Nuwiq 500unit Inj Kit
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor, Recombinant Factor VIII
Pregnancy Category
Not available
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 your blood doesn't clot properly because you're missing a protein called Factor VIII. Nuwiq replaces that missing protein, helping to stop or prevent 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, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
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 and discard any unused portion of the opened vial.
Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp 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 or concerns, consult your doctor or pharmacist.
Storage
If you are using this medication at home, 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, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
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 and discard any unused portion of the opened vial.
Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp 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 or concerns, consult your doctor or pharmacist.
Storage
If you are using this medication at home, 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
- Adhere strictly to your prescribed dosing schedule, especially for prophylaxis.
- Maintain a regular exercise routine, but avoid high-impact or contact sports that could lead to injury and bleeding.
- Wear medical alert identification (e.g., bracelet or necklace) indicating you have hemophilia A.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
- Report any new or unusual bleeding episodes, or signs of allergic reaction, to your healthcare provider immediately.
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 prophylaxis: 20-40 IU/kg 2-3 times per week. For on-demand treatment of bleeding: 10-50 IU/kg depending on the type and severity of bleeding.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
prophylaxis:
20-40 IU/kg 2-3 times per week
minor_bleeding:
10-20 IU/kg (target FVIII 20-40% of normal)
moderate_bleeding:
20-40 IU/kg (target FVIII 40-80% of normal)
major_bleeding:
30-50 IU/kg (target FVIII 60-100% of normal)
Pediatric Dosing
Neonatal:
Not established (use in neonates is rare and highly individualized)
Infant:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis, 10-50 IU/kg for on-demand treatment)
Child:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis, 10-50 IU/kg for on-demand treatment)
Adolescent:
Dosing is weight-based, similar to adults (e.g., 20-40 IU/kg for prophylaxis, 10-50 IU/kg for on-demand treatment)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
No specific adjustment recommended; Factor VIII is not significantly cleared by dialysis.
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 coagulation Factor VIII (rFVIII) that temporarily replaces the deficient endogenous Factor VIII in patients with hemophilia A. Factor VIII is an essential cofactor for activated Factor IX (Factor IXa) in the activation of Factor X to Factor Xa, which ultimately leads to the formation of thrombin and fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediately after intravenous administration
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 40-60 mL/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand Factor (vWF) in plasma, but Nuwiq is a B-domain deleted rFVIII that does not contain vWF and is not stabilized by vWF in the formulation. Once infused, it binds to endogenous vWF.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-19 hours (mean terminal half-life for Nuwiq)
Clearance:
Approximately 2.5-4.5 mL/hr/kg
ExcretionRoute:
Primarily catabolic degradation; no specific excretion route
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life and initial dose; typically 2-3 days for prophylactic effect, shorter for acute bleeding.
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
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 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
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:
- Increased frequency or severity of bleeding episodes
- Bleeding that does not stop after treatment
- New or worsening joint pain or swelling
- Rash, hives, itching, or redness of the skin
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing, wheezing, or shortness of breath
- Dizziness, lightheadedness, or fainting
- Chest tightness or pain
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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 evaluations 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:
- No specific symptoms of overdose are known for Factor VIII. Very high levels could theoretically increase thrombotic risk, but this is rare and not well-documented with recombinant Factor VIII.
What to Do:
In case of suspected overdose, contact a healthcare professional or poison control center immediately. Management is generally supportive. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To confirm diagnosis of hemophilia A and establish baseline deficiency.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors to Factor VIII, which can render therapy ineffective.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity level
Frequency: Periodically, especially during dose adjustments, before and after surgery, or if clinical response is suboptimal.
Target: Dependent on clinical situation (e.g., >1% for prophylaxis, 20-100% for bleeding/surgery)
Action Threshold: If levels are not within target range, adjust dose or frequency.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for the first few years, then annually, or if clinical response to Factor VIII is poor).
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitors are detected (>0.6 BU/mL), consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical response (bleeding episodes, joint health)
Frequency: Continuously
Target: Reduction or prevention of bleeding episodes
Action Threshold: Increased bleeding frequency or severity may indicate inadequate dosing or inhibitor development.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of hypersensitivity/allergic reaction (e.g., rash, hives, itching, facial swelling, tightness in chest, wheezing, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to previously effective doses of Factor VIII)
Special Patient Groups
Pregnancy
Use only if clearly needed. Factor VIII is a natural component of human plasma. While animal reproduction studies have not been conducted, the potential benefit to the mother should outweigh the potential risk to the fetus. Hemophilia A is a genetic disorder, and management during pregnancy is critical for maternal and fetal health.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified beyond general pregnancy considerations.
Second Trimester:
No specific increased risk identified beyond general pregnancy considerations.
Third Trimester:
No specific increased risk identified beyond general pregnancy considerations. Close monitoring of Factor VIII levels is crucial, especially around delivery, to prevent postpartum hemorrhage.
Lactation
Considered compatible with breastfeeding. Factor VIII is a natural component of human milk, and its large molecular size makes significant transfer to the infant unlikely. Any orally ingested Factor VIII would likely be degraded in the infant's gastrointestinal tract.
Infant Risk:
Low risk to infant (L3 - Moderately Safe, or L2 - Safer, depending on source)
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is weight-based and individualized, similar to adults. Close monitoring for inhibitor development is particularly important in previously untreated patients (PUPs) and minimally treated patients (MTPs).
Geriatric Use
No specific dose adjustment is required for geriatric patients. Dosing should be individualized based on Factor VIII levels and clinical response. Monitor for age-related comorbidities that might affect bleeding or treatment response.
Clinical Information
Clinical Pearls
- Nuwiq is a B-domain deleted recombinant Factor VIII, which may contribute to its longer half-life compared to some other rFVIII products.
- Always reconstitute Nuwiq according to the manufacturer's instructions, using the provided diluent and administration set.
- Administer intravenously over several minutes (typically 2-5 minutes).
- Do not mix Nuwiq with other intravenous medications or solutions.
- Patients should be educated on self-administration techniques, proper storage, and signs of adverse reactions or inhibitor development.
- Regular monitoring for Factor VIII inhibitors is crucial, especially in the first 50 exposure days or 5 years of treatment, as inhibitor development is the most serious complication of Factor VIII replacement therapy.
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., activated prothrombin complex concentrate (aPCC) like FEIBA, recombinant Factor VIIa (NovoSeven RT))
- Non-factor replacement therapies (e.g., emicizumab (Hemlibra) for prophylaxis in patients with or without inhibitors)
- Desmopressin (DDAVP) for mild hemophilia A
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per dose depending on unit strength and quantity. per vial (e.g., 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU, 4000 IU)
Insurance Coverage:
Specialty Tier / Tier 4 or 5 (requires prior authorization, often covered under medical benefit)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.