Novoseven Rt 2mg 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
Recombinant coagulation factor VIIa
Pregnancy 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 contains a man-made protein called Factor VIIa, which is normally found in your blood and helps stop bleeding. This medicine is used when your body can't make enough of its own clotting factors, or when other clotting factors don't work properly, to help control 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 accompanying information carefully. This medication is administered as an intravenous injection. If you are self-administering, your doctor or nurse will provide guidance on the proper injection technique.
Before and after handling the medication, wash your hands thoroughly. The medication must be mixed prior to use, following 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.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, contains particles, or has changed color. Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Prior to 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 next steps to take.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered as an intravenous injection. If you are self-administering, your doctor or nurse will provide guidance on the proper injection technique.
Before and after handling the medication, wash your hands thoroughly. The medication must be mixed prior to use, following 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.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, contains particles, or has changed color. Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Prior to 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 next steps to take.
Lifestyle & Tips
- Avoid activities that may increase the risk of bleeding (e.g., contact sports, certain medications like NSAIDs or aspirin) unless approved by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Carry identification indicating your bleeding disorder and medication.
- Follow your doctor's instructions for home administration, storage, and disposal of the medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and patient response.
Condition-Specific Dosing:
Hemophilia A or B with inhibitors:
90 mcg/kg IV bolus every 2 hours until hemostasis is achieved or bleeding stops. Dosing frequency may be extended to 3-6 hours once hemostasis is achieved. Duration of treatment depends on the severity of the bleed and clinical response.
Acquired Hemophilia:
90 mcg/kg IV bolus every 2-3 hours until hemostasis is achieved. Treatment duration typically 24-48 hours.
Congenital Factor VII Deficiency:
15-30 mcg/kg IV bolus every 4-6 hours until hemostasis is achieved. Dosing frequency and duration depend on the severity of the bleed and clinical response.
Glanzmann's Thrombasthenia with Refractoriness to Platelet Transfusions:
90 mcg/kg IV bolus (range 80-120 mcg/kg) at 2-hour intervals for at least 3 doses. Subsequent doses may be given at 2-hour intervals if needed. Duration of treatment depends on the severity of the bleed and clinical response.
Pediatric Dosing
Neonatal:
Dosing is typically weight-based (e.g., 90 mcg/kg IV bolus) and similar to older pediatric patients, but requires careful monitoring due to smaller blood volume and immature systems. Not specifically established for neonates in all indications.
Infant:
Dosing is typically weight-based (e.g., 90 mcg/kg IV bolus) and similar to older pediatric patients, but requires careful monitoring.
Child:
Dosing is typically weight-based (e.g., 90 mcg/kg IV bolus) and similar to adults for specific indications (e.g., hemophilia A/B with inhibitors, FVII deficiency, Glanzmann's).
Adolescent:
Dosing is typically weight-based (e.g., 90 mcg/kg IV bolus) and similar to adults for specific indications.
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 VIIa 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
Recombinant Factor VIIa (rFVIIa) is a vitamin K-dependent glycoprotein that structurally resembles human plasma-derived Factor VIIa. It binds to tissue factor (TF) at the site of vascular injury, initiating the extrinsic pathway of coagulation. In patients with hemophilia A or B with inhibitors, or acquired hemophilia, rFVIIa bypasses the need for Factor VIII or IX by directly activating Factor X to Factor Xa on the surface of activated platelets. This leads to a burst of thrombin generation, which converts fibrinogen to fibrin, stabilizing the platelet plug and promoting hemostasis. In Factor VII deficiency, it replaces the deficient factor. In Glanzmann's thrombasthenia, it promotes thrombin generation independent of platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV bolus)
FoodEffect:
Not applicable
Distribution:
Vd:
60-100 mL/kg (approximately plasma volume)
ProteinBinding:
Not applicable (protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
2.3-3.1 hours (terminal half-life)
Clearance:
33-50 mL/kg/hr
ExcretionRoute:
Primarily via proteolytic degradation and cellular uptake, not renal or hepatic excretion of intact protein.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of administration)
PeakEffect:
Within 10 minutes of administration
DurationOfAction:
Approximately 2-3 hours (correlates with half-life, but clinical effect may persist longer depending on the bleed)
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
Dizziness or fainting
Stomach pain or swelling
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
* Fever
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 have any side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, talk to 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
Dizziness or fainting
Stomach pain or swelling
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in eyesight
* Fever
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 have any side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, talk to 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 new or worsening bleeding (e.g., unusual bruising, nosebleeds, blood in urine/stools, prolonged bleeding from cuts, severe headache, joint pain/swelling)
- Signs of a blood clot (e.g., sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg, sudden weakness or numbness on one side of the body, vision changes, slurred speech)
- Signs of an allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat, dizziness, feeling faint)
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, any of 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 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.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure it is safe to do so. Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 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.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure it is safe to do so. Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the potential benefits and risks of this medication to 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 include discontinuation of rFVIIa and management of thrombotic complications. Call 1-800-222-1222 (Poison Control Center).
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 underlying thrombotic risk factors. Use with caution and close monitoring.
- Prothrombin complex concentrates (PCCs) or activated prothrombin complex concentrates (aPCCs): Concomitant use may increase the risk of thrombotic events. Avoid concurrent administration.
Moderate Interactions
- Factor VIII or Factor IX concentrates: Concurrent administration is generally not recommended due to potential for increased thrombotic risk, especially in high doses.
Monitoring
Baseline Monitoring
Diagnosis and bleeding history
Rationale: To confirm indication and guide dosing strategy.
Timing: Prior to initiation of therapy.
Baseline coagulation parameters (e.g., PT, aPTT, fibrinogen, platelet count)
Rationale: To assess baseline hemostatic status, though these may not normalize with rFVIIa and clinical response is primary.
Timing: Prior to first dose.
Assessment of thrombotic risk factors
Rationale: To identify patients at higher risk for thrombotic events.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of hemostasis (e.g., cessation of bleeding, reduction in blood loss, resolution of hematoma)
Frequency: Continuously during acute bleeding episodes, then as clinically indicated.
Target: Achieve and maintain hemostasis.
Action Threshold: If bleeding persists or recurs, consider additional doses, increased frequency, or alternative therapies.
Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, swelling, pain, redness in limbs, altered mental status)
Frequency: Regularly during treatment and for a period after cessation.
Target: Absence of thrombotic events.
Action Threshold: If signs/symptoms of thrombosis occur, discontinue rFVIIa and initiate appropriate management.
Vital signs
Frequency: As clinically indicated.
Target: Stable.
Action Threshold: Changes may indicate ongoing bleeding or other complications.
Symptom Monitoring
- Signs of ongoing bleeding (e.g., fresh blood, increasing hematoma size, decreasing hemoglobin/hematocrit, persistent oozing)
- Signs of thrombotic events (e.g., chest pain, dyspnea, sudden limb pain/swelling, neurological deficits, abdominal pain)
- Hypersensitivity reactions (e.g., rash, urticaria, pruritus, dyspnea, angioedema, hypotension)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of fetal harm at high doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential risk, but data are limited. Weigh benefits vs. risks.
Second Trimester:
Potential risk, but data are limited. Weigh benefits vs. risks.
Third Trimester:
Potential risk, but data are limited. Weigh benefits vs. risks. May be used for peripartum bleeding management if indicated.
Lactation
It is unknown whether Factor VIIa is excreted in human milk. Consider the developmental and health benefits of breastfeeding 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. A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk - no human data, animal data suggest risk or no data available; consider risk vs. benefit).
Pediatric Use
Dosing is weight-based and generally similar to adults for approved indications. Safety and efficacy have been established in pediatric patients. Close monitoring for efficacy and adverse events is crucial.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, elderly patients may have a higher incidence of underlying cardiovascular disease or other thrombotic risk factors, which should be considered when administering rFVIIa. Monitor closely for thrombotic events.
Clinical Information
Clinical Pearls
- NovoSeven RT is a bypassing agent, meaning it works independently of Factor VIII or IX, making it effective for patients with inhibitors.
- Clinical response (cessation of bleeding) is the primary measure of efficacy, as laboratory coagulation parameters (e.g., PT, aPTT) may not normalize and do not reliably predict clinical efficacy.
- Administer as an intravenous bolus injection. Do not mix with other infusion solutions.
- Reconstitute only with the supplied sterile water for injection. Do not shake vigorously.
- Monitor patients closely for signs of thrombotic events, especially those with pre-existing risk factors (e.g., atherosclerosis, crush injury, sepsis, DIC, concomitant use of antifibrinolytics or PCCs).
- The product contains trace amounts of mouse IgG and bovine IgG; patients with known hypersensitivity to these components should be monitored for allergic reactions.
Alternative Therapies
- Anti-inhibitor Coagulant Complex (AICC, e.g., FEIBA) for hemophilia with inhibitors.
- Emicizumab (Hemlibra) for hemophilia A with or without inhibitors (prophylaxis, not acute bleeding).
- Desmopressin (DDAVP) for mild hemophilia A or von Willebrand disease.
- Factor VIII or Factor IX concentrates (for patients without inhibitors).
- Tranexamic acid or aminocaproic acid (antifibrinolytics, often used adjunctively but with caution with rFVIIa).
- Platelet transfusions (for Glanzmann's thrombasthenia, if not refractory).
Cost & Coverage
Average Cost:
Extremely high, typically tens of thousands to hundreds of thousands of dollars per treatment course depending on dose and duration. per vial (e.g., 2mg vial)
Insurance Coverage:
Specialty Tier / Tier 4 or 5. Requires prior authorization and often managed by specialty pharmacies. Coverage is generally good for approved indications due to lack of alternatives for many patients.
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.