RiaSTAP

RiaSTAP is used for:

Treating bleeding in patients with congenital fibrinogen deficiency (eg, afibrinogenemia, hypofibrinogenemia).

RiaSTAP is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting.

Do NOT use RiaSTAP if:

• you are allergic to any ingredient in RiaSTAP

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

Before using RiaSTAP :

Some medical conditions may interact with RiaSTAP . 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

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

Ask your health care provider if RiaSTAP 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 RiaSTAP :

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

• RiaSTAP is usually given as an injection at your doctor's office, hospital, or clinic.
• Do not use RiaSTAP if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If you miss a dose of RiaSTAP , contact your doctor right away.

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

Important safety information:

• RiaSTAP contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used RiaSTAP .
• Blood clots may occur unexpectedly in patients with fibrinogen deficiency. This may occur with or without use of RiaSTAP . Contact your doctor right away if you experience signs of a blood clot (eg, chest pain, leg pain or swelling, trouble breathing, or coughing up blood).
• Lab tests, including fibrinogen levels, may be performed while you use RiaSTAP . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use RiaSTAP with caution in the ELDERLY; they may be more sensitive to its effects.
• RiaSTAP should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using RiaSTAP while you are pregnant. It is not known if RiaSTAP is found in breast milk. If you are or will be breast-feeding while you use RiaSTAP , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of RiaSTAP :

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:

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

RiaSTAP is usually handled and stored by a health care provider. If you are using RiaSTAP at home, store RiaSTAP as directed by your pharmacist or health care provider.

General information:

• If you have any questions about RiaSTAP , please talk with your doctor, pharmacist, or other health care provider.
• RiaSTAP 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.

This information is a summary only. It does not contain all information about RiaSTAP . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.