What is Profilnine SD (Factor Ix Complex)?
Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.
Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.
Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.
Factor IX may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Profilnine SD (Factor Ix Complex)?
Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.
Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.
Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.
Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
What should I discuss with my healthcare provider before taking Profilnine SD (Factor Ix Complex)?
Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.
Profilnine SD Side Effects
What are the possible side effects of Profilnine SD (Factor Ix Complex)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- cough, chest pain
- weak or shallow breathing
- feeling short of breath
- headache, feeling like you might pass out
- fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
- easy bruising, increased bleeding episodes; or
- bleeding from a wound or where the medicine was injected
Less serious side effects may include:
- mild nausea or stomach pain; or
- mild tingly or jittery feeling
This is not a complete list of side effects and others may occur. Tell your doctor about any
Profilnine SD Interactions
What other drugs affect Profilnine SD (Factor Ix Complex)?
There may be other drugs that can affect factor IX complex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
What should I avoid while taking Profilnine SD (Factor Ix Complex)?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity
Profilnine SD Dosage
How should I take Profilnine SD (Factor Ix Complex)?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.
Factor IX complex is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.
Always wash your hands before preparing and giving your injection.
Factor IX complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to warm to room temperature before mixing them. Do not heat the medicine or diluent.
After mixing, gently swirl the mixture and allow the medicine to completely dissolve.
After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.
Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.
Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.
Store the medication and the diluent in the refrigerator and do not allow them to freeze.
Throw away any leftover medicine and diluent if the expiration date has passed.
What happens if I overdose on Profilnine SD (Factor Ix Complex)?
Call your doctor if you think you have used too much of this medicine. An overdose of factor IX complex is not expected to produce life-threatening symptoms.
What happens if I miss a dose of Profilnine SD (Factor Ix Complex)?
Factor IX is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.
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while you are using factor IX complex.
unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.