Fibrinogen Concentrate ( Human) - @- Systemic - Hemostatics - (FDC - List)
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Clottable protein 75-115mg+ 30-05-2000
Trace of Fibronogen 79-110 mg +
Plasma Fibronectin 2-9 mg+
Factor XIII 10-50 U2 +
Plasminogen 40-120mcg +
Aprotinin solution 300 KIU /ml3 per mo of
reconstituted tissue solution
For acheiving hemostatis to seal or glue tissues and to support
wound healing
Fibrinogen deficiency
Adverse Reaction:
Common adverse reactions-
fever and headache
Most common adverse reactions in clinical studies-
allergic anaphylactoid reactions- dyspnea, rash,
general reactions such as chills, fever, nausea, vomiting,
and thromboembolic complications such as deep vein thrombosis,
myocardial infarction and pulmonary embolism
Allergic- anaphylaxis, dyspnea, rash
Cardiovascular- pulmonary embolism, tromboembolism
Miscellaneous- chills, fever, nausea, vomiting
Contra-Indications:
Severe immediate hypersensitivity reactions, including anaphylaxis to fibrinogen or its components
Special Precautions-
Thrombosis- thrombosis may occur spotaneously in patients with general fibrinogen deficiency
with or without the use of fibrinogen replacement therapy.
Monitor patients receiving fibrinogen for signs and symptoms of thrombosis.
Transmissible infectious agents- fibrinogen is made from human plasma. Products made from
humam plasma contain infectious agents eg viruses.
There is also a possibilty that unkown infectious agents may be present in the products.
Report all signs of infections to your healthcare provider.
Hypersensitivity reactions- allergic reactions may occur. If symptoms of allergy or early
signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest,
wheezing, hypotension, and anaphylaxis occur, immediately discontinue fibronogen administration.
Pregnancy- use fibrongen during pregnancy only if clearly needed.
Lactation- fibrinogen has not been studied in breast feeding mothers with congenital fibrinogen
deficiency
Children- fibrinogen studies have included younger than 16 years of age.
Elderly- the safety and efficacy of fibrinogen in elderly patients has not been studied.
Monitoring- monitor patients receiving fibrinogen for signs and symptoms of thrombosis.
Dosages/ Overdosage Etc:
Indication-
Fibronogen deficiency
Dosage-
Usual dosage-
Adults-
Base line fibronogen level is known- dose should be individually calculated for each patient based on
target plasma fubrinogen level, based on the type of bleeding .
Fibrinogen dose when baseline fubrinogen level is not known-
70mg per kg of body weight administered intravenously IV . A target fibrinogen level of 100mg/gL
should be maintained until hemostatis is obtained
Children-
Fibrinogen deficiency-
16 years of age and older- see adults dosing
Patient Information:
1. Inform patients of the early signs of allergic or hypersensitivity reactions of fibrinogen, including
hives, chest tightness, wheezing, hypotension and anaphylaxis
2. Advice patients to notify their health care provider immediately if they experience any of the above
symptoms.
3. Inform patients that fibrinogen that with or without embolization may be caused by underlying
fibrinogen deficiency and has been reported with the use of fibrinogen
4. Advice them to report any symptoms of thrombosis events such as unexplained pleuritic ,
chest and or leg pain, or edema, hemoptysis , dyspnea, tachypnea, or unexplained neurologic
symptoms to their health care provider
5. Inform patients about the fibrinogen which is made from human plasma may contain infectious
agents and can cause virus infection. The symptoms may include headache, fever, nausea,
vomiting, weakness, malaise, diarrhea, or in hepatitis, jaundice.
6. Inform patients to report if such symptoms if occurs, immediately to their health care provider
Pharmacology/ Pharmacokinetics:
Pharmacology-
Fibrinogen (Factor 1) is a soluble glycoprotein with a molecular weight of approximately 340kDa.
The native molecule is a dimer and consists of 3 pairs of polypepide chains.
Fibrinogen is substrare of 3 enzymes- thrombin, factor XIIIa and plasmin
Pregnancy and lactation:
Pregnancy-
Use fibrongen during pregnancy only if clearly needed.
Lactation-
Fibrinogen has not been studied in breast feeding mothers with congenital fibronogen
deficiency
Children-
Fibronogen studies have included younger than 16 years of age.
Elderly-
The safety and efficacy of fibrinogen in elderly patients has not been studied.