July 29, 2016
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BeneFIX

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BeneFIX




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX and have manifested as pruritus, rash, urticaria, hives, facial swelling, dizziness, hypotension, nausea, chest discomfort, cough, dyspnea, wheezing, flushing, discomfort (generalized) and fatigue. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors.

Closely monitor patients for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. Because of the potential for allergic reactions with factor IX concentrates, perform the initial (approximately 10 – 20) administrations of factor IX under medical supervision where proper medical care for allergic reactions could be provided. Advise patients to discontinue use of the product and contact their physician and/or seek immediate emergency care. Immediately discontinue the administration and initiate appropriate treatment if symptoms occur.

BeneFIX contains trace amounts of hamster (CHO) proteins. Patients treated with this product may develop hypersensitivity to these nonhuman mammalian proteins.

Thromboembolic Complications

There have been post-marketing reports of thrombotic events in patients receiving continuous-infusion BeneFIX through a central venous catheter, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates [see ADVERSE REACTIONS]. The safety and efficacy of BeneFIX administration by continuous infusion have not been established [see DOSAGE AND ADMINISTRATION].

Nephrotic Syndrome

Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. The safety and efficacy of using BeneFIX for immune tolerance induction have not been established.

Neutralizing Antibodies (Inhibitors)

Neutralizing antibodies (inhibitors) have been reported following administration of BeneFIX [see ADVERSE REACTIONS]. Evaluate patients using BeneFIX for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration.

Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis upon subsequent challenge with factor IX. Evaluate patients experiencing allergic reactions for the presence of an inhibitor and closely monitor patients with inhibitors for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product [see Hypersensitivity Reactions].

Monitoring Laboratory Tests

  • Monitor patients for factor IX activity levels by the one-stage clotting assay to confirm that adequate factor IX levels have been achieved and maintained, when clinically indicated [see DOSAGE AND ADMINISTRATION].
  • Monitor patients for the development of inhibitors if expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with the recommended dose of BeneFIX. Determine factor IX inhibitor levels in Bethesda Units (BUs).

Patient Counseling Information

  • Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
  • Allergic-type hypersensitivity reactions are possible. Inform patients of the early signs of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of the product and contact their physicians if these symptoms occur.
  • Advise patients to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

BeneFIX 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.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction and lactation studies have not been conducted with BeneFIX, Coagulation Factor IX (Recombinant). It is not known whether BeneFIX can affect reproductive capacity or cause fetal harm when given to pregnant women. BeneFIX should be administered to pregnant women only if needed.

Labor And Delivery

There is no information available on the effect of factor IX replacement therapy on labor and delivery. Use only if needed.

Nursing Mothers

It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if BeneFIX is administered to nursing mothers.

Use only if needed.

Pediatric Use

Safety, efficacy, and pharmacokinetics of BeneFIX have been evaluated in previously treated (PTP) and previously untreated pediatric patients (PUP) [see Clinical Studies and ADVERSE REACTIONS]. On average, lower recovery has been observed in pediatric patients younger than 15 years old [see CLINICAL PHARMACOLOGY]. Dose adjustment may be needed [see DOSAGE AND ADMINISTRATION].

Geriatric Use

Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be individualized [see DOSAGE AND ADMINISTRATION].

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/2/2016

Warnings
Precautions

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