Proplex T

Generic Name: factor ix (recombinant) complex (FAK-tuhr nine)
Brand Name: Examples include Bebulin VH and Profilnine SD

Because Proplex T is made from human blood, it is possible you may develop infections from it (eg, hepatitis, viral infections). Notify your doctor immediately if you develop any signs of an infection or hepatitis (eg, fever, persistent sore throat, unusual fatigue, yellowing eyes or skin, dark urine). You may develop blood clots with the use of Proplex T. Notify your doctor if you develop arm or leg pain/swelling, trouble breathing, or chest pain.


Proplex T is used for:

Controlling and preventing bleeding episodes in patients with hemophilia B.

Proplex T is a clotting factor. It works by correcting defects in patients who have deficiencies of certain clotting factors.

Do NOT use Proplex T if:

  • you are allergic to any ingredient in Proplex T
  • you are allergic to hamster protein
  • you have severe blood clotting problems (eg, fibrinolysis, disseminated intravascular coagulation)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Proplex T:

Some medical conditions may interact with Proplex T. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver disease, have a bleeding disorder, are at risk for blood clots, or have recently undergone surgery

Some MEDICINES MAY INTERACT with Proplex T. However, no specific interactions with Proplex T are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Proplex T may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Proplex T:

Use Proplex T as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Proplex T is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Proplex T at home, carefully follow the injection procedures taught to you by your health care provider.
  • Always wash your hands and carefully follow procedures for preparing and giving yourself Proplex T.
  • To use Proplex T, warm both vials to room temperature.
  • Do not shake vial after adding diluent.
  • Proplex T will be given through a vein after it is mixed with sterile water for injection.
  • Use Proplex T within 3 hours after the solution is mixed. Do not use leftover medicine or use Proplex T beyond the expiration date on the container.
  • If Proplex T contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Proplex T, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Proplex T.

Important safety information:

  • Additional monitoring of your dose or condition may be needed if you are taking drugs that aid blood clotting (eg, tranexamic acid, aminocaproic acid) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen).
  • LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Proplex T with extreme caution in NEWBORNS. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Proplex T, discuss with your doctor the benefits and risks of using Proplex T during pregnancy. It is unknown if Proplex T is excreted in breast milk. If you are or will be breast-feeding while you are using Proplex T, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Proplex T:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; flushing; headache; nausea; stinging at the injection site; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); arm or leg pain/swelling; chest pain; dark urine; fever; persistent sore throat; unusual fatigue; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Proplex T:

Store Proplex T in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). It may also be stored at room temperature, not to exceed 77 degrees F (25 degrees C), for up to 6 months. Do not freeze. Do not store in the bathroom. Keep Proplex T out of the reach of children and away from pets.

General information:

  • If you have any questions about Proplex T, please talk with your doctor, pharmacist, or other health care provider.
  • Proplex T is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Proplex T or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Proplex T. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Proplex T. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Proplex T.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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