Novoseven RT
Factor VIIa is an injectable medication used to treat or prevent bleeds in people with certain blood conditions. It's given through the vein (IV), typically at a treatment center or a healthcare provider's office, but some people might be able to continue treatment home.
What is Factor VIIa?
What is Factor VIIa used for?
- To treat or control bleeding in people with hemophilia A or hemophilia B with inhibitors
To treat active bleeds or to prevent bleeding episodes during surgery in people with the following conditions:
- Hemophilia A and B with inhibitors
- Acquired hemophilia
- Congenital Factor VII (FVII) deficiency
- Glanzmann thrombasthenia where platelet transfusions didn't work well
How Factor VIIa works
If you have hemophilia, your provider'll typically treat your condition by replacing the missing clotting factor (with either factor VIII or IX, depending on whether you have hemophilia A or B). But sometimes, this treatment stops working for you if your body develop antibodies (called inhibitors) against the clotting factor that's being replaced.
Factor VIIa is a bypassing agent that treats hemophilia with inhibitors. Instead of acting as an replacement for the missing clotting factors, it helps your body form clots by going around or "bypasses" the clotting factors that are blocked by the inhibitors.
Factor VIIa also helps stop other bleeding in people with platelet problems (i.e., Glanzmann thrombasthenia) by making more fibrin in your blood, a protein that's needed for blood clotting.
Drug facts
Side effects of Factor VIIa
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Infusion-site discomfort (15%)
- Dizziness (13%)
- Headache (7%)
- Infusion-site bruise (7%)
- Infusion-related reaction (7%)
- Blood clots (4%)
Less Common Side Effects
Sevenfact
- Fever
- Blood clots
Novoseven RT
- Nausea
- Trouble breathing
- Chest pain
- Fever
- Headache
Factor VIIa serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: rash, trouble breathing, swelling of lips, tongue, or throat
- Blood clots: chest pain, trouble breathing, swelling, pain in arms or legs, trouble speaking, confusion, loss of feeling
The following Factor VIIa side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common or rare
Bloating or swelling of the face, hands, lower legs, or feet
bluish color of the hands or feet
blurred vision
changes in facial color
chills
cold sweats
confusion
continuing thirst
dizziness
faintness
fast heartbeat
large flat blue or purplish patches on the skin
lightheadedness when getting up suddenly from a lying or sitting position
persistent bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder)
puffiness or swelling of the eyelids or around the eyes
shakiness
slow or irregular heartbeat (less than 50 beats per minute)
slurred speech
sudden decrease in the amount of urine
swelling of the face, fingers, feet, or lower legs
troubled breathing, tightness in the chest
unusual tiredness or weakness
unusual weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare
Burning or stinging at the injection site
drowsiness
feeling of warmth
headache
nausea or vomiting
pinpoint red or purple spots on the skin
redness of the face, neck, arms and occasionally, upper chest
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Factor VIIa
Pros
- Works well to treat and prevent bleeds in many blood conditions
- Not many common side effects
- Can be conveniently stored at room temperature
- Doesn't interact with many medications
Cons
- Can only be given through the vein (IV)
- Raises your risk of blood clots
- Dose must be mixed before using
- Brand only, so might be expensive
Pharmacist tips for Factor VIIa
- If your provider thinks it's safe and appropriate for you to give factor VIIa to yourself at home, make sure you complete the training with your provider on how to use it safely.
- Follow the instructions for use, or refer to the Sevenfact video or Novoseven RT video on how to mix factor VIIa before injecting it.
- Always check the expiration date on your kit. If it's expired, throw it away and ask your pharmacist for a refill.
- Factor VIIa is only meant to be injected into your vein. Never inject it into your muscle or under your skin. If you have questions about how to inject it, speak to your provider.
- Before mixing and injecting your dose, wash your hands with soap and water to prevent infection.
- Factor VIIa can be stored at room temperature. Once mixed, you can store Sevenfact at room temperature for up to 4 hours and Novoseven RT in the refrigerator or at room temperature for up to 3 hours. Never freeze factor VIIa or this could damage the medication.
- After your injection, throw out any vials, needles, and your empty syringe in a sharps container. If you don't have a sharps container, you can use a container made of punture-resistant material with a tight-fitting lid (e.g., plastic laundery detergent container). This will help avoid any needlestick injuries to yourself or others.
- Never reuse any components of your factor VIIa kit, since this can lead to infection.
- Once you've given yourself factor VIIa, avoid activities that can cause more bleeding. Speak to your provider if you have further questions.
- If you feel your bleed isn't controlled within the expected time discussed with your provider, call them right away.
Common questions about Factor VIIa
Both Novoseven RT and Sevenfact contain the same medication, factor VIIa. But, there are a few important differences. Sevenfact is only approved to treat bleeding in people 12 years and older with hemophilia A and B with inhibitors, while Novoseven RT can treat bleeding in many different blood conditions, including people of all ages with hemophilia A and B. In addition, Novoseven RT can be used to prevent bleeding in people with various blood conditions during and after surgery. Another important difference is the allergy warnings. Novoseven RT is made with components from mice, hamsters, and cows, whereas Sevenfact is made using components from rabbits. If you have any allergies, make sure to tell your provider before starting factor VIIa.
If you have hemophilia, your provider'll typically treat your condition by replacing the missing clotting factor (with either factor VIII or IX, depending on whether you have hemophilia A or B). But sometimes, this treatment stops working for you if your body develop antibodies (called inhibitors) against the clotting factor that's being replaced. If you have hemophilia with inhibitors, factor VIIa can be a possible option for you. Instead of replacing the clotting factors that you're missing, this medication takes a different route in your body to help you stop bleeding, so it's not affected by the inhibitors in your body.
There isn't enough information available to know if factor VIIa is safe to take during pregnancy. Let your provider know if you're pregnant, planning to become pregnant, or breastfeeding before using factor VIIa since it isn't known if it's safe for you or your baby under these circumstances.
No. Both Novoseven RT and Sevenfact are made using recombinant technology. This means they're made in a laboratory without using human blood or proteins. Instead, they're made using animal components. Each product is made using different animals, which is why it's important to tell your provider if you have any allergies.
Novoseven RT has been studied and proven to be safe to use with Hemlibra (emicizumab), a medication that's used to prevent bleeding in people who've hemophilia A with inhibitors. There are currently ongoing studies to find out if Sevenfact is safe to use with Hemlibra (emicizumab). If you have questions about this or other possible interactions with your medications, speak with your pharmacist or provider.
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Risks and warnings for Factor VIIa
Factor VIIa can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots
- Risk factors: History of blood clot | Having hemophilia and receiving certain other medications to stop bleeding at the same time | Heart (cardiovascular) problems | Blood vessel problems | History of serious infection (sepsis) | Past crush injuries
Because of the way factor VIIa works to stop bleeding, it can raise your risk for dangerous blood clots in parts of your body other than the site of your bleeding. Symptoms of a blood clot might be different depending on the location of the clot, but if you experience swelling and pain in your arms, legs, or stomach, chest pain, difficulty breathing, loss of feeling, confusion, or trouble speaking, get medical help right away.
Serious allergic reaction
- Risk factors: Certain milk protein (casein) or rabbit allergy (Sevenfact only) | Mouse, hamster, or cow protein allergy (Novoseven only)
Though rare, serious allergic reactions, including anaphylaxis, can happen with factor VIIa. Make sure to tell your provider all of your allergies before receiving treatment, since each product is made differently and has specific allergy warnings. If you experience rash, trouble breathing, or swelling in your lips, tongue, or throat after receiving factor VIIa, stop the infusion (if administering yourself at home) and get medical help right away.
Factor VIIa not working well (Novoseven RT)
- Risk factors: Low factor VII (Novoseven RT)
If you're being treated with Novoseven RT for low factor VII, there's a chance that your body might develop antibodies to this medication. When this happens, it means that Novoseven RT won't work well for you and your body will continue to have trouble forming clots. Your provider might check your blood work regularly to make sure that Novoseven RT is still working well for you.
Factor VIIa dosage
Kit| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1 vial of 5mg | 2 kits | $28,326.25 | $14,163.13 |
| 1 vial of 1mg | 18 kits | $50,982.25 | $2,832.35 |
| 1 vial of 2mg | 12 kits | $67,974.25 | $5,664.52 |
| 1 vial of 8mg | 2 kits | $45,318.25 | $22,659.13 |
Typical dosage for Factor VIIa
Your provider'll calculate your dose based on things like body weight, how serious your bleed is, and where your bleed is located. Both Novoseven RT and Sevenfact are infused through the veins, typically by a healthcare provider. Sometimes, if your provider thinks it's appropriate and safe, you might be able to give factor VIIa infusions to yourself after you've received the necessary training.
- You'll typically receive an infusion as an one-time dose or once every 2 to 3 hours, depending on your condition. Your provider'll continue treatment until your bleeding stops or is stable.
- You'll typically receive an infusion once every 2 to 6 hours or sometimes as a continuous infusion, depending on your condition. Your provider'll continue treatment until your bleeding stops or is stable.
Interactions between Factor VIIa and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Anti-Inhibitor Coagulant Complex
- Factor XIII
- Prothrombin Complex
How much does Factor VIIa cost?
$28,326.25
Factor VIIa contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Factor VIIa will not be safe for you to take.
- Allergy to rabbits or rabbit proteins (Sevenfact only)
What are alternatives to Factor VIIa?
To treat active bleeds or to prevent bleeding episodes during surgery in people with the following conditions: