Pronunciation:

koh-a-gyoo-LAY-shun FAK-tor NINE re-KOM-bin-ant

Brand Names:

• Benefix
• Ixinity
• Rixubis

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

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

Factor IX is a protein that is produced naturally in the body. This medicine is a man-made protein produced to replicate the naturally occurring factor IX in the body. It is used to stop bleeding by helping the blood to clot in patients with hemophilia B.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Ixinity® in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of BeneFIX® to prevent or decrease the frequency of bleeding episodes in children 16 years of age and older, or to treat and control bleeding episodes or prevent bleeding during surgery in children younger than 12 years of age. However, because of BeneFIX®'s toxicity, it should be used with caution and an adjustment in the dose is needed. Children should be carefully monitored during treatment.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rixubis™ in children.

Older adults—

Although appropriate studies on the relationship of age to the effects of coagulation factor IX, recombinant injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you 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 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 make this condition worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's closely and at regular visits to make sure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

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

Check with your doctor right away if you have a 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 you are 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.

Side Effects of This Medicine:

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