Novoseven Rt 5mg 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
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 similar to a natural protein in your body that helps stop bleeding. It's used for people who have certain bleeding disorders, like hemophilia with inhibitors, or other conditions where their blood doesn't clot properly.
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.
Preparation and Storage
Before 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 a refrigerator for up to 3 hours. However, do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, discard the solution if it changes color.
Safe Disposal
Dispose of used 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 or concerns, consult your doctor or pharmacist.
Storage and Disposal of Unmixed Medication
Store the unmixed medication at room temperature or in a 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 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.
Preparation and Storage
Before 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 a refrigerator for up to 3 hours. However, do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, discard the solution if it changes color.
Safe Disposal
Dispose of used 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 or concerns, consult your doctor or pharmacist.
Storage and Disposal of Unmixed Medication
Store the unmixed medication at room temperature or in a refrigerator. Avoid freezing the medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Report any new or worsening bleeding immediately.
- Report any signs of a blood clot (e.g., chest pain, shortness of breath, swelling/pain in a leg or arm, sudden vision changes, severe headache) immediately.
- Avoid activities that could lead to injury or bleeding, especially during active bleeding episodes.
- Carry identification indicating your bleeding disorder and medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication, bleeding severity, and patient response. For hemophilia A/B with inhibitors: 90 mcg/kg IV every 2 hours until hemostasis is achieved. For acquired hemophilia: 90 mcg/kg IV every 2-3 hours until hemostasis. For congenital Factor VII deficiency: 15-30 mcg/kg IV every 4-6 hours until hemostasis. For Glanzmann's thrombasthenia: 90 mcg/kg IV every 2 hours (initial dose), then 90 mcg/kg at 3 and 6 hours if needed.
Dose Range:
15 - 90 mg
Condition-Specific Dosing:
hemophilia_inhibitors:
90 mcg/kg IV every 2 hours
acquired_hemophilia:
90 mcg/kg IV every 2-3 hours
congenital_FVII_deficiency:
15-30 mcg/kg IV every 4-6 hours
glanzmanns_thrombasthenia:
90 mcg/kg IV every 2 hours (initial), then 90 mcg/kg at 3 and 6 hours if needed
Pediatric Dosing
Neonatal:
Dosing is similar to older children/adults (e.g., 90 mcg/kg for hemophilia with inhibitors), but close monitoring is crucial due to potential differences in pharmacokinetics and thrombotic risk.
Infant:
Dosing is similar to older children/adults (e.g., 90 mcg/kg for hemophilia with inhibitors), but close monitoring is crucial due to potential differences in pharmacokinetics and thrombotic risk.
Child:
Dosing is similar to adults (e.g., 90 mcg/kg IV every 2 hours for hemophilia A/B with inhibitors). Pharmacokinetics may differ, with a shorter half-life in children.
Adolescent:
Dosing is similar to adults (e.g., 90 mcg/kg IV every 2 hours for hemophilia A/B with inhibitors).
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 protein and not significantly cleared 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
Factor VIIa (recombinant) acts by binding to exposed tissue factor at the site of vascular injury, initiating the extrinsic pathway of coagulation. It also directly activates Factor X on the surface of activated platelets, leading to a burst of thrombin generation independent of Factors VIII and IX. This localized thrombin generation promotes the formation of a stable fibrin clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV bolus)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 100-150 mL/kg
ProteinBinding:
Not extensively protein bound; binds to tissue factor and activated platelets.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2.3-3.1 hours (adults); shorter in children (e.g., 1.9-2.9 hours in adolescents, 1.4-2.8 hours in children, 1.2-2.1 hours in infants)
Clearance:
Approximately 33-60 mL/kg/hr
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route (renal/hepatic) for intact protein.
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Approximately 2-3 hours (correlates with half-life, requiring frequent dosing)
Confidence:
Medium
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 concern you or do not go away, contact your doctor for advice.
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
You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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 concern you or do not go away, contact your doctor for advice.
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
You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine/stool, heavy menstrual bleeding)
- Signs of a blood clot (e.g., sudden chest pain, difficulty breathing, pain/swelling/warmth in an arm or leg, sudden numbness or weakness, vision changes, slurred speech)
- Signs of an allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing, dizziness)
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 cows, hamsters, or mice, as this may be relevant to your treatment.
If you are currently receiving or plan to receive activated prothrombin complex concentrate (aPCC), as this may interact with this medication.
If you are taking or plan to take another medication similar to this one, as this may increase the risk of adverse interactions.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and prevent potential interactions.
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 cows, hamsters, or mice, as this may be relevant to your treatment.
If you are currently receiving or plan to receive activated prothrombin complex concentrate (aPCC), as this may interact with this medication.
If you are taking or plan to take another medication similar to this one, as this may increase the risk of adverse interactions.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and prevent potential interactions.
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 are 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 discontinuing the drug and managing 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 non-hemophiliac patients or those with underlying thrombotic risk factors. Use with caution and only if clinically indicated.
Monitoring
Baseline Monitoring
Baseline coagulation status (PT, aPTT, fibrinogen, platelet count)
Rationale: To assess the patient's underlying coagulation disorder and establish a baseline for monitoring treatment response.
Timing: Prior to initiation of therapy
Clinical assessment of bleeding
Rationale: To determine the severity and location of bleeding and guide initial dosing.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of hemostasis (cessation of bleeding)
Frequency: Continuously during acute bleeding episodes, then periodically as needed
Target: Cessation or significant reduction of bleeding
Action Threshold: Continued or worsening bleeding may indicate need for additional doses or alternative therapy.
Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, limb swelling, neurological changes)
Frequency: Continuously during and after treatment
Target: Absence of thrombotic events
Action Threshold: Immediate medical evaluation if signs/symptoms of thrombosis occur.
Vital signs (blood pressure, heart rate, temperature)
Frequency: Regularly during infusion and post-infusion
Target: Within normal limits
Action Threshold: Significant deviations may indicate adverse reactions or complications.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, hematoma, blood in urine/stool, prolonged bleeding from cuts)
- Signs of thrombosis (e.g., sudden chest pain, shortness of breath, swelling/pain in a limb, sudden weakness/numbness on one side of the body, vision changes, severe headache)
- Signs of allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of embryo-fetal toxicity at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for embryo-fetal toxicity based on animal data; human data lacking.
Second Trimester:
Potential for embryo-fetal toxicity based on animal data; human data lacking.
Third Trimester:
Potential for embryo-fetal toxicity based on animal data; human data lacking.
Lactation
It is unknown whether Factor VIIa (recombinant) 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:
Not available
Pediatric Use
Used in pediatric patients, including neonates, for approved indications. Dosing is weight-based. Pharmacokinetics may differ, with a shorter half-life in younger children, potentially requiring more frequent dosing. Close monitoring for efficacy and adverse events (especially thrombosis) is essential.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may have a higher incidence of underlying cardiovascular disease or other risk factors for thrombosis, requiring careful monitoring.
Clinical Information
Clinical Pearls
- NovoSeven RT is a bypass agent used when Factor VIII or IX replacement therapy is ineffective due to inhibitors.
- Dosing is highly individualized and requires close clinical monitoring of bleeding cessation. Coagulation assays (PT/aPTT) do not reliably reflect clinical efficacy for this drug.
- The primary serious adverse event is thrombosis. Patients with underlying thrombotic risk factors (e.g., atherosclerosis, crush injury, DIC, extensive burns, sepsis, concomitant antifibrinolytics) should be monitored very closely.
- Reconstitute only with the provided diluent. Do not shake vigorously. Administer immediately after reconstitution.
- Store refrigerated (2°C to 8°C) and protect from light. Do not freeze.
Alternative Therapies
- Anti-inhibitor Coagulant Complex (AICC) / Activated Prothrombin Complex Concentrate (aPCC) (e.g., FEIBA)
- Emicizumab (Hemlibra) - for hemophilia A with or without inhibitors (prophylaxis only, not for acute bleeding)
- Bypassing agents (general term)
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on strength) per 1 vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often limited to specific indications)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.