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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

EFTRENONACOG ALFA (UNII: 02E00T2QDE) (EFTRENONACOG ALFA - UNII:02E00T2QDE)

Διαθέσιμο από:

Bioverativ Therapeutics Inc.

INN (Διεθνής Όνομα):

eftrenonacog alfa

Σύνθεση:

eftrenonacog alfa 500 [iU] in 5 mL

Οδός χορήγησης:

INTRAVENOUS

Θεραπευτικές ενδείξεις:

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. 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). Risk Summary There are no studies of ALPROLIX use in pregnant women to inform a drug-associated risk. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2%–4% and of misca

Περίληψη προϊόντος:

How Supplied ALPROLIX is supplied as a kit comprising: ALPROLIX is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU or 4000 IU nominal (approximate) dosage strengths. The actual Factor IX potency, expressed in IU, is stated on each rFIXFc vial and carton label. Not made with natural rubber latex. Storage and Handling

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

ALPROLIX- COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN
BIOVERATIV THERAPEUTICS 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
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.
_Limitation 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:
Each vial of ALPROLIX contains the labeled amount of coagulation
Factor IX potency in international
units (IU). (2.1)
On average, one unit per kilogram body weight of ALPROLIX increased
the circulating Factor IX level by
approximately 1% (IU/dL) in adults and children ≥6 years of age and
by 0.6% (IU/dL) in children under 6
years of age. (2.1)
INITIAL DOSE: TYPE
OF BLEEDING
TARGET CIRCULATING FIX
(IU/DL)
DOSING INTERVAL
(HOURS)
Minor and Moderate
30–60
Repeat every 48 hours as needed if there is further
evidence of bleeding.
Major
80–100
Consider repeat dose after 6–10 hours, then every 24
hours for 3 days, then every 48 hours until healing
achieved.
Perioperative management:
Minor surgery: a single infusion to reach FIX level of 50–80 IU/dL
may be sufficient. Repeat as needed
after 24–48 hours until bleeding stops and healing is achieved.
(2.1)
Major surgery: initial infusion to reach FIX level of 60–100 IU/dL.
Consider a repeat dose after 6–10 hours
and then every 2