Novoeight 250unit 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
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, a condition where the blood doesn't clot properly. It works by replacing a missing protein in the blood called Factor VIII, which is essential for blood clotting.
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 instruct you 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. Discard any unused portion of the opened vial after use, and dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the full box.
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 instruct you 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. Discard any unused portion of the opened vial after use, and dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the full box.
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
- Administer as directed by your healthcare provider, typically by intravenous (IV) injection.
- Keep a detailed record of each infusion, including date, time, dose, and lot number.
- Store the medication as directed (refrigerated or at room temperature, depending on specific product instructions, but protect from light). Do not freeze.
- Do not shake the vial.
- Report any signs of bleeding or allergic reactions immediately to your doctor.
- Carry identification indicating you have hemophilia A and are on Factor VIII replacement therapy.
- Avoid activities that carry a high risk of injury or bleeding.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's Factor VIII level, type of bleeding, and body weight. For on-demand treatment of bleeding episodes: 20-40 IU/kg for minor to moderate bleeding, 40-60 IU/kg for major bleeding. For routine prophylaxis: 20-40 IU/kg 2-3 times per week.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
onDemandTreatmentMinorModerateBleeding:
20-40 IU/kg
onDemandTreatmentMajorBleeding:
40-60 IU/kg
routineProphylaxis:
20-40 IU/kg 2-3 times per week
perioperativeManagement:
Initial dose 40-60 IU/kg, then adjust to maintain Factor VIII levels
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Individualized based on patient's Factor VIII level, type of bleeding, and body weight. Similar to adult dosing, but often higher per kg due to higher clearance in younger children. For routine prophylaxis: 20-40 IU/kg 2-3 times per week.
Child:
Individualized based on patient's Factor VIII level, type of bleeding, and body weight. Similar to adult dosing, but often higher per kg due to higher clearance in younger children. For routine prophylaxis: 20-40 IU/kg 2-3 times per week.
Adolescent:
Individualized based on patient's Factor VIII level, type of bleeding, and body weight. Similar to adult dosing. For routine prophylaxis: 20-40 IU/kg 2-3 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 removed 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 deficient coagulation Factor VIII that is necessary 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 with IV administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Not applicable (circulates as a complex with von Willebrand factor)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-18 hours (terminal half-life)
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolic degradation, no specific excretion route
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Dependent on half-life and Factor VIII levels achieved, typically 12-24 hours for clinical effect, but Factor VIII levels decline over 2-3 days.
Confidence:
High
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 attention immediately:
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 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 attention immediately:
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 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:
- Hives, rash, itching
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Chest tightness
- Dizziness or faintness
- Sudden severe headache
- Vision changes
- Weakness or numbness on one side of the body
- Slurred speech
- Unusual bruising or bleeding that doesn't stop
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, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Inform your doctor and pharmacist about any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication, including this one, to ensure your safety and optimal treatment outcomes.
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, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Inform your doctor and pharmacist about any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication, including this one, to ensure your safety and optimal treatment outcomes.
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 product, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots).
What to Do:
In case of suspected overdose, contact a healthcare professional or poison control center immediately (Call 1-800-222-1222). Management is supportive and may involve monitoring for signs of thrombosis.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to first administration and periodically thereafter.
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to first administration.
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after initial dose, then as clinically indicated (e.g., before subsequent doses, during bleeding episodes, before surgery).
Target: Depends on clinical situation (e.g., >1% for prophylaxis, >30% for minor bleeding, >80-100% for major surgery).
Action Threshold: If levels are not achieved or bleeding persists, consider inhibitor development or increased clearance.
Inhibitor (neutralizing antibody) assay (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months for previously untreated patients, annually for previously treated patients, or if treatment efficacy decreases).
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: Positive result (≥0.6 BU/mL) indicates inhibitor development, requiring alternative treatment strategies.
Signs and symptoms of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion.
Target: N/A
Action Threshold: Stop infusion immediately if symptoms occur.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, nosebleeds)
- Signs of hypersensitivity/allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., decreased efficacy of Factor VIII treatment, recurrent bleeding despite adequate dosing)
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 management during pregnancy and delivery requires careful consideration.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of fetal exposure.
Second Trimester:
Limited data.
Third Trimester:
Limited data, potential need for Factor VIII replacement during labor and delivery to prevent bleeding complications.
Lactation
L3 (Moderately Safe). It is not known whether Novoeight is excreted in human milk. 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. Factor VIII is a large protein and unlikely to be absorbed intact by the infant.
Infant Risk:
Low risk, but caution advised due to lack of data.
Pediatric Use
Novoeight is approved for use in pediatric patients with hemophilia A, including neonates. Dosing is individualized based on weight and Factor VIII levels. Younger children may require higher doses per kg due to higher clearance rates.
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.
- It has an extended half-life compared to some older Factor VIII products, which may allow for less frequent dosing in prophylaxis.
- Always reconstitute the product immediately before use and administer within 3 hours of reconstitution.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs), as this is a significant complication of Factor VIII replacement therapy.
- Patients should be educated on self-administration techniques and proper storage.
- Ensure patients have access to emergency contact information and a hemophilia treatment center.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Hemlibra (emicizumab - a Factor IXa/X bispecific antibody, not a Factor VIII replacement but used for prophylaxis), Adynovate, Xyntha, Kogenate FS, Recombinate)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Desmopressin (DDAVP) for mild hemophilia A
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and quantity. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by medical benefit)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.