Nuwiq 4000unit 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
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 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 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.
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 for any signs of cloudiness, leakage, or particulate matter; do not use if any of these conditions are present. Additionally, do not use the medication if the solution has changed color. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation. Dispose of any unused portion of the opened vial after use. Properly discard needles and other sharp objects in a designated disposal container. Do not reuse needles or other items. When the disposal container is full, follow local regulations for its 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.
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 for any signs of cloudiness, leakage, or particulate matter; do not use if any of these conditions are present. Additionally, do not use the medication if the solution has changed color. After mixing, do not refrigerate the medication. Use the medication within 3 hours of preparation. Dispose of any unused portion of the opened vial after use. Properly discard needles and other sharp objects in a designated disposal container. Do not reuse needles or other items. When the disposal container is full, follow local regulations for its 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
- Always carry your medication and identification indicating you have hemophilia.
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Avoid medications that interfere with clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically advised by your doctor.
- Regular exercise, under medical guidance, can help strengthen joints and muscles, reducing 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 VIII level, type of bleeding, and clinical condition. For on-demand treatment of bleeding episodes: 10-50 IU/kg depending on severity. For routine prophylaxis: 20-40 IU/kg 2-3 times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
on_demand_minor_bleed:
10-20 IU/kg to achieve 20-40% FVIII activity
on_demand_moderate_bleed:
20-30 IU/kg to achieve 40-60% FVIII activity
on_demand_major_bleed:
30-50 IU/kg to achieve 60-100% FVIII activity
prophylaxis:
20-40 IU/kg 2-3 times per week
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is individualized based on patient's Factor VIII level, type of bleeding, and clinical condition, similar to adults on a per-kg basis. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Child:
Dosing is individualized based on patient's Factor VIII level, type of bleeding, and clinical condition, similar to adults on a per-kg basis. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Adolescent:
Dosing is individualized based on patient's Factor VIII level, type of bleeding, and clinical condition, similar to adults on a per-kg basis. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
No specific adjustment recommended; Factor VIII is a large protein not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant coagulation Factor VIII (rFVIII) that temporarily replaces the missing coagulation Factor VIII needed for effective hemostasis. Factor VIII is an essential cofactor for Factor IXa in the activation of Factor X to Factor Xa, which ultimately leads to the formation of thrombin and fibrin clot. In patients with hemophilia A, Factor VIII is deficient or defective, leading to impaired coagulation and increased bleeding tendency. Administration of Nuwiq provides the necessary Factor VIII to restore the coagulation cascade.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (after IV infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Mean terminal half-life of 19.3 ± 4.8 hours (adults)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily catabolism; not excreted renally or hepatically as intact protein.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life and initial dose, typically 2-3 days for prophylactic effect, shorter for acute bleeding.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 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 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
+ Tingling
Change in mouth color to blue
Chest pain or pressure
Fast 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 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 allergic reaction: rash, hives, itching, facial swelling, difficulty breathing, chest tightness, dizziness, feeling faint. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, or if your usual dose of Nuwiq doesn't stop bleeding as expected. Contact your doctor immediately.
- Signs of bleeding: new or worsening joint pain/swelling, unusual bruising, prolonged bleeding from cuts, blood in urine or stools, severe headaches.
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so. It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so. It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
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 evaluations should be performed as directed by your doctor to monitor your condition.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dose is not effective, and your doctor may need to adjust your treatment.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout 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 to make an informed decision about your treatment.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication that your current dose is not effective, and your doctor may need to adjust your treatment.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout 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 to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- While an overdose of Factor VIII is unlikely to cause acute toxicity, very high levels 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:
If an overdose is suspected, contact your healthcare provider or emergency services immediately. Management is supportive and may involve monitoring for signs of thrombosis. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors to Factor VIII, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity level
Frequency: Periodically, especially during acute bleeding episodes or surgical procedures, and to confirm adequate therapeutic levels.
Target: Dependent on clinical situation (e.g., 20-40% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency.
Inhibitor (neutralizing antibody) assay
Frequency: Regularly (e.g., every 3-6 months, or more frequently in the first year of treatment, or if expected clinical response is not achieved).
Target: Negative (<0.6 Bethesda Units/mL).
Action Threshold: If positive, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical response to treatment
Frequency: Continuously during therapy.
Target: Cessation of bleeding, resolution of symptoms.
Action Threshold: Persistent bleeding or lack of improvement indicates need for dose adjustment or inhibitor testing.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds)
- 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 episodes, lack of response to usual doses of Factor VIII)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Nuwiq in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Animal reproduction studies are not always predictive of human response.
Trimester-Specific Risks:
First Trimester:
Risk not ruled out; use only if clearly needed.
Second Trimester:
Risk not ruled out; use only if clearly needed.
Third Trimester:
Risk not ruled out; use only if clearly needed.
Lactation
It is not known whether Nuwiq is excreted in human milk. 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. Use with caution.
Infant Risk:
Unknown; potential risk cannot be excluded.
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is individualized based on body weight and Factor VIII levels, similar to adults. Safety and efficacy have been demonstrated in pediatric clinical trials.
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 PEGylated recombinant Factor VIII, which contributes to its extended half-life compared to some older non-PEGylated products.
- Always confirm the patient's Factor VIII activity level and monitor for inhibitor development, especially in previously untreated patients (PUPs) or if clinical response is suboptimal.
- Reconstitute Nuwiq using the provided diluent and administration set. Do not shake the vial.
- Administer intravenously over several minutes (typically 1-5 mL/minute).
- Patients should be educated on self-administration techniques, signs of bleeding, and symptoms of allergic reactions or inhibitor development.
- Nuwiq does not contain von Willebrand factor, human albumin, or other human- or animal-derived proteins.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate FS, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT, Hemlibra (emicizumab))
- Desmopressin (DDAVP) for mild hemophilia A (not for severe hemophilia A or Nuwiq patients)
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of dollars per dose depending on unit strength and quantity. For 4000 IU, it can range from $4,000 to $8,000+. per 4000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans due to medical necessity 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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.