Profilnine SD

Generic Name: factor IX complex (FAK tor NINE KOM plex)
Brand Name: Bebulin VH, Profilnine SD, Proplex T

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 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 deficiency.

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.

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Stop using factor IX and call your doctor at once if you have chest pain, weak or shallow breathing, headache, warmth or tingling, fast or slow heart rate, easy bruising, increased bleeding episodes, bleeding from a wound or where the medicine was injected, or feeling like you might pass out.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.

What should I discuss with my healthcare provider before using Profilnine SD (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX deficiency.

To make sure factor IX complex is safe for you, tell your doctor if you have liver disease.

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) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but 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.

How should I use Profilnine SD (factor IX complex)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Factor IX is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Always check the strength of the medicine on the label to be sure you are using the correct potency.

Always wash your hands before preparing and giving your injection.

Factor IX must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Take the medicine and diluent out of the refrigerator and allow them to reach room temperature before mixing your dose. Do not heat the medicine or diluent.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve. The mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your pharmacist for new medication.

A single dose of factor IX may be enough to control minor bleeding. If you need another dose, wait at least 24 hours before using the medication again.

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 a disposable needle only once. 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.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.

You may need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

Store the medication and the diluent in the refrigerator and do not allow them to freeze.

Throw away any unused medicine or diluent after the expiration date on the label has passed.

What happens if I miss a dose?

Factor IX is sometimes used only when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Profilnine SD (factor IX complex)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Profilnine SD (factor IX complex) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using factor IX and call your doctor at once if you have a serious side effect such as:

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • weak or shallow breathing;

  • feeling short of breath;

  • headache, feeling like you might pass out;

  • flushing (warmth, redness, or tingly feeling);

  • fast or slow heart rate;

  • fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

  • nausea, upper stomach pain, itching, 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;

  • mild stomach pain; or

  • mild tingly or jittery feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Profilnine SD (factor IX complex)?

Tell your doctor about all other medicines you use, especially:

  • aminocaproic acid (Amicar); or

  • tranexamic acid (Cyklokapron, Lysteda).

This list is not complete and other drugs may interact with factor IX. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about factor IX.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2012-10-15, 11:19:35 PM.

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