ix recombinant) after the expiry date on the label.

Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.

HOW SUPPLIED

BeneFIX®, Coagulation Factor IX (Recombinant), is supplied in single use vials which contain nominally 250, 500, or 1000 IU per vial (NDC # 58394-003-01, 58394-002-01, and 58394-001- 01, respectively) with sterile diluent, sterile double-ended needle for reconstitution, sterile filter spike for withdrawal, sterile infusion set, and two (2) alcohol swabs. Actual factor IX activity in IU is stated on the label of each vial.

REFERENCES

3. Roberts HR, Eberst ME. Current management of hemophilia B. Hematol Oncol Clin North Am. 1993;7(6):1269-1280.

This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 02/08. FDA Rev date: 7/11/2006

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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