Novoeight

Last updated on RxList: 12/4/2020
Novoeight Side Effects Center

What Is Novoeight?

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. Novoeight is not indicated for the treatment of von Willebrand disease.

What Are Side Effects of Novoeight?

Common side effects of Novoeight include:

  • injection site reactions such as swelling or itching,
  • increased hepatic enzymes, and
  • fever.
Tell your doctor if you experience serious side effects of of Novoeight including:
  • allergic reactions (rash, itching, hives, difficulty breathing or swallowing, tightness in the chest, swelling in the lips or tongue),
  • dizziness,
  • lightheadedness,
  • fainting,
  • pale and cold skin,
  • fast heartbeat,
  • red or swollen face or hands,
  • severe nausea or vomiting, or
  • shortness of breath.

Dosage for Novoeight

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.

What Drugs, Substances, or Supplements Interact with Novoeight?

Novoeight may interact with other drugs. Tell your doctor all medications and supplements you use.

Novoeight During Pregnancy and Breastfeeding

During pregnancy, Novoeight should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

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Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Novoeight Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • increased bleeding episodes;
  • any bleeding that will not stop;
  • chest pain; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nose bleeds;
  • nausea, vomiting, diarrhea;
  • headache, dizziness;
  • muscle or joint pain;
  • rash;
  • flushing (sudden warmth, redness, or tingly feeling);
  • fever, chills;
  • cough;
  • weakness; or
  • pain, swelling, itching, or redness where the injection was given.

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.

Read the entire detailed patient monograph for Novoeight (Antihemophilic Factor (Recombinant) Lyophilized Powder for Intravenous Injection)

QUESTION

What is hemophilia? See Answer
Novoeight Professional Information

SIDE EFFECTS

The most frequently reported adverse reactions observed in clinical trials (≥ 1%) were injection site reactions, 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, 301 male patients (242 previously treated patients (PTPs); exposed to a factor VIII-containing product for ≥150 days and 59 Previously Untreated Patients (PUPs)) 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, Immune Tolerance Induction (ITI) or pharmacokinetic evaluation of Novoeight with more than 140,000 exposure days (corresponding to over 900 patient years). During prophylaxis treatment subjects received a median of 468 injections of Novoeight (range 1-1317).

Table 4: Summary of Adverse Reactions (ARs ) with a Frequency ≥ 1% in 301 Subjects

MedDRA System Organ classAdverse ReactionsFrequency N (%)
General disorders and administration site conditionsPyrexia3 (1.0%)
Injection site reaction3 (1.0%)

Immunogenicity

Subjects were monitored for neutralizing antibodies to factor VIII and binding antibodies to CHO and murine protein. No PTPs developed confirmed neutralizing antibodies to factor VIII. One twenty-two month old previously treated 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. In the completed main phase of the clinical trial in PUPs, 24 of 56 (42.9%) patients developed inhibitors with a mean of 14.1 exposure days at the time of the first positive inhibitor test; 15 (26.8%) PUPs developed high titer (≥ 5 BU) inhibitors. High risk genetic mutations were identified in 91.7% of the overall inhibitors and 93.3% of the high titer inhibitors.

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. For these reasons, it may be misleading to compare the incidence of antibodies to Novoeight with the incidence of antibodies to other products.

Postmarketing Experience

Adverse reactions reported during post marketing period were similar in nature to those observed during clinical trials.

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

© Novoeight Patient Information is supplied by Cerner Multum, Inc. and Novoeight Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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