(fi BRIN o gin KON suhn trate HYU man)
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 or any component of the formulation.
Congenital fibrinogen deficiency: IV: Note: Adjust dose based on laboratory values and condition of patient. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is achieved.
When baseline fibrinogen level is known:
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.
Congenital fibrinogen deficiency: IV: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Transfer sterile water for injection 50 mL into fibrinogen concentrate vial. Gently swirl until dissolved; do not shake.
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. Administrations should be completed within 8 hours after reconstitution.
Store at 2 ‚ °C to 25 ‚ °C (36 ‚ °F to 77 ‚ °F) in original carton; do not freeze. Protect from light. Stable for 8 hours after reconstitution when stored at 20 ‚ °C to 25 ‹ šC (68 ‚ °F to 77 ‚ °F); do not freeze reconstituted solution. Discard partially used vials.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution:
RiaSTAP: 900-1300 mg [contains albumin (human); exact potency labeled on vial]
Do not mix with other drugs or IV solutions and administer through a separate injection line.
Antifibrinolytic Agents: May enhance the adverse/toxic effect of Fibrinogen Concentrate (Human). Specifically, the risk for thrombosis may be increased. Fibrinogen Concentrate (Human) may enhance the adverse/toxic effect of Antifibrinolytic Agents. Specifically, the risk for thrombosis may be increased. Monitor therapy
Fibrinogen level; signs/symptoms of hypersensitivity and thrombosis
>1%: Central nervous system: Fever, headache
Postmarketing and/or case reports: Allergic reactions, anaphylaxis, arterial thrombosis, chills, DVT, dyspnea, MI, nausea, pulmonary embolism, rash, thromboembolism, vomiting
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.
Other warnings/precautions:
- Appropriate use: Not indicated for the treatment of dysfibrinogenemia.
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Animal reproduction studies have not been conducted. Increased pregnancy loss is associated with untreated congenital fibrinogen disorders (Acharya 2008).
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:52.7 ‚ ± 7.48 mL/kg (range: 36 to 68 mL/kg)
Clearance faster in pediatric patients <16 years than adults
Biological fibrinogen: 100 hours (Kamath 2003)
Pediatric patients <16 years: Initial data suggests decreasesd compared to adults (Manco-Johnson 2009): 69.9 ‚ ± 8.5 hours
Adults: 78.7 ‚ ± 18.13 hours (range: 56 to 117 hours)
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), severe dizziness, passing out, coughing up blood, shortness of breath, angina, loss of strength and energy, diarrhea, jaundice, severe headache, fast breathing, nausea, vomiting, or chills (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.