IXINITY (coagulation factor ix- recombinant kit

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:

Aptevo BioTherapeutics LLC

INN (International Name):

COAGULATION FACTOR IX RECOMBINANT HUMAN

Composition:

COAGULATION FACTOR IX RECOMBINANT HUMAN 250 [iU] in 5 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated for the treatment of: - Adults and children ≥ 12 years of age with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management - On-demand treatment and control of bleeding episodes - Perioperative management - Adults with hemophilia B for: Routine prophylaxis to reduce the frequency of bleeding episodes - Routine prophylaxis to reduce the frequency of bleeding episodes IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3) ]. IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein [see Warnings and Precautions (5.1) ]. Risk Summary There are no data with IXINITY use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with IXINITY. In the U.S. general population, the estimated b

Product summary:

IXINITY is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial. Kits include one single-use vial (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, and a vial adapter with filter. None of the kit components are made with natural rubber latex. 250 IU strength only; store at 2 to 8°C (36 to 46°F). 500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F). Do not freeze. Keep the vial in the carton and protect from light. Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

IXINITY- COAGULATION FACTOR IX (RECOMBINANT)
APTEVO BIOTHERAPEUTICS LLC
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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..
IXINITY [COAGULATION FACTOR IX (RECOMBINANT)]
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2020
Dosage and Administration (2.1) 09/2020
Warnings and Precautions (5.1, 5.4) 09/2020
INDICATIONS AND USAGE
IXINITY, Coagulation Factor IX (Recombinant), is a human blood
coagulation factor indicated for the
treatment of:
Adults and children ≥ 12 years of age with hemophilia B for:
On-demand treatment and control of bleeding episodes (1)
Perioperative management (1)
Adults with hemophilia B for:
Routine prophylaxis to reduce the frequency of bleeding episodes (1)
IXINITY 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:_
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:_
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). (2.1)
The maintenance dose depends on the type of bleed or surgery, the
intensity of the hemostatic
challenge, and number of days until adequate wound healing is
achieved. (2.1)
_Routine prophylaxis:_
40 to 70 IU/kg twice weekly. (2.1)
DOSAGE FORMS AND STRENGTHS
IXINITY is available as a lyophilized white or almost white powder, in
single-use glass vials containing
nominally 250, 500, 1000, 1500, 2000, or 3000 international units (IU)
per vial (3)
CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to IXINITY or its
excipients, including ham