factor IX human recombinant, pegylated 500 (+/-) unit IV solution

Generic name:
Factor ix, recombinant, pegylated - injection

Pronunciation
(FAK-tor)

Brand name(s)
Rebinyn

This medication is used to prevent, treat, and control bleeding episodes in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein normally found in the blood that helps the blood to thicken (clot) and stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication contains a man-made form of factor IX.

This medication is given by injection into a vein over several minutes as directed by your doctor. After first receiving this medication in a hemophilia treatment center or hospital, some people may be able to give it to themselves at home. If your doctor directs you to use this medication at home, read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard medical supplies safely. If you have any questions, ask your health care professional.

The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse. If the medication and the solution used to mix it were refrigerated, bring both to room temperature before mixing. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using, check this product for particles or discoloration. If either is present, do not use the liquid.

The dosage is based on your medical condition (amount and location of bleeding), weight, and response to treatment.

Tell your doctor right away if your bleeding does not stop or if this medication stops working well.

Swelling, pain, or irritation at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney disease (such as change in the amount of urine, frothy urine, loss of appetite, tiredness, stomach/abdominal pain, muscle loss)

This medication may rarely cause blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other clotting disorders (such as disseminated intravascular coagulation-DIC)
• recent surgery/procedure
• liver disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• drugs that help with clotting (such as aminocaproic acid, tranexamic acid)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as factor IX activity) may be done while you are using this medication. Keep all medical and lab appointments.

If more than one dose is needed, it is important to follow the dosing schedule as directed by your doctor. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store the unmixed vial in the refrigerator. Do not freeze. Keep the medication in the original box to protect from light. The unmixed vial may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 6 months. After the powder is mixed into solution, use it within 4 hours and discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.