Coagulation factor ix recombinant (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 made naturally in the body. This medicine is a man-made version of the naturally occurring factor IX in the body. It helps stop bleeding by aiding blood clotting 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 for your doctor to monitor you or your child closely during regular visits to ensure this medicine is working properly. Blood and urine tests will be needed to check 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, itchy skin, difficulty 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.

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 signs of a serious kidney issue called nephrotic syndrome.

This medicine may increase your risk of blood clotting problems. Tell 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 worked well for you in the past.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how Ixinity® affects children younger than 12 years old. Its safety and effectiveness have not been established.

Studies so far have not shown any pediatric-specific problems that would limit the usefulness of BeneFIX® for preventing or reducing bleeding episodes in children 16 years and older, or for treating bleeding episodes or preventing 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 so far have not shown any pediatric-specific problems that would limit the usefulness of Rixubis™ in children.

Geriatric

While there have not been appropriate studies on how coagulation factor IX, recombinant injection affects older adults, no specific problems have been documented to date.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh 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 might happen. In these instances, your doctor may want to change the dose, or other precautions may be necessary. 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 close to mealtime or with certain foods because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

• 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) (blood clotting problem) or
• Fibrinolysis, signs of—Rixubis™ should not be used in patients with these conditions.

• Nephrotic syndrome (kidney problem)—Use with caution. May worsen this condition.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your healthcare professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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.