Rixubis (Intravenous)

Coagulation factor IX, recombinant injection is used to treat, control, prevent, and reduce the number of bleeding episodes, and to prevent bleeding during surgery in patients with hemophilia B (congenital Factor IX deficiency or Christmas disease).

Factor IX is a protein that the body naturally produces. This medicine is a man-made version created to mimic the naturally occurring factor IX in the body. It helps stop bleeding by assisting the blood to clot in patients with hemophilia B.

This medicine must be given only by or under the supervision of your doctor and is available only with your doctor's prescription.

It is very important for your doctor to check you or your child's condition closely and regularly to ensure this medicine is working properly. Blood and urine tests will be needed to monitor for any unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Inform your doctor or nurse right away if you or your child experience a rash, itching skin, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in the face, hands, tongue, or throat, or chest pain after receiving the medicine.

Contact your doctor immediately if you have cloudy or bloody urine, dizziness, headache, numbness or tingling in the face, arms, or legs, swelling of the face, feet, or lower legs, or vision problems. These may be symptoms of a serious kidney issue called nephrotic syndrome.

This medicine may increase your risk of blood clotting problems. Notify your doctor right away if you or your child experience a sudden or severe headache, vision or speech issues, chest pain, trouble breathing, or numbness or weakness while receiving this medicine.

Call your doctor immediately if you or your child begin to have bleeding problems, especially if this medicine has previously worked well for you.

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine compared to the benefits it provides. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to determine how effective Ixinity® is for children younger than 12 years old. Safety and effectiveness have not been established.

So far, studies have not shown any specific issues in children 16 years of age and older that would limit the use of BeneFIX® to prevent or reduce bleeding episodes, or to treat and control bleeding episodes or prevent bleeding during surgery in children younger than 12 years. However, due to BeneFIX®'s toxicity, it should be used with caution and the dose may need to be adjusted. Children should be closely monitored during treatment.

Studies have not shown any specific issues that would limit the use of Rixubis™ in children.

Geriatric

There have not been specific studies on how coagulation factor IX, recombinant injection affects older adults, but no specific problems have been reported so far.

Breast Feeding

There are not enough studies in women to assess the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be combined even if there is a chance of interaction. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems can affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to hamster protein—This medicine should not be used if you have this allergy.

• Blood clots or a history of medical problems caused by blood clots or
• Liver disease—Use with caution. These conditions may increase the risk of developing blood clots.

• Disseminated intravascular coagulation (DIC) (a blood clotting issue) or
• Signs of fibrinolysis—Rixubis™ should not be used in patients with these conditions.

• Nephrotic syndrome (a kidney issue)—Use with caution. This condition may worsen.

• Patients with factor IX inhibitors—This may raise the risk of an allergic reaction.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Cough
• Fever

Less common

• Back or side pain
• Blurred vision
• Chest tightness
• Chills
• Confusion
• Difficult or labored breathing
• Fast heartbeat
• Hives
• Itching, pain, redness, swelling, tenderness, blue discoloration, or warmth of the skin at the injection site
• Nausea
• Swelling of the foot or leg
• Vomiting

Incidence not known

• Anxiety
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest pain
• Cloudy or bloody urine
• Difficulty with swallowing
• Dizziness
• Dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• Headache
• Itching, skin rash
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Pain, redness, or swelling in the arm or leg
• Pains in the chest, groin, or legs, especially calves of the legs
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Restlessness
• Severe headaches of sudden onset
• Sudden loss of coordination
• Sudden onset of slurred speech
• Sudden vision changes
• Sweating
• Tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• Trouble breathing
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Vision problems

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Change in or loss of taste
• Drowsiness
• Feeling of warmth
• Pain in the arms or legs
• Redness of the face, neck, arms, and occasionally, the upper chest
• Shaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Benefix
• Ixinity
• Rixubis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

A doctor or other trained health professional will give you or your child this medicine. You may also be trained to administer this medicine yourself. It is given through a needle placed into one of your veins.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

Call your doctor or pharmacist for instructions.