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RiaSTAP

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RiaSTAP

RiaSTAP Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

RiaSTAP (fibrinogen concentrate human for intravenous use) is a man-made form of the protein albumin and is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency. This medication is available in generic form. Common side effects include fever, chills, nausea, or vomiting.

RiaSTAP dosing, duration of dosing and frequency of administration is individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient. RiaSTAP may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, RiaSTAP should be used only if prescribed. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our RiaSTAP (fibrinogen concentrate human for intravenous use) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

RiaSTAP in Detail - Patient Information: Side Effects

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.

Call your doctor at once if you have any other serious side effect, such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden cough, rapid breathing, fast heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • pain or swelling in one or both legs.

Less serious side effects may include:

  • fever
  • chills;
  • nausea; or
  • vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for RiaSTAP (Fibrinogen Concentrate (Human) For Intravenous Use) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

RiaSTAP FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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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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