Novoeight 2000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor VIII
Pregnancy Category
Category C
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 genetic disorder where the blood doesn't clot properly because of a missing protein called Factor VIII. Novoeight replaces this missing protein, helping your blood to clot 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.
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. 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.
Disposal and Storage
After use, discard any remaining medication from the opened vial. Dispose of needles and other sharp objects in a designated 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, consult your doctor or pharmacist.
Storage of Unopened Containers
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 its color has changed. 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.
Disposal and Storage
After use, discard any remaining medication from the opened vial. Dispose of needles and other sharp objects in a designated 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, consult your doctor or pharmacist.
Storage of Unopened Containers
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
- Maintain a regular treatment schedule as prescribed by your doctor, especially for prophylaxis.
- Carry your medication and emergency contact information at all times.
- Avoid activities that carry a high risk of injury or bleeding.
- Inform all healthcare providers (dentists, other specialists) that you have hemophilia and are on Factor VIII replacement therapy.
- Learn how to self-administer the medication safely and aseptically.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient's Factor VIII level, type and severity of bleeding, and patient's clinical condition. Dosing is expressed in International Units (IU). 1 IU/kg body weight is expected to increase Factor VIII activity by approximately 2 IU/dL (2%).
Condition-Specific Dosing:
onDemandTreatment:
Initial dose: 20-40 IU/kg for minor bleeding; 30-60 IU/kg for moderate bleeding; 40-80 IU/kg for major bleeding. Subsequent doses and frequency based on clinical response and Factor VIII levels.
prophylaxis:
20-50 IU/kg two to three times per week. Adjust frequency and dose based on patient response and bleeding episodes.
surgicalProphylaxis:
Pre-operative dose: 30-60 IU/kg to achieve Factor VIII levels of 80-120% of normal. Post-operative doses as needed to maintain levels.
Pediatric Dosing
Neonatal:
Not established (use in neonates is rare and highly specialized)
Infant:
Dosing is similar to adults on a per kg basis, but careful monitoring is crucial. Prophylaxis: 20-50 IU/kg two to three times per week.
Child:
Dosing is similar to adults on a per kg basis. Prophylaxis: 20-50 IU/kg two to three times per week.
Adolescent:
Dosing is similar to adults on a per kg basis. Prophylaxis: 20-50 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.
Dialysis:
No specific dose adjustment recommended. Factor VIII is a large protein and 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) (Novoeight) is a recombinant DNA-derived coagulation Factor VIII. It temporarily replaces the missing coagulation Factor VIII that is needed for effective hemostasis in patients with hemophilia A. Factor VIII acts as a cofactor for Factor IXa in the activation of Factor X to Factor Xa, which ultimately leads to the formation of thrombin and fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect after IV administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05-0.08 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 12-18 hours (terminal half-life, varies between individuals)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Dependent on half-life and initial dose, typically 24-48 hours for a single dose to maintain hemostatic levels, but clinical effect may last longer depending on the bleeding severity and target factor level.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
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, facial swelling, shortness of breath, chest tightness, dizziness, faintness. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding episodes, bleeding that doesn't stop with your usual dose of Novoeight. Report these to your doctor immediately.
- Any new or unusual bleeding that is difficult to control.
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 potential interactions with other medications or health conditions. To ensure safe treatment, your doctor and pharmacist need to know about all the medications you are taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any health problems you have, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure your safety and the effectiveness of your treatment.
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 potential interactions with other medications or health conditions. To ensure safe treatment, your doctor and pharmacist need to know about all the medications you are taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any health problems you have, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure your safety and the effectiveness of your treatment.
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 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, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. These symptoms may indicate 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:
- While overdose is unlikely to cause acute toxicity due to the nature of the protein, very high levels of Factor VIII could theoretically increase the risk of thrombosis, though this is rare in hemophilia patients.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is generally supportive. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To establish baseline Factor VIII deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) assay (Bethesda assay)
Rationale: To detect pre-existing Factor VIII inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity level
Frequency: Regularly during treatment, especially for surgical procedures or severe bleeding episodes; periodically for prophylaxis.
Target: Dependent on clinical situation (e.g., 80-120% for major surgery, 30-60% for moderate bleeding, >1% for prophylaxis).
Action Threshold: If levels are not within target range, adjust dose or frequency.
Inhibitor (neutralizing antibody) assay (Bethesda assay)
Frequency: Periodically (e.g., every 3-6 months) or if expected Factor VIII levels are not achieved, or if bleeding is not controlled with adequate dosing.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor levels are detected or rise significantly, consider alternative treatments or immune tolerance induction.
Clinical response (cessation of bleeding, absence of new bleeding episodes)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: If bleeding persists or recurs, re-evaluate Factor VIII levels, inhibitor status, and consider dose adjustment or alternative therapy.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of allergic reaction (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 episodes, poor response to previously effective doses)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Novoeight in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Hemophilia A is rare in women, but Factor VIII levels may increase during pregnancy, requiring careful monitoring.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of adverse effects on fetal development, but unlikely given the large protein nature.
Second Trimester:
Limited data.
Third Trimester:
Limited data. Factor VIII levels may rise naturally in late pregnancy, potentially reducing the need for exogenous factor, but individual monitoring is essential, especially around delivery.
Lactation
It is unknown whether Novoeight is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Novoeight is administered to a nursing woman. The large molecular weight makes significant transfer into breast milk unlikely.
Infant Risk:
Risk is considered low due to the large molecular weight of Factor VIII, which is unlikely to be absorbed intact by the infant.
Pediatric Use
Novoeight is approved for use in pediatric patients with hemophilia A. Dosing is weight-based and similar to adults. Pediatric patients, especially previously untreated patients (PUPs), have a higher risk of developing Factor VIII inhibitors. Close monitoring for inhibitor development is crucial.
Geriatric Use
Clinical studies of Novoeight 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
- 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.
- Always reconstitute Novoeight immediately before use and administer within 3 hours of reconstitution.
- Administer intravenously over several minutes (e.g., 2-5 minutes). Do not administer faster than 10 mL/minute.
- Patients should be educated on the signs and symptoms of inhibitor development, as this is the most serious complication of Factor VIII replacement therapy.
- Regular Factor VIII activity monitoring is essential to ensure adequate hemostatic levels, especially during acute bleeding or surgery.
- Patients should be advised to report any signs of allergic reaction immediately.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Hemlibra (emicizumab - a Factor IXa/X bispecific antibody, not a Factor VIII replacement but a prophylactic alternative))
- 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:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on unitage) per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans due to medical necessity for hemophilia A)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance. 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.