Coagulation factor IX injection (human)

Generic Name: coagulation factor ix injection (human) (ko-ag-yoo-LAY-shun)
Brand Name: Examples include AlphaNine SD and Mononine

Coagulation factor IX injection (human) is used for:

Preventing and controlling bleeding in patients with factor IX deficiency caused by hemophilia B.

Coagulation factor IX injection (human) is a human clotting factor derived from human plasma. It works by increasing the amount of clotting factor IX in the blood, which helps the blood form clots and stop bleeding.

Do NOT use coagulation factor IX injection (human) if:

  • you are allergic to any ingredient in coagulation factor IX injection (human), including mouse proteins

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

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Before using coagulation factor IX injection (human):

Some medical conditions may interact with coagulation factor IX injection (human). 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, including mouse proteins
  • if you have liver disease
  • if you are at risk for developing blood clots or if you have a history of bleeding problems other than hemophilia B
  • if you have recently had surgery or if you have a weakened immune system (eg, HIV infection, AIDS)

Some MEDICINES MAY INTERACT with coagulation factor IX injection (human). However, no specific interactions with coagulation factor IX injection (human) are known at this time.

Ask your health care provider if coagulation factor IX injection (human) 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 coagulation factor IX injection (human):

Use coagulation factor IX injection (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Coagulation factor IX injection (human) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using coagulation factor IX injection (human) at home, a health care provider will teach you how to use it. Be sure you understand how to use coagulation factor IX injection (human). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use coagulation factor IX injection (human) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of coagulation factor IX injection (human), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use coagulation factor IX injection (human).

Important safety information:

  • Some of these products contain mouse proteins. If you have ever had an allergic reaction to mouse proteins, ask your pharmacist if your product has mouse proteins in it.
  • Tell your doctor or dentist that you take coagulation factor IX injection (human) before you receive any medical or dental care, emergency care, or surgery.
  • Coagulation factor IX injection (human) is made from human plasma, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with human plasma. No cases of these problems have been found in patients who have used coagulation factor IX injection (human).
  • Lab tests, including factor IX levels, may be performed while you use coagulation factor IX injection (human). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: It is not known if coagulation factor IX injection (human) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using coagulation factor IX injection (human) while you are pregnant. It is not known if coagulation factor IX injection (human) is found in breast milk. If you are or will be breast-feeding while you are using coagulation factor IX injection (human), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of coagulation factor IX injection (human):

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:

Mild chills; nausea; stinging at the injection site.

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; unusual hoarseness); chest pain; chills; dark urine; faintness; fast or irregular heartbeat; fever; lightheadedness, especially upon standing; loss of appetite; pain, swelling, or tenderness in the calf; severe or persistent dizziness; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; unusual bruising or bleeding; unusual tiredness; wheezing; yellowing of the skin or eyes.

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 coagulation factor IX injection (human):

Store the unmixed medicine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Prior to the expiration date, it may also be stored at room temperature not to exceed 77 degrees F (25 degrees C) for up to 1 month. When removed from refrigeration, record the date removed on the space provided on the carton. Keep coagulation factor IX injection (human) out of the reach of children and away from pets.

General information:

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

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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