Nuwiq 3000unit 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 assigned; generally low risk (biologic)
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. It works by replacing a missing protein in the blood called Factor VIII, which is needed for blood to clot properly. It is given as an injection into a vein.
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.
Preparation and Handling
If the medication has been refrigerated, 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. Inspect the solution carefully; do not use if it appears cloudy, is leaking, contains particles, or 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 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
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best 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.
Preparation and Handling
If the medication has been refrigerated, 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. Inspect the solution carefully; do not use if it appears cloudy, is leaking, contains particles, or 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 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
For home administration, store unopened containers in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best course of action.
Lifestyle & Tips
- Maintain a regular treatment schedule as prescribed by your doctor.
- Avoid activities that increase the risk of bleeding (e.g., contact sports) or take appropriate precautions.
- Wear medical alert identification indicating hemophilia A.
- Maintain good dental hygiene to prevent gum bleeding.
- Report any new or worsening bleeding episodes to your healthcare provider immediately.
- Store the medication as directed and do not use if expired or improperly stored.
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, type of bleeding, and patient weight. For prophylaxis: 20-40 IU/kg 2-3 times per week. For on-demand treatment: 20-50 IU/kg for minor/moderate bleeds.
Condition-Specific Dosing:
Prophylaxis:
20-40 IU/kg 2-3 times per week
On-demand treatment (minor/moderate bleeds):
20-50 IU/kg
On-demand treatment (major bleeds/surgery):
50-100 IU/kg, target Factor VIII activity 80-100% of normal
Pediatric Dosing
Neonatal:
Not established (rarely indicated)
Infant:
Dosing established, individualized based on weight and Factor VIII levels
Child:
Dosing established, individualized based on weight and Factor VIII levels
Adolescent:
Dosing established, individualized based on weight and Factor VIII levels
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required
Moderate:
No specific adjustment required
Severe:
No specific adjustment required
Dialysis:
No specific considerations; not renally cleared
Hepatic Impairment:
Mild:
No specific adjustment required
Moderate:
No specific adjustment required
Severe:
No specific adjustment required
Pharmacology
Mechanism of Action
Simoctocog alfa is a recombinant coagulation Factor VIII. It replaces the deficient endogenous Factor VIII, which acts as a cofactor for activated Factor IX (Factor IXa) in the activation of Factor X to Factor Xa. This leads to the formation of thrombin and ultimately fibrin, restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 12-18 hours
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Protein degradation products
Unchanged:
Not applicable (degraded)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Dependent on half-life and initial dose, typically 1-3 days for prophylactic effect
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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, 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 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 bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool, joint pain or swelling, severe headache, vision changes.
- Signs of allergic reaction: hives, rash, itching, swelling of the face/lips/tongue/throat, dizziness, lightheadedness, shortness of breath, chest tightness, wheezing.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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:
- No specific symptoms of overdose are known for Factor VIII. Extremely high levels might theoretically increase clotting risk, but this is rare and not well-documented.
What to Do:
Contact emergency services or poison control immediately. Management is supportive and based on clinical presentation.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
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
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after dosing for acute bleeds; periodically (e.g., weekly to monthly) for prophylaxis
Target: Varies based on indication (e.g., >1% for prophylaxis, 80-100% for major bleeds)
Action Threshold: Adjust dose if levels are outside target range or if clinical response is inadequate
Inhibitor (neutralizing antibody) screen
Frequency: Periodically (e.g., every 3-6 months) or if treatment efficacy decreases
Target: Negative
Action Threshold: Investigate for inhibitor development if positive or if bleeding is not controlled with expected Factor VIII levels
Signs and symptoms of bleeding
Frequency: Continuously by patient/caregiver
Target: Absence of bleeding
Action Threshold: Administer dose or seek medical attention if bleeding occurs
Symptom Monitoring
- Signs of bleeding (e.g., unusual bruising, prolonged bleeding, joint pain/swelling, blood in urine/stool)
- Signs of allergic/hypersensitivity reactions (e.g., hives, rash, itching, swelling, dizziness, shortness of breath, chest tightness)
Special Patient Groups
Pregnancy
Use only if clearly needed. Factor VIII levels can increase during pregnancy, and monitoring may be required. Data on Nuwiq use in pregnant women are limited.
Trimester-Specific Risks:
First Trimester:
No specific risks identified; limited data.
Second Trimester:
No specific risks identified; limited data.
Third Trimester:
No specific risks identified; limited data. Factor VIII levels may naturally rise in late pregnancy.
Lactation
It is unknown if simoctocog alfa is excreted in human milk. However, due to its large molecular size and protein nature, it is unlikely to be transferred into milk in significant amounts or to cause harm to a breastfed infant. Generally considered compatible with breastfeeding.
Infant Risk:
Low
Pediatric Use
Nuwiq is safe and effective in pediatric patients with hemophilia A. Dosing is individualized based on weight and Factor VIII levels, similar to adults. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs).
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are typically required based on age alone, but individual patient factors should be considered.
Clinical Information
Clinical Pearls
- Dosing is highly individualized and should be based on Factor VIII activity levels, the type and severity of bleeding, and the patient's clinical response.
- The development of neutralizing antibodies (inhibitors) to Factor VIII is a major complication of hemophilia A treatment, particularly in previously untreated patients (PUPs). Patients should be monitored regularly for inhibitor development.
- Nuwiq is administered intravenously only. Ensure proper aseptic technique during preparation and administration.
- Patients should be educated on self-administration techniques, signs of bleeding, and signs of allergic reactions.
- Store Nuwiq according to manufacturer's instructions (refrigerated, but can be stored at room temperature for a limited period).
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Adynovate, Xyntha, Kogenate, Recombinate, Novoeight, Esperoct)
- Plasma-derived Factor VIII products
- Emicizumab (Hemlibra - a bispecific antibody mimicking Factor VIIIa, not a Factor VIII replacement)
- Gene therapy for hemophilia A (e.g., Roctavian)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial (e.g., $1,000 - $5,000+ per 1000 IU vial) per vial
Insurance Coverage:
Specialty Tier, often requires prior authorization and is covered under medical benefit for hemophilia A
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.