Novoeight 500unit Inj, 1 Vial
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 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Novoeight 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. Novoeight replaces this missing protein, helping your blood to clot normally and stop bleeding.
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.
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, and you should follow the instructions provided by your doctor. Avoid shaking the medication, and do not use it if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication. It is essential to understand the shelf life of the mixed product and the proper storage procedure. If you are unsure, consult your doctor or pharmacist. 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, and never reused. 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 you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
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.
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, and you should follow the instructions provided by your doctor. Avoid shaking the medication, and do not use it if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication. It is essential to understand the shelf life of the mixed product and the proper storage procedure. If you are unsure, consult your doctor or pharmacist. 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, and never reused. 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 you are using this medication at home, store unopened containers in the refrigerator, but do not freeze.
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 with you, especially when traveling.
- Wear a medical alert bracelet or necklace indicating you have hemophilia A.
- Avoid activities that carry a high risk of injury or bleeding.
- Avoid medications that interfere with blood clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically advised by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your doctor's instructions for regular infusions, even if you feel well, to prevent bleeding episodes (prophylaxis).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient's factor VIII levels, bleeding severity, and body weight. Dosing is calculated to achieve a desired factor VIII activity level. For on-demand treatment of bleeding episodes: 10-50 IU/kg depending on bleed severity. For routine prophylaxis: 20-50 IU/kg 2-3 times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
minor_hemorrhage:
10-20 IU/kg to achieve 20-40% FVIII activity, repeat every 12-24 hours as needed.
moderate_hemorrhage:
20-40 IU/kg to achieve 40-80% FVIII activity, repeat every 8-24 hours as needed.
major_hemorrhage_or_surgery:
30-50 IU/kg to achieve 60-100% FVIII activity, repeat every 8-24 hours as needed to maintain target levels.
Pediatric Dosing
Neonatal:
Not established (use in neonates is rare and highly specialized, typically plasma-derived FVIII if needed).
Infant:
Dosing is individualized based on weight and desired FVIII levels, similar to older children/adults (e.g., 20-50 IU/kg for prophylaxis).
Child:
Dosing is individualized based on weight and desired FVIII levels, similar to adults (e.g., 20-50 IU/kg for prophylaxis).
Adolescent:
Dosing is individualized based on weight and desired FVIII levels, similar to adults (e.g., 20-50 IU/kg for prophylaxis).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; not significantly cleared by 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) is a glycoprotein that temporarily replaces the missing coagulation factor VIII (FVIII) in patients with hemophilia A. FVIII is an essential cofactor for activated factor IX (FIXa) in the intrinsic pathway of coagulation, accelerating the activation of factor X (FX) to factor Xa (FXa). FXa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, forming a stable clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (peak activity achieved shortly after infusion completion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05-0.08 L/kg
ProteinBinding:
Primarily binds to von Willebrand factor (vWF) in plasma, which stabilizes FVIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-18 hours (terminal half-life, can vary between individuals)
Clearance:
Approximately 2-5 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route (e.g., renal/hepatic) for intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on half-life and initial dose, typically 12-24 hours for significant therapeutic effect, but can extend up to 48 hours for some residual activity.
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 unusual 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 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, 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 unusual 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 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 bleeding: new or worsening joint pain/swelling, unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stools, severe headache (could indicate brain bleed).
- Signs of allergic reaction: rash, hives, itching, facial swelling, difficulty breathing, wheezing, chest tightness, dizziness, fainting. Seek immediate medical attention.
- Signs of inhibitor development: if your usual dose of Novoeight doesn't stop bleeding as effectively as it used to, or if you need more frequent doses.
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.
If you are allergic 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. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other treatments.
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.
If you are allergic 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. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other treatments.
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 acute overdose is unlikely to cause severe adverse effects beyond potential transient elevation of FVIII levels, very high levels could theoretically increase the risk of thrombosis (blood clots), though this is rare in hemophilia patients.
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is generally supportive. For severe symptoms, call 911 or your local emergency number. For poison control, call 1-800-222-1222.
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) screening
Rationale: To detect pre-existing inhibitors that could render therapy ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically during treatment, especially for surgical prophylaxis or severe bleeding, to ensure adequate levels are maintained. For routine prophylaxis, less frequent monitoring may be sufficient.
Target: Varies based on clinical situation (e.g., 20-40% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: If levels are below target or clinical response is inadequate, consider dose adjustment or inhibitor testing.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly, especially in the first 50 exposure days or annually for patients on prophylaxis, or if clinical response to treatment is suboptimal.
Target: Negative (less than 0.6 Bethesda Units/mL)
Action Threshold: Positive inhibitor titer requires consultation with a hemophilia treatment center for management (e.g., immune tolerance induction, bypassing agents).
Clinical response (cessation of bleeding, absence of new bleeding episodes)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding despite adequate FVIII levels suggests potential inhibitor development or other complications.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, difficulty breathing, chest tightness, dizziness)
- Signs of inhibitor development (e.g., lack of response to previously effective doses of factor VIII)
Special Patient Groups
Pregnancy
Use in pregnancy should be considered only if clearly needed. Hemophilia A is rare in females, but carriers may have lower FVIII levels and be at increased risk of bleeding during pregnancy and delivery. Factor VIII replacement may be necessary to manage bleeding complications. Consult with a hematologist and obstetrician.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified.
Second Trimester:
No specific increased risk identified.
Third Trimester:
Increased risk of bleeding during labor and delivery for carriers with low FVIII levels; Factor VIII replacement may be required.
Lactation
It is unknown if Novoeight is excreted in human milk. However, as a large protein, it is unlikely to be absorbed systemically by the infant. The benefits of breastfeeding should be weighed against any potential risks. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk to the infant.
Pediatric Use
Novoeight is approved for use in pediatric patients with hemophilia A. Dosing is weight-based and individualized. Pediatric patients, especially young children, may have a higher risk of inhibitor development, requiring close monitoring.
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 clinical response and FVIII levels, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Novoeight is a standard half-life recombinant Factor VIII product. Patients requiring extended half-life products may be switched to other formulations.
- Always reconstitute Novoeight according to package insert instructions using the provided diluent and administration set.
- Administer intravenously over several minutes (typically 1-10 minutes) at a rate comfortable for the patient.
- Do not mix Novoeight with other intravenous medications or solutions.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) and during the first 50 exposure days.
- Patients should be educated on self-administration techniques, signs of bleeding, and symptoms of allergic reactions.
- Regular follow-up with a Hemophilia Treatment Center (HTC) is crucial for comprehensive care, including inhibitor testing and management.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Hemlibra (emicizumab) - a non-factor bypassing agent)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Gene therapy (e.g., Roctavian) for severe hemophilia A
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and pharmacy acquisition cost. per 500 IU 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 is 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 it's a good idea 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 medication taken, the amount, and the time it happened.