Novoeight 3000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor, Recombinant Factor VIII
Pregnancy Category
Category C
FDA Approved
Oct 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Novoeight is a medicine that helps your blood clot. It's used for people with hemophilia A, a condition where the blood doesn't clot properly because they are missing a protein called Factor VIII. Novoeight replaces this missing protein, helping to stop or prevent bleeding episodes.
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 will be 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 it has changed color. After mixing, do not refrigerate the medication. It is essential to understand the shelf life of the mixed product and the appropriate storage method. If you are unsure, consult your doctor or pharmacist.
Disposal
Dispose of any unused portion of the opened vial after use. Needles and other sharp objects should be discarded 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
If you are 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 will be 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 it has changed color. After mixing, do not refrigerate the medication. It is essential to understand the shelf life of the mixed product and the appropriate storage method. If you are unsure, consult your doctor or pharmacist.
Disposal
Dispose of any unused portion of the opened vial after use. Needles and other sharp objects should be discarded 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
If you are 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
- Always carry your medication and supplies, especially when traveling.
- Follow your prescribed dosing schedule carefully, whether for prophylaxis or on-demand treatment.
- Learn to recognize the signs of bleeding and administer treatment promptly.
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene and inform your dentist about your hemophilia.
- Wear medical alert identification (e.g., bracelet or necklace).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on Factor VIII levels, bleeding severity, and patient weight. For prophylaxis: 20-40 IU/kg 2-3 times per week. For on-demand treatment: 10-50 IU/kg depending on bleed severity (e.g., minor bleed: 10-20 IU/kg; major bleed: 30-50 IU/kg).
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
prophylaxis:
20-40 IU/kg 2-3 times per week
on_demand_minor_bleed:
10-20 IU/kg
on_demand_major_bleed:
30-50 IU/kg
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Dosing is weight-based, similar to adults, but often higher frequency or dose per kg due to higher clearance in younger children. Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg.
Child:
Dosing is weight-based, similar to adults. Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg.
Adolescent:
Dosing is weight-based, similar to adults. Prophylaxis: 20-40 IU/kg 2-3 times per week. On-demand: 10-50 IU/kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Dialysis:
No specific adjustment needed; Factor VIII is not significantly cleared by the kidneys or dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant) (Novoeight) is a recombinant DNA-derived coagulation Factor VIII. It temporarily replaces the deficient endogenous Factor VIII, which is an essential cofactor for activated Factor IX (Factor IXa) in the activation of Factor X to Factor Xa. This process is crucial for the intrinsic pathway of blood coagulation, leading to the formation of thrombin and ultimately a stable fibrin clot, thereby correcting the coagulation defect in patients with hemophilia A.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.05-0.08 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in circulation, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-18 hours (terminal half-life, can vary between individuals)
Clearance:
Approximately 2.5-4.5 mL/hr/kg
ExcretionRoute:
Primarily catabolic degradation; no specific excretion route
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Immediate (at end of infusion)
DurationOfAction:
Dependent on half-life, typically 24-48 hours for clinical effect, but Factor VIII levels decline over time.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 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
A burning, numbness, or tingling feeling that is not normal
Change in color of mouth to blue
Chest pain or pressure, or a fast heartbeat
Dizziness or passing out
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling very 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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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, 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 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
A burning, numbness, or tingling feeling that is not normal
Change in color of mouth to blue
Chest pain or pressure, or a fast heartbeat
Dizziness or passing out
Feeling cold
Fever or chills
Flushing
Pale skin
Restlessness
Shortness of breath
Upset stomach or vomiting
Feeling very 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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
- Signs of inhibitor development: increased frequency or severity of bleeding, or lack of response to treatment.
- Signs of bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool, joint pain or swelling, muscle pain, severe headache.
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.
If you have an allergy to hamster or mouse protein, as this may be relevant to your treatment.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose 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 allergic reaction you experienced, including any symptoms that occurred.
If you have an allergy to hamster or mouse protein, as this may be relevant to your treatment.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose 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 or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication 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. 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 or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication 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. 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 have been reported with recombinant Factor VIII. High doses may lead to elevated Factor VIII levels, but this is generally well-tolerated.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services. Management is generally supportive. Call 1-800-222-1222 (Poison Control) for advice.
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) screening
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during initial treatment, dose adjustments, or if clinical response is suboptimal. Also, 10-30 minutes post-infusion to confirm peak levels and calculate recovery.
Target: Target levels vary based on clinical indication (e.g., 80-120% for major surgery, 40-60% for moderate bleeds, >1% for prophylaxis trough).
Action Threshold: If levels are not achieved or clinical bleeding persists, investigate for inhibitors or adjust dose.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Frequency: Regularly, especially in previously untreated patients (PUPs) or during the first 50 exposure days, and annually thereafter or if clinical response to Factor VIII is poor.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: >0.6 BU/mL indicates inhibitor presence, requiring alternative treatment strategies.
Clinical response (cessation of bleeding, absence of new bleeds)
Frequency: Continuously during treatment
Target: Resolution of bleeding symptoms
Action Threshold: Persistent or recurrent bleeding despite adequate Factor VIII levels may indicate inhibitor development or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, 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., lack of response to Factor VIII treatment, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Use during pregnancy only if clearly needed. Factor VIII is a natural component of human plasma, and its replacement is often necessary to manage bleeding in pregnant women with hemophilia A. The potential benefits should outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk as it's a replacement protein.
Second Trimester:
Limited data, but generally considered low risk.
Third Trimester:
Important for managing peripartum bleeding risk in affected mothers.
Lactation
It is not known whether Novoeight is excreted in human milk. However, Factor VIII is a natural component of human plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Novoeight and any potential adverse effects on the breastfed infant from Novoeight or from the underlying maternal condition. Generally considered compatible with breastfeeding if clinically indicated.
Infant Risk:
Low risk, as Factor VIII is a large protein unlikely to be absorbed intact by the infant.
Pediatric Use
Novoeight is approved for use in pediatric patients. Dosing is weight-based and similar to adults, but younger children may have higher clearance rates, potentially requiring more frequent or higher doses per kg. Close monitoring of Factor VIII levels and inhibitor development is crucial.
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 Factor VIII levels and clinical response, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Novoeight is a third-generation recombinant Factor VIII product, meaning it is not derived from human or animal plasma and is produced without human or animal protein additives in the cell culture or purification process, reducing theoretical risks of viral transmission.
- The dosage and frequency of administration are highly individualized based on the patient's Factor VIII levels, the severity and location of the bleeding, and the patient's clinical response.
- Patients should be educated on self-administration techniques and the importance of aseptic technique to prevent infections.
- Regular monitoring for Factor VIII inhibitors is critical, especially in previously untreated patients (PUPs) and during the first 50 exposure days, as inhibitor development can lead to treatment failure.
- Patients should be advised to report any signs of allergic reaction immediately.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Adynovate, Afstyla, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in hemophilia A with or without inhibitors.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on unit strength and pharmacy markup. per 3000 IU vial
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 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.