Novoseven Rt 8mg 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 when your body can't stop bleeding on its own, especially in certain bleeding disorders like hemophilia with inhibitors or Factor VII deficiency.
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, or contains particles. Additionally, discard the solution if it 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, or contains particles. Additionally, discard the solution if it 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.
- Report any signs of blood clots (e.g., chest pain, shortness of breath, swelling/pain in a leg or arm, sudden weakness or numbness) immediately.
- Follow your doctor's instructions for dose and administration carefully.
- Keep all appointments for follow-up care and laboratory tests.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication and patient response. For hemophilia A or B with inhibitors: 90 mcg/kg IV every 2 hours until hemostasis is achieved. 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 3-6 hour intervals if needed.
Dose Range:
15 - 90 mg
Condition-Specific Dosing:
Hemophilia A/B with inhibitors:
90 mcg/kg IV every 2 hours
Congenital Factor VII deficiency:
15-30 mcg/kg IV every 4-6 hours
Glanzmann's thrombasthenia:
90 mcg/kg IV every 2-6 hours
Pediatric Dosing
Neonatal:
Dosing is weight-based, similar to adult dosing (e.g., 90 mcg/kg for hemophilia with inhibitors), but clinical experience is more limited. Close monitoring is essential.
Infant:
Dosing is weight-based, similar to adult dosing (e.g., 90 mcg/kg for hemophilia with inhibitors).
Child:
Dosing is weight-based, similar to adult dosing (e.g., 90 mcg/kg for hemophilia with inhibitors).
Adolescent:
Dosing is weight-based, similar to adult dosing (e.g., 90 mcg/kg for hemophilia with inhibitors).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
Not applicable; Factor VIIa is a protein and not significantly cleared by dialysis. No specific adjustment recommended.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Factor VIIa (recombinant) is a vitamin K-dependent glycoprotein that activates the extrinsic pathway of coagulation. It binds to tissue factor (TF) at the site of vascular injury, forming a TF-FVIIa complex. This complex activates Factor X to Factor Xa and Factor IX to Factor IXa. In patients with hemophilia with inhibitors, FVIIa can activate Factor X directly on the surface of activated platelets, bypassing the need for Factor VIII or IX. This leads to a burst of thrombin generation and subsequent fibrin formation, promoting hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 100 mL/kg
ProteinBinding:
Not extensively protein-bound in the typical sense; interacts with cell surfaces.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2.3 to 3.1 hours
Clearance:
Approximately 33-39 mL/kg/hr
ExcretionRoute:
Metabolized and excreted as amino acids and small peptides; not renally excreted as intact protein.
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of administration)
PeakEffect:
Within minutes of administration
DurationOfAction:
Approximately 2-4 hours, requiring repeated dosing for sustained effect.
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
As with all medications, side effects can occur. 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.
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:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
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
As with all medications, side effects can occur. 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.
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:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, hives, itching, difficulty breathing, swelling of your face, lips, tongue, or throat.
- Signs of a blood clot: chest pain, shortness of breath, sudden numbness or weakness on one side of your body, sudden severe headache, problems with vision or speech, swelling or pain in your arm or leg.
- Persistent or worsening bleeding despite treatment.
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.
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
Carefully review your medications and health conditions with your doctor to ensure it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting 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.
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
Carefully review your medications and health conditions with your doctor to ensure it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 Center) for advice.
Drug Interactions
Moderate Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Concomitant use may increase the risk of thrombotic events. Use with caution and monitor closely.
Monitoring
Baseline Monitoring
Type of bleeding and severity
Rationale: To determine appropriate dosing and assess initial response.
Timing: Prior to first dose
Patient history (e.g., thrombotic risk factors, underlying conditions)
Rationale: To identify patients at increased risk of thrombotic events.
Timing: Prior to first dose
Coagulation parameters (e.g., PT, aPTT, Factor VII activity)
Rationale: While PT/aPTT are not reliable for monitoring efficacy of Factor VIIa, baseline values may be useful. Factor VII activity may be measured in Factor VII deficiency.
Timing: Prior to first dose
Routine Monitoring
Clinical assessment of hemostasis (cessation of bleeding)
Frequency: Continuously during treatment and for several hours post-treatment
Target: Achieve and maintain hemostasis
Action Threshold: If bleeding persists or recurs, consider additional doses or alternative therapies.
Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, limb swelling, neurological changes)
Frequency: Continuously during treatment and for several days post-treatment
Target: Absence of thrombotic events
Action Threshold: If signs of thrombosis occur, discontinue Factor VIIa and initiate appropriate management.
Vital signs
Frequency: Regularly during infusion and post-infusion
Target: Within normal limits
Action Threshold: Significant changes may indicate adverse reactions (e.g., allergic reaction).
Symptom Monitoring
- Cessation of bleeding
- Signs of allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue)
- Signs of thrombotic events (e.g., chest pain, shortness of breath, sudden weakness or numbness on one side of the body, vision changes, severe headache, swelling or pain in a limb)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; human data lacking.
Second Trimester:
Potential risk based on animal data; human data lacking.
Third Trimester:
Potential risk based on animal data; human data lacking.
Lactation
Caution should be exercised when administering to a nursing mother. It is unknown whether Factor VIIa is excreted in human milk. However, as a large protein, it is unlikely to be absorbed intact by the infant.
Infant Risk:
Low risk, but unknown. Monitor infant for adverse effects.
Pediatric Use
Approved for use in pediatric patients. Dosing is weight-based. Safety and efficacy profiles are generally similar to adults, but careful monitoring for thrombotic events is important, especially in neonates and infants.
Geriatric Use
No specific dose adjustment is required. However, elderly patients may have a higher baseline risk of thrombotic events, so close monitoring for signs of thrombosis is recommended.
Clinical Information
Clinical Pearls
- NovoSeven RT is a bypassing agent, meaning it works independently of Factor VIII or IX, making it effective in patients with inhibitors to these factors.
- It is crucial to administer NovoSeven RT as soon as possible after a bleeding event to maximize efficacy.
- Coagulation tests like PT and aPTT do not reliably reflect the in vivo hemostatic effect of Factor VIIa and should not be used to monitor treatment efficacy or guide dosing.
- The primary serious adverse effect is the risk of thrombotic events. Careful patient selection and monitoring for signs of thrombosis are paramount.
- Not indicated for prophylactic use or for treatment of bleeding in patients without congenital hemophilia with inhibitors, acquired hemophilia, congenital Factor VII deficiency, or Glanzmann's thrombasthenia, unless specifically indicated for other severe bleeding situations under expert guidance.
Alternative Therapies
- Anti-inhibitor Coagulant Complex (FEIBA) - another bypassing agent for hemophilia with inhibitors.
- Emicizumab (Hemlibra) - a bispecific antibody for hemophilia A with or without inhibitors (prophylaxis only).
- Specific factor concentrates (e.g., Factor VIII, Factor IX) - for patients without inhibitors.
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) - adjunct therapy for bleeding.
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on strength) per 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 is 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 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 information about what was taken, the amount, and the time it occurred.