Fibrinogen

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Fibrinogen
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Fibrinogen is a {{{drugClass}}} that is FDA approved for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Common adverse reactions include fever, headache, pulmonary embolism, myocardial infarction, deep vein thrombosis, anaphylactic reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • 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

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.

Adverse Reactions

Clinical Trials Experience

  • 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.
  • The following adverse reactions, identified by system organ class, have shown a possible causal relationship with RiaSTAP.

Drug Interactions

There is limited information regarding Fibrinogen Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • 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.

Mechanism of Action

Structure

File:Fibrinogen01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fibrinogen in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fibrinogen in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fibrinogen in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fibrinogen in the drug label.

How Supplied

Storage

There is limited information regarding Fibrinogen Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fibrinogen in the drug label.

Precautions with Alcohol

  • Alcohol-Fibrinogen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Fibrinogen Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "RIASTAP- fibrinogen injection, powder, lyophilized, for solution".

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