Nuwiq 250unit 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
Not available
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 protein, helping your blood to clot and stop bleeding.
How to Use This Medicine
Proper Use 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.
Administration
This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation
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 instructions provided by your doctor. Avoid shaking the medication. Do not use if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use if the solution has changed color. After mixing, do not refrigerate the medication.
Usage and Disposal
Use the mixed 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 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 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 for guidance on the appropriate 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.
Administration
This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation
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 instructions provided by your doctor. Avoid shaking the medication. Do not use if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use if the solution has changed color. After mixing, do not refrigerate the medication.
Usage and Disposal
Use the mixed 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 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 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 for guidance on the appropriate course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you.
- Follow your doctor's instructions for dosing and administration carefully.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports) unless approved by your doctor.
- Avoid medications that can increase bleeding risk, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically instructed by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Wear a medical alert bracelet or carry an identification card indicating your hemophilia A diagnosis.
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:
Highly individualized based on patient's Factor VIII level, severity of bleeding, and clinical response. For on-demand treatment of bleeding episodes: 20-50 IU/kg. For routine prophylaxis: 20-50 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 clinical response and FVIII levels.
routineProphylaxis:
20-50 IU/kg 2-3 times per week, or as determined by physician based on individual patient needs.
surgicalProphylaxis:
Initial dose 30-60 IU/kg pre-surgery to achieve FVIII activity of 80-120% of normal. Maintain FVIII activity >50% for major surgery for 1 week or more.
Pediatric Dosing
Neonatal:
Not established (limited data in neonates, use with caution and individualized dosing if necessary).
Infant:
Dosing is weight-based and individualized, similar to adult dosing (e.g., 20-50 IU/kg for prophylaxis or on-demand treatment).
Child:
Dosing is weight-based and individualized, similar to adult dosing (e.g., 20-50 IU/kg for prophylaxis or on-demand treatment).
Adolescent:
Dosing is weight-based and individualized, similar to adult dosing (e.g., 20-50 IU/kg for prophylaxis or on-demand treatment).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No specific considerations; Factor VIII is not renally cleared.
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 human coagulation Factor VIII (rFVIII) produced in a human cell line. It temporarily replaces the deficient coagulation Factor VIII 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, which ultimately leads to the formation of thrombin and fibrin clot formation, thereby restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Primarily binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17-19 hours (terminal half-life, varies by patient)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Immediate (within minutes of administration)
DurationOfAction:
Dependent on half-life and initial dose, typically 2-3 days for maintaining therapeutic levels, but clinical effect for bleeding may be shorter.
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
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 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
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:
- Unusual or prolonged bleeding (e.g., from cuts, nosebleeds, gums)
- Joint pain, swelling, or stiffness (signs of a joint bleed)
- Severe headache, neck stiffness, vomiting, or changes in vision (signs of a head bleed)
- Blood in urine or stools
- Allergic reaction symptoms: rash, hives, itching, swelling of the face/lips/tongue/throat, dizziness, shortness of breath, chest tightness, wheezing.
- Signs of inhibitor development: increased bleeding frequency or severity, or poor response to treatment.
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken with all your current 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken with all your current 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. 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 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 overdose is unlikely to cause acute toxicity, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), though this is rare in hemophilia patients.
- Symptoms of thrombosis could include chest pain, shortness of breath, swelling or pain in a limb.
What to Do:
In case of suspected overdose, contact your healthcare provider immediately or call emergency services. Management would involve careful monitoring for signs of thrombosis and supportive care. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors to Factor VIII, which can render treatment ineffective.
Timing: Prior to initiation of therapy and periodically thereafter.
Routine Monitoring
Factor VIII activity level
Frequency: Periodically, especially during prophylaxis, before and after surgery, or during acute bleeding episodes to ensure adequate hemostasis.
Target: Varies based on clinical situation (e.g., >1% for prophylaxis, >50% for minor surgery, >80-100% for major surgery/severe bleeding).
Action Threshold: If levels are below target, increase dose or frequency; if levels are unexpectedly low, investigate for inhibitor development.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months, or more frequently in newly treated patients or those with poor response to treatment).
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor levels are >0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical response (cessation of bleeding, absence of new bleeding episodes)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding despite adequate FVIII levels may indicate inhibitor development or other underlying issues.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from minor cuts, blood in urine/stools, nosebleeds, headaches, vision changes)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, shortness of breath, chest tightness)
- Signs of inhibitor development (e.g., decreased response to Factor VIII treatment, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Use in pregnant women should only be considered if clearly needed. There are no adequate and well-controlled studies of Nuwiq in pregnant women. Hemophilia A in women is rare, but Factor VIII levels may increase during pregnancy. Close monitoring of Factor VIII levels is recommended, especially during the third trimester and around delivery.
Trimester-Specific Risks:
First Trimester:
No specific data; theoretical risk is low as Factor VIII is a natural protein.
Second Trimester:
No specific data; theoretical risk is low.
Third Trimester:
No specific data; Factor VIII levels may naturally increase, but monitoring is crucial to manage bleeding risk during labor and delivery.
Lactation
It is unknown whether Nuwiq is excreted in human milk. Factor VIII is a large protein, so transfer into breast milk is expected to be minimal. 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:
Low risk due to large molecular size and likely minimal transfer into milk; any ingested protein would likely be digested.
Pediatric Use
Dosing is weight-based and individualized. Nuwiq has been studied in pediatric patients as young as 0 years. Pharmacokinetic parameters may vary in younger children, potentially requiring more frequent dosing or higher doses per kg. 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. Dosing should be individualized based on clinical response and Factor VIII levels, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Nuwiq is a recombinant Factor VIII produced in a human cell line, which means it is free from animal-derived additives and human plasma proteins, potentially reducing the risk of viral transmission and allergic reactions.
- Individualize dosing based on the patient's Factor VIII levels, the severity of the bleeding episode, and the patient's clinical response.
- Regular monitoring for inhibitor development is critical, especially in previously untreated patients (PUPs) and those with severe hemophilia A.
- Patients should be educated on self-administration techniques, proper storage, and signs of bleeding or adverse reactions.
- The extended half-life of Nuwiq compared to some other FVIII products may allow for less frequent dosing in prophylaxis for some patients.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate, Xyntha, Adynovate, Hemlibra (emicizumab - a bypassing agent, not FVIII replacement), Alprolix (Factor IX for hemophilia B))
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors.
- Gene therapy (e.g., Roctavian) for severe hemophilia A.
Cost & Coverage
Average Cost:
Highly variable, typically several dollars per IU (e.g., $1-$2+ per IU), making a 250 IU vial ~$250-$500+. per IU
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered for diagnosed 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.