ALPROLIX (coagulation factor ix- recombinant, fc fusion protein kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

eftrenonacog alfa (UNII: 02E00T2QDE) (eftrenonacog alfa - UNII:02E00T2QDE)

Available from:

Biogen Inc.

INN (International Name):

eftrenonacog alfa

Composition:

eftrenonacog alfa 500 [iU] in 5 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B (congenital Factor IX deficiency) for: - On demand treatment and control of bleeding episodes, - Perioperative management of bleeding, - Routine prophylaxis to reduce the frequency of bleeding episodes. Limitation of Use ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)]. ALPROLIX is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients (sucrose, mannitol, sodium chloride, L-histidine and polysorbate 20) . . Pregnancy Category C Animal reproductive studies have not been conducted with ALPROLIX. It is also not known whether ALPROLIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALPROLIX should be given to a pregnant woma

Product summary:

How Supplied ALPROLIX is supplied as a kit comprising: ALPROLIX vials are available in 250, 500, 1000, 2000, 3000, or 4000 IU nominal dosage strengths. The actual Factor IX potency, expressed in IU is stated on every rFIXFc vial and kit carton label. Components used in the packaging of ALPROLIX do not contain natural rubber latex. Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ALPROLIX- COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN
BIOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPROLIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ALPROLIX.
ALPROLIX [COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN],
LYOPHILIZED POWDER FOR SOLUTION FOR
INTRAVENOUS INJECTION.
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.2)
04/2017
INDICATIONS AND USAGE
ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a
recombinant DNA derived, coagulation Factor IX
concentrate indicated in adults and children with hemophilia B for:
On demand treatment and control of bleeding episodes,
Perioperative management of bleeding,
Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
ALPROLIX is not indicated for induction of immune tolerance in
patients with hemophilia B. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
On demand treatment and control of bleeding episodes and perioperative
management of bleeding:
Each vial of ALPROLIX contains the labeled amount of coagulation
Factor IX potency in international units (IU). (2.1)
One unit per kilogram body weight of ALPROLIX increased the
circulating Factor IX level by 1% [IU/dL]. (2.1)
INITIAL DOSE: TYPE OF
BLE E DING
CIRCULATING FIX (IU/DL)
DOSING INTERVAL
(HO URS)
Minor and Moderate
30-60
Repeat every 48 hours as needed
Major
80-100
Consider repeat dose after 6-10 hours, then every 24 hours for
3 days, then every 48 hours until healing achieved
The maintenance dose or frequency of ALPROLIX administration is
determined by the type of bleeding episode and
the recommendation of the treating healthcare provider. (2.1)
Routine prophylaxis:
50 IU/kg once weekly or 100 IU/kg once every 10 days. Adjust dosing
regimen based on individual response. (2.1)
DOSAGE FORMS AND STRENGTHS
ALPROLIX is available as a lyophilized powder in single use vials
containing nomina