FACTOR IX CONCENTRATES
Brand Name
AlphaNine SD
Bebulin
Mononine
Profilnine SD
Alprolix
BeneFix
Rixubis
Ixinity
Idelvion
Kcentra
Generic Name
Factor IX (plasma-derived)
Factor IX (plasma-derived)
Factor IX (plasma-derived)
Factor IX (plasma-derived)
Factor IX (recombinant)
Factor IX (recombinant)
Factor IX (recombinant)
Factor IX (recombinant)
Factor IX (recombinant)
Prothrombin Complex Concentrate (Human)
Length of Authorization
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Per Medical Guidelines
Approvable Criteria:
Factor IX is considered medically necessary if ANY ONE of the following is met:
•
For long term bleeding prophylaxis in members with severe Hemophilia B (congenital factor
IX deficiency or Christmas disease).
o Prophylaxis is only indicated for individuals with severe hemophilia B as defined by
factor IX < 1%.
o 25-40 International Units/kg IV two times weekly is a commonly used regimen.
o For Alprolix: The recommended starting regimens are either 50 IU/kg once
weekly, or 100 IU/kg once every 10 days.
o If criteria met, approve for Calendar Year.
•
For the control of hemorrhage including surgical bleeding and hemarthrosis in members
with Hemophilia B (congenital factor IX deficiency or Christmas disease).
o If criteria met, approve according to the dosing chart below.
Continued on the following page…
FACTOR IX CONCENTRATES
Type of Hemorrhage
Minor
Hemarthroses, uncomplicated
Superficial muscular
Superficial soft tissue
Moderate
Intramuscular with dissection
Soft tissue with dissection
Mucous membranes
Dental extractions
Hematuria
Factor IX Level Required (%)*/
Frequency of Doses (hours)
Duration of Therapy
1-2 days
For Alprolix: Repeat every 48
hours if there is further
evidence of bleeding.
Treat until bleeding stops
25-50% / 12-24 hours
and healing begins; about 2
For Alprolix: 30-60% / 48 hours
to 7 days.
For Alprolix: Repeat every 48
hours if there is further
evidence of bleeding.
50-100% / 12-24 hours
7-10 days
Major
For Alprolix: 80-100% /
For Alprolix: The dose may
Pharynx
consider a repeat dose after 6be reduced and the
Retropharynx
10 hours and then every 24
frequency of dosing may be
Retroperitoneum
hours for the first 3 days
extended after day 3 to every
CNS
48 hours or longer until
bleeding stops and healing is
achieved.
Factor IX is Not Approved for any of the following indications:
• For the treatment of other factor deficiencies (e.g., Factors II, VII, VIII, and X).
• For the treatment of hemophilia A members with inhibitors to Factor VIII.
• For the reversal of coumarin-induced anticoagulation.
• For the treatment of bleeding due to low levels of liver-dependent coagulation factors.
20-30% / 12-24 hours
For Alprolix: 30-60% / 48 hours
NOTE: Kcentra is indicated for the urgent reversal of acquired coagulation factor deficiency
induced by vitamin K antagonist therapy with acute major bleeding or the need for urgent
surgery or other invasive procedure.
• Dosing should be individualized based on the patient’s baseline INR value, body weight,
and actual potency of Factor IX as stated on the product carton.
o Pre-treatment INR 2 -<4: 25 units Factor IX/kg not to exceed 2500 units of Factor IX.
o Pre-treatment INR 4 – 6: 35 units Factor IX/kg not to exceed 3500 units of Factor IX.
o Pre-treatment INR >6: 50 units Factor IX/kg not to exceed 5000 units of Factor IX.
SPECIALTY PHARMACY PRODUCT
* Reference
• Alphanine SD [prescribing information]. Los Angeles, CA: Alpha Therapeutic Corporation; January 2004.
• Mononine [prescribing information]. Kankakee, IL: Aventis Behring; January 2007.
• BeneFix [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc.; December 2009.
• Bebulin [prescribing information]. Westlake Village, CA: Baxter Healthcare Corporation; July 2012.
• Profilnine SD [prescribing information]. Los Angeles, CA: Alpha Therapeutic Corporation; January 2004.
• Alprolix [prescribing information]. Cambridge, MA: Biogen Idec, Inc.; March 2004.
•
•
•
•
Kcentra prescribing information. Kankakee, IL: CSL Behring LLC; December 2013.
Rixubis prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; September 2014.
Ixinity prescribing information. Winnipeg, Manitoba, Canada and Baltimore, MD: Cangene Corporation, a
subsidiary of Emergent BioSolutions, Inc.; April 2015.
Idelvion prescribing information. Kankakee, IL: CSL Behring LLC; March 2016.