April 29, 2017
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"The Centers for Disease Control and Prevention has identified a cluster of newborns in Tennessee with late vitamin K deficiency bleeding (VKDB). VKDB is a serious, but preventable bleeding disorder that can cause bleeding in the brain. In each"...





Included as part of the PRECAUTIONS section.


Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, are possible with Novoeight®. Novoeight® contains trace amounts of hamster proteins. Patients treated with this product may develop hypersen­sitivity to these non-human mammalian proteins. Early signs of hypersensitivity reactions that can progress to anaphylaxis include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.

Neutralizing Antibodies

Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of Novoeight®. Monitor all patients for the development of inhibitors by appropriate clinical observation and laboratory testing. If the expected plasma levels of factor VIII activity are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors.

Monitoring Laboratory Tests

  • Monitor plasma factor VIII activity levels by the one-stage clotting assay or the chromogenic substrate assay to confirm that adequate factor VIII levels have been achieved and maintained, when clinically indicated. [See DOSAGE AND ADMINISTRATION]
  • Perform assay to determine if factor VIII inhibitor is present if expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with the expected dose of Novoeight®. Determine inhibitor levels in Bethesda Units.

Patient Counseling Information

  • Advise patients to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
  • Allergic-type hypersensitivity reactions or anaphylaxis are possible with use of Novoeight®. Inform patients of the early signs of hypersensitivity reactions including rash, hives, itching, facial swelling, tightness of the chest and wheezing. Advise patients to discontinue use of Novoeight® immediately and contact their physician, and go to the emergency department 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 VIII replacement therapy, as this may be a manifestation of an inhibitor.
  • Advise patients to consult with their healthcare provider prior to traveling. While traveling, patients should be advised to bring an adequate supply of Novoeight® based on their current treatment regimen.
  • Advise patients to follow the recommendations regarding proper sharps disposal provided in the FDA-approved Instructions for Use.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Use In Specific Populations


Risk Summary

As hemophilia mainly affects males, there are no adequate and well-controlled studies using Novoeight® in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with Novoeight®.

In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no reliable data on the incidences specific to the hemophilia A population.


Risk Summary

There is no information regarding the presence of Novoeight® in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Novoeight® and any potential adverse effects on the breastfed infant from Novoeight® or from the underlying maternal condition.

Pediatric Use

Children have shorter half–life and lower recovery of factor VIII than adults. Because clearance (based on per kg body weight) has been demonstrated to be higher in the pediatric population, higher or more frequent dosing based on body weight may be needed. [See CLINICAL PHARMACOLOGY]

Safety and efficacy studies have been performed in 79 previously treated pediatric patients < 16 years of age. Thirty-one of these subjects (39%) were < 6 years of age, 32 (41%) were 6 to < 12 years of age, and 16 (20%) were adolescents (12 to < 16 years of age). All subjects received preventive treatment every other day or three times weekly at the dose levels described in Table 3. A total of 244 bleeds in 54 subjects were treated with Novoeight®. The majority of the bleeds (91%) were of mild/moderate severity, 41% of the bleeds were spontaneous and 58% of the bleeds were localized in joints. Of these 244 bleeds, 210 (86%) were rated excellent or good in their response to treatment with Novoeight® and 3 (1.2%) were rated as having no response. A total of 222 (91%) of the bleeds were resolved with one or two injections of Novoeight®. Routine prophylactic treatment has been shown to reduce joint bleeding. [See Clinical Studies]

Geriatric Use

Clinical studies of Novoeight® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

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

Last reviewed on RxList: 4/5/2016


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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