Sevenfact is an FDA-approved medication used to treat or control bleeding in patients with hemophilia A or B with inhibitors. In this article, you will learn about its mechanism of action, dosage, side effects, cost, and more.
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What Is Sevenfact?
Sevenfact is a brand-name prescription medication. The active ingredient in this product is coagulation factor VIIa (recombinant)-jncw, also called eptacog beta.
Sevenfact belongs to a class of medications known as hemostatics.
The term “recombinant” means this medication is made in a lab using recombinant DNA technology. The four lowercase letters “jncw” are used to distinguish Sevenfact from other similar products.
The U.S. FDA approved Sevenfact in April 2020 to treat and control bleeding in individuals 12 years and older with hemophilia A or B with inhibitors.
This product should not be used to treat individuals with congenital Factor VII deficiency.
What Is Sevenfact Used For?
Sevenfact is used to treat and control bleeding episodes in patients with hemophilia A or B who have developed inhibitors to standard clotting factor treatments.
Inhibitors are antibodies that develop in some patients and block standard clotting factor treatments, making bleeding more difficult to control.
Sevenfact Mechanism of Action
Recombinant coagulation Factor VIIa (rFVIIa) in Sevenfact helps the blood to clot by activating another clotting factor called Factor X.
Normally, activation of Factor X depends on Factors VIII and IX. Sevenfact bypasses this pathway, allowing clot formation even when these factors are absent. For this reason, it is known as a “bypassing agent.”
Sevenfact Dosing
This medication comes as a white to off-white powder for solution (reconstitution) for intravenous (IV) injection in single-dose vials.
The following strengths are available in the U.S.:
- 1 mg of coagulation factor VIIa (recombinant)-jncw
- 2 mg of coagulation factor VIIa (recombinant)-jncw
- 5 mg of coagulation factor VIIa (recombinant)-jncw
The liquid to prepare the solution comes in single-dose prefilled glass syringes. Each syringe contains 1.1 ml, 2.2 ml, or 5.2 ml of sterile water for injection.
The dose and duration of treatment depend on:
- Location and severity of bleeding
- Need for urgent bleeding control
- Frequency of administration
- Response to bypassing agents during earlier bleeding episodes
Recommended Sevenfact Dosing:
Mild and moderate bleeding: 75 mcg/kg repeated every 3 hours until bleeding stops. Alternatively, a 225 mcg/kg initial dose may be used. If bleeding doesn’t stop within 9 hours, an extra dose of 75 mcg/kg every 3 hours may be given as needed to stop bleeding.
If bleeding doesn’t stop within 24 hours after the first dose, your healthcare provider will likely switch you to an alternative treatment.
Severe bleeding: 225 mcg/kg initial dose. If needed after 6 hours, give 75 mcg/kg every 2 hours until bleeding stops.
The duration of treatment depends on the site and severity of bleeding.
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Talk to a Specialist To Find OutSevenfact Side Effects
Common Side Effects
- Headache
- Dizziness
- Pain, redness, or swelling at the infusion site
- Fever
- Joint pain
- Mild itching
- Nausea
- Vomiting
Serious Side Effects
Call your healthcare provider immediately if you experience any of the following signs:
Stroke
- Sudden numbness or weakness
- Severe headache
- Slurred speech
- Difficulty with vision or balance
Blood clot in the lung
- Chest pain
- Sudden cough or breathing difficulty
- Dizziness
- Coughing up blood
Blood clot deep in the body
- Pain, swelling, or warmth in one of your legs
Allergic Reactions
This medication may cause allergic reactions, which can be fatal. Seek emergency medical care if you experience:
- Hives
- Breathing difficulty
- Swelling in the face or throat
- Chest tightness
- Fast heartbeat
Warnings and Precautions
This medication can cause severe or life-threatening reactions. Call your healthcare provider immediately if you experience:
- Hives, itching, or rash
- Chest pain or tightness
- Shortness of breath
- Wheezing
- Dizziness
- Low blood pressure
- Pain, swelling, and warmth in one leg
- Sudden numbness or weakness (particularly affecting one side of the body)
- Severe headache
- Slurred speech
- Problems with vision or balance
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Before Using Sevenfact
You should not use this medication if you:
- Have a history of allergic reactions to rabbits or rabbit proteins
- Are allergic to this product or any product components
Before you receive your first dose of Sevenfact, inform your healthcare provider if you have or have ever had:
- Coronary artery disease (narrowing of the arteries that supply oxygen to the heart)
- Heart attack or stroke
- Severe injury or infection
- Allergic reactions to mouse, hamster, or cow proteins
- Liver disease
Also, inform your healthcare provider if you are:
- Pregnant or planning to get pregnant
- Breastfeeding or planning to breastfeed
Sevenfact vs. NovoSeven
Sevenfact and NovoSeven are coagulation factors. The differences are listed below:
| Features | Sevenfact | NovoSeven |
| Approved Use | Hemophilia A or B with inhibitors in adults and adolescents 12 years and older | Adults and children with hemophilia A or B with inhibitors, congenital Factor VII deficiencyAdults with acquired hemophilia |
| FDA approval date | 2020 | 1999 |
| Active ingredient | eptacog beta | eptacog alfa |
| Available strengths | 1 mg, 2 mg, and 5 mg of coagulation factor VIIa (recombinant)-jncw | 1 mg, 2 mg, 5 mg, or 8 mg recombinant coagulation factor VIIa (FVIIa) |
| Manufacturer | HEMA Biologics | Novo Nordisk Limited |
| Contraindications | Known allergy to rabbits or rabbit proteinsSevere allergy to this product or any product components | None |
Sevenfact Cost
Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization.
The manufacturer of Sevenfact, HEMA Biologics, offers several support services through its “HEMA Biologics Cares” program for eligible patients. These include:
Sevenfact Co-pay Savings Program
Eligible patients may receive up to $12,000 in savings per calendar year through HEMA Biologics Cares.
Patient Assistance Program (PAP)
The Patient Assistance Program (PAP) provides this medication at no cost if patients meet specific income requirements.
Quick Start Program
This program is for new users who are having an insurance coverage-related delay in getting their treatment.
Bridge Program
This program is for current users who are having a delay in getting their treatment due to changes in their insurance coverage.
Contact us if you are interested in exploring financial assistance opportunities or copay assistance for Sevenfact.
