We are sharing this information so you’ll know what to expect from the process of preparing a NovoSeven® RT dose. For full instructions, refer to the FDA-approved patient information and Instructions for Use.

Do not attempt an infusion unless you have been trained by your health care provider or hemophilia treatment center.

Performing an infusion.

You probably have questions about what it’s like to infuse your factor product.

First, there are a few things you should know:

  • Accidental sticks with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. If injury occurs, you should obtain immediate medical attention. Be sure to place needles in a sharps container after single-use
  • Before administration, inspect the reconstituted NovoSeven® RT solution visually for particulate matter and discoloration, whenever solution and container permit. Do not use if you see particulate matter or discoloration
  • Do not administer NovoSeven® RT in the same tubing or container with other medicinal products

Administration, step by step.

You’ll be administering your factor by intravenous injection, either at a Hemophilia Treatment Center, a health care provider’s office, or at home, after you’ve received training.



First, invert the NovoSeven® RT vial and slowly draw the solution into the syringe.


Next, detach the syringe from the vial adapter by turning the syringe counterclockwise.


Attach the syringe to the luer end of an infusion needle set.


Then, inject the reconstituted NovoSeven® RT intravenously slowly over 2 to 5 minutes.


When you’re finished, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused NovoSeven® RT, and other waste materials.

Be sure to track your bleeds.

It’s important to maintain accurate records of your bleeds and infusions. We’ve created ways to help. Every NovoSeven® RT vial comes with a peel-off label that you can add to your infusion log, and now you can download your own infusion logbook to make it easy to keep information organized.

For even more convenience, download a free mobile app that helps you track and share details about your treatment.

 

Selected Important Safety Information

WARNING: BLOOD CLOTS

  • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported.
  • Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function.
  • Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for:

  • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and people with Glanzmann’s thrombasthenia who have a decreased or absent response to platelet transfusions
  • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

Important Safety Information

WARNING: BLOOD CLOTS

  • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported.
  • Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function.
  • Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT.

Warnings and Precautions

  • NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT.
  • Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.
  • People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.

Side Effects

  • The most common and serious side effects are blood clots.
  • Tell your healthcare provider about any side effects that bother you or do not go away.

Use with Other Drugs

  • Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).

Please click here for Prescribing Information.

NovoSeven® RT is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.