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Alprolix

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Alprolix

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor IX replacement products, and are possible with ALPROLIX™. Early signs of allergic reactions, which can progress to anaphylaxis, may include angioedema, chest tightness, hypotension, rash, nausea, vomiting, parasthesia, restlessness, wheezing and dyspnea. Discontinue use of ALPROLIX™ if hypersensitivity symptoms occur, and initiate appropriate treatment.

Neutralizing Antibodies (Inhibitors)

Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported during factor replacement therapy in the treatment of hemophilia B. Monitor all patients regularly for the development of inhibitors by appropriate clinical observations and laboratory tests [see Monitoring Laboratory Tests].

An association between the occurrence of a Factor IX inhibitor and allergic reactions has been reported1. Evaluate patients experiencing allergic reactions for the presence of an inhibitor. Closely observe patients for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of exposure to the product.

Individuals with Factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with ALPROLIX™.

Thromboembolic Complications

The use of Factor IX products has been associated with the development of thromboembolic complications, especially in individuals receiving continuous infusion through a central venous catheter. ALPROLIX™ should be administered as bolus infusion over several minutes [see DOSAGE AND ADMINISTRATION]. The safety of ALPROLIX™ administration by continuous infusion has not been studied.

Monitoring Laboratory Tests

  • To confirm adequate Factor IX levels have been achieved and maintained, monitor plasma Factor IX activity by performing the one-stage clotting assay [see DOSAGE AND ADMINISTRATION]. Factor IX results can be affected by the type of aPTT reagent used. Measurement with a one-stage clotting assay using a kaolin-based aPTT reagent will likely result in an underestimation of activity level.
  • Monitor for the development of Factor IX inhibitors if the expected Factor IX activity levels in plasma are not attained, or if bleeding is not controlled with the recommended dose of ALPROLIX™. Perform a Bethesda assay to determine if Factor IX inhibitors are present.

Patient Counseling Information

  • Advise patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
  • Advise patients to report any adverse reactions or problems following ALPROLIX™ administration to their physician or healthcare provider.
  • Advise patients to contact their healthcare provider or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to Factor IX therapy, as this may indicate the development of an inhibitor.
  • Inform patients of the early signs of hypersensitivity reactions (including hives, chest tightness, wheezing, difficulty breathing and swelling of the face) and anaphylaxis. Instruct patients to discontinue use of the product and contact their healthcare provider if these symptoms occur.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of ALPROLIX™, or studies to determine the effects of ALPROLIX™ on genotoxicity or fertility have not been performed. An assessment of the carcinogenic potential of ALPROLIX™ was completed and no carcinogenic risk from product use has been identified.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproductive studies have not been conducted with ALPROLIX™. It is also not known whether ALPROLIX™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALPROLIX™ should be given to a pregnant woman only if clearly needed.

Labor And Delivery

There is no information available on the effect of Factor IX replacement therapy on labor and delivery. Use only if the potential benefit justifies the potential risk.

Nursing Mothers

It is not known if ALPROLIX™ is excreted into human milk. Because many drugs are excreted in human milk, caution should be exercised if ALPROLIX™ is administered to nursing women.

Pediatric Use

Safety, efficacy, and pharmacokinetics of ALPROLIX™ have been evaluated in previously treated pediatric patients 12 years of age and older. No dose adjustment is required for adolescents.

Children under 12 years of age may have higher Factor IX bodyweight-adjusted clearance, shorter half-life, and lower recovery. Higher dose per kilogram bodyweight or more frequent dosing may be needed in these patients [see CLINICAL PHARMACOLOGY].

The use of ALPROLIX™ in children younger than 12 years of age is supported by the clinical study of ALPROLIX™ in subjects 12 years of age and older and interim pharmacokinetic and safety data from a study of pediatric subjects including 8 subjects 2 to 5 years of age and 15 subjects 6 to 11 years of age who were exposed for a median of 21.3 weeks (1.1 to 45.7 weeks). The safety profile in subjects under 12 years of age is acceptable. Efficacy data can be extrapolated from pharmacokinetic data to subjects < 2 years of age. [See CLINICAL PHARMACOLOGY]

Geriatric Use

Clinical studies of ALPROLIX™ did not include a sufficient number of subjects age 65 and over to determine whether or not they respond differently than younger subjects.

REFERENCES

1. Chitlur M, Warrier I, Rajpurkar M, et al. Inhibitors in factor IX deficiency a report of the ISTH-SSC international FIX inhibitor registry (1997-2006). Haemophilia. 2009;15(5):1027-31.

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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