NovoSeven RT

Pronunciation: Noe-voe-sev-in are-tee
Generic name: coagulation factor VIIa (recombinant)
Dosage form: powder for intravenous injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is NovoSeven RT?

NovoSeven RT (coagulation factor VIIa, recombinant) is an injectable, coagulation factor VIIa that may be used to treat bleeding episodes, including managing expected bleeding during surgery, in adults and children with:

• hemophilia A or B with inhibitors
• congenital Factor VII (FVII) deficiency
• Glanzmann’s thrombasthenia which does not respond to platelet transfusions with or without antibodies to platelets.

NovoSeven RT is also approved to treat bleeding episodes, including managing expected bleeding during surgery, in adults with acquired hemophilia.

NovoSeven RT (coagulation Factor VIIa, recombinant) works by attaching itself (complexing) to tissue factor (TF) which plays a central role in stopping bleeding (hemostasis). The NovoSeven RT-TF complex activates coagulation Factor X to Factor Xa, as well as coagulation Factor IX to Factor IXa. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, which leads to the formation of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing local hemostasis. This process may also occur on the surface of activated platelets.

NovoSeven RT with MixPro is a kit that may be used for self-administration. It comes in a compact package, and contains a:

• Vial with NovoSeven RT powder
• Vial adapter
• Prefilled syringe with diluent
• Plunger rod.

NovoSeven RT was FDA-approved on July 7, 2014. It is available from a specialty pharmacy distributor, a hemophilia home care agency, or a hemophilia treatment center.

What are the side effects of NovoSeven RT?

NovoSeven RT can cause serious side effects (see warnings below).

The most common side effect of NovoSeven RT is blood clotting events. In clinical trials, these occurred at a rate of 4% of those with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia. Other side effects reported in 2% or more of patients were fever, high blood pressure, and a decrease in the levels of plasma fibrinogen.

These are not the only side effects possible with NovoSeven RT. To learn more, talk to your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or does not go away. You may report side effects to Novo Nordisk Inc. at 1-877-668-6777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

Rebinyn, Idelvion, tranexamic acid, desmopressin, Hemgenix, Hemlibra, Cyklokapron

Warnings and serious effects

Do not receive NovoSeven RT if you:

• have had life-threatening hypersensitivity reactions to NovoSeven RT, coagulation factor VIIa, or any inactive ingredients in the vial or diluent.
• are allergic to mouse, hamster, or bovine proteins
• are also receiving aPCCs (activated prothrombin complex concentrates) or coagulation factor XIII (FXIII).

Serious blood clotting events have been reported following NovoSeven RT administration. Patients taking other blood clotting medications or with heart or vascular disease are more at risk.  Seek emergency medical help if you develop symptoms of a blood clot such as chest heaviness or pain; pain, swelling, or tenderness in an arm or leg; shortness of breath; severe abdominal pain; limb or facial weakness, difficulty speaking, vision problems, dizziness, or a sudden and severe headache.

Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven RT. Patients with a known allergy to mouse, hamster, or bovine proteins may be at a higher risk. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor VII, which may stop NovoSeven RT from working properly. Your healthcare provider may need to test your prothrombin time (PT) and factor VII coagulant activity before and after administration of NovoSeven RT and perform an analysis for antibodies if antibody formation may be suspected. Note that certain assays may give different results for different reagents.

Before taking

Before receiving NovoSeven RT, you should tell your healthcare provider if you:

• have or had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• have had an allergic reaction to any Factor VIIa product before using NovoSeven RT
• have any allergies, including allergies to mouse, bovine, or hamster proteins
• have been told that you have inhibitors to Factor VIIa (because NovoSeven RT may not work for you)
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

It is not known if NovoSeven RT can harm your unborn baby. Talk to your healthcare provider about the risks involved with receiving NovoSeven RT if you are pregnant.

Breastfeeding

It is not known if NovoSeven RT passes into your milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with NovoSeven RT.

How is NovoSeven RT administered?

NovoSeven RT is administered by an intravenous (into a vein) infusion, directly into the bloodstream. It is usually administered by a healthcare provider initially, but people can be taught how to self-administer it themselves, or a caregiver can be taught how to administer it to a person with hemophilia A or B, congenital Factor VII (FVII) deficiency, or Glanzmann’s thrombasthenia.

• Do not attempt to administer NovoSeven RT yourself unless you have been shown how to do so by a healthcare provider.
• Follow the step-by-step instructions provided in the product information.
• NovoSeven RT needs to be diluted before use. Once diluted, it should be administered immediately or within 3 hours of mixing.

Your healthcare provider will tell you how much NovoSeven RT to administer based on your weight, and the condition being treated.

Call your healthcare provider right away if your bleeding does not stop after administering NovoSeven RT.

It is a good idea to record the lot number from the NovoSeven RT label every time you use NovoSeven RT. You can use the peel-off label found on the vial to record the lot number.

The frequency of administration depends on the underlying cause and severity of the bleeding episode but NovoSeven RT is usually administered every 2 to 6 hours.

Do not use NovoSeven RT for a condition for which it is not prescribed or share it with other people, even if they have the same symptoms that you have.

What are the dosage strengths of NovoSeven RT?

NovoSeven RT comes in four different dosage strengths which are printed on the vial label:

• 1mg
• 2mg
• 5mg
• 8mg.

Each vial is supplied with a diluent for reconstitution which is a 10 mmol solution of L-histidine in water for injection.

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.

What happens if I miss a dose?

If you forget a dose, infuse the missed dose when you discover the mistake. Do not infuse a double dose to make up for a forgotten dose. Proceed with the next infusions as scheduled and speak to your healthcare provider if you have any questions or concerns.

What happens if I overdose?

Always take NovoSeven RT exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you inject more NovoSeven RT than recommended, tell your healthcare provider as soon as possible.

What other drugs will affect NovoSeven RT?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NovoSeven RT may affect the way other medicines work. Especially tell your healthcare provider if you take other medications:

• That affect blood clotting, such as carfilzomib
• That affect other coagulation factors, such as efgartigimod alfa, rozanolixizumab, or other coagulation factors, such as coagulation factor XIII (FXIII)
• Such as aPCCs (activated prothrombin complex concentrates), such as FEIBA NF and VH.

NovoSeven RT should not be mixed with other infusion solutions.

NovoSeven RT is safe to use with Hemlibra, which is a monoclonal antibody that works as a “bridge” between other clotting factors to replace missing factor VIII in people with hemophilia A.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store the unmixed vial of NovoSeven RT in its original carton to protect it from light. It can be stored in the refrigerator or at room temperature 36–77°F (2–25°C). Do not freeze.

Do not use past the expiration date.

After reconstitution, store NovoSeven RT either at room temperature (less than 77°F (25°C), or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven RT or store it in syringes.

Discard any unused reconstituted NovoSeven RT.

NovoSeven RT ingredients

Active:  recombinant coagulation Factor VIIa (rFVIIa). It is structurally similar to endogenous human coagulation factor VIIa.

Inactive: 10mmol solution of L-histidine in water for injection.

Contains no preservatives.

NovoSeven RT package is available in the following unit strengths:

• 1mg vial supplied with 1.1ml vial histidine diluent
• 2mg vial supplied with 2.1ml vial histidine diluent
• 5mg vial supplied with 5.2ml vial histidine diluent
• 8mg vial supplied with 8.1ml vial histidine diluent.

NovoSeven RT with MixPro package contains 1 single-dose vial of NovoSeven RT powder and 1 pre-filled histidine diluent syringe with sterile vial adapter which allows patients or healthcare providers to reconstitute the solution without having to use a needle. It is available in the following unit strengths:

• 1mg vial supplied with pre-filled histidine diluent in syringe, 1 mL and vial adapter
• 2mg vial supplied with pre-filled histidine diluent in the syringe, 2 mL, and vial adapter
• 5mg vial supplied with pre-filled histidine diluent in syringe, 5 mL and vial adapter
• 8mg vial supplied with pre-filled histidine diluent in syringe, 8 mL and vial adapter

The vials, the rubber stopper on the vials, or the rubber plunger are not made with natural rubber latex.

Manufacturer

Novo Nordisk.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer