Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Nuwiq include:
- injection site inflammation or pain
- non-neutralizing anti-Factor VIII antibody formation
- back pain
- spinning sensation (vertigo), and
- dry mouth
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. Nuwiq may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Nuwiq should only be administered if prescribed. It is unknown if Nuwiq passes into breast milk. Consult your doctor before breastfeeding.
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.
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.
The most common adverse reactions ( > 0.5% of subjects) reported in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo, and dry mouth.
Clinical Trial 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 NUWIQwas evaluated in five 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, 135 patients were stratified, among them, 74 were adults, 3 adolescents between 12 and 17 years old, and 58 pediatric patients between 2 and 11 years old. A total of 127 (94.1%) subjects were treated for at least 180 days. Collectively, patients received between 24,005 and 996,550 IU (555 to 8629 IU/kg) from14 to 319 infusions over 14 to 299 exposure days, over a period of 33 to 563 days. An exposure day was defined as any day on which at least one infusion was started.
With a total of 16,134 infusions over 15,950 EDs, reported adverse reactions included paresthesia, headache, injection site inflammation, injection site pain, back pain, vertigo, and dry mouth. Each of these adverse reactions occurred once in the study population of 135, and thus each had a rate of 0.7%. Non-neutralizing anti-
Factor VIII antibodies (without inhibitory activity as measured by the modified Bethesda assay) were reported in four patients, 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.
All clinical trial subjects (N = 135) 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, at defined intervals (at ED 10 to 15, at 3 months, and every further 3 months) during the studies and at the completion visit. No subject developed neutralizing antibodies to Factor VIII. Four subjects (3%) developed a non-neutralizing antibody without any inhibitory activity.
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)