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Novoeight

"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...

Novoeight

Novoeight

Novoeight Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Novoeight, Antihemophilic Factor (Recombinant) is a recombinant (r) analogue of human coagulation factor VIII (FVIII) used in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for control and prevention of bleeding episodes, perioperative management, and to prevent or reduce the frequency of bleeding episodes. It is not indicated for the treatment of von Willebrand disease. Common side effects include injection site reactions, increased hepatic enzymes, and fever.

Dosage and duration of treatment with Novoeight depends on the severity of the factor VIII deficiency, on the location and extent of bleeding, and the patient's clinical condition. Novoeight may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Novoeight should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Novoeight, Antihemophilic Factor (Recombinant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Novoeight FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequently reported adverse reactions ( ≥ 0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

During the clinical development of Novoeight, 214 male previously treated patients (PTPs; exposed to a factor VIII-containing product for ≥ 150 days) with severe hemophilia A (factor VIII level ≤ 1%) received at least one dose of Novoeight as part of either routine prophylaxis, on-demand treatment of bleeding episodes, perioperative management of major and minor surgical, dental, or other invasive procedures, or pharmacokinetic evaluation of Novoeight. Thirty-one subjects (14%) were < 6 years of age, 32 (15%) were 6 to < 12 years of age, 16 (7%) were adolescents (12 to < 16 years of age), and 135 (63%) were adults (16 years of age and older). The subjects received a total of 33,272 injections with a median of 127 injections of Novoeight (range 1-442) per subject, and had a total of 32,929 exposure days during prevention and treatment of bleeds.

The most frequently reported adverse reactions in previously treated patients was injection site reactions (2.3%), increased hepatic enzymes (1.4%), and pyrexia (0.9%).

Immunogenicity

Subjects were monitored for neutralizing antibodies to factor VIII and binding antibodies to CHO and murine protein. No subjects developed confirmed neutralizing antibodies to factor VIII. One twenty-two month old child had a positive neutralizing antibody to factor VIII of 1.3 [BU] in the Bethesda assay after 15 exposure days that was not confirmed when checked after 20 exposure days. In vivo recovery was normal for this child and no clinical adverse findings were observed.

No patients developed de novo anti-murine antibodies. Nineteen subjects were positive for anti-Chinese hamster ovary (CHO) cell protein antibodies. Two of these subjects changed from anti-CHO negative to anti-CHO positive and 6 subjects changed from anti-CHO positive to anti-CHO negative. The remaining 11 subjects were either positive throughout the trials (n=6), negative at baseline and end-of trial but with transient positive samples (n=2), or positive at baseline and end-of trial but with negative samples in between (n=3). No clinical adverse findings were observed in any of these subjects.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

Read the entire FDA prescribing information for Novoeight (Antihemophilic Factor (Recombinant) Lyophilized Powder for Intravenous Injection) »

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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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