Factor IX Concentrates, Injection

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KEY POINTS

• This medicine is given by IV injection to prevent and control bleeding caused by hemophilia B. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihemophilic; coagulation factor

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

What is this medicine used for?

This medicine is used to prevent and control bleeding in people with hemophilia B.

This medicine may be used to treat other conditions 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, to hamsters or mice, or to latex
• A stroke or transient ischemic attack (TIA)
• Blood clots
• Heart disease
• Heparin-induced thrombocytopenia (HIT)
• Liver disease

Also tell your healthcare provider if you have recently had a long period of bedrest after major surgery or after wearing a cast.

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 given by IV injection (shots into a large vein). These injections may be given by your healthcare provider. You may be able to inject this medicine yourself or with the help of someone at home. Your healthcare provider or a hemophilia center can teach you the proper way to give the shots. If you take this medicine on a regular schedule, do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children.

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you take this medicine on a regular schedule and you miss a dose, contact your healthcare provider. Do not take double doses.

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 some forms of this medicine are 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.

You may be at a higher risk of for developing a blood clot after treatment with this medicine. Talk with your healthcare provider about this.

Your body may make antibodies that prevent this medicine from working. Tell your healthcare provider if this medicine does not seem to be working as well as usual. If your bleeding is not controlled after you receive this medicine, contact your healthcare provider right away.

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

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you need special care.

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); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fever and chills; unexplained sore throat; unusual tiredness or weakness, unexplained cough; chest pain; trouble breathing; redness, warmth, or swelling in your hands, ankles or feet; trouble urinating; unusual bruising or bleeding; severe lightheadedness or fainting.

Other: Headache, flushing, tingling, mild dizziness, drowsiness, nausea, vomiting, diarrhea, 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, Lysteda)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. 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.

How should I store this medicine?

If you keep this medicine at home, store it in the refrigerator. Do not let it freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Follow the storage instructions in the medicine package carefully.

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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.