FACTOR IX, RECOMBINANT, PEGYLATED - INJECTION

FACTOR IX, RECOMBINANT, PEGYLATED - INJECTION

PHONETIC PRONUNCIATION: (FAK-tor)

COMMON BRAND NAME(S): Rebinyn

GENERIC NAME(S): factor IX (human) recombinant, pegylated

Uses

USES: This medication is used to 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.


How to use FACTOR IX, RECOMBINANT, PEGYLATED - INJECTION

HOW TO USE: 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 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 combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using, check this product visually 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.

Side Effects

SIDE EFFECTS: 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 your doctor has prescribed this medication because he or she 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 pulmonary embolism, stroke, heart attack, deep vein thrombosis). Get medical help right away if any of these side effects occur: 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 headache, 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.

Precautions

PRECAUTIONS: Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or to hamster protein; 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 breast-feeding.

Interactions

DRUG INTERACTIONS: 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).

Overdose

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Disclaimer

IMPORTANT: 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.