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RiaSTAP

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RiaSTAP

SIDE EFFECTS

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 RiaSTAP (fibrinogen concentrate (human) for intravenous use) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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