Take Rixubis exactly as prescribed.
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.
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.
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Rixubis at the same time.
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Rixubis falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. Rixubis should be given to a pregnant woman only if clearly needed.
Rixubis (generic: coagulation factor IX recombinant) is a prescription medicine used to prevent and control bleeding in people with hemophilia B, an inherited bleeding disorder. Rixubis belongs to a group of drugs called antihemophilic agents which work by replacing clotting factors missing in people with hemophilia B. Rixubis belongs to a group of drugs called antihemophilic agents, which work by providing factors in the blood that prevent bleeding.
This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
Common side effects of Rixubis include distorted taste and pain in the extremities.
Serious side effects have been reported with Rixubis including:
- Hypersensitivity reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms…
- swelling of the face or lips
- chest tightness
- a drop in blood pressure
- lethargy (sluggishness)
- nausea
- vomiting
- tingling in hands or feet
- restlessness
- wheezing
- difficulty breathing
- Development of proteins that inhibit (stop) the activity of factor IX. Your healthcare provider will want to monitor for this development.
- Nephrotic syndrome (kidney damage). Tell your healthcare provider right away if you have some or all of the following symptoms…
- urine with a foamy appearance
- poor or decreased appetite
- swelling around the eyes, feet, and ankles, and in the abdomen (stomach area)
- weight gain from an increase in fluid in the body
- Thromboembolic complications. This is a process of blood clot formation. This can be especially dangerous if a blood clot gets stuck in the leg (deep vein thrombosis), the lungs (pulmonary embolism), or if you have a stroke (clotting of a vessel leading to the brain).
Do not take Rixubis if you:
- have a known hypersensitivity (allergic reaction) to Rixubis or its ingredients
- are allergic to hamsters
- develop disseminated intravascular coagulation (DIC). DIC is when clotting and bleeding of the blood becomes unbalanced
- develop signs of fibrinolysis. Fibrinolysis is when your blood loses its ability to clot
Before taking Rixubis, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- have or have had any medical problems
- 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)
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
If you take too much Rixubis call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
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:
- Light Blue: dosage strength of about 250 international units
- Pink: dosage strength of about 500 international units
- Green: dosage strength of about 1000 international units
- Orange: dosage strength of about 2000 international units
- Silver: dosage strength of about 3000 international units
Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
Active ingredient: coagulation factor IX recombinant
Inactive ingredients: sterile water for injection (once reconstituted)
No Rixubis drug interactions have been reported, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.
Take Rixubis exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
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.
Rixubis is a prescription medication used for:
- control and prevention of bleeding episodes in adults with hemophilia B
- perioperative (before and after surgery) use in adults with hemophilia B
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known whether Rixubis crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Rixubis.
- Store at refrigerated temperature 2° to 8°C (35 to 46°F) for up to 18 months. Do not freeze.
- May store at room temperature not to exceed 30°C (86°F) for up to 6 months within the 18 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.
- Do not share Rixubis with other people, even if they have the same symptoms as you do.
- Keep out of reach of children.
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Rixubis, there are no specific foods that you must exclude from your diet when receiving this medication.
Serious side effects have been reported with Rixubis. See “Drug Precautions” section.
Common side effects of Rixubis include distorted taste and pain in the extremities.
This is not a complete list of Rixubis side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.