Nuwiq 2000unit 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
Not available
FDA Approved
Apr 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 to clot 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 will be 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 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, 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 will be 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 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, 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
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Avoid medications that interfere with blood clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically advised by your doctor.
- Regular exercise, especially activities that strengthen muscles around joints, can help protect joints from bleeding.
- Always carry your medication and identification indicating your hemophilia status.
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 level, type of bleeding, and clinical condition. 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. Adjust frequency and dose based on patient response and FVIII levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adults (20-50 IU/kg for prophylaxis or on-demand treatment).
Child:
Dosing is weight-based, similar to adults (20-50 IU/kg for prophylaxis or on-demand treatment).
Adolescent:
Dosing is weight-based, similar to adults (20-50 IU/kg for prophylaxis or on-demand treatment).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Simoctocog alfa is a recombinant coagulation Factor VIII (FVIII) that temporarily replaces the missing coagulation FVIII in patients with hemophilia A. FVIII is an essential cofactor in the intrinsic coagulation pathway, where it binds to activated Factor IX (FIXa) and calcium to form a complex that activates Factor X (FX) to Factor Xa (FXa). FXa then converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin, leading to clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-18 hours (terminal half-life)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Immediate (within minutes of infusion)
DurationOfAction:
Dependent on half-life and initial dose; typically maintains hemostatic levels for 1-3 days depending on dose and patient.
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 an exhaustive list of 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 an exhaustive list of 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: hives, rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing, chest tightness, dizziness, feeling faint.
- Signs of bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stools, severe joint pain or swelling, headache with stiff neck or vision changes.
- Signs that the medication is not working (possible inhibitor development): increased frequency or severity of bleeding episodes, or bleeding that doesn't stop with your usual dose.
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. This is crucial to avoid potential interactions.
* Any existing health problems, as this medication may affect your condition or interact with other health issues.
To ensure your safety, it is vital to verify that this medication is compatible with all your 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions.
* Any existing health problems, as this medication may affect your condition or interact with other health issues.
To ensure your safety, it is vital to verify that this medication is compatible with all your 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 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 an overdose is unlikely to cause severe adverse effects, very high Factor VIII levels could theoretically increase the risk of thrombotic events (blood clots).
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 911 or the Poison Control Center at 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline FVIII levels and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screening
Rationale: To detect pre-existing inhibitors to FVIII, which can render treatment ineffective.
Timing: Prior to initiation of therapy, especially in previously untreated patients (PUPs).
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during treatment of bleeding episodes or surgical procedures, and to guide prophylactic dosing.
Target: Dependent on clinical situation (e.g., >30% for minor bleeds, >80-100% for major surgery).
Action Threshold: Adjust dose or frequency if levels are not within target range or if clinical response is inadequate.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly (e.g., every 3-6 months) in all patients, and particularly if expected clinical response is not achieved.
Target: Negative (less than 0.6 Bethesda Units/mL)
Action Threshold: If inhibitors are detected, treatment strategy may need to be altered (e.g., higher doses, bypassing agents).
Clinical response to treatment
Frequency: Continuously during bleeding episodes or prophylaxis.
Target: Cessation of bleeding, prevention of bleeding episodes.
Action Threshold: If bleeding persists or prophylaxis fails, re-evaluate dose, frequency, or consider inhibitor development.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from minor cuts, blood in urine/stools)
- Signs of allergic or hypersensitivity reactions (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, lack of response to usual doses of Factor VIII)
Special Patient Groups
Pregnancy
Use only if clearly needed. Animal reproduction studies have not been conducted with Nuwiq. It is not known whether Nuwiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Factor VIII is a natural component of human plasma, and its replacement is essential for hemostasis in hemophilia A.
Trimester-Specific Risks:
First Trimester:
Risk unknown, but unlikely to be teratogenic given its nature as a protein.
Second Trimester:
Risk unknown.
Third Trimester:
Risk unknown. May be used for management of bleeding during labor and delivery if indicated.
Lactation
It is not known whether Nuwiq is excreted in human milk. However, human Factor VIII is a normal component of human plasma. Consider the developmental and health benefits of breastfeeding 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.
Infant Risk:
Low risk expected, as Factor VIII is a large protein unlikely to be absorbed intact by the infant.
Pediatric Use
Nuwiq is approved for use in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based and individualized, similar to adults. Pediatric patients, especially previously untreated patients (PUPs), may have a higher risk of inhibitor development.
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, no specific dose adjustments are typically required based on age alone for Factor VIII products.
Clinical Information
Clinical Pearls
- Nuwiq is a third-generation recombinant Factor VIII product, produced in a human cell line (HEK 293F) and free of animal- or human-derived additives in the cell culture, purification, and final formulation steps, which may be preferred by some patients.
- Individualize dosing based on the patient's Factor VIII levels, type and severity of bleeding, and clinical response.
- Regular monitoring for Factor VIII inhibitors is crucial, especially in previously untreated patients (PUPs) and young children, as inhibitor development is the most serious complication of Factor VIII replacement therapy.
- Patients should be educated on self-administration techniques, proper storage, and signs of allergic reactions or inhibitor development.
- Prophylaxis is the standard of care for severe hemophilia A to prevent bleeding episodes and joint damage.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate, Novoeight, Recombinate, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Extended half-life Factor VIII products (e.g., Eloctate, Jivi, Adynovate, Hemlibra (emicizumab) - a bispecific antibody that mimics FVIIIa activity, not a FVIII replacement)
- Bypassing agents (for patients with inhibitors): Activated Prothrombin Complex Concentrate (aPCC, e.g., FEIBA), Recombinant Factor VIIa (rFVIIa, e.g., NovoSeven RT)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy for mild bleeding or prophylaxis during dental procedures.
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of dollars per dose, depending on strength and patient weight) per 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 is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.