Novoeight 1500unit 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 that helps your blood clot. People with hemophilia A don't have enough of a natural protein called Factor VIII, which is needed for blood to clot properly. 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 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.
Disposal
After use, discard any unused portion of the opened vial. Dispose of needles and other sharp objects 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, 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 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.
Disposal
After use, discard any unused portion of the opened vial. Dispose of needles and other sharp objects 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, 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
- Administer Novoeight as prescribed by your doctor, either to stop bleeding or to prevent it regularly (prophylaxis).
- Learn proper infusion techniques if you are self-infusing at home.
- Keep a detailed log of all infusions, including date, time, dose, and reason for infusion (e.g., bleeding location, prophylaxis).
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical alert identification (e.g., bracelet, necklace) indicating you have hemophilia A.
- Maintain good dental hygiene and inform your dentist about your hemophilia.
- Discuss all medications, including over-the-counter drugs and supplements, with your doctor, especially those that affect blood clotting (e.g., aspirin, NSAIDs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII levels, bleeding severity, and patient weight. For on-demand treatment of bleeding episodes, typical doses range from 10-50 IU/kg. For prophylaxis, typical doses are 20-50 IU/kg 2-3 times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
on_demand_bleeding:
10-50 IU/kg IV, repeat as needed based on clinical response and Factor VIII levels.
surgical_prophylaxis:
Pre-operative: 50 IU/kg IV to achieve 100% FVIII activity. Post-operative: 25-50 IU/kg IV every 8-24 hours for 1-14 days depending on surgery type.
routine_prophylaxis:
20-50 IU/kg IV 2-3 times per week.
Pediatric Dosing
Neonatal:
Not established (use in neonates with hemophilia A is rare and highly individualized by specialist).
Infant:
Dosing is individualized based on weight, bleeding severity, and Factor VIII levels, similar to older children. Prophylaxis typically 20-50 IU/kg 2-3 times per week.
Child:
Dosing is individualized based on weight, bleeding severity, and Factor VIII levels. Prophylaxis typically 20-50 IU/kg 2-3 times per week.
Adolescent:
Dosing is individualized based on weight, bleeding severity, and Factor VIII levels, similar to adults. Prophylaxis typically 20-50 IU/kg 2-3 times per week.
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 a large protein and 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) (Novoeight) is a recombinant DNA-derived coagulation Factor VIII. It temporarily replaces the missing 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 is a crucial step in the intrinsic coagulation pathway, leading to thrombin generation and fibrin clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, peak activity is immediate post-infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 40-60 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-19 hours (terminal half-life, varies between individuals)
Clearance:
Approximately 2.5-5 mL/hr/kg
ExcretionRoute:
Metabolites excreted via renal and biliary routes; intact protein is not excreted.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of IV infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life and initial dose; typically 8-24 hours for significant hemostatic effect, but Factor VIII levels decline over time. Clinical effect can last longer depending on the target Factor VIII level for the specific bleeding event.
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. 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 or seek medical help:
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.
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. 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 or seek medical help:
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 bleeding: new or worsening joint pain/swelling, muscle pain/swelling, unusual bruising, nosebleeds that won't stop, blood in urine or stool, prolonged bleeding from cuts, severe headache (could indicate brain bleed).
- Signs of allergic reaction: rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing, chest tightness, wheezing, dizziness, fainting. **Seek immediate medical attention if these occur.**
- Signs of inhibitor development: increased frequency or severity of bleeding, or if your usual dose of Novoeight doesn't stop bleeding as 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.
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 health conditions.
Any existing health problems you have, as these may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to review all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 health conditions.
Any existing health problems you have, as these may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to review all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 evaluations 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 to last throughout 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 to last throughout 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 (blood clots), though this is rare in hemophilia patients.
What to Do:
In case of suspected overdose, contact your healthcare provider or poison control center immediately (1-800-222-1222). Management would be supportive and focused on monitoring for thrombotic events, though specific antidote is not available or typically needed.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To confirm diagnosis of hemophilia A and establish baseline deficiency.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity level
Frequency: During treatment of bleeding episodes (e.g., 1-2 hours post-infusion, then as clinically indicated) and periodically during prophylaxis (e.g., trough levels before next dose).
Target: Dependent on indication (e.g., >30% for minor bleeds, >80-100% for major bleeds/surgery).
Action Threshold: Adjust dose or frequency if levels are not within target range or if bleeding is not controlled.
Inhibitor (neutralizing antibody) screen
Frequency: Regularly, especially in the first 50 exposure days or if treatment efficacy decreases (e.g., every 3-6 months for previously untreated patients, annually for previously treated patients, or if bleeding is not controlled with expected doses).
Target: Negative
Action Threshold: If positive, consider immune tolerance induction (ITI) or switch to bypassing agents.
Clinical response (bleeding episodes)
Frequency: Continuously during treatment.
Target: Cessation of bleeding, resolution of symptoms.
Action Threshold: If bleeding persists or recurs, re-evaluate Factor VIII levels, consider inhibitor development, or adjust dose.
Signs of hypersensitivity/allergic reaction
Frequency: During and immediately after infusion.
Target: Absence of symptoms (e.g., rash, urticaria, dyspnea, hypotension).
Action Threshold: Stop infusion immediately, provide supportive care.
Symptom Monitoring
- Bleeding (e.g., joint pain/swelling, muscle hematoma, epistaxis, gastrointestinal bleeding, hematuria, prolonged bleeding from minor cuts)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, fainting)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to Factor VIII treatment)
Special Patient Groups
Pregnancy
Use only if clearly needed. Factor VIII levels naturally increase during pregnancy, but individual monitoring is crucial. Consult a hematologist and obstetrician.
Trimester-Specific Risks:
First Trimester:
Limited data. Risk of Factor VIII deficiency in the fetus is possible if the fetus is male and affected.
Second Trimester:
Limited data. Monitoring of maternal Factor VIII levels is important.
Third Trimester:
Factor VIII levels typically rise in the third trimester. Close monitoring of Factor VIII levels is essential, especially around delivery, to manage bleeding risk for the mother and potentially the neonate.
Lactation
It is not known whether Novoeight is excreted in human milk. Consider the developmental and health benefits of breastfeeding 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:
L3 - Moderate risk. While unlikely to be harmful due to large molecular size and poor oral bioavailability, caution is advised due to lack of specific data.
Pediatric Use
Novoeight is approved for use in pediatric patients, including neonates, infants, children, and adolescents with hemophilia A. Dosing is weight-based and individualized. Inhibitor development is a significant concern, particularly in previously untreated patients (PUPs).
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 plasma and is manufactured without human or animal protein additives in the cell culture or purification process.
- The primary serious complication of Factor VIII replacement therapy is the development of inhibitors (neutralizing antibodies), which can render the treatment ineffective. Patients should be monitored regularly for inhibitor development.
- Dosing is highly individualized and guided by Factor VIII activity levels, clinical response, and the type/severity of bleeding or surgical procedure.
- Patients should be educated on early recognition of bleeding symptoms and signs of allergic reactions.
- Proper storage (refrigerated or room temperature for limited periods) and reconstitution are crucial for product efficacy and safety.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Hemlibra (emicizumab - a bispecific antibody mimicking FVIIIa), Adynovate, Afstyla, Xyntha, Kogenate FS, Recombinate)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Bypassing agents (for patients with inhibitors): Activated Prothrombin Complex Concentrate (aPCC, e.g., FEIBA), Recombinant Factor VIIa (rFVIIa, e.g., NovoSeven RT)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy for mucosal bleeding.
- Desmopressin (DDAVP) for mild hemophilia A (not effective for severe hemophilia A or Novoeight patients).
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength (e.g., 1500 IU vial). per 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 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 consult with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, including its use, potential side effects, or interactions, discuss your concerns 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 name of the medication, the amount taken, and the time it was taken.