Novoeight 1000unit 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 condition where your blood doesn't clot properly because you don't have enough of a protein called Factor VIII. Novoeight replaces this missing protein, helping your blood to clot normally.
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; 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. Be aware of the product's expiration time and storage instructions after mixing; consult your doctor or pharmacist if you are unsure.
Dispose of any unused portion of the opened vial after use. Properly discard 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 its 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. 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 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; 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. Be aware of the product's expiration time and storage instructions after mixing; consult your doctor or pharmacist if you are unsure.
Dispose of any unused portion of the opened vial after use. Properly discard 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 its 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. 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 with you.
- Follow your doctor's instructions for dosing and administration carefully.
- Keep a detailed record of your infusions, including date, time, dose, and reason for infusion.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear a medical alert bracelet or carry an identification card stating you have hemophilia A.
- Maintain good dental hygiene to prevent gum bleeding.
- Discuss any planned surgeries or dental procedures with your healthcare provider well in advance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII levels, type of bleed, and patient weight. Dosing is expressed in International Units (IU). For on-demand treatment of bleeding episodes, 20-40 IU/kg for minor to moderate bleeds, 30-60 IU/kg for major bleeds. For routine prophylaxis, 20-50 IU/kg 2-3 times per week.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
onDemandTreatment:
Target Factor VIII activity: Minor/Moderate Hemorrhage (e.g., joint, muscle, oral bleed): 20-40 IU/kg to achieve 40-80% activity. Major Hemorrhage (e.g., intracranial, retroperitoneal, GI bleed): 30-60 IU/kg to achieve 60-100% activity. Surgical Prophylaxis: 30-60 IU/kg pre-op to achieve 60-100% activity, then maintain 30-60% activity for 1-2 weeks.
routineProphylaxis:
20-50 IU/kg 2-3 times per week. Adjust based on patient response.
Pediatric Dosing
Neonatal:
Not established (use in neonates is rare and highly individualized by specialist)
Infant:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical need. Routine prophylaxis: 20-50 IU/kg 2-3 times per week.
Child:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical need. Routine prophylaxis: 20-50 IU/kg 2-3 times per week.
Adolescent:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical need. Routine prophylaxis: 20-50 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 (IV 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:
Limited
Elimination:
HalfLife:
Mean terminal half-life is approximately 12-18 hours (range 9-25 hours), can vary between individuals.
Clearance:
Approximately 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally or hepatically excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak Factor VIII activity)
DurationOfAction:
Dependent on half-life and initial dose; typically maintains therapeutic levels for 24-48 hours, requiring repeat dosing for sustained effect.
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
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, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
Irritation at the injection site
* Headache
This is not an exhaustive list of potential 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
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, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
Irritation at the injection site
* Headache
This is not an exhaustive list of potential 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: unusual bruising, prolonged bleeding from minor cuts, nosebleeds, blood in urine or stools, joint pain or swelling (indicating a joint bleed), severe headache (may indicate brain bleed).
- Signs of allergic reaction: rash, hives, itching, redness, swelling of the face, lips, tongue, or throat, difficulty breathing, wheezing, chest tightness, dizziness, feeling faint.
- Signs of inhibitor development: if your usual dose of Novoeight doesn't stop a bleed, or if you need much higher doses than expected.
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.
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
Any existing health problems, 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.
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
Any existing health problems, 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. 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.
If you experience unexplained bruising, 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:
- 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.
- Symptoms would be related to excessive clotting, such as chest pain, shortness of breath, swelling/pain in a limb.
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) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Baseline Factor VIII activity levels
Rationale: To determine the severity of hemophilia A and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) assay
Rationale: To detect pre-existing inhibitors to Factor VIII, which can affect treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during initial treatment, before and after surgery, or if bleeding is not controlled.
Target: Dependent on clinical situation (e.g., 40-80% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: If levels are not within target range or bleeding persists, adjust dose or frequency.
Inhibitor (neutralizing antibody) assay
Frequency: Regularly (e.g., every 3-6 months, or more frequently in high-risk patients, or if bleeding is not controlled with expected doses).
Target: Negative (less than 0.6 Bethesda Units/mL).
Action Threshold: If inhibitors develop, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Signs and symptoms of hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: N/A
Action Threshold: Stop infusion immediately if signs of anaphylaxis or severe hypersensitivity 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., lack of expected Factor VIII activity increase, persistent bleeding despite adequate dosing)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Novoeight in pregnant women. Animal reproduction studies have not been conducted. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Hemophilia A is rare in women, but treatment may be necessary for bleeding complications during pregnancy or delivery.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk is low as it's a replacement protein.
Second Trimester:
Limited data, theoretical risk is low.
Third Trimester:
Limited data, theoretical risk is low. May be used to manage bleeding complications during labor and delivery if indicated.
Lactation
L3 (Moderately Safe). It is not known whether Novoeight is excreted in human milk. Endogenous Factor VIII is a normal 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. Consult with a healthcare provider.
Infant Risk:
Low risk. Factor VIII is a large protein and unlikely to be absorbed intact by the infant. No known adverse effects reported.
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 compared to adults, requiring close monitoring.
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. Dosing should be individualized based on Factor VIII levels and clinical response, similar to younger adults. No specific dose adjustments are generally required based on age alone.
Clinical Information
Clinical Pearls
- Novoeight is a B-domain deleted recombinant Factor VIII, which may have implications for its immunogenicity profile compared to full-length Factor VIII products.
- Always reconstitute Novoeight according to the manufacturer's instructions, using the provided diluent and administration set.
- Administer intravenously over several minutes (typically 2-5 minutes). Do not administer by continuous infusion.
- Patients should be educated on self-administration techniques, proper storage, and signs of bleeding or adverse reactions.
- Regular monitoring for Factor VIII inhibitors is crucial, especially in previously untreated patients (PUPs) and minimally treated patients (MTPs), as inhibitor development is the most serious complication of Factor VIII replacement therapy.
- Ensure patients understand the importance of adherence to prophylactic regimens to prevent bleeding episodes and associated joint damage.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Kogenate FS, Recombinate, Xyntha, Adynovate, Afstyla, Esperoct)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate (aPCC) like FEIBA, recombinant Factor VIIa (rFVIIa) like NovoSeven RT)
- Non-factor therapies (e.g., Emicizumab (Hemlibra) for prophylaxis in patients with or without inhibitors)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and quantity. per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for hemophilia A patients)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.