Profilnine SD

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

Because Profilnine SD 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 Profilnine SD. Notify your doctor if you develop arm or leg pain/swelling, trouble breathing, or chest pain.


Profilnine SD is used for:

Controlling and preventing bleeding episodes in patients with hemophilia B.

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

Do NOT use Profilnine SD if:

  • you are allergic to any ingredient in Profilnine SD
  • 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 Profilnine SD:

Some medical conditions may interact with Profilnine SD. 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 Profilnine SD. However, no specific interactions with Profilnine SD are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Profilnine SD 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 Profilnine SD:

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

  • Profilnine SD is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Profilnine SD 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 Profilnine SD.
  • To use Profilnine SD, warm both vials to room temperature.
  • Do not shake vial after adding diluent.
  • Profilnine SD will be given through a vein after it is mixed with sterile water for injection.
  • Use Profilnine SD within 3 hours after the solution is mixed. Do not use leftover medicine or use Profilnine SD beyond the expiration date on the container.
  • If Profilnine SD 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 Profilnine SD, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Profilnine SD.

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 Profilnine SD with extreme caution in NEWBORNS. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Profilnine SD, discuss with your doctor the benefits and risks of using Profilnine SD during pregnancy. It is unknown if Profilnine SD is excreted in breast milk. If you are or will be breast-feeding while you are using Profilnine SD, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Profilnine SD:

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 Profilnine SD:

Store Profilnine SD 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 Profilnine SD out of the reach of children and away from pets.

General information:

  • If you have any questions about Profilnine SD, please talk with your doctor, pharmacist, or other health care provider.
  • Profilnine SD 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 Profilnine SD 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 Profilnine SD. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Profilnine SD. 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 Profilnine SD.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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