RIXUBIS (coagulation factor ix- recombinant kit

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Takeda Pharmaceuticals America, Inc.

INN（国际名称）:

COAGULATION FACTOR IX RECOMBINANT HUMAN

组成:

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

疗效迹象:

RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor 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. RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)] . RIXUBIS is contraindicated in patients who have: - Known hypersensitivity to RIXUBIS or its excipients including hamster protein - Disseminated Intravascular Coagulation (DIC) [see Warnings and Precautions (5.4)] - Signs of fibrinolysis [see Warnings and Precautions (5.4)] Risk Summary There are no data with RIXUBIS use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with RIXUBIS. It is also not known whether RIXUBIS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population,

產品總結:

How Supplied RIXUBIS is available as single-dose vials containing the following product strengths: Actual factor IX activity in international units is stated on the unit carton and vial label. Each kit also contains 5 mL of Sterile Water for Injection and a BAXJECT II transfer device. Not made with natural rubber latex. Storage and Handling

授权状态:

Biologic Licensing Application

产品特点

RIXUBIS- COAGULATION FACTOR IX (RECOMBINANT)
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIXUBIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIXUBIS.
RIXUBIS [COAGULATION FACTOR IX (RECOMBINANT)]
FOR INTRAVENOUS INJECTION, LYOPHILIZED POWDER FOR SOLUTION
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic
factor 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.
RIXUBIS is not indicated for induction of immune tolerance in patients
with Hemophilia B. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY. (2)
_On-demand treatment and control of bleeding episodes and
perioperative management of bleeding:_
One international unit of RIXUBIS per kg of body weight increases the
circulating activity of factor IX by
0.7 international units/dL for patients <12 years of age and 0.9
international units/dL for patients ≥12
years of age. (2.1)
_Initial Dose:_
Required international units = body weight (kg) × desired factor IX
increase (% of normal or IU/dL) ×
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. (2.2)
_Routine prophylaxis:_
Patients <12 years of age: 60 to 80 international units per kg twice
weekly.
Patients ≥12 years of age: 40 to 60 international units per kg twice
weekly. (2.1)
DOSAGE FORMS AND STRENGTHS
RIXUBIS is available as a lyophilized powder in single-dose vials
containing nominally 250, 500, 1000, 2000
or 3000 international units. (3)
CONTRAINDICATIONS
Do not use in patients with:
Known hypersensitivity to RIXUBIS or its excipients including hamster
protein. (4