Novoseven Rt 1mg Inj, 1 Vial
WARNING: Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm. @ COMMON USES: It is used to treat or prevent bleeding.
Drug Class
Hemostatic agent
Pharmacologic Class
Coagulation factor, recombinant
Pregnancy Category
Category C
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
NovoSeven RT is a medicine that helps your blood clot. It is used for people who have certain bleeding disorders, like hemophilia with inhibitors, or other conditions where their blood doesn't clot properly. It works by helping your body form a strong clot to stop bleeding.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all accompanying information and adhere to the provided guidelines. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
Prior to use, this medication must be mixed according to the instructions provided by your doctor. After mixing, the solution can be stored at room temperature or in the refrigerator for up to 3 hours. However, do not use the solution if it appears cloudy, is leaking, contains particles, or has changed color.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Never reuse needles or other items. Once the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Before mixing, store the medication at room temperature or in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on the appropriate course of action.
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all accompanying information and adhere to the provided guidelines. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
Prior to use, this medication must be mixed according to the instructions provided by your doctor. After mixing, the solution can be stored at room temperature or in the refrigerator for up to 3 hours. However, do not use the solution if it appears cloudy, is leaking, contains particles, or has changed color.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Never reuse needles or other items. Once the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Before mixing, store the medication at room temperature or in the refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on the appropriate course of action.
Lifestyle & Tips
- Report any new or worsening bleeding immediately to your healthcare provider.
- Report any signs of a blood clot (e.g., chest pain, shortness of breath, swelling/pain in an arm or leg, sudden weakness or numbness) immediately.
- Avoid activities that could lead to injury or bleeding, especially during active bleeding episodes.
- Follow your healthcare provider's instructions regarding activity levels and wound care.
- Carry identification indicating your bleeding disorder and medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response.
Condition-Specific Dosing:
Hemophilia A or B with inhibitors (bleeding episodes):
90 mcg/kg IV every 2 hours until hemostasis is achieved. Dosing interval may be extended to 3-6 hours once hemostasis is achieved. Duration of treatment varies.
Congenital Factor VII deficiency (bleeding episodes):
15-30 mcg/kg IV every 4-6 hours until hemostasis is achieved. Dosing interval and duration vary.
Glanzmann's thrombasthenia with refractoriness to platelet transfusions (bleeding episodes):
90 mcg/kg IV every 2 hours (initial dose). Subsequent doses may be given every 2-6 hours. Duration of treatment varies.
Acquired Hemophilia (bleeding episodes):
90 mcg/kg IV every 2-3 hours until hemostasis is achieved. Duration of treatment varies.
Pediatric Dosing
Neonatal:
Dosing is individualized; generally, 90 mcg/kg IV every 2 hours for bleeding episodes in hemophilia with inhibitors. Consult specialist.
Infant:
Dosing is individualized; generally, 90 mcg/kg IV every 2 hours for bleeding episodes in hemophilia with inhibitors. Consult specialist.
Child:
Dosing is individualized; generally, 90 mcg/kg IV every 2 hours for bleeding episodes in hemophilia with inhibitors. Consult specialist.
Adolescent:
Dosing is individualized; generally, 90 mcg/kg IV every 2 hours for bleeding episodes in hemophilia with inhibitors. Consult specialist.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
Not significantly cleared by dialysis. No specific dose adjustment recommended, but clinical monitoring is crucial.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Factor VIIa (recombinant) acts by activating Factor X directly on the surface of activated platelets, bypassing the need for Factor VIII or IX. This leads to a localized thrombin burst, which converts fibrinogen to fibrin, stabilizing the platelet plug and forming a clot. It also activates Factor IX and Factor VII, further amplifying the coagulation cascade.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 100 mL/kg (similar to plasma volume)
ProteinBinding:
Not applicable (is a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2.3-3.1 hours (terminal half-life)
Clearance:
Approximately 33-39 mL/kg/hr
ExcretionRoute:
Metabolites excreted renally
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Approximately 2-6 hours, depending on the patient's underlying condition and the bleeding severity.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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
Dizziness or fainting
Stomach pain or swelling
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Fever
Other Possible Side Effects
As with all medications, side effects can occur. However, many individuals do not experience any side effects or only have mild ones. If you are bothered by any side effects or if they persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Contact your doctor for medical advice
Call the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, including:
+ 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
Dizziness or fainting
Stomach pain or swelling
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
Fever
Other Possible Side Effects
As with all medications, side effects can occur. However, many individuals do not experience any side effects or only have mild ones. If you are bothered by any side effects or if they persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Contact your doctor for medical advice
Call the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat, dizziness.
- Signs of blood clot: sudden chest pain, shortness of breath, pain/swelling/warmth in an arm or leg, sudden numbness or weakness on one side of the body, sudden severe headache, vision changes.
- Signs of ongoing bleeding: persistent bleeding from a wound, nosebleeds that won't stop, blood in urine or stool, unusual bruising, severe joint or muscle pain.
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.
If you have an allergy to cows, hamsters, or mice.
If you are currently receiving or plan to receive activated prothrombin complex concentrate (aPCC).
If you are taking or will be taking another medication similar to this one.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
If you have an allergy to cows, hamsters, or mice.
If you are currently receiving or plan to receive activated prothrombin complex concentrate (aPCC).
If you are taking or will be taking another medication similar to this one.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, regular blood tests will be necessary to monitor your condition, and you should discuss any concerns or questions with your doctor. If you are pregnant, planning to become pregnant, or breastfeeding, you must notify your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Increased risk of thrombotic events (blood clots)
- Disseminated intravascular coagulation (DIC)
What to Do:
Seek immediate medical attention. Treatment is supportive and may involve discontinuation of the drug and management of thrombotic complications. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Concomitant use may increase the risk of thrombotic events, especially in patients with Glanzmann's thrombasthenia. Use with caution and close monitoring.
Monitoring
Baseline Monitoring
Baseline coagulation parameters (PT, aPTT, fibrinogen, platelet count)
Rationale: To assess baseline hemostatic status and guide initial dosing.
Timing: Prior to first administration.
Clinical assessment of bleeding site and severity
Rationale: To determine the need for treatment and monitor response.
Timing: Prior to first administration and throughout treatment.
Routine Monitoring
Clinical assessment of hemostasis (cessation of bleeding, reduction in blood loss)
Frequency: Continuously during acute bleeding episodes, then as needed.
Target: Achieve and maintain hemostasis.
Action Threshold: If bleeding persists or worsens, consider additional doses, increased frequency, or alternative therapies.
Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, limb swelling, neurological changes)
Frequency: Regularly throughout treatment and for a period after discontinuation.
Target: Absence of thrombotic events.
Action Threshold: Immediately investigate any suspected thrombotic event and discontinue treatment if confirmed.
Vital signs (blood pressure, heart rate)
Frequency: As clinically indicated, especially during acute bleeding.
Target: Stable vital signs.
Action Threshold: Significant changes may indicate ongoing bleeding or other complications.
Symptom Monitoring
- Signs of ongoing bleeding (e.g., fresh blood, increasing hematoma size, drop in hemoglobin)
- Signs of hypersensitivity reaction (e.g., rash, urticaria, pruritus, dyspnea, hypotension)
- Signs of thrombotic events (e.g., chest pain, shortness of breath, sudden limb pain/swelling, neurological deficits, abdominal pain)
Special Patient Groups
Pregnancy
Use only if the potential benefit justifies the potential risk to the fetus. Limited human data available. Animal studies have shown no evidence of direct harm to the fetus, but there is a theoretical risk of thrombotic events in the mother.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of maternal thrombosis.
Second Trimester:
Limited data, theoretical risk of maternal thrombosis.
Third Trimester:
Limited data, theoretical risk of maternal thrombosis, especially around delivery.
Lactation
It is not known whether Factor VIIa is excreted in human milk. Caution should be exercised when administering to a nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NovoSeven RT and any potential adverse effects on the breastfed infant from NovoSeven RT or from the underlying maternal condition.
Infant Risk:
L3 - Moderate risk. Potential for thrombotic events in the infant is theoretical but unlikely given the large protein nature and likely poor oral absorption. Monitor infant for any unusual bleeding or clotting issues.
Pediatric Use
Dosing is weight-based and individualized. Safety and efficacy have been established in pediatric patients for approved indications. Close monitoring for efficacy and adverse events is crucial.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may have an increased risk of thrombotic events due to underlying comorbidities. Use with caution and close monitoring.
Clinical Information
Clinical Pearls
- NovoSeven RT is a bypass agent used when traditional factor replacement therapy is ineffective (e.g., in hemophilia with inhibitors).
- Dosing is highly individualized and requires careful clinical assessment of bleeding and patient response.
- The primary serious adverse event is thrombosis, though it is rare. Monitor patients closely for signs of clotting.
- Avoid concomitant use with antifibrinolytic agents unless absolutely necessary and with extreme caution due to increased thrombotic risk.
- Administer intravenously as a bolus injection. Do not mix with other infusion solutions.
- Reconstituted solution should be used within 3 hours and stored at room temperature or refrigerated.
Alternative Therapies
- Bypassing Agent (BPA) products for hemophilia with inhibitors: Anti-inhibitor Coagulant Complex (AICC, e.g., FEIBA)
- Emicizumab (Hemlibra) for hemophilia A with or without inhibitors (prophylaxis only, not for acute bleeding)
- Desmopressin (DDAVP) for mild hemophilia A or von Willebrand disease (not for Factor VII deficiency or hemophilia with inhibitors)
- Factor VIII or Factor IX concentrates (for hemophilia A or B without inhibitors)
- Platelet transfusions (for Glanzmann's thrombasthenia, if not refractory)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on strength and quantity. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered for approved indications by most major insurance plans, including Medicare/Medicaid)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.