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NOVOSEVEN
FACTOR VIIA, RECOMBINANT - INJECTABLE

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FACTOR VIIA, RECOMBINANT - INJECTABLE

(factor VIIA,ree-KOM-bin-unt)

COMMON BRAND NAME(S): Novoseven

Uses

This medication is a protein used to treat bleeding problems in people with hemophilia type A or B. People with these types of hemophilia must also have certain inhibitors of clotting factors in their blood (e.g., Factor VIII or Factor IX) for this drug to be effective.

How To Use

Follow all instructions for proper mixing with Sterile Water for Injection. Do not inject the water directly into the powder; aim the syringe so that the water gently flows down the side of the vial. Injecting the water directly at the powder may cause this drug to become ineffective. If any of the information is unclear, consult your pharmacist. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Use the liquid within 3 hours after mixing. This medication is injected into a vein (IV) usually every 2 to 6 hours; or as directed by your doctor. The dosage and length of treatment is based on your weight, medical condition, and response to therapy. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

No side effects are expected to occur. If side effects do occur, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: pain/redness/irritation at the injection site, fever, headache, dizziness, blurred vision, vomiting, swelling or pain in the joints. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: pain in the legs or groin, unusual weakness or tiredness, slowed heartbeat, low urine production. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: other bleeding problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious injury or infection, any allergies. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use. Do not mix this medication with any other injectable drugs. Doing so may cause this drug to be ineffective. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., PT, PTT) will be performed to monitor your progress and for serious side effects.

Missed Dose

If you miss a dose or a dose is interrupted, contact the doctor to establish a new dosing schedule.

Storage

Store the unmixed powder/vials refrigerated between 36 and 46 degrees F (2 and 8 degrees C) away from light. Do not freeze. Once mixed, the vial is good at room temperature (59 and 86 degrees F or 15 and 30 degrees C) or refrigerated for up to 3 hours. Discard any unused portion of the vial(s).

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).