Nuwiq 500unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor
Pregnancy Category
Not assigned by FDA (biologic), consult label for risk summary
FDA Approved
Oct 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 clot normally and reducing bleeding episodes.
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 provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Mixing is required before use; follow the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it 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 use. Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, 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 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 provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. Mixing is required before use; follow the instructions provided by your doctor. Avoid shaking the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it 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 use. Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, 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 to determine the best course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you.
- Follow your prescribed dosing schedule for prophylaxis to prevent bleeding.
- Administer Nuwiq as soon as possible after a bleed starts.
- Avoid activities that put you at high risk for 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.
- Wear a medical alert identification (e.g., bracelet or necklace).
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 Factor VIII levels, bleeding severity, and patient weight. For on-demand treatment of bleeding episodes, typical doses range from 20-80 IU/kg. For routine prophylaxis, typical doses are 20-40 IU/kg 2-3 times per week.
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
onDemandTreatment:
Target Factor VIII activity level depends on the severity of the hemorrhage. Minor hemorrhage: 20-40 IU/kg (target FVIII 40-60% of normal). Moderate hemorrhage: 30-60 IU/kg (target FVIII 60-80% of normal). Severe hemorrhage: 40-80 IU/kg (target FVIII 80-100% of normal).
routineProphylaxis:
20-40 IU/kg 2-3 times per week. Adjust frequency and dose based on patient response and bleeding episodes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is individualized based on Factor VIII levels, bleeding severity, and patient weight, similar to adults. Prophylaxis often initiated early.
Child:
Dosing is individualized based on Factor VIII levels, bleeding severity, and patient weight, similar to adults. Prophylaxis often initiated early.
Adolescent:
Dosing is individualized based on Factor VIII levels, bleeding severity, and patient weight, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
Not applicable; Factor VIII is a protein and not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant coagulation Factor VIII. It temporarily replaces the deficient coagulation Factor VIII that is necessary for effective hemostasis in patients with hemophilia A. Factor VIII acts as a cofactor for activated Factor IX (Factor IXa) in the activation of Factor X to Factor Xa. Factor Xa, in turn, converts prothrombin into thrombin, which then converts fibrinogen into fibrin, leading to clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-18 hours (terminal half-life, varies by patient)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally or hepatically excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak Factor VIII activity)
DurationOfAction:
Dependent on half-life and initial dose, typically 1-3 days for a single dose to maintain hemostatic levels, but varies based on target Factor VIII level and patient's individual pharmacokinetics.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help right away:
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
Common cold symptoms
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 help right away:
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
Common cold symptoms
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: rash, hives, itching, flushing, swelling of the face, lips, or tongue, difficulty breathing, wheezing, chest tightness, dizziness, fainting, or low blood pressure. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, or if your usual dose of Nuwiq doesn't stop bleeding as expected. Report this to your doctor immediately.
- Any new or unusual bleeding (e.g., joint pain/swelling, muscle pain, severe headache, blood in urine/stools).
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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- While overdose is unlikely to cause acute toxicity, very high doses might theoretically increase the risk of thrombotic events, though this is rare with Factor VIII concentrates.
- Symptoms could include signs of abnormal clotting, but this is not a common concern.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services. Management would be supportive and aimed at monitoring for and treating any potential thrombotic complications. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors to Factor VIII, which would render therapy ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially to guide dosing for surgical procedures, severe bleeding, or if clinical response is inadequate.
Target: Depends on clinical situation (e.g., 80-100% for severe bleeding/surgery, 1-5% for prophylaxis trough).
Action Threshold: Adjust dose or frequency if levels are outside target range or if bleeding occurs.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for the first few years, then annually, or more frequently if efficacy decreases or bleeding increases).
Target: Negative (<0.6 Bethesda Units/mL).
Action Threshold: If inhibitors develop, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Signs and symptoms of allergic reactions
Frequency: During and after each infusion.
Target: N/A
Action Threshold: Stop infusion immediately if signs of hypersensitivity occur.
Symptom Monitoring
- Increased or unusual bleeding episodes (e.g., joint bleeds, muscle bleeds, nosebleeds, bruising)
- Signs of allergic reaction: rash, hives, itching, flushing, swelling (face, lips, tongue), difficulty breathing, wheezing, chest tightness, dizziness, fainting, low blood pressure
- Signs of inhibitor development: decreased efficacy of Factor VIII, increased frequency or severity of bleeding episodes despite adequate dosing.
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Nuwiq in pregnant women. Animal reproduction studies have not been conducted. Nuwiq should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Hemophilia A is a genetic disorder, and management during pregnancy should be carefully planned with a hematologist and obstetrician.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of adverse effects on fetal development, but unlikely given the nature of the drug.
Second Trimester:
Limited data, unlikely to pose significant risk.
Third Trimester:
Limited data, unlikely to pose significant risk. Management of delivery in hemophilia A patients is critical.
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. Consult with a healthcare provider.
Infant Risk:
Risk is considered low, as Factor VIII is a large protein and unlikely to be absorbed intact by the infant. However, data are limited.
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is individualized based on weight, Factor VIII levels, and clinical response, similar to adults. Prophylaxis is often initiated early in life to prevent joint damage. Pediatric patients, especially previously untreated patients (PUPs), have a higher risk of developing Factor VIII inhibitors.
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 age-related dose adjustments are generally required beyond those based on weight and clinical need.
Clinical Information
Clinical Pearls
- Nuwiq is a recombinant Factor VIII product that is not derived from human plasma, reducing the risk of transmitting human blood-borne pathogens.
- Individualized dosing is crucial; Factor VIII levels should be monitored to ensure adequate hemostasis, especially for surgery or severe bleeding.
- Patients should be monitored for the development of Factor VIII inhibitors (neutralizing antibodies), which can render the treatment ineffective. This is particularly important in previously untreated patients (PUPs).
- Patients should be educated on the signs and symptoms 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 important to maintain product integrity.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Adynovate, Xyntha, Recombinate, Kogenate FS)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in hemophilia A with or without inhibitors.
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on strength and market) per vial
Insurance Coverage:
Specialty drug, typically covered under medical benefit or pharmacy benefit with prior authorization. High co-pays or deductibles may apply, but patient assistance programs are common.
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, 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 occurred.