NovoSeven RT (eptacog alfa) for hemophilia

Written by Lila Levinson, PhD | Last updated Sept. 14, 2026
Fact-checked by Lindsey Shapiro, PhD

What is NovoSeven RT for hemophilia?

NovoSeven RT (eptacog alfa-activated) is an approved bypassing agent used to treat bleeding episodes, including during surgery, in adults and children with hemophilia A or hemophilia B who have developed inhibitors, which are neutralizing antibodies against certain clotting factors. It is also approved for adults with acquired hemophilia.

Hemophilia is characterized by a lack or malfunction of certain clotting factors — proteins important in blood clotting — leading to easy and uncontrolled bleeding. The affected clotting factor in hemophilia A is factor VIII (FVIII), while hemophilia B affects factor IX (FIX). Replacing the deficient protein with a lab-made version is a standard treatment approach.

However, some people exposed to these treatments develop hemophilia inhibitors that target the supplied clotting factors, making treatment less effective. People with acquired hemophilia, an autoimmune disease, naturally produce similar types of antibodies.

NovoSeven RT supplies a different clotting protein called factor VIIa (FVIIa). Because it works via a different mechanism to promote blood clotting, bypassing the need for FVIII or FIX, it is suitable for people with inhibitors targeting those proteins.

Novo Nordisk originally developed the therapy as NovoSeven. The medication is now sold in a newer formulation called NovoSeven RT, which contains the same active ingredient but is stable at room temperature, making at-home use easier. In Canada, it is marketed as Niastase RT.

The therapy, administered via intravenous (into-the-vein) injections, is also approved for certain people with other inherited bleeding disorders, including congenital FVII deficiency and Glanzmann’s thrombasthenia.

Therapy snapshot

Who can take NovoSeven RT?

NovoSeven RT is approved in the U.S. to treat bleeding episodes and manage bleeding around the time of surgery in:

• adults and children with hemophilia A or B who have inhibitors
• adults with acquired hemophilia

The medication has similar approvals in other regions, including the European Union and Canada.

The U.S. prescribing information doesn’t list any contraindications for NovoSeven RT. However, it includes a boxed warning stating that the medication can increase the risk of dangerous blood clots forming in blood vessels and blocking blood flow, called thrombosis. 

How is NovoSeven RT administered?

NovoSeven RT is administered via intravenous injection by healthcare providers or appropriately trained patients and caregivers. The injection typically takes two to five minutes.

The recommended on-demand dose and injection frequency depend on the diagnosis:

• hemophilia A or B with inhibitors: 90 micrograms (mcg) per kg of body weight every two hours until bleeding is controlled, with additional injections possible for more severe bleeds. The dosage and frequency can be adjusted as needed.
• acquired hemophilia: 70 mcg to 90 mcg/kg every two to three hours until bleeding is controlled

Dosing during surgery depends on the type of procedure, but the medication is typically given before, during, and after surgery. For surgical management, it may be given as a continuous infusion.

NovoSeven RT comes as a powder that must be reconstituted in the provided liquid no more than three hours before use.

NovoSeven RT in clinical trials

There have been several NovoSeven and NovoSeven RT clinical trials conducted since the 1990s. Because the two formulations work the same way in the body, the original trials of NovoSeven for hemophilia also supported the approval of NovoSeven RT. These included:

• A large, open-label study included 483 people with hemophilia A or B (with or without inhibitors), acquired hemophilia, or an inherited FVII deficiency who received the medication for a variety of bleeds and surgeries. Overall, treatment led to effective or excellent control of 62% to 88% of serious bleeds and 81% to 92% of surgery-related bleeds. Among people with hemophilia and inhibitors who experienced internal bleeding, control was effective or excellent in about three-quarters of cases.
• Another trial tested two doses of NovoSeven — 35 mcg/kg or 70 mcg/kg — as on-demand treatment for hemophilia A or B, with or without inhibitors. Both doses were associated with effective or excellent bleed control in 71% of cases.
• A pair of trials tested the use of NovoSeven during and after surgery. One study found that doses of 90 mcg/kg were more effective than 35 mcg/kg in controlling bleeds. The other showed that a single intravenous dose and a slower, continuous intravenous infusion had similar efficacy for surgical management.
• Four studies, including compassionate use cases and registry-based studies, assessed the medication for acquired hemophilia. Together, these included 70 participants, who received individualized treatment for 113 bleeding episodes, surgeries, and injuries. NovoSeven was at least partially effective in controlling bleeding for 78% of cases. This rate was higher for people who received NovoSeven as their first-line therapy than for those who had previously received other treatment (86% vs. 70%).

NovoSeven RT side effects

The most common — and also the most serious — side effect of NovoSeven RT in clinical trials was thrombotic events. According to the boxed warning, patients should discuss these risks and review potential signs of blood clotting complications with their doctor before starting treatment. If thrombosis occurs, a doctor may recommend reducing the dose of NovoSeven RT or stopping it altogether.

Allergic reactions, including a potentially life-threatening reaction called anaphylaxis, can develop in response to NovoSeven RT. Patients should be monitored for these hypersensitivities. If symptoms emerge, NovoSeven RT treatment should be stopped, and the reaction should be treated appropriately.

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