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Alprolix

Generic Name: coagulation factor ix injection (recombinant) (rfixfc) (ko-ag-yoo-LAY-shun)
Brand Name: Alprolix

Alprolix is used for:

Preventing and controlling bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease), including control and prevention of bleeding in surgical settings.

Alprolix is a synthetic protein, clotting factor IX. It works by increasing the amount of clotting factor IX in the blood, helping the blood form clots and stop bleeding.

Do NOT use Alprolix if:

  • you are allergic to any ingredient in Alprolix

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

Before using Alprolix:

Some medical conditions may interact with Alprolix. 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 ever had a blood clot
  • if you have recently had surgery

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

Ask your health care provider if Alprolix 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 Alprolix:

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

  • An extra patient leaflet is available with Alprolix. Talk to your pharmacist if you have questions about this information.
  • Alprolix may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Alprolix at home, a health care provider will teach you how to use it. Be sure you understand how to use Alprolix. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Alprolix 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 away from 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 Alprolix, contact your doctor right away.

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

Important safety information:

  • Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes Alprolix less effective. If Alprolix stops working or does not work as well as it has before, contact your doctor immediately for instructions.
  • Tell your doctor or dentist that you take Alprolix before you receive any medical or dental care, emergency care, or surgery.
  • Blood clots have happened in certain people using products that contain factor IX. Discuss any questions or concerns with your doctor.
  • LAB TESTS, including factor IX levels, may be performed while you use Alprolix. 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 Alprolix can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alprolix while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Alprolix, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Alprolix:

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:

Headache; burning, numbness, or tingling in the mouth.

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 or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling that is not normal; calf or leg pain, swelling, or tenderness; chest pain or pressure; confusion; coughing up blood; fainting; one-sided weakness; restlessness; severe nausea or vomiting; shortness of breath; sudden, severe headache or dizziness; vision or speech changes.

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 Alprolix:

Store Alprolix in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Be sure you know how long you can store Alprolix. Do not freeze. Alprolix may be stored at room temperature up to 86 degrees F (30 degrees C) for up to 6 months. You should make note of the date the product was placed at room temperature in the space provided on the outer carton. Do not use past the expiration date. Do not place back in the refrigerator after storage at room temperature. After mixing, Alprolix must be used within 3 hours. Throw away any unused portion. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alprolix out of the reach of children and away from pets.

General information:

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

Review Date: November 3, 2016

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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