Nuwiq 1000unit 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
Oct 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nuwiq is a medicine that helps your blood clot. It's used for people with hemophilia A, a condition where the blood doesn't clot properly because they are missing a protein called Factor VIII. Nuwiq replaces this missing protein, helping to stop or prevent bleeding.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to the medication. Mixing is required before use; follow the specific instructions provided by your doctor. Avoid shaking the medication. Inspect the solution for any signs of cloudiness, leakage, or particulate matter; do not use if any of these conditions are present. 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. Discard any unused portion of the opened vial after administration. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other items. Once the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best course of action.
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to the medication. Mixing is required before use; follow the specific instructions provided by your doctor. Avoid shaking the medication. Inspect the solution for any signs of cloudiness, leakage, or particulate matter; do not use if any of these conditions are present. 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. Discard any unused portion of the opened vial after administration. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other items. Once the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you.
- Wear a medical alert bracelet or necklace indicating you have hemophilia A.
- Avoid activities that put you at high risk for injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Discuss all medications, including over-the-counter drugs and supplements, with your doctor, especially those that affect clotting (e.g., aspirin, NSAIDs).
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 levels, type of bleeding, and clinical condition. For on-demand treatment of bleeding episodes, typical doses range from 20-50 IU/kg. For prophylaxis, typical doses are 20-40 IU/kg 2-3 times per week.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
onDemandBleeding:
20-50 IU/kg, repeat as needed based on FVIII levels and clinical response.
prophylaxis:
20-40 IU/kg 2-3 times per week.
surgicalProphylaxis:
Pre-operative dose to achieve FVIII levels of 80-120% of normal, followed by post-operative doses to maintain levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adults (20-50 IU/kg for on-demand, 20-40 IU/kg 2-3 times per week for prophylaxis).
Child:
Dosing is weight-based, similar to adults (20-50 IU/kg for on-demand, 20-40 IU/kg 2-3 times per week for prophylaxis).
Adolescent:
Dosing is weight-based, similar to adults (20-50 IU/kg for on-demand, 20-40 IU/kg 2-3 times per week for prophylaxis).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended; monitor FVIII levels and clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Confidence:
Medium
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant coagulation factor VIII (rFVIII) that temporarily replaces the deficient endogenous factor VIII needed for effective hemostasis in patients with hemophilia A. Factor VIII acts as a cofactor for activated factor IX (FIXa) in the intrinsic coagulation pathway, accelerating the conversion of factor X to activated factor X (FXa). FXa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, leading to clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
End of infusion (intravenous administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 14-19 hours (terminal half-life, longer than some other FVIII products due to Fc fusion protein)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily via protein degradation pathways; no specific excretion route.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
At the end of infusion
DurationOfAction:
Dependent on half-life and achieved factor VIII levels; typically 2-3 days for prophylactic effect, shorter for acute bleeding.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, chest tightness, dizziness, lightheadedness.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, bleeding that doesn't stop with your usual dose of Nuwiq.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 is essential to avoid potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 is essential to avoid potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate that your current dose 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.
Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate that your current dose 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 overdose is unlikely to cause acute harm, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots).
- Symptoms of thrombosis can include chest pain, shortness of breath, swelling or pain in a limb, sudden weakness or numbness on one side of the body.
What to Do:
In case of suspected overdose, contact your healthcare provider immediately or call emergency services. Management would involve monitoring for signs of thrombosis and supportive care. Call 1-800-222-1222 for 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) screen
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Clinical assessment of bleeding episodes
Rationale: To understand the patient's bleeding phenotype and guide treatment strategy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during acute bleeding, surgery, or when adjusting prophylaxis. At least annually for prophylaxis.
Target: Dependent on clinical situation (e.g., >30% for minor bleeding, >80-100% for major surgery).
Action Threshold: Levels below target range may require dose adjustment or additional doses.
Inhibitor (neutralizing antibody) screen
Frequency: Regularly (e.g., every 3-6 months for the first few years, then annually, or if treatment efficacy decreases).
Target: Negative (less than 0.6 Bethesda Units/mL)
Action Threshold: Positive inhibitor titer requires alternative treatment strategies.
Clinical response to treatment
Frequency: Continuously during acute bleeding episodes; regularly for prophylactic efficacy.
Target: Cessation of bleeding, prevention of bleeding episodes.
Action Threshold: Persistent or recurrent bleeding indicates inadequate treatment or inhibitor development.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from minor cuts, blood in urine/stools, nosebleeds)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness)
- Signs of inhibitor development (e.g., decreased efficacy of treatment, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Nuwiq is a Pregnancy Category C drug. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hemophilia A in pregnant women is rare, but Factor VIII replacement may be necessary to manage bleeding complications.
Trimester-Specific Risks:
First Trimester:
Risk unknown; use only if clearly needed.
Second Trimester:
Risk unknown; use only if clearly needed.
Third Trimester:
Risk unknown; use only if clearly needed, especially important for managing peripartum bleeding.
Lactation
It is not known whether Nuwiq is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nuwiq is administered to a nursing woman. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
L3 (Moderately safe; limited data, but unlikely to cause harm due to large molecular size and protein nature, unlikely to be absorbed orally by infant).
Pediatric Use
Dosing is weight-based and similar to adults. Nuwiq has been studied in pediatric patients as young as 12 years of age. Safety and efficacy in children under 12 years of age are supported by extrapolation from adult data and pharmacokinetic studies. Inhibitor development is a significant concern in previously untreated pediatric patients.
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 FVIII levels and clinical response, similar to younger adults. No specific dose adjustments are generally required based on age alone.
Clinical Information
Clinical Pearls
- Nuwiq is a third-generation recombinant Factor VIII, produced in a human cell line (HEK 293F) and free of animal-derived additives, which may reduce theoretical risks of viral transmission.
- It is an Fc-fusion protein, which contributes to its extended half-life compared to some other FVIII products.
- Always reconstitute Nuwiq according to the manufacturer's instructions, using the provided diluent and administration set.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) and minimally treated patients (MTPs), as this is the most significant complication of FVIII replacement therapy.
- Patients should be educated on self-administration techniques, proper storage, and signs of bleeding or adverse reactions.
- The dose and frequency of administration should be guided by clinical response and laboratory monitoring of FVIII activity levels.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate FS, Novoeight, Recombinate, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in hemophilia A with or without inhibitors.
- Gene therapy (e.g., Roctavian) - for severe hemophilia A.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on strength and quantity. per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by medical benefit)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.