Fibrinogen Concentrate

RiaSTAP™ (fibrinogen concentrate (human) for intravenous use) , Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

RiaSTAP (fibrinogen concentrate (human) for intravenous use) is not indicated for dysfibrinogenemia

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

Fibrinogen is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency.

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

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any 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.

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. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling in your one or both legs, and problems with vision, speech, or balance.

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.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using fibrinogen.

The most serious adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP (fibrinogen concentrate (human) for intravenous use) treatment are allergic-anaphylactic reactions and thromboembolic episodes, including myocardial infarction, pulmonary embolism, deep vein thrombosis, and arterial thrombosis.

The most common adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP (fibrinogen concentrate (human) for intravenous use) treatment are allergic reactions and generalized reactions such as chills, fever, nausea, and vomiting.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in practice.

The most common adverse reactions observed in more than one subject in clinical studies (frequency > 1%) were fever and headache.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Adverse reactions reported in patients receiving RiaSTAP (fibrinogen concentrate (human) for intravenous use) for treatment of fibrinogen deficiency include allergic-anaphylactic reactions (including rash, dyspnea, etc.), general reactions such as chills, fever, nausea, vomiting and thromboembolic complications such as myocardial infarction, pulmonary embolism, and deep vein thrombosis.

The following adverse reactions, identified by system organ class, have shown a possible causal relationship with RiaSTAP (fibrinogen concentrate (human) for intravenous use) .

• Allergic-anaphylactic reactions: anaphylaxis, dyspnea, rash
• Cardiovascular: thromboembolism, pulmonary embolism (see WARNINGS AND PRECAUTIONS, Thrombosis)
• General/Body as a Whole: chills, fever, nausea, vomiting

Read the entire FDA prescribing information for RiaSTAP (Fibrinogen Concentrate (Human) For Intravenous Use)