RiaSTAP is a man-made form of a protein that occurs naturally in the body and helps the blood to clot.

RiaSTAP is used to treat bleeding episodes in people with a congenital fibrinogen deficiency.

RiaSTAP may also be used for purposes not listed in this medication guide.

You should not use RiaSTAP if you are allergic to fibrinogen, or if you have ever had a severe allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using RiaSTAP, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject RiaSTAP if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

RiaSTAP is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

RiaSTAP is given as an injection through a needle placed into a vein. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

RiaSTAP is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to use the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

RiaSTAP is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not mix RiaSTAP with any other medicines, or give other medicines through the same IV line.

RiaSTAP contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. The mixture should be clear or slightly colored. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Mixed medicine must be used within 24 hours if you keep it at room temperature.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Tell your doctor if you have any changes in weight. RiaSTAP doses are based on weight, and any changes may affect the dose.

You may need frequent medical tests to help your doctor determine how long to treat you with RiaSTAP.

Store the unmixed powder in a refrigerator or in a dark cool place. Protect from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.

Usual Adult Dose for Congenital Fibrinogen Deficiency:

Dose when fibrinogen level is unknown:
Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight)

Dose when fibrinogen level is unknown:
Dose = 70 mg/kg body weight.

The injection rate should not exceed 5 mL per minute.

You should not use RiaSTAP if you are allergic to fibrinogen, or if you have ever had a severe allergic reaction.

To make sure RiaSTAP is safe for you, tell your doctor if you have:

• a history of stroke or blood clot.

It is not known whether RiaSTAP will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

RiaSTAP is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any signs of an allergic reaction to RiaSTAP: hives, rash; tightness in your chest; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using RiaSTAP and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common RiaSTAP side effects may include:

• fever; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with fibrinogen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.