Nuwiq 2500unit Kit
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor
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 condition where your blood doesn't clot properly because you are missing a protein called Factor VIII. Nuwiq replaces this missing protein, helping your blood to clot normally.
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 are 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 its color has changed. 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.
Disposal of Used Needles and Containers
Dispose of used needles 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
If using this medication at home, store unopened containers in the refrigerator. Avoid freezing 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 are 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 its color has changed. 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.
Disposal of Used Needles and Containers
Dispose of used needles 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
If using this medication at home, store unopened containers in the refrigerator. Avoid freezing 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.
- Inform all healthcare providers (including dentists) about your hemophilia and Nuwiq treatment.
- Carry identification indicating your hemophilia status.
- Follow your prescribed dosing schedule for prophylaxis to prevent bleeding episodes.
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 activity levels, bleeding severity, and patient weight. Dosing is expressed in International Units (IU).
Condition-Specific Dosing:
onDemandTreatment:
Initial dose of 20-40 IU/kg for minor to moderate bleeding. For major bleeding (e.g., intracranial hemorrhage), initial dose of 40-60 IU/kg, followed by subsequent doses as needed to maintain target Factor VIII levels.
prophylaxis:
Typically 20-40 IU/kg two to three times per week. Some patients may benefit from 40-50 IU/kg twice weekly or 50-60 IU/kg once weekly, depending on individual response and bleeding phenotype.
Pediatric Dosing
Neonatal:
Not established (limited data in neonates).
Infant:
Dosing is individualized based on Factor VIII activity levels, bleeding severity, and patient weight, similar to adults. Prophylaxis often starts at 20-40 IU/kg two to three times per week.
Child:
Dosing is individualized based on Factor VIII activity levels, bleeding severity, and patient weight, similar to adults. Prophylaxis often starts at 20-40 IU/kg two to three times per week.
Adolescent:
Dosing is individualized based on Factor VIII activity levels, bleeding severity, and patient weight, similar to adults. Prophylaxis often starts at 20-40 IU/kg two to three times per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution and monitor Factor VIII levels.
Dialysis:
No specific recommendations. Factor VIII is a large protein and not significantly removed by dialysis. Monitor Factor VIII levels.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution and monitor Factor VIII levels.
Pharmacology
Mechanism of Action
Nuwiq (Antihemophilic Factor (Recombinant)) is a recombinant human coagulation Factor VIII (rFVIII) produced in a human cell line (HEK 293F). It is a B-domain deleted, PEGylated rFVIII. Factor VIII is an essential cofactor for Factor IXa in the activation of Factor X to Factor Xa, which is a critical step in the intrinsic pathway of blood coagulation. In hemophilia A, Factor VIII is deficient or defective, leading to impaired coagulation. Administration of Nuwiq temporarily replaces the missing Factor VIII, allowing for the restoration of normal hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, peak activity is at the end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg (based on non-compartmental analysis)
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited (large protein, does not cross the blood-brain barrier significantly)
Elimination:
HalfLife:
Approximately 14-19 hours (terminal half-life, can vary between individuals)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; no specific excretion route like renal or biliary.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of intravenous infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on the half-life and the target Factor VIII level required for hemostasis, typically 2-3 days for prophylaxis, but can be shorter for acute bleeding events requiring higher sustained levels.
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
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 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
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 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:
- New or worsening joint pain or swelling
- Unusual bruising or bleeding under the skin
- Prolonged bleeding from minor cuts or after dental procedures
- Blood in urine or stools
- Severe headache, neck stiffness, or vision changes (could indicate intracranial bleeding)
- Signs of allergic reaction: rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, feeling faint (seek immediate medical attention)
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 treatment, 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 with your doctor to confirm that it is safe to take this drug in conjunction with your other treatments. 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 treatment, 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 with your doctor to confirm that it is safe to take this drug in conjunction with your other treatments. 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. This could be an indication 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. This could be an indication 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. Very high doses may theoretically increase the risk of thrombosis, but this is rare with Factor VIII products.
What to Do:
In case of suspected overdose, contact your healthcare provider or a poison control center (1-800-222-1222). Management is generally supportive and based on clinical presentation. Monitor for signs of thrombosis.
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, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during acute bleeding episodes or when adjusting prophylaxis. At least annually for patients on prophylaxis.
Target: Dependent on clinical situation (e.g., >30% for minor bleeding, >80-100% for major bleeding).
Action Threshold: If levels are not achieved or maintained as expected, consider inhibitor development or pharmacokinetic variability.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Regularly, especially in the first 50 exposure days or if clinical response to Factor VIII is suboptimal. At least annually for all patients.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor levels are ≥0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) and consult a hemophilia treatment center.
Signs and symptoms of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion.
Target: N/A
Action Threshold: If symptoms occur (e.g., rash, urticaria, dyspnea, chest tightness), discontinue infusion and provide supportive care.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds)
- Signs of allergic/hypersensitivity reactions (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to previously effective doses of Factor VIII)
Special Patient Groups
Pregnancy
Use in pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Factor VIII levels may increase during pregnancy, but individual monitoring is crucial. Consult a hematologist.
Trimester-Specific Risks:
First Trimester:
Limited data. Risk of Factor VIII deficiency in the fetus is possible if the mother is a carrier.
Second Trimester:
Limited data. Monitor maternal Factor VIII levels.
Third Trimester:
Limited data. Monitor maternal Factor VIII levels, especially approaching delivery, as Factor VIII levels may rise naturally. However, if the mother has severe hemophilia A, Factor VIII replacement may be necessary to prevent bleeding complications during delivery.
Lactation
It is unknown 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. Factor VIII is a large protein, and absorption by the infant is unlikely.
Infant Risk:
L3 (Moderate risk - no human data, animal data suggest low risk or no data, but potential for adverse effects cannot be ruled out. Consider monitoring infant for adverse effects if used.)
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is individualized based on weight and Factor VIII levels. Children, especially younger ones, may have faster Factor VIII clearance and may require more frequent dosing or higher doses per kg compared to adults. Close monitoring of Factor VIII levels 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, not age.
Clinical Information
Clinical Pearls
- Nuwiq is a PEGylated recombinant Factor VIII, which may offer extended half-life compared to some non-PEGylated products, potentially allowing for less frequent dosing in prophylaxis.
- Always reconstitute Nuwiq according to the manufacturer's instructions, using the provided diluent and administration set.
- Administer intravenously over several minutes (typically 2-5 minutes). Do not administer by continuous infusion.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) and minimally treated patients (MTPs), as this is the most serious complication of Factor VIII replacement therapy.
- Patients should be educated on self-administration techniques, proper storage, and recognition of bleeding episodes and adverse reactions.
- Keep a treatment diary to record infusions, bleeding episodes, and any adverse reactions.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Hemlibra (emicizumab - a bispecific antibody mimicking FVIIIa activity), Esperoct, Afstyla, Kovaltry, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors.
Cost & Coverage
Average Cost:
Highly variable, typically several dollars per IU. A 2500 IU vial can range from $2,000 - $5,000+. per IU
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.