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Nuwiq

  • Generic Name: antihemophilic factor recombinant intravenous infusion
  • Brand Name: Nuwiq

Nuwiq (Antihemophilic Factor Recombinant Intravenous Infusion) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Nuwiq Side Effects Center

What Is Nuwiq?

Nuwiq, Antihemophilic Factor (Recombinant) is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Nuwiq is not indicated for the treatment of von Willebrand Disease.

What Are Side Effects of Nuwiq?

Common side effects of Nuwiq include:

Dosage for Nuwiq

The dose of Nuwiq is based on the patient's body weight, and the desired Factor VIII rise (%) (IU/dL). Frequency and duration of therapy with Nuwiq depends on severity of the FVIII deficiency, location and extent of bleeding, and patient's clinical condition.

What Drugs, Substances, or Supplements Interact with Nuwiq?

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

Nuwiq During Pregnancy and Breastfeeding

During pregnancy, Nuwiq should only be administered if prescribed. It is unknown if Nuwiq passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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

 

Nuwiq Consumer Information

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 Nuwiq (Antihemophilic Factor Recombinant Intravenous Infusion)

 

Nuwiq Professional Information

SIDE EFFECTS

The most common adverse reactions (>5% of subjects) reported in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.

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 the rate in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety profile of NUWIQ was evaluated in seven prospective, open-label clinical studies in previously treated patients (PTPs - exposed to a Factor VIII containing product for ≥150 exposure days (EDs) in the case of adolescents and adults or ≥50 EDs in the case of subjects below 12 years of age) with severe Hemophilia A (Factor VIII ≤ 1%). Subjects who had a history of detectable Factor VIII inhibitor, severe liver or kidney disease, were not immune competent (CD4+ count <200/μL), or scheduled to receive immunomodulating drugs, were excluded.

Across all clinical studies, 190 patients were stratified, among them, 129 were adults, 3 were adolescents between 12 and 17 years old, and 58 were pediatric patients between 2 and 11 years old. A total of 182 (95.8%) subjects were treated for at least 180 days. Collectively, patients received between 24,005 and 2.12 million IU (555 to 34,713 IU/kg) from 14 to 918 infusions over a period of 14 to 896 exposure days. An exposure day was defined as any day on which at least one infusion was started.

With a total of 43,264 infusions over 42,808 EDs, adverse reactions reported in at least 5 of the 190 subjects (2.6%) were upper respiratory tract infection (22%), headache (11%), fever (10%), cough (9.5%), lower respiratory tract infection (8.4%), rhinitis (7.9%), chills (6.8%), abdominal pain (5.3%), arthralgia (5.3%), pharyngitis (5.3%), diarrhea (4.7%), varicella (4.2%), device-related problems (4.2%), back pain (3.7%), extremity pain (3.7%), toothache (3.2%), vomiting (3.2%), head injury (2.6%), injury (2.6%), rash (2.6%), tonsillitis (2.6%), and tooth abscess (2.6%). Notably, dizziness was reported in 4 subjects (2.1%); dyspnea, insomnia, and malaise in 2 subjects (1.1%) each; and injection site pain, injection site inflammation, benign renal neoplasm, deterioration in neurological function/behavior, and syncope in 1 subject (0.5%) each.

Considering only the pediatric cohort of 59 subjects (ages 2-12 years at initial enrollment), 48 of whom continued participation in a long-term extension study, 26,311 infusions totalling 1,019,528 IU/kg NUWIQ were administered. The most commonly reported adverse reactions (>10% of the 59 subjects) were upper respiratory tract infection (49%), lower respiratory tract infection (24%), cough (20%), fever (20%), rhinitis (19%), pharyngitis (19%), chills (15%), varicella (14%), headache (12%), abdominal pain (10%), and extremity pain (10%). Dizziness was reported in 2 subjects (3.4%), while deterioration in neurological function/behavior, insomnia, and syncope were each reported in 1 subject (1.7%).

Immunogenicity

All clinical trial subjects (N = 190) were monitored for neutralizing antibodies (inhibitors) to Factor VIII by the modified Bethesda assay using blood samples obtained prior to the first infusion of NUWIQ in all studies, at defined intervals (at ED 10 to 15, at three months, and every further three months) in five studies, and every three months in one study and at the completion visit in all studies. No subject developed neutralizing antibodies to Factor VIII.

Non-neutralizing anti-Factor VIII antibodies (without inhibitory activity as measured by the modified Bethesda assay) were reported in four of 135 patients tested, giving a rate of 3%. Three of four subjects had pre-existing non-neutralizing antibodies prior to exposure with NUWIQ. The binding antibodies were transient in two of these three subjects. In one subject who was tested negative at screening, the non-neutralizing antibody was measured once at study end.

In a clinical trial, which enrolled 110 previously untreated patients (age range 0-146 months, no previous treatment with FVIII concentrates or other blood products containing FVIII was allowed), 108 had evaluable data post-treatment with NUWIQ. The primary endpoint of the study, inhibitor formation, was realized in 28 of 105 patients (26.7%; 95% CI: 18.5-36.2) with at least one inhibitor analysis after ED1. Seventeen patients (16.2%; 95% CI: 9.7-24.7) developed high-titer inhibitors and 11 (10.5%; 95% CI: 5.3-18) developed low-titer inhibitors, 5 of whom had transient inhibitors. Of the 28 patients who developed an inhibitor, 25 did so with ≤20 EDs prior to detection. All inhibitors developed within 34 ED.

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, comparison of the incidence of antibodies to NUWIQ with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Nuwiq (Antihemophilic Factor Recombinant Intravenous Infusion)

&Copy; Nuwiq Patient Information is supplied by Cerner Multum, Inc. and Nuwiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.