IXINITY coagulation factor (recombinant)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (COAGULATION FACTOR IX RECOMBINANT HUMAN - UNII:382L14738L)

Available from:

Cangene BioPharma

INN (International Name):

COAGULATION FACTOR IX RECOMBINANT HUMAN

Composition:

COAGULATION FACTOR IX RECOMBINANT HUMAN 500 [iU] in 5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

IXINITY- COAGULATION FACTOR IX (RECOMBINANT)
CANGENE BIOPHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IXINITY SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IXINITY.
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
IXINITY is a coagulation factor IX (recombinant) indicated in adults
and children ≥ 12 years of age with hemophilia B for
control and prevention of bleeding episodes, and for perioperative
management (1)
IXINITY is not indicated for induction of immune tolerance in patients
with hemophilia B
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
One international unit (IU) of IXINITY per kg body weight increases
the circulating activity of factor IX by 0.98 IU/dL (2.1)
Initial dose (2.1)
Required factor IX units (IU) = body weight (kg) x desired factor IX
increase (% of normal or IU/dL) x reciprocal of
observed recovery (IU/kg per IU/dL).
Maintenance dose:
Depends upon the type of bleed or surgery, clinical response, and the
severity of the underlying factor IX deficiency (2.1)
DOSAGE FORMS AND STRENGTHS
IXINITY is available as a lyophilized white or almost white powder, in
single-use glass vials containing nominally 500, 1000,
or 1500 international units (IU) per vial (3).
CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to IXINITY or its
excipients, including hamster protein (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, may occur. Should
symptoms occur, discontinue IXINITY and
administer appropriate treatment. Patients may also develop
hypersensitivity to hamster (CHO) protein, which is
present in trace amounts in the product (5.1).
Development of neutralizing antibodies (inhibitors) to IXINITY may
occur. If expected factor IX activity plasma levels
are not attained, or if bleeding is not controlled with an appropriate
dose, perform an assay that measures factor IX
inhibitor concentration (5.2).
Nephrotic syndrome has been reported follow