Nuwiq 4000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent
Pharmacologic Class
Coagulation factor IX, recombinant
Pregnancy Category
Not available
FDA Approved
Jul 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nuwiq is a medicine used to treat and prevent bleeding in people with hemophilia B. Hemophilia B is a genetic condition where the body doesn't make enough of a protein called Factor IX, which is needed for blood clotting. Nuwiq replaces this missing protein, helping your blood to clot properly 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 responsible for self-administering the injection, 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 stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. Avoid shaking the mixture. Inspect the solution for any signs of cloudiness, leakage, or particulate matter, and do not use if any of these conditions are present. Additionally, do not use the solution if it has changed color. After mixing, do not refrigerate the solution. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box, and do not reuse them. 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 of this medication in the refrigerator, avoiding freezing temperatures.
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 responsible for self-administering the injection, 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 stored in the refrigerator, allow it to reach room temperature before mixing. Do not apply heat to the medication. Prior to use, the medication must be mixed according to the instructions provided by your doctor. Avoid shaking the mixture. Inspect the solution for any signs of cloudiness, leakage, or particulate matter, and do not use if any of these conditions are present. Additionally, do not use the solution if it has changed color. After mixing, do not refrigerate the solution. Use the medication within 3 hours of preparation and discard any unused portion of the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box, and do not reuse them. 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 of this medication in the refrigerator, avoiding freezing temperatures.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best course of action.
Lifestyle & Tips
- Maintain regular physical activity as advised by your doctor, avoiding high-impact sports that could lead to injury.
- Wear medical alert identification (e.g., bracelet or necklace) indicating hemophilia B and Factor IX deficiency.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion (e.g., bleeding episode, prophylaxis).
- Follow your healthcare provider's instructions for home infusion, including proper sterile technique and disposal of needles and syringes.
- Avoid aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) unless specifically approved by your doctor, as they can increase bleeding risk.
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 IX level, bleeding severity, and clinical response.
Condition-Specific Dosing:
on-demand_treatment_bleeding_episodes:
Initial dose: 40 IU/kg for minor/moderate bleeding, 80 IU/kg for major bleeding. Subsequent doses and frequency based on clinical response and Factor IX levels.
routine_prophylaxis:
40 IU/kg once weekly. May be adjusted to 30-50 IU/kg every 5-7 days or 60 IU/kg every 10 days based on individual response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is individualized based on weight, Factor IX levels, and clinical response, similar to adults. Prophylaxis: 40 IU/kg once weekly.
Child:
Dosing is individualized based on weight, Factor IX levels, and clinical response, similar to adults. Prophylaxis: 40 IU/kg once weekly.
Adolescent:
Dosing is individualized based on weight, Factor IX levels, and clinical response, similar to adults. Prophylaxis: 40 IU/kg once weekly.
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 recommendations; monitor Factor IX levels and clinical response closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Confidence:
Medium
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant coagulation Factor IX, a vitamin K-dependent single-chain glycoprotein. It replaces the missing or deficient endogenous Factor IX in patients with hemophilia B, thereby restoring the coagulation cascade and enabling effective hemostasis. Factor IX is activated by Factor XIa (in the intrinsic pathway) or Factor VIIa/tissue factor (in the extrinsic pathway) to Factor IXa. Factor IXa, in conjunction with Factor VIIIa, calcium, and phospholipid, converts Factor X to Factor Xa. Factor Xa then converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin, forming a stable clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.02 L/kg
ProteinBinding:
Not applicable (is a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Mean terminal half-life: 60.3 hours (range 43.8-82.6 hours) in adults; 50.8 hours (range 35.8-70.1 hours) in pediatric patients.
Clearance:
Mean clearance: 0.0003 L/hr/kg (adults); 0.0004 L/hr/kg (pediatrics)
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak Factor IX activity)
DurationOfAction:
Extended due to glycoPEGylation, allowing for less frequent dosing (up to 7-10 days for prophylaxis).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 immediately:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 immediately:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 minor cuts, nosebleeds, blood in urine or stool, joint pain or swelling, severe headache.
- Signs of allergic reaction: rash, hives, itching, flushing, swelling of the face/lips/tongue, dizziness, chest tightness, difficulty breathing.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes despite adequate dosing, or failure to achieve expected Factor IX levels after infusion.
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, any of 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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
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. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
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. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose are known, but very high levels of Factor IX 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. Management would involve close monitoring for signs of thrombosis and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor IX 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 IX, which can impact treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor IX activity levels
Frequency: Regularly, especially during initial treatment, dose adjustments, or in cases of inadequate clinical response.
Target: Depends on bleeding severity (e.g., >1% for prophylaxis, higher for bleeding episodes/surgery).
Action Threshold: If levels are not within target range or if bleeding persists, adjust dose or frequency.
Clinical assessment of bleeding episodes
Frequency: Continuously during treatment.
Target: Cessation of bleeding.
Action Threshold: Persistent or recurrent bleeding indicates need for dose adjustment or investigation of inhibitor development.
Inhibitor (neutralizing antibody) screen
Frequency: Periodically (e.g., every 3-6 months, or if clinical response is suboptimal).
Target: Negative.
Action Threshold: Positive inhibitor titer requires alternative treatment strategies (e.g., bypassing agents).
Signs and symptoms of hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately if symptoms occur.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds)
- Signs of allergic reaction/hypersensitivity (e.g., rash, hives, itching, flushing, swelling, dizziness, chest tightness, difficulty breathing)
- Signs of thrombotic events (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, vision changes, slurred speech)
Special Patient Groups
Pregnancy
Use only if clearly needed. Limited data on Nuwiq use in pregnant women. Animal reproduction studies have not been conducted. Factor IX levels may fluctuate during pregnancy, requiring close monitoring and dose adjustment.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk low as it's a replacement protein.
Second Trimester:
Limited data, theoretical risk low.
Third Trimester:
Factor IX levels may increase naturally in late pregnancy, but replacement therapy may still be needed, especially around delivery. Close monitoring of Factor IX levels is crucial.
Lactation
It is unknown whether Nuwiq is excreted in human milk. However, Factor IX is a large protein and unlikely to pass into breast milk in significant amounts or be absorbed orally by the 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 (L3).
Infant Risk:
Low
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia B. Dosing is individualized based on weight, Factor IX levels, and clinical response. The half-life may be slightly shorter in younger children, potentially requiring more frequent dosing or higher doses per kg.
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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Nuwiq is a glycoPEGylated Factor IX product, which contributes to its extended half-life, allowing for less frequent prophylactic dosing compared to some other Factor IX products.
- Always confirm the specific unit strength of the vial before reconstitution and administration to avoid dosing errors.
- Reconstitute Nuwiq using the provided diluent and administration set. Do not shake the vial; gently swirl to dissolve the powder.
- Administer intravenously at a rate comfortable for the patient, typically up to 4 mL/minute. Do not exceed 10 mL/minute.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) or those with a history of inhibitors, as this can lead to treatment failure.
- Patients should be educated on self-administration techniques, proper storage, and signs of adverse reactions or bleeding that require medical attention.
Alternative Therapies
- Other recombinant Factor IX products (e.g., BeneFIX, Alprolix, Idelvion, Rixubis)
- Plasma-derived Factor IX products (e.g., AlphaNine SD, Mononine)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with Factor IX inhibitors.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and quantity. per vial (e.g., 4000 IU)
Insurance Coverage:
Specialty Tier/Tier 4 or 5. Requires prior authorization and is typically covered under medical benefit for hemophilia B.
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.