Factor IX Concentrates, Injection

What are other names for this medicine?

Type of medicine: antihemorrhagic

Generic and brand names: factor IX complex concentrates, injection; prothrombin complex concentrate, injection; AlphaNine SD; Bebulin; BeneFIX; Mononine; Profilnine SD

What is this medicine used for?

This medicine is used to prevent and control bleeding caused by too little Factor IX in the blood. This condition is called hemophilia B or Christmas disease. It is usually hereditary. This medicine may be used for other bleeding problems as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine, or to hamsters or mice
• a stroke
• blood clots or a long period of bedrest after major surgery or wearing a cast
• heart disease
• liver disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is usually given by IV infusion (slow drip into a large vein) by your healthcare provider. You will be given the amount needed to restore the normal clotting of your blood.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Because this medicine is made from human blood, you may be at risk of virus infections. Contact your healthcare provider right away if you develop any signs of an infection.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Fever, chills, unexplained sore throat, unusual tiredness, unexplained cough, chest pain, trouble breathing, arm or leg pain or swelling, trouble urinating, unusual bleeding or bruising.

Other: Headache, flushing, tingling, dizziness, drowsiness, nausea, vomiting, injection site pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• aminocaproic acid (Amicar)
• tranexamic acid (Cyklokapron)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.