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Pronunciation |
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(FAK
ter nyne KOM pleks HYU
man) |
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U.S. Brand
Names |
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AlphaNine® SD; BeneFix™;
Hemonyne®; Konyne® 80; Profilnine® SD;
Proplex®
T |
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Generic
Available |
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No |
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Synonyms |
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Prothrombin Complex Concentrate |
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Pharmacological Index |
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Antihemophilic Agent; Blood Product Derivative |
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Use |
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Control bleeding in patients with factor IX deficiency (hemophilia B or
Christmas disease) NOTE: Factor IX concentrate containing ONLY factor IX is
also available and preferable for this indication.
Prevention/control of bleeding in hemophilia A patients with inhibitors to
factor VIII
Prevention/control of bleeding in patients with factor VII deficiency
Emergency correction of the coagulopathy of warfarin excess in critical
situations. |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Liver disease with signs of intravascular coagulation or fibrinolysis, not
for use in factor VII deficiencies, patients undergoing elective
surgery |
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Warnings/Precautions |
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Use with caution in patients with liver dysfunction; prepared from pooled
human plasma - the risk of viral transmission is not totally eradicated; monitor
patients who receive repeated doses twice daily with PTT and prothrombin time
and level of factor being replaced (eg, usually VII or IX); if PT is <10
seconds, this may indicate risk of hypercoagulable
complication |
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Adverse
Reactions |
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1% to 10%:
Central nervous system: Fever, headache, chills
Neuromuscular & skeletal: Tingling
Miscellaneous: Following rapid administration: Transient fever
<1%: Flushing, DIC, thrombosis following high dosages because of presence
of activated clotting factors, tightness in chest, somnolence, urticaria,
nausea, vomiting, tightness in neck |
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Overdosage/Toxicology |
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Symptoms of overdose include disseminated intravascular coagulation
(DIC) |
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Drug
Interactions |
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Increased toxicity: Do not coadminister with aminocaproic acid may increase
risk for thrombosis |
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Stability |
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When stored at refrigerator temperature, 2°C to
8°C (36°F to
46°F), Coagulation Factor IX is stable for the period
indicated by the expiration date on its label. Avoid freezing which may damage
container for the diluent.
Standard diluent: Dose in units/bag
Minimum volume: Use complete vial(s) for entire dose
Comments: Infusion rate should be 2 mL/minute |
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Mechanism of
Action |
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Replaces deficient clotting factor including factor X; hemophilia B, or
Christmas disease, is an X-linked recessively inherited disorder of blood
coagulation characterized by insufficient or abnormal synthesis of the clotting
protein factor IX. Factor IX is a vitamin K-dependent coagulation factor which
is synthesized in the liver. Factor IX is activated by factor XIa in the
intrinsic coagulation pathway. Activated factor IX (IXa), in combination with
factor VII:C activates factor X to Xa, resulting ultimately in the conversion of
prothrombin to thrombin and the formation of a fibrin clot. The infusion of
exogenous factor IX to replace the deficiency present in hemophilia B
temporarily restores hemostasis. |
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Pharmacodynamics/Kinetics |
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Half-life:
IX component: 24 hours |
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Usual Dosage |
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Children and Adults: Dosage is expressed in units of factor IX activity and
must be individualized. I.V. only:
Total blood volume (mL blood/kg) = 70 mL/kg (adults), 80 mL/kg (children)
Plasma volume = total blood volume (mL) x [1 - Hct (in decimals)]
For example, for a 70 kg adult with a Hct = 40%: Plasma volume = [70 kg x 70
mL/kg] x [1 - 0.4] = 2940 mL
To calculate number of units needed to increase level to desired range
(highly individualized and dependent on patient's condition): Number of units =
desired level increase [desired level - actual level] x plasma volume (in mL)
For example, for a 100% level in the above patient who has an actual level of
20%: Number of units needed = [1 (for a 100% level) - 0.2] x 2940 mL = 2352
units
As a general rule, the level of factor IX required for treatment of different
conditions is listed below:
Minor Spontaneous Hemorrhage, Prophylaxis:
Desired levels of factor IX for hemostasis: 15% to 25%
Initial loading dose to achieve desired level: <20-30 units/kg
Frequency of dosing: Once; repeated in 24 hours if necessary
Duration of treatment: Once; repeated if necessary
Major Trauma or Surgery:
Desired levels of factor IX for hemostasis: 25% to 50%
Initial loading dose to achieve desired level: <75 units/kg
Frequency of dosing: q18-30h, depending on half-life and measured factor IX
levels
Duration of treatment: Up to 10 days, depending upon nature of insult
Factor VIII inhibitor patients: 75 units/kg/dose; may be given every
6-12 hours
Anticoagulant overdosage: I.V.: 15 units/kg |
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Administration |
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I.V. administration only; rate of administration should not exceed 10
mL/minute; use filter needle to draw product into syringe |
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Monitoring
Parameters |
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Levels of factors being replaced (eg, VII or IX), PT,
PTT |
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Reference Range |
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Average normal factor VII and factor IX levels are 50% to 150%; patients with
severe hemophilia will have levels <1%, often undetectable. Moderate forms of
the disease have levels of 1% to 10% while some mild cases may have 11% to 49%
of normal factor IX.
In preparation for and following surgery:
Level to prevent spontaneous hemorrhage: 5%
Minimum level for hemostasis following trauma and surgery: 30% to 50%
Severe hemorrhage: >60%
Major surgery: >60% prior to procedure, 30% to 50% for several days after
surgery, and >20% for 7-10 days thereafter |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Early signs of hypersensitivity reactions including hives, generalized
urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis
indicate discontinuation of use of the concentrate and physician should be
contacted if these symptoms occur |
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Dosage Forms |
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Injection:
BeneFix™: 250 units, 500 units, 1000 units
Konyne® 80: 20 mL, 40 mL
Hemonyne®: 20 mL, 40 mL
Profilnine® SD: Single dose vial
Proplex® T: 30 mL vial |
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References |
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Lusher JM,
"Thrombogenicity Associated With Factor IX Complex Concentrates," Semin
Hematol, 1991, 28(3 Suppl 6):3-5.
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