Nuwiq 2500unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor
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 special 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 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. 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. Discard any unused portion of the opened vial after administration. Dispose of 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 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 to determine 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 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. 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. Discard any unused portion of the opened vial after administration. Dispose of 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 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 to determine the appropriate course of action.
Lifestyle & Tips
- Always carry your medication and supplies with you, especially when traveling.
- Follow your doctor's instructions for dosing and administration carefully.
- Keep a detailed record of all infusions, including date, time, dose, and lot number.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear a medical alert bracelet or carry an identification card stating you have hemophilia A.
- Maintain good dental hygiene to prevent gum bleeding.
- Report any new or unusual bleeding, or signs of an allergic reaction, to your doctor immediately.
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 FVIII levels, bleeding severity, and patient weight. Dosing is expressed in International Units (IU). For on-demand treatment of bleeding episodes, typical doses range from 20-50 IU/kg. For routine prophylaxis, typical doses are 20-40 IU/kg every other day or 20-50 IU/kg three times per week.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
on_demand_bleeding:
20-50 IU/kg, repeat as needed based on FVIII levels and clinical response.
routine_prophylaxis:
20-40 IU/kg every other day or 20-50 IU/kg three times per week. Adjust frequency and dose based on patient response and FVIII trough levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is individualized based on FVIII levels, bleeding severity, and patient weight, similar to adults. Prophylaxis: 20-40 IU/kg every other day or 20-50 IU/kg three times per week.
Child:
Dosing is individualized based on FVIII levels, bleeding severity, and patient weight, similar to adults. Prophylaxis: 20-40 IU/kg every other day or 20-50 IU/kg three times per week.
Adolescent:
Dosing is individualized based on FVIII levels, bleeding severity, and patient weight, similar to adults. Prophylaxis: 20-40 IU/kg every other day or 20-50 IU/kg 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.
Dialysis:
No specific dose adjustment recommended. Factor VIII is not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Nuwiq) is a recombinant coagulation Factor VIII (rFVIII) that temporarily replaces the deficient endogenous Factor VIII in patients with hemophilia A. 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. By providing exogenous Factor VIII, Nuwiq helps to restore the normal coagulation cascade and achieve hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, peak effect is immediate)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg (based on non-steady state data)
ProteinBinding:
Binds to von Willebrand Factor (vWF) in circulation, which stabilizes FVIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Mean terminal half-life: 14.5 to 19.1 hours (range observed in clinical studies, can vary between individuals).
Clearance:
Mean clearance: 2.6 to 3.6 mL/hr/kg.
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally or hepatically excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life and initial dose; typically maintains hemostatic levels for 24-48 hours, requiring dosing every other day or three times per week for prophylaxis.
Confidence:
Medium
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, 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, 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, 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 allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, chest tightness, dizziness, faintness.
- Signs of inhibitor development: increased frequency or severity of bleeding, bleeding that doesn't stop with your usual dose of Nuwiq.
- Signs of bleeding: joint pain or swelling, muscle pain, unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stools, severe headache, sudden weakness or numbness.
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 other 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 information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All existing health problems, as they may impact the safety and efficacy of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other 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 information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All existing health problems, as they may impact the safety and efficacy of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
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 conducted 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, and your doctor will help you make an informed decision.
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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, and your doctor will help you make an informed decision.
Overdose Information
Overdose Symptoms:
- While overdose is unlikely to cause severe adverse effects due to the nature of the product, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots), though this is rare in hemophilia A patients.
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb, sudden severe headache, vision changes.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 911 or your local emergency number. For general poison control, call 1-800-222-1222. Management would involve monitoring for thrombotic events and supportive care.
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, which would render therapy ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during initial dosing, before and after surgery, or if bleeding is not controlled.
Target: Target levels vary based on indication (e.g., >1% for prophylaxis, 30-60% for minor bleeds, 80-120% for major bleeds/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency. If unexpected low levels, consider inhibitor development.
Inhibitor (neutralizing antibody) testing (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for the first few years, then annually) or if there is a lack of clinical response to treatment.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor levels are âĨ0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical assessment for bleeding episodes
Frequency: Continuously by patient/caregiver and during routine clinic visits.
Target: Absence of spontaneous bleeding or effective control of bleeding episodes.
Action Threshold: Increased frequency or severity of bleeding may indicate inadequate dosing or inhibitor development.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of hypersensitivity/allergic 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 Factor VIII doses)
Special Patient Groups
Pregnancy
Nuwiq has not been studied in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Hemophilia A is a genetic disorder, and management during pregnancy requires careful consideration due to the risk of bleeding in the mother and potential for Factor VIII deficiency in the fetus.
Trimester-Specific Risks:
First Trimester:
No specific data, theoretical risk of fetal exposure to drug.
Second Trimester:
No specific data.
Third Trimester:
No specific data, but Factor VIII levels naturally increase in late pregnancy, which may reduce the need for exogenous Factor VIII in some women with mild hemophilia A. However, severe hemophilia A still requires careful management to prevent bleeding complications during delivery.
Lactation
It is unknown whether Nuwiq is excreted in human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, 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:
Not available, but generally considered low risk for protein-based therapies due to likely degradation in the infant's GI tract.
Pediatric Use
Nuwiq is approved for use in pediatric patients with hemophilia A. Dosing is individualized based on weight, FVIII levels, and clinical response, similar to adults. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs) and minimally treated patients (MTPs).
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 B-domain deleted recombinant Factor VIII, which means it does not contain the B-domain of the Factor VIII molecule. This may reduce the potential for certain post-translational modifications and improve manufacturing consistency.
- It is produced in a human cell line (HEK 293F), which means it is not exposed to animal- or human-derived protein additives in the cell culture or purification process, potentially reducing the risk of viral transmission or allergic reactions to animal proteins.
- Always reconstitute Nuwiq with the provided sterile water for injection and administer intravenously. Do not shake the vial vigorously during reconstitution.
- Patients should be educated on self-administration techniques, proper storage, and signs of adverse reactions or inhibitor development.
- Regular monitoring of Factor VIII activity levels is essential to ensure adequate hemostasis and to adjust dosing as needed.
- The development of Factor VIII inhibitors (neutralizing antibodies) is the most serious complication of Factor VIII replacement therapy and should be suspected if bleeding is not controlled with expected doses.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Hemlibra (emicizumab - a bypassing agent, not FVIII replacement but used for prophylaxis))
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors
- Desmopressin (DDAVP) for mild hemophilia A
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and quantity. A 2500 IU vial can range from $2,500 - $5,000+. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.