Factor ix (Intravenous, Injection)

Factor IX is a protein that your body makes naturally. It helps your blood form clots to stop bleeding. Injections of factor IX are used to treat hemophilia B, also known as Christmas disease. This condition means your body doesn’t make enough factor IX. If you have low levels of factor IX and get injured, your blood won't clot properly, which can lead to bleeding and damage to your muscles and joints.

Injections of a type of factor IX called factor IX complex are also used to treat some people with hemophilia A. In hemophilia A, sometimes referred to as classical hemophilia, your body does not produce enough factor VIII. As in hemophilia B, this means your blood can't clot properly. Injections of factor IX complex may be used for patients who find that their current treatment for hemophilia A is no longer working. Factor IX complex injections may also be used for other conditions based on your doctor's judgment.

The factor IX product your doctor will give you comes from human blood or is made through a man-made process. Factor IX from human blood has been treated to reduce the risk of harmful viruses like hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). The man-made factor IX product does not have these viruses.

You can only get factor IX with a prescription from your doctor.

If you were recently diagnosed with hemophilia B, you should get hepatitis A and hepatitis B vaccines to lower your risk of getting hepatitis A or hepatitis B from factor IX products.

Over time, your body may develop a defense (antibody) against this medicine. Tell your doctor if this medicine appears to be less effective than usual.

It is advised that you carry identification that states you have hemophilia A or hemophilia B. If you have questions about what type of identification to carry, ask your health care professional.

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

Allergies

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

Pediatric

Blood clots may be more likely in premature and newborn babies, who tend to be more sensitive than adults to the effects of injections of factor IX.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older adults compared to younger adults.

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.

Studies in women indicate that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if there is a chance of interaction. In these situations, your doctor may need to 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

Certain medicines should not be taken right before or after eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor about any other medical problems, especially:

• Blood clots or a history of medical issues caused by blood clots or
• Liver disease—This may increase the risk of bleeding or forming blood clots.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may need medical attention.

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

Less common or rare

• Changes in facial skin color
• Fast or irregular breathing
• Puffiness or swelling of the eyelids or around the eyes
• Shortness of breath, troubled breathing, tightness in the chest, and/or wheezing
• Skin rash, hives, and/or itching

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

More common

• Bluish coloring (especially of the hands and feet)
• Convulsions
• Dizziness or lightheadedness when getting up from a lying or sitting position
• Increased heart rate
• Large blue or purplish patches in the skin (at places of injection)
• Nausea or vomiting
• Pains in the chest, groin, or legs (especially calves)
• Persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine
• Severe pain or pressure in the chest and/or the neck, back, or left arm
• Severe, sudden headache
• Shortness of breath or fast breathing
• Sudden loss of coordination
• Sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in an arm or leg

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

Less common

• Burning or stinging at the place of injection
• Changes in blood pressure or pulse rate
• Chills
• Drowsiness
• Fever
• Headache
• Nausea or vomiting
• Redness of face
• Shortness of breath

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.

• Alphanine SD
• Alprolix
• Bebulin
• Bebulin VH
• Benefix
• Idelvion
• Ixinity
• Mononine
• Profilnine SD
• Proplex T
• Rebinyn
• Rixubis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

To prepare this medicine:

• Take the dry medicine and the liquid (diluent) out of the refrigerator and bring them to room temperature, as directed by your doctor.
• When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the container of dry medicine to prevent foaming.
• Swirl the container gently to dissolve the medicine. Do not shake the container.

Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared.

A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• The condition for which you are using this medicine.
• Your body weight.
• The amount of factor IX your body is able to make.
• How much, how often, and where in your body you are bleeding.
• Whether or not your body has built up a defense (antibody) against this medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.