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What should I discuss with my health care provider before using fibrinogen (RiaSTAP)?
You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any other life-threatening allergic reaction.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using fibrinogen, tell your doctor if you have a history of stroke or blood clot.
FDA pregnancy category C. It is not known whether fibrinogen is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Fibrinogen 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.
How should I use fibrinogen (RiaSTAP)?
Fibrinogen is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine 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.
You will need to mix fibrinogen 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 medication. Do not mix fibrinogen with any other medicines, or give other medicines through the same IV line.
Fibrinogen 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 vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your fibrinogen dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it.
After mixing fibrinogen with a diluent, use it right away or store the mixture at room temperature and use it within 24 hours. The mixed medicine should be clear or slightly colored. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles in it.
Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.
To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with fibrinogen. Do not miss any follow-up visits to your doctor.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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