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Proplex-T

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Proplex-T

Proplex-T Patient Information Including Side Effects

Brand Names: Bebulin VH, Profilnine SD, Proplex T

Generic Name: factor IX complex (Pronunciation: FAK tor NINE KOM plex)

What is factor IX complex (Proplex-T)?

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 are the possible side effects of factor IX complex (Proplex-T)?

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.

Read the Proplex-T (factor ix complex) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about factor IX complex (Proplex-T)?

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.

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.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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