Factor IX Concentrates Injection

What is this medication?

FACTOR IX CONCENTRATES (FAK ter nine KAAN suhn trayts) prevents and treats bleeding episodes in people with hemophilia B, a condition caused by low levels of blood clotting factor IX. It works by increasing factor IX levels in your body. This helps your blood clot normally, which reduces bleeding.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AlphaNine SD, BeneFIX, IXINITY, Mononine, RIXUBIS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• An unusual or allergic reaction to factor IX, other medications, human or animal (mouse or hamster) protein, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into a vein. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Let the powder and solution warm to room temperature before use. Follow mixing directions carefully to avoid foaming. Swirl but do not shake the solution. Get rid of any unused portion. Use exactly as directed. Do not take more often than directed. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

This medication may interact with the following:

• Aminocaproic acid
• Factor VIIa
• Tranexamic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Some blood factor products are made from donated human blood. There is a small risk that they may contain bacteria or viruses, such as hepatitis or HIV. All products are processed to kill most bacteria and viruses. Talk to your care team if you have questions about the risk of infection.

Avoid taking medications that contain aspirin, ibuprofen, or naproxen. These medications may increase your risk of bleeding. Your care team may recommend acetaminophen for mild pain or fever.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Flushing
• Headache
• Nausea
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

See product label for storage information. Each product may have different instructions. Get rid of any unused medication as instructed or after the expiration date, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.