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Coagulation Factor IX Recombinant Immunoglobulin G1 Fusion Protein Injection (FACTOR IX, RECOMBINANT - INJECTION)

For hemophilia (bleeding disorder).

Brand Name(s): Alprolix

Generic Name: Coagulation Factor IX Recombinant Immunoglobulin G1 Fusion Protein

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.

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.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

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

Cautions

Do not use the medication any more than instructed.

Speak with your doctor before taking any medicine with aspirin.

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

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or 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.

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
  • 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.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

 
 

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