Factor IX Injection (FACTOR IX, RECOMBINANT - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

Follow package direction for diluting medicine with IV fluids or as instructed by your doctor or nurse.

Do not dilute the medicine until ready to use.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

Keep medicine in refrigerator. Do not freeze. If frozen, throw away.

When you are ready to use the medicine, remove it from the refrigerator and then keep it at room temperature - below 77 degrees F (25 degrees C). Do not put it back in the refrigerator.

Protect medicine from light.

Inject the medicine immediately after mixing.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Wash your hands before and after handling this medicine.

You or a family member can be trained to give this medicine at home.

Tell your doctor if you have ever had an allergic reaction to latex.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Call your doctor right away if you notice any unusual bleeding or bruising.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• feeling of heat or flushing
• fever or chills
• headaches
• pain, redness, swelling near injection
• nausea
• sudden change or loss of vision
• severe or persistent vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• increased risk of bleeding
• unusual bruising or discoloration on skin
• chest pain
• swelling of the legs, feet, and hands
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• sudden leg pain, swelling, warmth or redness
• pale or blue skin, lips or fingernails
• rapid heartbeat
• shortness of breath

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.