* RiaSTAP®, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital [[fibrinogen deficiency]], including [[afibrinogenemia]] and [[hypofibrinogenemia]].
* Dosing Information
* The effectiveness of RiaSTAP is based on maximum clot firmness, which measures the structural integrity of a clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot.
* There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with RiaSTAP.
* RiaSTAP is not indicated for dysfibrinogenemia.
:* Dosage
==Dosage For Congenital Fibrinogen Deficiency==
=====Condition2=====
* RiaSTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.
* Dosing Information
'''RiaSTAP dose when baseline fibrinogen level is known'''
:* Dosage
* Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight, using the following formula
=====Condition3=====
[[File:Riastap dose.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* Dosing Information
'''RiaSTAP dose when baseline fibrinogen level is not known'''
:* Dosage
* If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.
=====Condition4=====
* Monitoring of patient's fibrinogen level is recommended during treatment with RiaSTAP. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.
* Dosing Information
==DOSAGE FORMS AND STRENGTHS==
:* Dosage
* RiaSTAP is available as a single-use vial containing 900 mg to 1300 mg lyophilized fibrinogen concentrate powder for reconstitution with 50 mL of Sterile Water for Injection.
<!--Off-Label Use and Dosage (Adult)-->
* The actual fibrinogen potency for each lot is printed on the vial label and carton.
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====
Line 110:
Line 115:
<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* RiaSTAP is contraindicated in individuals who have manifested severe immediate [[hypersensitivity]] reactions, including [[anaphylaxis]] to RiaSTAP or its components.
|warnings='''Allergic Reactions'''
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
* Allergic reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including [[hives]], generalized [[urticaria]], [[tightness of the chest]], [[wheezing]], [[hypotension]], and [[anaphylaxis]]) occur, immediately discontinue administration. The treatment required depends on the nature and severity of the reaction.
=====Miscellaneous=====
'''Thrombosis'''
* [[Thrombosis]] may occur spontaneously in patients with congenital fibrinogen deficiency with or without the use of fibrinogen replacement therapy.1 Thromboembolic events have been reported in patients treated with RiaSTAP. Weigh the benefits of RiaSTAP administration versus the risk of thrombosis. Patients receiving RiaSTAP should be monitored for signs and symptoms of thrombosis.
'''Transmissible Infectious Agents'''
<!--Postmarketing Experience-->
* RiaSTAP is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the [[Creutzfeldt-Jakob disease]] agent [CJD]) that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing.Despite these measures, such products may still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=* 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]].
=====Body as a Whole=====
* The most common adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP treatment are [[allergy|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.
=====Cardiovascular=====
* The most common adverse reactions observed in more than one subject in clinical studies (frequency >1%) were [[fever]] and [[headache]].
|postmarketing=* 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.
:*''General/Body as a Whole'': [[chills]], [[fever]], [[nausea]], [[vomiting]]
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
Line 263:
Line 160:
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|administration=* Intravenous
* Reconstitute prior to use.
* Do not mix RiaSTAP with other medicinal products or intravenous solutions, and should be administered through a separate injection site.
* Use aseptic technique when administering RiaSTAP.
* Administer RiaSTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.
'''Preparation and Reconstitution'''
* The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP.
* Do not use RiaSTAP beyond the expiration date. RiaSTAP contains no preservative. Use aseptic technique when preparing and reconstituting RiaSTAP.
* Reconstitute RiaSTAP at room temperature as follows:
* Remove the cap from the product vial to expose the central portion of the rubber stopper.
* Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry.
* Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial.
* Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.
* After reconstitution, the RiaSTAP solution should be colorless and clear to slightly opalescent. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not freeze RiaSTAP solution. Discard partially used vials.
* RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25ºC and should be administered within this time period.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose====Acute Overdose===
Line 320:
Line 241:
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
<!--Look-Alike Drug Names-->
|brandNames=* RIASTAP ®<ref>{{Cite web | title =RIASTAP- fibrinogen injection, powder, lyophilized, for solution| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=903dc8d0-39da-462c-9dac-004e0c7a26cc }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
The effectiveness of RiaSTAP is based on maximum clot firmness, which measures the structural integrity of a clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot.
There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with RiaSTAP.
RiaSTAP is not indicated for dysfibrinogenemia.
Dosage For Congenital Fibrinogen Deficiency
RiaSTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.
RiaSTAP dose when baseline fibrinogen level is known
Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight, using the following formula
This image is provided by the National Library of Medicine.
RiaSTAP dose when baseline fibrinogen level is not known
If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.
Monitoring of patient's fibrinogen level is recommended during treatment with RiaSTAP. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.
DOSAGE FORMS AND STRENGTHS
RiaSTAP is available as a single-use vial containing 900 mg to 1300 mg lyophilized fibrinogen concentrate powder for reconstitution with 50 mL of Sterile Water for Injection.
The actual fibrinogen potency for each lot is printed on the vial label and carton.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Fibrinogen in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fibrinogen in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Fibrinogen in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Fibrinogen in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fibrinogen in pediatric patients.
Contraindications
RiaSTAP is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components.
Warnings
Allergic Reactions
Allergic reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, immediately discontinue administration. The treatment required depends on the nature and severity of the reaction.
Thrombosis
Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without the use of fibrinogen replacement therapy.1 Thromboembolic events have been reported in patients treated with RiaSTAP. Weigh the benefits of RiaSTAP administration versus the risk of thrombosis. Patients receiving RiaSTAP should be monitored for signs and symptoms of thrombosis.
Transmissible Infectious Agents
RiaSTAP is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the Creutzfeldt-Jakob disease agent [CJD]) that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing.Despite these measures, such products may still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL.
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.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fibrinogen in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fibrinogen during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fibrinogen with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Fibrinogen with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Fibrinogen with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Fibrinogen with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fibrinogen with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fibrinogen in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fibrinogen in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fibrinogen in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fibrinogen in patients who are immunocompromised.
Administration and Monitoring
Administration
Intravenous
Reconstitute prior to use.
Do not mix RiaSTAP with other medicinal products or intravenous solutions, and should be administered through a separate injection site.
Use aseptic technique when administering RiaSTAP.
Administer RiaSTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.
Preparation and Reconstitution
The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP.
Do not use RiaSTAP beyond the expiration date. RiaSTAP contains no preservative. Use aseptic technique when preparing and reconstituting RiaSTAP.
Reconstitute RiaSTAP at room temperature as follows:
Remove the cap from the product vial to expose the central portion of the rubber stopper.
Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry.
Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial.
Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.
After reconstitution, the RiaSTAP solution should be colorless and clear to slightly opalescent. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not freeze RiaSTAP solution. Discard partially used vials.
RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25ºC and should be administered within this time period.
Monitoring
There is limited information regarding Monitoring of Fibrinogen in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Fibrinogen in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Fibrinogen in the drug label.
Pharmacology
There is limited information regarding Fibrinogen Pharmacology in the drug label.
