RiaSTAP Side Effects

Please note - some side effects for RiaSTAP may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of RiaSTAP - for the Consumer

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 when using RiaSTAP:

Headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; fever; symptoms of a blood clot (eg, chest pain; confusion; coughing up blood; fainting; numbness of arms or legs; one-sided weakness, slurred speech, mental changes; pain, numbness, or swelling of an arm or leg; sudden, severe headache or vomiting; shortness of breath).

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

RiaSTAP Side Effects - for the Professional

RiaSTAP

The most serious adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP 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 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 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.

• Allergic-anaphylactic reactions: anaphylaxis, dyspnea, rash
• Cardiovascular: thromboembolism, pulmonary embolism
• General/Body as a Whole: chills, fever, nausea, vomiting

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included thromboembolic episodes, including myocardial infarction, pulmonary embolism, deep vein thrombosis, and arterial thrombosis.

Hypersensitivity

Hypersensitivity side effects have included allergic-anaphylactic reactions (including rash and dyspnea).

General

General side effects have included chills, fever, nausea, and vomiting.

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