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Generic Name: antihemophilic factor (recombinant) (AN-tye-HEE-moe-FIL-ik FAK-tor)
Brand Name: Examples include Helixate FS and Kogenate FS

Genarc is used for:

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

Genarc is a man-made clotting factor. It is identical to the naturally occurring protein in the body. It works by increasing the amount of clotting factor VIII in the blood, which helps the blood to clot normally.

Do NOT use Genarc if:

  • you are allergic to Genarc, any part of Genarc, or to mice or hamsters

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

Before using Genarc:

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

Ask your health care provider if Genarc 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 Genarc:

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

  • An extra patient leaflet is available with Genarc. Talk to your pharmacist if you have questions about this information.
  • Genarc is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Genarc at home, a health care provider will teach you how to use it. Be sure you understand how to use Genarc. 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 Genarc was stored in the refrigerator, let it reach room temperature before mixing it. Do not heat it.
  • Mix by gently swirling. Do not shake.
  • After mixing, Genarc must be used within 3 hours. Throw away any unused portion.
  • This product should be clear to slightly cloudy and colorless after mixing. Do not use Genarc if it contains particles, is very cloudy or discolored, or if the vial is cracked or damaged.
  • 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 Genarc, call your doctor to find out what to do.

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

Important safety information:

  • Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes it less effective. If Genarc stops working or does not work as well as it has before, contact your doctor immediately for instructions.
  • Talk with your doctor before you travel. You will need to bring enough of this drug to use during travel.
  • Tell your doctor or dentist that you take Genarc before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests may be performed while you use Genarc. 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 Genarc can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Genarc 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 Genarc, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Genarc:

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:

Pain, swelling, or 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; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; cough; dizziness or light-headedness; fainting; fast heartbeat; fever or chills; flushing; nausea or vomiting; redness or warmth at the injection site; restlessness; severe or persistent fatigue; severe or persistent pain, swelling, or irritation at the injection site; shortness of breath; tingling; 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 Genarc:

Store Genarc in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). This product may also be stored at room temperature up to 77 degrees F (25 degrees C) for up to 12 months. Do not freeze. If stored at room temperature, make note of the date the product was placed at room temperature. Do not use past the expiration date. Do not place it back in the refrigerator after storage at room temperature or after mixing it. Discard any medicine remaining in the vial after you use it. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Genarc out of the reach of children and away from pets.

General information:

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

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.