Nuwiq 3000unit Kit
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Recombinant Coagulation Factor VIII
Pregnancy Category
Not assigned (Risk cannot be ruled out)
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 genetic bleeding disorder where the blood doesn't clot properly because of a missing or faulty protein called Factor VIII. Nuwiq replaces this missing Factor VIII, helping your blood to clot normally and 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 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 is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. The medication must be mixed before use, following 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.
Disposal of Used Needles and Containers
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 and Disposal
If you are using this medication at home, store unopened containers in the refrigerator. Do not freeze 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 is stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. The medication must be mixed before use, following 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.
Disposal of Used Needles and Containers
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 and Disposal
If you are using this medication at home, store unopened containers in the refrigerator. Do not freeze 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, especially when traveling.
- Follow your prescribed dosing schedule strictly, whether for prophylaxis or on-demand treatment.
- Learn how to self-infuse correctly or ensure a caregiver is trained.
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene and inform your dentist about your hemophilia.
- Avoid medications that interfere with clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Wear a medical alert bracelet or carry an identification card indicating you have hemophilia.
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 and severity of bleeding, and clinical response. Prophylaxis: 30-40 IU/kg twice weekly or 40-50 IU/kg three times weekly. On-demand treatment: 15-100 IU/kg depending on bleed severity.
Dose Range:
15 - 100 mg
Condition-Specific Dosing:
prophylaxis:
30-40 IU/kg twice weekly or 40-50 IU/kg three times weekly
minor_bleed:
15-25 IU/kg (target FVIII activity 30-50%)
moderate_bleed:
25-50 IU/kg (target FVIII activity 50-80%)
major_bleed:
50-100 IU/kg (target FVIII activity 80-120%)
surgery:
Pre-operative: 50-100 IU/kg (target FVIII activity 80-120%); Post-operative: individualized
Pediatric Dosing
Neonatal:
Not established (use with caution, consult hematologist)
Infant:
Dosing is weight-based, similar to adults (e.g., 30-40 IU/kg twice weekly for prophylaxis), individualized based on FVIII levels and clinical response.
Child:
Dosing is weight-based, similar to adults (e.g., 30-40 IU/kg twice weekly for prophylaxis), individualized based on FVIII levels and clinical response.
Adolescent:
Dosing is weight-based, similar to adults (e.g., 30-40 IU/kg twice weekly for prophylaxis), individualized based on FVIII levels and clinical response.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; not renally cleared. Monitor Factor VIII levels as clinically indicated.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant DNA-derived coagulation Factor VIII. It temporarily replaces the missing coagulation Factor VIII that is needed for effective hemostasis in patients with hemophilia A. Factor VIII acts as a cofactor for 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% (intravenous administration)
Tmax:
Immediate (at end of infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05 L/kg
ProteinBinding:
Circulates bound to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 19.4 hours (range 11.6-29.5 hours) in adults
Clearance:
Approximately 2.6 mL/hr/kg
ExcretionRoute:
Not renally or hepatically excreted as intact protein; degraded into peptides and amino acids
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Immediate (at end of infusion)
DurationOfAction:
Dependent on half-life and Factor VIII consumption, typically 24-48 hours for clinical effect, but FVIII levels decline over time.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 an exhaustive 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 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 an exhaustive 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 allergic reaction: rash, hives, itching, redness, swelling (especially of face, lips, tongue, or throat), chest tightness, wheezing, difficulty breathing, dizziness, lightheadedness.
- Signs of bleeding that is not controlled by treatment: persistent bleeding, severe pain, swelling, bruising, blood in urine or stool, severe headache, vision changes, slurred speech.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, or bleeding that does not respond to usual doses of Nuwiq.
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.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 work and laboratory tests 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 to last throughout 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 to last throughout 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 acute overdose is unlikely to cause severe adverse effects, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), though this is rare in hemophilia A patients.
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb.
What to Do:
In case of suspected overdose or unusual symptoms, seek immediate medical attention. Contact your healthcare provider or emergency services. For general poison control, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to first infusion, especially for surgical procedures or severe bleeds.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Rationale: To detect the development of antibodies against Factor VIII, which can render treatment ineffective.
Timing: Prior to first infusion, and regularly thereafter (e.g., every 3-6 months, or if bleeding is not controlled).
Routine Monitoring
Factor VIII activity levels
Frequency: As clinically indicated, especially during acute bleeding episodes, before and after surgery, or to adjust prophylactic dosing.
Target: Dependent on clinical situation (e.g., 30-50% for minor bleeds, 80-120% for major bleeds/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency; if levels are unexpectedly low, consider inhibitor development.
Clinical response (cessation of bleeding, absence of new bleeds)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding may indicate inadequate dosing, inhibitor development, or other complications.
Inhibitor screening (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for severe hemophilia A, or if clinical response is poor).
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: >0.6 BU/mL indicates inhibitor presence, requiring alternative treatment strategies.
Signs and symptoms of allergic/hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately if symptoms occur; manage symptomatically.
Symptom Monitoring
- Bleeding episodes (frequency, severity, location)
- Joint pain or swelling (hemarthrosis)
- Muscle pain or swelling (hematoma)
- Headache, stiff neck, vomiting (intracranial hemorrhage)
- Rash, hives, itching
- Chest tightness, wheezing, difficulty breathing
- Dizziness, lightheadedness
- Swelling of face, lips, tongue, or throat
- Fever, chills
Special Patient Groups
Pregnancy
Nuwiq should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies of Nuwiq in pregnant women. Animal reproduction studies have not been conducted. Hemophilia A is a serious condition, and treatment should not be withheld if clinically indicated. Close monitoring by a hematologist is essential.
Trimester-Specific Risks:
First Trimester:
No specific data; theoretical risk of fetal exposure to large protein, but unlikely to cross placenta significantly.
Second Trimester:
No specific data; continued need for treatment should be balanced against theoretical risks.
Third Trimester:
No specific data; continued need for treatment, especially around delivery, is critical to prevent maternal hemorrhage.
Lactation
It is unknown whether Nuwiq is excreted in human milk. However, Factor VIII is a large protein, and it is unlikely to be excreted in human milk in significant amounts or to be orally absorbed by a breastfed infant. 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.
Infant Risk:
Low risk; unlikely to cause adverse effects in breastfed infants.
Pediatric Use
Dosing is weight-based and individualized, similar to adults. Nuwiq has been studied in pediatric patients as young as 6 years of age. Younger children may have higher clearance rates and require more frequent dosing or higher doses to maintain target Factor VIII levels. Close monitoring of Factor VIII levels and inhibitor development is crucial.
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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. No specific dose adjustments are typically required based on age alone, but comorbidities should be considered.
Clinical Information
Clinical Pearls
- Nuwiq is a third-generation recombinant Factor VIII product, meaning it is not derived from human or animal plasma and is produced without human or animal protein additives in the cell culture or purification process.
- It is important to reconstitute Nuwiq correctly using the provided diluent and administration set. Do not shake the vial.
- Administer Nuwiq intravenously over several minutes. The rate of administration should be determined by the patient's comfort level, typically not exceeding 10 mL/minute.
- 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.
- Regular monitoring for Factor VIII inhibitors is critical, especially in previously untreated patients (PUPs) and those with severe hemophilia A.
- Individualized pharmacokinetic (PK) assessment can help optimize dosing regimens for prophylaxis, especially for patients on extended half-life products or those with variable responses.
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)
- Extended half-life Factor VIII products (e.g., Eloctate, Adynovate, Jivi)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Non-factor replacement therapies (e.g., Emicizumab [Hemlibra])
- Gene therapy for hemophilia A (e.g., Roctavian)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per 3000 IU vial per 3000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for hemophilia A)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.