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Novoeight

Generic Name: antihemophilic factor (recombinant) (AN-tye-HEE-moe-FIL-ik FAK-tor)
Brand Name: Novoeight

Novoeight is used for:

Preventing and controlling bleeding in patients with hemophilia A (factor VIII deficiency), including in surgical settings. It may also be used for certain other bleeding conditions.

Novoeight is a clotting factor. It works by increasing the amount of clotting factor VIII in the blood, which helps the blood to clot normally.

Do NOT use Novoeight if:

  • you are allergic to any ingredient in Novoeight or to hamsters

Contact your doctor or health care provider right away if this applies to you.

Before using Novoeight:

Some medical conditions may interact with Novoeight. 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 been told that you have inhibitors to factor VIII

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

Ask your health care provider if Novoeight 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 Novoeight:

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

  • An extra patient leaflet is available with Novoeight. Talk to your pharmacist if you have questions about this information.
  • Novoeight is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Novoeight at home, a health care provider will teach you how to use it. Be sure you understand how to use Novoeight. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Wash your hands before and after use.
  • If Novoeight was stored in the refrigerator, let it reach room temperature before mixing. Do not heat it.
  • Mix by gently swirling. Do not shake.
  • Do not use Novoeight if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use Novoeight within 4 hours after it has been mixed. Keep the medicine at room temperature in the vial during this time. Throw Novoeight away if it has not been used within 4 hours.
  • When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you by your doctor to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
  • Carefully check that you have drawn the correct dose before administration.
  • 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 Novoeight, call your doctor to find out what to do.

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

Important safety information:

  • Tell your doctor or dentist that you take Novoeight before you receive any medical or dental care, emergency care, or surgery.
  • Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes it less effective. If Novoeight stops working or does not work as well as it has before, contact your doctor right away for instructions.
  • Talk with your doctor before you travel while you are using Novoeight. Be sure to take along enough of Novoeight for your treatment while you are traveling.
  • Lab tests may be performed while you use Novoeight. 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: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Novoeight 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 Novoeight, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Novoeight:

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:

Irritation 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 or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); dizziness or light-headedness; fainting; fever; severe nausea or vomiting; shortness of breath; wheezing.

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 Novoeight:

Store Novoeight in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store in the original package to protect from light. Do not use past the expiration date.

Novoeight may also be stored at room temperature, below 86 degrees F (30 degrees C), for up to 12 months. Make note of the date the product was placed at room temperature. If stored at room temperature, throw away any unused vials after 12 months or after the expiration date, whichever comes first. Do not put this drug back in the refrigerator.

Store Novoeight away from heat, moisture, and light. Do not store in the bathroom. Keep Novoeight out of the reach of children and away from pets.

General information:

  • If you have any questions about Novoeight, please talk with your doctor, pharmacist, or other health care provider.
  • Novoeight 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 Novoeight 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 Novoeight. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Novoeight. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Novoeight.

Review Date: August 8, 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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