"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
[Coagulation Factor IX (Recombinant)]
This leaflet summarizes important information about RIXUBIS. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about RIXUBIS. If you have any questions after reading this, ask your healthcare provider.
What is RIXUBIS?
RIXUBIS is a medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents blood from clotting normally. RIXUBIS is used to prevent and control bleeding in people with hemophilia B. Your healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can reduce the number of bleeding episodes when used regularly (prophylaxis).
Who should not use RIXUBIS?
You should not use RIXUBIS if you
- are allergic to hamsters
- are allergic to any ingredients in RIXUBIS.
Tell your healthcare provider if you are pregnant or breastfeeding because RIXUBIS may not be right for you.
What should I tell my healthcare provider before using RIXUBIS?
You should tell your healthcare provider if you
- have or have had any medical problems
- take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
- have any allergies, including allergies to hamsters
- are breastfeeding. It is not known if RIXUBIS passes into your milk and if it can harm your baby
- are pregnant or planning to become pregnant. It is not known if RIXUBIS may harm your unborn baby
- have been told that you have inhibitors to factor IX (because RIXUBIS may not work for you).
How should I infuse RIXUBIS?
RIXUBIS is given directly into the bloodstream. RIXUBIS should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse their RIXUBIS by themselves or with the help of a family member.
Your healthcare provider will tell you how much RIXUBIS to use based on your weight, the severity of your hemophilia B, and where you are bleeding. You may have to have blood tests done after getting RIXUBIS to be sure that your blood level of factor IX is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking RIXUBIS.
What are the possible side effects of RIXUBIS?
Allergic reactions may occur with RIXUBIS. Call your healthcare provider or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting. Some common side effects of RIXUBIS were unusual taste in the mouth and limb pain. Tell your healthcare provider about any side effects that bother you or do not go away. These are not all the side effects possible with RIXUBIS. You can ask your healthcare provider for information that is written for healthcare professionals.
What are the RIXUBIS dosage strengths?
RIXUBIS comes in five different dosage strengths: 250, 500, 1000, 2000 and 3000 international units. The actual strength will be imprinted on the label and on the box. The five different strengths are color coded, as follows:
|Dosage strength of approximately 250 international units per vial|
|Dosage strength of approximately 500 international units per vial|
|Dosage strength of approximately 1000 international units per vial|
|Dosage strength of approximately 2000 international units per vial|
|Dosage strength of approximately 3000 international units per vial|
Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
How should I store RIXUBIS?
- Store at refrigerated temperature 2° to 8°C (36° to 46°F) for up to 24 months. Do not freeze.
- May store at room temperature not to exceed 30°C (86°F) for up to 12 months within the 24 month time period. Write on the carton the date RIXUBIS is removed from refrigeration. After storage at room temperature, do not return the product to the refrigerator.
- Do not use after the expiration date printed on the carton or vial.
- Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any RIXUBIS left in the vial at the end of your infusion.
What else should I know about RIXUBIS?
Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor IX.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use RIXUBIS for a condition for which it is not prescribed. Do not share RIXUBIS with other people, even if they have the same symptoms that you have.
Recredits at Baxter available to patients
For information on patient assistance programs that are available to you, including the Baxter CARE Program, please contact the Baxter Insurance Assistance Helpline at 1-888-229-8379.
INSTRUCTIONS FOR USE
[Coagulation Factor IX (Recombinant)]
For intravenous use only
Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using RIXUBIS. If you are unsure of the procedures, please call your healthcare provider before using RIXUBIS. Call your healthcare provider right away if bleeding is not controlled after using RIXUBIS. Your healthcare provider will prescribe the dose that you should take. Your healthcare provider may need to take blood tests from time to time. Talk to your healthcare provider before traveling. Plan to bring enough RIXUBIS for your treatment during this time. Dispose of all materials, including any leftover reconstituted RIXUBIS product, in an appropriate container.
1. Prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the vial with the RIXUBIS concentrate and the Sterile Water for Injection, USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional.
2. Remove caps from the RIXUBIS concentrate and diluent vials to expose the centers of the rubber stoppers.
3. Disinfect the stoppers with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center) by rubbing the stoppers firmly for several seconds and allow them to dry prior to use. Place the vials on a flat surface.
4. Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. Do not remove the BAXJECT II device from the package.
5. Turn the package with the BAXJECT II device upside down and place it over the top of the diluent vial. Fully insert the clear plastic spike of the device into the center of the diluent vial stopper by pushing straight down. Grip the package at its edge and lift it off the device. Be careful not to touch the white plastic spike. Do not remove the blue cap from the BAXJECT II device. The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the RIXUBIS vial.
6. To connect the diluent vial to the RIXUBIS vial, turn the diluent vial over and place it on top of the vial containing RIXUBIS concentrate. Fully insert the white plastic spike into the RIXUBIS vial stopper by pushing straight down. Diluent will flow into the RIXUBIS vial. This should be done right away to keep the liquid free of germs.
7. Swirl the connected vials gently and continuously until the powder is completely dissolved. Do not shake. The RIXUBIS solution should look clear and colorless. If not, do not use it and notify Baxter immediately.
8. Take off the blue cap from the BAXJECT II device and connect the syringe by screwing it clockwise until the syringe is secured. Do not over tighten. Be careful to not inject air.
9. Turn over the connected vials so that the RIXUBIS vial is on top. Draw the RIXUBIS solution into the syringe by pulling back the plunger slowly. Disconnect the syringe from the BAXJECT II unscrewing it counterclockwise.
10. If you are using more than one vial of RIXUBIS, the contents of more than one vial may be drawn into the same syringe. Make sure you mix each vial of RIXUBIS with the Sterile Water for Injection, USP that is provided in the box (following Steps 1-9). You will need a separate BAXJECT II device to mix each additional vial of RIXUBIS.
11. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.
12. Apply a tourniquet and get the infusion site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center).
13. Insert the needle into the vein and remove the tourniquet. Slowly infuse the RIXUBIS. Do not infuse any faster than 10 mL per minute.
14. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes. Do not recap the needle. Place it with the used syringe in a hard-walled sharps container for proper disposal.
15. Dispose of the used vials and BAXJECT II system in your hard-walled sharps container without taking them apart. Do not dispose of these supplies in ordinary household trash.
16. Remove the peel-off label from the RIXUBIS vial and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution.
Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems.
Last reviewed on RxList: 2/29/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Rixubis Information
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