Nuwiq 250unit Inj 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
Category C
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 does not clot properly because of a missing or faulty protein called Factor VIII. Nuwiq replaces this missing protein, helping the blood to clot and stop 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.
If the medication is 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. Use the medication within 3 hours of preparation. Discard any unused portion of the opened vial after administration. Dispose of needles in a designated needle/sharp disposal container. 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
For home administration, 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.
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.
If the medication is 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. Use the medication within 3 hours of preparation. Discard any unused portion of the opened vial after administration. Dispose of needles in a designated needle/sharp disposal container. 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
For home administration, 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
- Follow your prescribed dosing schedule for prophylaxis to prevent bleeding episodes.
- Administer Nuwiq as soon as possible after a bleeding episode starts.
- Learn how to self-infuse or have a caregiver trained to administer the medication.
- Keep a detailed record of all infusions, including dose, date, time, and reason for infusion.
- Avoid activities that carry a high risk of injury or bleeding.
- Inform all healthcare providers (including dentists) that you have hemophilia 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 patient's Factor VIII levels, type of bleeding, and clinical condition. For on-demand treatment of bleeding episodes: 20-40 IU/kg for minor bleeding, 40-60 IU/kg for moderate bleeding, 60-80 IU/kg for major bleeding. For routine prophylaxis: 20-40 IU/kg 2-3 times per week, or individualized.
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
prophylaxis:
20-40 IU/kg 2-3 times per week
on_demand_minor_bleeding:
20-40 IU/kg
on_demand_moderate_bleeding:
40-60 IU/kg
on_demand_major_bleeding:
60-80 IU/kg
perioperative_management:
Initial dose to achieve target FVIII activity (e.g., 80-100% for major surgery), followed by maintenance doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adults. Individualized based on FVIII levels and clinical response.
Child:
Dosing is weight-based, similar to adults. Individualized based on FVIII levels and clinical response.
Adolescent:
Dosing is weight-based, similar to adults. Individualized based on FVIII levels and clinical response.
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, as Factor VIII is a large protein 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
Simoctocog alfa is a recombinant human 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 intrinsic coagulation pathway, accelerating the conversion of Factor X to activated Factor X (Factor Xa). Factor Xa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, leading to clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 50 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in circulation, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 19 hours (terminal half-life)
Clearance:
Approximately 2.6 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally 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 maintains hemostatic levels for 2-3 days for prophylaxis, or until bleeding is controlled for on-demand treatment.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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, 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, some people may experience severe and potentially life-threatening side effects while 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, 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 an allergic reaction: rash, hives, itching, redness, swelling (especially of the face, lips, tongue, or throat), dizziness, lightheadedness, chest tightness, difficulty breathing, wheezing, low blood pressure.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, or lack of response to your usual dose of Nuwiq.
- Signs of blood clots (rare): pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath; chest pain.
- Any new or worsening bleeding.
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in conjunction with them. 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.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in conjunction with them. 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 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 overdose with Factor VIII is unlikely to cause severe adverse effects, very high levels could theoretically increase the risk of thrombotic events (blood clots), though this is rare in hemophilia A patients.
- Symptoms of thrombosis could include pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath; chest pain.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 911 or your local emergency number. 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 initiation of therapy.
Bleeding history and severity
Rationale: To assess the patient's hemophilia phenotype and guide treatment strategy.
Timing: Prior to initiation of therapy.
Inhibitor screening (Bethesda assay)
Rationale: To detect pre-existing Factor VIII inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during acute bleeding episodes, surgery, or when adjusting prophylaxis. At least annually for prophylaxis.
Target: Varies by indication (e.g., >1% for prophylaxis, 80-100% for major surgery, 30-50% for minor bleeding).
Action Threshold: Levels below target range may indicate need for dose adjustment or inhibitor development.
Inhibitor screening (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for the first few years of treatment, then annually for patients without inhibitors, or more frequently if clinical response is poor).
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: Positive inhibitor titer requires alternative treatment strategies (e.g., bypassing agents, immune tolerance induction).
Clinical assessment for bleeding episodes
Frequency: Continuously by patient/caregiver, and at each clinic visit.
Target: Absence of spontaneous bleeding or effective control of bleeding episodes.
Action Threshold: Increased frequency or severity of bleeding may indicate inadequate dosing or inhibitor development.
Signs of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion, and ongoing.
Target: Absence of symptoms (e.g., rash, urticaria, dyspnea, hypotension).
Action Threshold: Presence of symptoms requires immediate discontinuation and appropriate medical management.
Symptom Monitoring
- Increased bleeding (e.g., joint bleeds, muscle bleeds, nosebleeds, bruising)
- Lack of response to usual dose of Factor VIII
- Signs of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, chest tightness, difficulty breathing)
- Fever
- Headache
Special Patient Groups
Pregnancy
Nuwiq is a Category C medication. There are no adequate and well-controlled studies of Nuwiq in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hemophilia A is a genetic disorder, and management during pregnancy requires careful consideration of maternal and fetal bleeding risks.
Trimester-Specific Risks:
First Trimester:
Potential risks are theoretical; Factor VIII is a large protein and unlikely to cross the placenta significantly. Focus on maternal hemostasis.
Second Trimester:
Continued focus on maintaining adequate maternal Factor VIII levels to prevent bleeding complications.
Third Trimester:
Crucial to ensure adequate Factor VIII levels, especially around delivery, to prevent maternal hemorrhage. Fetal Factor VIII levels should also be considered if the fetus is affected.
Lactation
It is not known whether Nuwiq is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Nuwiq is administered to a nursing woman. However, Factor VIII is a large protein and is unlikely to be absorbed systemically by the infant if present in breast milk. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
L3 (Moderately safe; limited data, but unlikely to cause significant harm due to protein nature and poor oral absorption).
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is weight-based and individualized, similar to adults. Pediatric patients, especially young children, may have higher Factor VIII clearance rates and may require more frequent dosing or higher doses per kg to maintain target levels. Close monitoring of Factor VIII activity 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. However, Factor VIII dosing is primarily based on weight and Factor VIII levels, rather than age-related organ function.
Clinical Information
Clinical Pearls
- Nuwiq is a B-domain deleted recombinant Factor VIII, which may have a lower immunogenic potential compared to full-length Factor VIII products, though inhibitor development remains a risk.
- The half-life of Nuwiq (approximately 19 hours) is relatively long compared to some other Factor VIII products, potentially allowing for less frequent dosing in prophylaxis.
- Always reconstitute Nuwiq immediately before use and administer intravenously. Do not refrigerate after reconstitution.
- Patients should be educated on the signs and symptoms of inhibitor development and hypersensitivity reactions.
- Regular monitoring of Factor VIII activity levels is essential to ensure adequate therapeutic levels, especially during surgery or severe bleeding episodes.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate, Novoeight, Recombinate, Xyntha, Hemlibra (emicizumab - a bypassing agent, not FVIII replacement))
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Desmopressin (DDAVP) for mild hemophilia A
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength. per 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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 this 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.