Nuwiq 1000unit Inj Kit
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 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 specific 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 mixed 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 any 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 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 specific 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 mixed 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 any 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 appropriate course of action.
Lifestyle & Tips
- Maintain a regular infusion schedule as prescribed by your doctor, especially for prophylaxis.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical identification (e.g., bracelet) indicating hemophilia A.
- Keep a detailed record of infusions, doses, and bleeding episodes.
- Discuss any planned surgeries or dental procedures with your healthcare provider well in advance.
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:
Highly individualized based on FVIII levels, bleeding severity, and patient weight. For on-demand treatment, 20-40 IU/kg for minor bleeds, 30-60 IU/kg for moderate, 40-80 IU/kg for severe. For prophylaxis, 20-40 IU/kg 2-3 times per week.
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
onDemandTreatment:
Target FVIII activity: Minor hemorrhage (20-40% of normal), Moderate hemorrhage (30-60% of normal), Severe hemorrhage (40-80% of normal). Dose (IU) = Body Weight (kg) Ã Desired FVIII Increase (%) Ã 0.5 (IU/kg per % increase).
prophylaxis:
20-40 IU/kg 2-3 times per week. May be adjusted based on patient response and bleeding episodes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing similar to adults based on weight and FVIII levels. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Child:
Dosing similar to adults based on weight and FVIII levels. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Adolescent:
Dosing similar to adults based on weight and FVIII levels. Prophylaxis: 20-40 IU/kg 2-3 times per week.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; Factor VIII is a large protein not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
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 acts as a cofactor for Factor IXa, accelerating the conversion of Factor X to Factor Xa. Factor Xa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, leading to clot formation. Nuwiq is produced in a human cell line (HEK 293F) and is devoid of human or animal-derived additives in the cell culture, purification, and final formulation.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect after IV administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.04-0.06 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, but Nuwiq is a B-domain deleted rFVIII that does not require vWF for stability or transport, leading to a longer half-life compared to some other FVIII products.
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 17.9 Âą 4.5 hours (range 12.1-27.9 hours) in adults and adolescents; 13.9 Âą 3.1 hours in children (6-11 years); 11.9 Âą 2.6 hours in children (2-5 years).
Clearance:
Approximately 2.8 Âą 0.7 mL/hr/kg in adults and adolescents.
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak FVIII activity)
DurationOfAction:
Dependent on half-life and initial dose; typically maintains therapeutic levels for 2-3 days for prophylaxis.
Confidence:
High
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency medical attention:
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 immediately or seek emergency medical attention:
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 (especially of the face, lips, tongue, or throat), dizziness, lightheadedness, shortness of breath, chest tightness, wheezing.
- Signs of inhibitor development: increased frequency or severity of bleeding, bleeding that doesn't stop after treatment, or a need for higher doses to control bleeding.
- Signs of thrombosis (rare): pain, swelling, warmth, or redness in an arm or leg; sudden chest pain; sudden shortness of breath; sudden vision changes; slurred speech.
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 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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:
- While overdose is unlikely to cause severe adverse effects due to the nature of the protein, very high levels of Factor VIII could theoretically increase the risk of thrombotic events.
What to Do:
In case of suspected overdose, 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).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) titers
Rationale: To detect pre-existing inhibitors which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during initial treatment, surgery, or severe bleeding episodes. For prophylaxis, periodically to ensure adequate trough levels.
Target: Dependent on clinical situation (e.g., >1% for prophylaxis, 20-100% for bleeding/surgery).
Action Threshold: If levels are not within target range, adjust dose or frequency.
Inhibitor (neutralizing antibody) titers
Frequency: Regularly (e.g., every 3-6 months, or more frequently in the first 50 exposure days, or if bleeding is not controlled).
Target: Negative or <0.6 BU/mL (Bethesda Units).
Action Threshold: If inhibitor levels rise, especially >0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical signs of bleeding or thrombosis
Frequency: Continuously by patient/caregiver and during clinical visits.
Target: Absence of uncontrolled bleeding or thrombotic events.
Action Threshold: If bleeding occurs, increase dose or frequency; if thrombosis occurs, investigate and manage appropriately.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, shortness of breath, chest tightness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to Factor VIII treatment)
Special Patient Groups
Pregnancy
Use only if clearly needed. Hemophilia A is rare in women, but Factor VIII levels may increase during pregnancy. Close monitoring of Factor VIII levels is recommended, especially during the third trimester and around delivery, to manage bleeding risk.
Trimester-Specific Risks:
First Trimester:
No specific risks identified.
Second Trimester:
No specific risks identified.
Third Trimester:
Factor VIII levels may increase naturally, but monitoring is crucial to ensure adequate levels for delivery and to prevent postpartum hemorrhage.
Lactation
It is unknown if Nuwiq is excreted in human milk. However, Factor VIII is a large protein and is unlikely to be absorbed systemically by the infant. The benefits of breastfeeding should be weighed against any potential risks. Generally considered low risk.
Infant Risk:
Low risk
Pediatric Use
Nuwiq is approved for use in pediatric patients of all ages. Dosing is individualized based on weight, FVIII levels, and clinical response. Children, especially younger ones, may have a faster Factor VIII clearance and may require higher doses or more frequent administration compared to adults.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on FVIII levels and clinical response, similar to younger adults. No specific dose adjustments are generally required based on age alone.
Clinical Information
Clinical Pearls
- Nuwiq is a B-domain deleted recombinant Factor VIII produced in a human cell line, which means it is free from human or animal-derived protein additives in its manufacturing process, potentially reducing the risk of viral transmission and allergic reactions to non-human proteins.
- Its pharmacokinetic profile, particularly its half-life, can be advantageous for prophylaxis, potentially allowing for less frequent infusions compared to some other FVIII products.
- Patients should be educated on proper aseptic technique for reconstitution and administration to prevent infections.
- Always have a bleeding diary to record infusions, bleeding episodes, and any adverse reactions.
- The development of Factor VIII inhibitors is a serious complication of hemophilia A treatment. Patients should be monitored regularly for inhibitor development, especially during the first 50 exposure days.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate, Novoeight, Recombinate, Xyntha)
- Plasma-derived Factor VIII products (e.g., Hemofil M, Koate-DVI)
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in patients with or without inhibitors.
- Bypassing agents (e.g., FEIBA, NovoSeven RT) - used for bleeding episodes in patients with inhibitors.
Cost & Coverage
Average Cost:
Extremely high, varies by unit strength (e.g., 1000 IU kit). per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy plans for hemophilia A)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.