Fibrinogen Concentrate (Human)
Medically reviewed by Drugs.com. Last updated on Jun 7, 2020.
(fi BRIN o gin KON suhn trate HYU man)
- Coagulation Factor I
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution:
Fibryga: ~1 g [exact potency labeled on vial]
RiaSTAP: 900-1300 mg [contains albumin (human); exact potency labeled on vial]
Brand Names: U.S.
- Blood Product Derivative
Fibrinogen (coagulation factor I), a protein found in normal plasma, is required to clot blood. Fibrinogen concentrate made from pooled human plasma replaces this protein which is missing or reduced in patients with a congenital fibrinogen deficiency.
Vd: Fibryga: Patients 12 to 53 years: 70.2 ± 29.9 mL/kg (range: 36.9 to 149.1 mL/kg); RiaSTAP: Patients 8 to 61 years: 52.7 ± 7.48 mL/kg (range: 36.22 to 67.67 mL/kg)
RiaSTAP: Clearance is faster in pediatric patients <16 years than adults
Patients <16 years: 0.73 ± 0.14 mg/L
Patients ≥16 years: 0.53 ± 0.07 mg/L
Similar to biological fibrinogen
Biological fibrinogen: 100 hours (Kamath 2003)
Fibryga: Patients 12 to 53 years: 75.9 ± 23.8 (40 to 157 hours)
Patients <16 years: 69.9 ± 8.5 hours
Patients ≥16 years: 82.5 ± 20 hours
Use: Labeled Indications
Congenital fibrinogen deficiency: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Severe, immediate hypersensitivity reactions, including anaphylaxis to fibrinogen, human plasma-derived products, or any component of the formulation.
Congenital fibrinogen deficiency: IV: Note: Maintain a target fibrinogen level of 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.
When baseline fibrinogen level is known:
Fibryga: Dose (mg/kg) = [Target level (mg/dL) - measured level (mg/dL)] divided by 1.8 (mg/dL per mg/kg body weight)
RiaSTAP: Dose (mg/kg) = [Target level (mg/dL) - measured level (mg/dL)] divided by 1.7 (mg/dL per mg/kg body weight)
When baseline fibrinogen level is not known: 70 mg/kg
Refer to adult dosing.
Note: Dosing must be individualized for each patient based on the extent of bleeding, laboratory values, clinical condition of the patient, and target fibrinogen concentration.
Congenital fibrinogen deficiency; treatment of acute bleeding: Note: The recommended target fibrinogen concentration is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.
When baseline fibrinogen concentration is known: IV:
RiaSTAP: Infants, Children, and Adolescents (Kreuz 2005; Manco-Johnson 2009; RiaSTAP prescribing information [UK] 2016):
Dose (mg/kg) = [Target fibrinogen concentration (mg/dL) - measured fibrinogen concentration (mg/dL)] divided by 1.7 (mg/dL per mg/kg body weight)
Dose (mg/kg) = [Target fibrinogen concentration (mg/dL) - measured fibrinogen concentration (mg/dL)] divided by 1.8 (mg/dL per mg/kg body weight)
When baseline fibrinogen level is not known: Fibryga, RiaSTAP: Infants, Children, and Adolescents: IV: 70 mg/kg
Adjust dose based on laboratory values and condition of patient. Administer additional doses if the fibrinogen concentration falls below 80 mg/dL for minor bleeding and below 130 mg/dL for major bleeding until hemostasis is achieved.
Fibryga: Prior to reconstitution, warm both powder and sterile water for injection to room temperature; if water bath is used for warming, the water bath should not exceed 37°C (98°F). Reconstitute with 50 mL of SWFI; gently swirl until dissolved (~5 to 10 minutes), do not shake.
RiaSTAP: Transfer 50 mL of SWFI into fibrinogen concentrate vial. Gently swirl until dissolved; do not shake. Filter reconstituted solution with a 17-micron filter (not supplied) into an appropriate syringe before administration. Solution should be colorless and clear to slightly opalescent; discard if cloudy or contains particulates.
IV: For IV administration only; infuse at a rate not exceeding 5 mL/minute. Solution should be infused at room temperature. Do not administer with other products or IV solutions. Administration should be completed within 8 hours (RiaSTAP) or 4 hours (Fibryga) after reconstitution. For RiaSTAP, filter reconstituted solution with a 17-micron filter (not supplied) into an appropriate syringe before administration.
Fibryga: Store intact vials at 2°C to 25°C (36°F to 77°F) in original carton; do not freeze. Protect from light. Discard partially used vials. Reconstituted solution should be used within 4 hours; do not refrigerate or freeze.
RiaSTAP: As of May 2019, the manufacturer recommends storing intact vials at 2°C to 8°C (36°F to 46°F) (prior recommendation was to store at 2°C to 25°C [36°F to 77°F]) in original carton; do not freeze. Protect from light. Discard partially used vials. Reconstituted solution is stable for 8 hours when stored at 20°C to 25°C (68°F to 77°F).
There are no known significant interactions.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache (>1%)
Dermatologic: Erythema (≤8%), pruritus (≤8%)
Gastrointestinal: Vomiting (>5%)
Neuromuscular & skeletal: Weakness (>5%)
Miscellaneous: Fever (>5%)
<1%, postmarketing, and/or case reports: Anaphylaxis, arterial thrombosis, chills, deep vein thrombosis, dyspnea, hypersensitivity reaction, myocardial infarction, nausea, pulmonary embolism, skin rash, thromboembolism
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions (eg, hives, generalized urticaria, chest tightness, wheezing, hypotension, anaphylaxis) may occur. In the event of hypersensitivity reactions, treatment should be discontinued immediately.
• Thrombotic events: Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without fibrinogen replacement therapy. Thromboembolic events have been reported in patients receiving fibrinogen concentrate. Consider potential risk of thrombosis with use; monitor for signs and symptoms of thrombosis.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease (eg, viruses and theoretically the Creutzfeldt-Jakob disease [CJD]). Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.
• Appropriate use: Not indicated for the treatment of dysfibrinogenemia.
Fibrinogen level; signs/symptoms of hypersensitivity and thrombosis
Patients with congenital fibrinogen deficiency may have an increased risk of bleeding, thrombosis, and pregnancy loss; replacement therapy may be initiated prior to conception (RCOG [Pavord 2017]).
Pregnant patients with congenital fibrinogen deficiency may have an increased risk of bleeding, thrombosis, and pregnancy loss; therefore, close surveillance is recommended. Maternal fibrinogen concentrations increase during pregnancy but do not protect against potential complications. Prophylaxis throughout pregnancy may be needed and higher doses may be required as pregnancy progresses. Plasma derived fibrinogen concentrate may be used for treatment or prevention of bleeding in patients with severe deficiency (RCOG [Pavord 2017]).
What is this drug used for?
• It is used to stop bleeding.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
• Severe dizziness
• Passing out
• Loss of strength and energy
• Yellow skin
• Severe headache
• Fast breathing
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
More about fibrinogen
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- Drug class: miscellaneous coagulation modifiers
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