Drug: Benefix

BeneFIX®, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology for use in therapy of factor IX deficiency, known as hemophilia B or Christmas disease. Coagulation Factor IX (Recombinant) is a glycoprotein with an approximate molecular mass of 55,000 Da consisting of 415 amino acids in a single chain. It has a primary amino acid sequence that is identical to the Ala148allelic form of plasma-derived factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX® (coagulation factor ix recombinant) is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized and shown to be free of known infectious agents. The stored cell banks are free of blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain any proteins derived from animal or human sources, and the recombinant factor IX is purified by a chromatography purification process that does not require a monoclonal antibody step and yields a high-purity, active product. A membrane filtration step that has the ability to retain molecules with apparent molecular weights >70,000 (such as large proteins and viral particles) is included for additional viral safety. BeneFIX® (coagulation factor ix recombinant) is predominantly a single component by SDS-polyacrylamide gel electrophoresis evaluation. The potency (in international units, IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One international unit is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. The specific activity of BeneFIX® (coagulation factor ix recombinant) is greater than or equal to 200 IU per milligram of protein. BeneFIX® (coagulation factor ix recombinant) is not derived from human blood and contains no preservatives or added animal or human components. BeneFIX® (coagulation factor ix recombinant) is inherently free from the risk of transmission of human blood-borne pathogens such as HIV, hepatitis viruses, and parvovirus. BeneFIX® (coagulation factor ix recombinant) is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. BeneFIX® (coagulation factor ix recombinant) is intended for intravenous (IV) injection. It is available in single use vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, or 1000 IU of Coagulation Factor IX (Recombinant). After reconstitution of the lyophilized drug product, the concentrations of excipients in the 500 and 1000 IU dosage strengths are 10 mM L-histidine, 1% sucrose, 260 mM glycine, 0.005% polysorbate 80. The concentrations after reconstitution in the 250 IU dosage strength are half those of the other two dosage strengths. The 500 and 1000 IU dosage strengths are isotonic after reconstitution, and the 250 IU dosage strength has half the tonicity of the other two dosage strengths after reconstitution. All dosage strengths yield a clear, colorless solution upon reconstitution.

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See also CLINICAL PHARMACOLOGY: Clinical Studies. As with the intravenous administration of any protein product, the following reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate counter measures and supportive therapy should be administered. During uncontrolled open-label clinical studies with BeneFIXR, Coagulation Factor IX (Recombinant), conducted in previously treated patients (PTPs), 131 adverse reactions with definite, probable, possible or unknown relation to BeneFIX (coagulation factor ix recombinant) R therapy were reported among 27 of 65 subjects (with some subjects reporting more than one event) who received a total of 7573 infusions. These adverse reactions are summarized in Table 1 below. Table 1: Adverse Events Reported for PTPs*
Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=129) Number and (%) of patients from which the reports originated
(n=65) Number and (%) of infusions temporally associated with thereaction1
(n=7573) Nausea 27 4 (6.2 %) 27 (0.36 %) Taste perversion (Altered taste) 14 3 (4.6 %) 19 (0.25 %) Hypoxia (Urge to cough with hypoxemia) 11 1 (1.5 %) 11 (0.15 %) Injection site reaction 11 5 (7.7 %) 12 (0.16 %) Injection site pain 10 4 (6.2 %) 16 (0.21 %) Headache 10 7 (10.8 %) 13 (0.17 %) Dizziness 7 5 (7.7 %) 8 (0.11 %) Allergic rhinitis 7 3 (4.6 %) 9 (0.12 %) Pain (Burning sensation in the jaw and skull) 6 1 (1.5 %) 7 (0.09 %) Rash 6 5 (7.7 %) 7 (0.09 %) Hives 3 2 (3.1 %) 3 (0.04 %) Flushing 3 2 (3.1 %) 4 (0.05 %) Fever 2 2 (3.1 %) 2 (0.03 %) Shaking 2 2 (3.1%) 1 (0.01%) Factor IX inhibitor 2 1 1 (1.5 %) 2 (0.03 %) Chest tightness 1 1 (1.5 %) 4 (0.05 %) Drowsiness 1 1 (1.5 %) 1 (0.01 %) Visual disturbance 1 1 (1.5 %) 1 (0.01 %) Cellulitis at the IV site 1 1 (1.5 %) 7 (0.09 %) Phlebitis at the IV site 1 1 (1.5 %) 7 (0.09 %) Dry cough 1 1 (1.5 %) 0 (0.00 %) Allergic reaction 1 1 (1.5 %) 1 (0.01 %) Diarrhea 1 1 (1.5 %) 1 (0.01 %) Lung disorder 1 1 (1.5 %) 1 (0.01 %) Vomiting 1 1 (1.5 %) 1 (0.01 %) Renal infarct3 1 1 (1.5 %) 1 (0.01 %) Total 131 27/65 (41.5 %) 148/7573 (2.2 %) *More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1 Reaction occurring within 72 hours after infusion.
2 Low titer transient inhibitor formation.
3 The renal infarct developed in a hepatitis C antibody positive patient 12 days after a dose of BeneFIX® (coagulation factor ix recombinant) for a bleeding episode. The relationship of the infarct to the prior administration of BeneFIX® (coagulation factor ix recombinant) is uncertain. One subject discontinued BeneFIX® (coagulation factor ix recombinant) due to pulmonary allergic-type symptoms. In the 63 treated PUPS, who received a total of 5538 infusions, 22 adverse reactions were reported as having definite, probable, possible or unknown relationship to BeneFIX® (coagulation factor ix recombinant) . These events are summarized in Table 2 below. Table 2: Adverse Events reported for PUPs*
Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=22) Number and (%) of patients from which the reports originated
(n=63) Number and (%) of infusions temporally associated with there action1
(n=5538) Diarrhea 5 1 (1.6 %) 11 (0.20%) Urticaria (hives) 3 3 (4.8 %) 3 (0.05%) Factor IX inhibitor2 2 2 (3.2%) 4 (0.07%) Dyspnea (Respiratory distress) 2 2 (3.2 %) 2 (0.04%) Increased alkaline phosphatase 1 1 (1.6 %) 3 (0.05%) Elevated ALT 1 1 (1.6 %) 0 (0.00 %) Rash (Body rash) 1 1 (1.6 %) 1 (0.02%) Elevated AST 1 1 (1.6 %) 0 (0.00 %) Chills (Rigors) 1 1 (1.6 %) 3 (0.05%) Photosensitivity reaction 1 1 (1.6 %) 0 (0.00 %) Injection site reaction 1 1 (1.6%) 2 (0.04%) HAV seroconversion3 1 1 (1.6 %) 2 (0.04%) Parvovirus B19 seroconversion4 1 1 (1.6%) 1 (0.02%) Asthma 1 1 (1.6 %) 1 (0.02%) Total 22 11/63 (17.5%) 27/5538 (0.60%) *More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1Reaction occurring within 72 hours after infusion.
2Two subjects developed high titer inhibitor formation during treatment with BeneFIX® (coagulation factor ix recombinant) .
3 Relationship of HAV seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. HAV seroconversion was noted on 2 occasions in a single patient but was negative at final visit. The patient had no laboratory or clinical findings associated with active infection.
4Relationship of Parvovirus B19 seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. It was unlikely that seroconversion was related to BeneFIX® (coagulation factor ix recombinant) due to the frequency of community acquired infection and viral safeguards built into the manufacturing process (See DESCRIPTION). If any adverse reaction takes place that is thought to be related to the administration of BeneFIX® (coagulation factor ix recombinant) , the rate of infusion should be decreased or the infusion stopped. Post-marketing Experience The following post-marketing adverse reactions have been reported for BeneFIX® (coagulation factor ix recombinant) , as well as for plasma-derived factor IX products: inadequate factor IX recovery, inadequate therapeutic response, inhibitor development (see CLINICAL PHARMACOLOGY), anaphylaxis (see WARNINGS), laryngeal edema, angioedema, cyanosis, dyspnea, hypotension, and thrombosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The safety and efficacy of BeneFIX® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see WARNINGS). There have been post-marketing reports of thrombotic events including life-threatening SVC syndrome in critically ill neonates, while receiving continuousinfusion BeneFIX® (coagulation factor ix recombinant) through a central venous catheter. Cases of peripheral thrombophlebitis and DVT have also been reported. In some, BeneFIX (coagulation factor ix recombinant) was administered via continuous infusion, which is not an approved method of administration (See Instruction For Use, Administration). Read the Benefix (coagulation factor ix recombinant) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.

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No information provided.Read the Benefix Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.

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Because BeneFIX®, Coagulation Factor IX (Recombinant), is produced in a Chinese hamster ovary cell line, it may be contraindicated in patients with a known history of hypersensitivity to hamster protein.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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No information provided.

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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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General Activity-neutralizing antibodies (inhibitors) have been detected in patients receiving factor IXcontaining products. As with all factor IX products, patients using BeneFIX® (coagulation factor ix recombinant) should be monitored for the development of factor IX inhibitors (see CLINICAL PHARMACOLOGY and WARNINGS). Patients with factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with factor IX.2 Patients experiencing allergic reactions should be evaluated for the presence of inhibitor. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. In view of the potential for allergic reactions with factor IX concentrates, the initial (approximately 10 - 20) administrations of factor IX should be performed under medical supervision where proper medical care for allergic reactions could be provided. Dosing of BeneFIX® (coagulation factor ix recombinant) may differ from that of plasma-derived factor IX products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Carcinogenesis, Mutagenesis, Impairment of Fertility BeneFIX (coagulation factor ix recombinant) ®, Coagulation Factor IX (Recombinant), has been shown to be nonmutagenic in the Ames assay and non-clastogenic in a chromosomal aberrations assay. No investigations on carcinogenesis or impairment of fertility have been conducted. Pregnancy Category C Animal reproduction and lactation studies have not been conducted with BeneFIX®, Coagulation Factor IX (Recombinant). It is not known whether BeneFIX® (coagulation factor ix recombinant) can affect reproductive capacity or cause fetal harm when given to pregnant women. BeneFIX® (coagulation factor ix recombinant) should be administered to pregnant and lactating women only if clearly indicated. Pediatric Use Additional safety and efficacy studies are ongoing in previously treated, minimally treated, and previously untreated pediatric patients (see CLINICAL PHARMACOLOGY, WARNINGS and DOSAGE AND ADMINISTRATION). Data from BeneFIX (coagulation factor ix recombinant) R safety, efficacy, and pharmacokinetic studies have been evaluated in previously treated and previously untreated pediatric patients. Nineteen (19) previously treated pediatric patients (range 4 to ≤ 15 years) underwent pharmacokinetic evaluations for up to 24 months. The mean increase in circulating factor IX activity was 0.7 ± 0.2 IU/dL per IU/kg infused (range 0.3 to 1.1 IU/dL per IU/kg; median of 0.6 IU/dL per IU/kg). The mean biological half-life was 20.2 ± 4.0 hours (range 14 to 28 hours). Fifty-eight previously untreated patients [PUPs] less than 15 years of age at baseline [3 neonates (0-<1 month), 45 infants ( ≥ 1 month-<2 years), 9 children ( ≥ 2 years-<12 years) and 1 adolescent (>12 years)] underwent at least one recovery assessment within 30 minutes post-infusion in the presence or absence of hemorrhage during the study. The mean increase in circulating FIX activity was 0.7 ± 0.3 IU/dL per IU/kg infused (range 0.2 to 2.1 IU/dL per IU/kg; median of 0.6 IU/dL per IU/kg). In addition, there was no difference in the recoveries noted when data were evaluated by age group for infants (0.7 ± 0.4 IU/dL per IU/kg; range 0.2 to 2.1 IU/dL per IU/kg) and children (0.7 ± 0.2 IU/dL per IU/kg; range 0.2 to 1.5 IU/dL per IU/kg). The recoveries in these age groups were consistent with the recovery for the PUP study as a whole. There was insufficient sample size in the neonate and adolescent age groups to perform an analysis in these groups. Data from 57 subjects who underwent repeat recovery testing for up to 60 months demonstrated that the average incremental FIX recovery was consistent over time. Geriatric Use Clinical studies of BeneFIX (coagulation factor ix recombinant) R did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As with any patient receiving BeneFIX (coagulation factor ix recombinant) R, dose selection for an elderly patient should be individualized (see DOSAGE AND ADMINISTRATION). REFERENCES 1. Lusher JM. Thrombogenicity associated with factor IX complex concentrates. Semin Hematol. 1991;28(3 Suppl. 6):3-5. 2. Shapiro AD, Ragni MV, Lusher JM, et al. Safety and efficacy of monoclonal antibody purified factor IX concentrate in previously untreated patients with hemophilia B. Thromb Haemost. 1996;75(1):30-35. 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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