Nuwiq 2000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Recombinant Coagulation Factor VIII
Pregnancy Category
Category C
FDA Approved
Sep 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nuwiq is a medicine used to treat and prevent bleeding in people with hemophilia A. Hemophilia A is a condition where your blood doesn't clot properly because you're missing a protein called Factor VIII. Nuwiq replaces this missing protein, helping your blood to clot and stop bleeding.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
If the medication is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. When mixing, do not shake the medication. Inspect the solution for any signs of cloudiness, leakage, or particles, and do not use it if you notice any of these issues. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items, and when the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
If you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
If the medication is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. When mixing, do not shake the medication. Inspect the solution for any signs of cloudiness, leakage, or particles, and do not use it if you notice any of these issues. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items, and when the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
If you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) that you have hemophilia A and are on Factor VIII replacement therapy.
- Carry identification indicating your hemophilia status.
- Follow your prescribed dosing schedule carefully, whether for prophylaxis or on-demand treatment.
- Learn proper self-administration techniques if you are infusing at home.
Available Forms & Alternatives
Available Strengths:
- Nuwiq 1000unit Inj, 1 Vial
- Nuwiq 1000unit Inj Kit
- Nuwiq 2000unit Inj, 1 Vial
- Nuwiq 2000unit Inj Kit
- Nuwiq 250unit Inj, 1 Vial
- Nuwiq 250unit Inj Kit
- Nuwiq 500unit Inj, 1 Vial
- Nuwiq 500unit Inj Kit
- Nuwiq 2500unit Kit
- Nuwiq 2500unit Inj, 1 Vial
- Nuwiq 3000unit Kit
- Nuwiq 3000unit Inj, 1 Vial
- Nuwiq 4000unit Kit
- Nuwiq 4000unit Inj, 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's Factor VIII level, type of bleeding, and clinical condition. For prophylaxis: 40-50 IU/kg 2-3 times weekly. For on-demand treatment: Dose to achieve target FVIII level (e.g., 20-40 IU/dL for minor bleeds, 60-100 IU/dL for major bleeds).
Condition-Specific Dosing:
prophylaxis:
40-50 IU/kg 2-3 times weekly
on_demand_minor_bleed:
15-30 IU/kg (target FVIII 30-60 IU/dL)
on_demand_major_bleed:
30-50 IU/kg (target FVIII 60-100 IU/dL)
surgical_prophylaxis:
Pre-op: 30-50 IU/kg (target FVIII 60-100 IU/dL); Post-op: 15-25 IU/kg every 8-24 hours for 1-14 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adults (e.g., 40-50 IU/kg 2-3 times weekly for prophylaxis). Close monitoring of FVIII levels is crucial.
Child:
Dosing is weight-based, similar to adults (e.g., 40-50 IU/kg 2-3 times weekly for prophylaxis).
Adolescent:
Dosing is weight-based, similar to adults (e.g., 40-50 IU/kg 2-3 times weekly for prophylaxis).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
No specific adjustment recommended; not renally cleared.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant DNA-derived coagulation Factor VIII (rFVIII) product. Factor VIII is an essential cofactor for Factor IXa in the intrinsic pathway of the coagulation cascade. It binds to activated Factor IX (FIXa) and Factor X (FX) on a phospholipid surface, accelerating the activation of Factor X to Factor Xa (FXa). FXa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, forming a stable clot. In patients with hemophilia A, Factor VIII is deficient or defective, leading to impaired clot formation. Administration of Nuwiq temporarily replaces the missing Factor VIII, restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect with IV administration)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand Factor (vWF) in plasma, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
Mean terminal half-life of approximately 19 hours (range 11-27 hours), which is longer than some other FVIII products due to its lack of human or animal derived additives and specific glycosylation pattern.
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; not renally or hepatically excreted in an intact form.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (corresponds to peak plasma levels)
DurationOfAction:
Dependent on half-life and initial dose; typically maintains hemostatic levels for 2-3 days for prophylaxis, or several hours to days for on-demand treatment depending on bleed severity.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Discoloration of the mouth, turning blue
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling extremely tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Irritation at the injection site
Headache
Cough
Signs of a common cold
Nose or throat irritation
Joint pain or swelling
Diarrhea
Back pain
Dry mouth
* Stomach pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Discoloration of the mouth, turning blue
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling extremely tired or weak
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Irritation at the injection site
Headache
Cough
Signs of a common cold
Nose or throat irritation
Joint pain or swelling
Diarrhea
Back pain
Dry mouth
* Stomach pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: hives, rash, itching, swelling of the face/lips/tongue, difficulty breathing, chest tightness, dizziness, fainting. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding, or if your usual dose of Nuwiq doesn't stop bleeding as effectively as before. Report these to your doctor immediately.
- Any new or unusual bleeding episodes that are not controlled by your usual dose.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dosage is not effective.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dosage is not effective.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While an acute overdose is unlikely to cause specific symptoms beyond potentially increasing the risk of thrombotic events (though rare with Factor VIII), excessively high Factor VIII levels could theoretically increase the risk of thrombosis.
What to Do:
In case of suspected overdose or unusually high Factor VIII levels, contact your healthcare provider or emergency services immediately. Management is generally supportive and may involve monitoring for signs of thrombosis. For general poisoning concerns, call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Rationale: To detect pre-existing inhibitors, which can render therapy ineffective.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during dose adjustments, major bleeds, or surgery. For prophylaxis, trough levels may be monitored.
Target: Individualized based on clinical need (e.g., >1% for prophylaxis, 30-60% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: Levels below target may require dose increase or more frequent administration.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Frequency: Regularly, especially in the first 50 exposure days or if clinical response to Factor VIII is suboptimal.
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: Positive result (≥0.6 BU/mL) indicates inhibitor development, requiring alternative treatment strategies.
Clinical response (e.g., cessation of bleeding, absence of new bleeds)
Frequency: Continuously during therapy.
Target: Effective hemostasis.
Action Threshold: Persistent or recurrent bleeding may indicate inadequate dosing, inhibitor development, or other complications.
Signs/symptoms of hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Development of rash, urticaria, pruritus, dyspnea, chest tightness, or anaphylaxis requires immediate discontinuation and supportive care.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds, headaches, vision changes)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, fainting)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to previously effective Factor VIII doses)
Special Patient Groups
Pregnancy
Nuwiq is Pregnancy Category C. There are no adequate and well-controlled studies of Nuwiq in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hemophilia A is rare in women, but management of bleeding during pregnancy and delivery is critical.
Trimester-Specific Risks:
First Trimester:
No specific data; theoretical risk of fetal exposure.
Second Trimester:
No specific data; theoretical risk of fetal exposure.
Third Trimester:
No specific data; theoretical risk of fetal exposure. Close monitoring of Factor VIII levels is crucial during labor and delivery to prevent hemorrhage.
Lactation
It is not known whether Nuwiq is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Nuwiq and any potential adverse effects on the breastfed infant from Nuwiq or from the underlying maternal condition. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
L3 (Moderate risk - no human data, animal studies show no adverse effects, or human data is limited but suggests minimal risk).
Pediatric Use
Nuwiq is approved for use in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and individualized. Pediatric patients, especially young children, may have a higher risk of inhibitor development, requiring close monitoring.
Geriatric Use
Clinical studies of Nuwiq did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on Factor VIII levels and clinical response, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Nuwiq is a third-generation recombinant Factor VIII product, meaning it is not derived from human plasma and contains no human or animal protein additives in its formulation, which may reduce theoretical risks of viral transmission or allergic reactions to animal proteins.
- Its extended half-life (compared to some older FVIII products) may allow for less frequent dosing in prophylaxis.
- Always reconstitute Nuwiq according to package insert instructions, using the provided diluent and administration set. Do not shake the vial.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) or those with severe hemophilia A, as this is the most serious complication of Factor VIII replacement therapy.
- Patients should be educated on the signs of allergic reactions and inhibitor development and instructed to seek immediate medical attention if these occur.
- Proper storage (refrigerated, but can be stored at room temperature for a limited time) is crucial to maintain product integrity.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Hemlibra (emicizumab - a bispecific antibody mimicking FVIIIa activity), Esperoct, Altuviiio)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Gene therapy for hemophilia A (e.g., Roctavian)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on unit strength and pharmacy. A 2000 IU vial can range from $2,000 - $4,000+. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high deductibles/copays)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.