Coagulation Factor IX , Fc Fusion Protein Solution for injection
What is this medicine?
FACTOR IX Fc FUSION PROTEIN (fak tir nine Fc FYOO zhuh n PROH teen) is used in patients with hemophilia B to help prevent and control bleeding.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to factor IX products, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
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 healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. While this medicine 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 your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
This medicine may interact with the following medications:
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 medicine?
If you are a hemophilia patient, carry an identification card with you at all times. The card should have your name, the name and dose of your medication(s), the name and phone number of your doctor or health care professional, and a contact person in case of emergency.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
shortness of breath, chest pain, swelling in a leg
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
pain, redness, or irritation at site where injected
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 medicine?
Keep out of the reach of children.
This drug is usually given in a hospital or clinic and will not be stored at home.
In rare cases, this medicine may be given at home. If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.
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.
March 21, 2017
U.S. FDA-approved Package Insert