Ixinity (Intravenous)

Coagulation factor IX, recombinant injection is used to treat, control, prevent, and reduce the frequency 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 is naturally made in the body. This medicine is a man-made protein created to mimic the naturally occurring factor IX in the body. It works to stop bleeding by helping the blood to clot in patients with hemophilia B.

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

It is very important that your doctor checks you or your child's health closely and regularly to ensure this medicine is working properly. Blood and urine tests will be needed to look for unwanted effects.

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

Check with your doctor right away 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 problem called nephrotic syndrome.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing, or numbness or weakness while receiving this medicine.

Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about regarding 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 healthcare professional know about any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of Ixinity® in children younger than 12 years. Its safety and effectiveness in this age group have not been established.

So far, studies have not shown any specific problems that would limit the use of BeneFIX® to prevent or reduce the frequency of bleeding episodes in children 16 years and older, 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 carefully, and the dose may need to be adjusted. Children should be closely monitored during treatment.

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

Geriatric

Although there have not been appropriate studies on the effects of coagulation factor IX, recombinant injection in older adults, no specific problems related to this age group have been reported so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In situations where an interaction might occur, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Allergy to hamster protein—Should not be used in patients with this condition.

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

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

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

• Patients with factor IX inhibitors—May increase the risk of having 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 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.