RiaSTAP

RiaSTAP

RiaSTAP

What is RiaSTAP?

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

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

Warnings

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

If you have certain medical conditions, dosage adjustments or special testing may be needed to use this medication safely. Before using RiaSTAP, tell your doctor if you have had a stroke or blood clot in the past.

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

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

Before you use this medicine

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

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

• a history of stroke or blood clots.

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 medication.

It is not known whether fibrinogen passes into breast milk or whether it could harm a breastfed baby. Tell your doctor if you are breastfeeding 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 that it contains infectious agents. However, there is still a small possibility that it could transmit disease. Talk to your doctor about the risks and benefits of taking this medication.

How should I use RiaSTAP?

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

Follow all instructions 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 infusion at home. Do not self-inject this medicine if you do not know how to give the injection, and do not properly dispose of used needles, intravenous tubes, or other items used to inject the medicine.

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

Do not mix RiaSTAP with other medicines or administer other medicines through the same intravenous line.

RiaSTAP does not contain any preservative. Once you have pierced the rubber cap of a vial with a needle, use the vial immediately or throw it away.

Do not shake the medication bottle or you may ruin the medication. Do not prepare your dose until you are ready to give an injection. The mixture should be clear or slightly colored. Do not use if the medicine has changed color or contains particles. Call your pharmacist for a new medicine.

The mixed medicine must be used within 24 hours if kept at room temperature.

Each disposable vial (bottle) of this medicine is for single use only. Throw it away after a single use, even if there is some medicine left in it after your dose is injected.

Use a disposable needle only once. Follow all state or local laws about throwing away used needles and syringes. Use a puncture-resistant 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 experience any changes in your weight. RiaSTAP dosage is based on weight and any changes may affect the dose.

Frequent medical tests may be needed to help your doctor determine how long you should be treated with RiaSTAP.

Store the unmixed powder in the refrigerator or in a dark, cool place. Protect from light and do not allow to freeze. Discard unused bottles after the expiration date stated on the label.

Dosage information

Usual adult dosage for congenital fibrinogen deficiency:

Dosage if 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)

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

The injection rate should not exceed 5 ml per minute.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when using RiaSTAP?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

Side effects of RiaSTAP

If necessary, get emergency medical helpSigns of an allergic reaction to RiaSTAP: hives, rash; chest tightness; wheezing, difficulty breathing; the feeling of fainting; Swelling of your face, lips, tongue, or throat.

Stop using RiaSTAP and call your doctor immediately 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 lungs – 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 – pain or pressure in the chest, pain spreading to the jaw or shoulder, nausea, sweating.

Common side effects of RiaSTAP 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RiaSTAP?

Other medications can interact with fibrinogen, including prescription and over-the-counter medications, vitamins, and herbal products. Tell each of your healthcare providers about all medications you are taking now and any medications you are starting or stopping taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use RiaSTAP for the prescribed indication.