THYMOGLOBULIN (anti-thymocyte globulin- rabbit injection, powder, lyophilized, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN (UNII: D7RD81HE4W) (LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN - UNII:D7RD81HE4W)

Διαθέσιμο από:

Genzyme Corporation

INN (Διεθνής Όνομα):

LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN

Σύνθεση:

LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant immunosuppression. THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression [see Warnings and Precautions (5.2, 5.5) and Adverse Reactions (6.2)] . Risk Summary Animal reproduction studies have not been conducted with THYMOGLOBULIN. It is also not known whether THYMOGLOBULIN can cause fetal harm. THYMOGLOBULIN should be given to a pregnant woman only if the benefit outweighs the risk. Risk Summary THYMOGLOBULIN has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during THYMOGLOBULIN therapy. Contracepti

Περίληψη προϊόντος:

THYMOGLOBULIN is supplied as a single-dose clear glass 10 mL vial containing 25 mg of lyophilized (solid) THYMOGLOBULIN. Each carton contains one THYMOGLOBULIN vial (NDC 58468-0080-1).

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

THYMOGLOBULIN- ANTI-THYMOCYTE GLOBULIN (RABBIT) INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
THYMOGLOBULIN SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THYMOGLOBULIN.
THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN [RABBIT]) FOR INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
WARNING: IMMUNOSUPPRESSION
THYMOGLOBULIN SHOULD ONLY BE USED BY PHYSICIANS EXPERIENCED IN
IMMUNOSUPPRESSIVE THERAPY IN TRANSPLANTATION. (5.1)
INDICATIONS AND USAGE
THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and
treatment of acute rejection
in patients receiving a kidney transplant. (1)
Use in conjunction with concomitant immunosuppression. (1)
DOSAGE AND ADMINISTRATION
The first dose should be infused over at least 6 hours; doses on
subsequent days should be infused
over at least 4 hours. (2.2)
Premedication with corticosteroids, acetaminophen, and/or an
antihistamine prior to each infusion is
recommended. (2.2)
The THYMOGLOBULIN dose should be reduced by one-half if the white
blood cell (WBC) count is between
2,000 and 3,000 cells/mm or if the platelet count is between 50,000
and 75,000 cells/mm . Stopping
THYMOGLOBULIN treatment should be considered if the WBC count falls
below 2,000 cells/mm or if the
platelet count falls below 50,000 cells/mm . (2.3)
INDICATION
DOSE
Prophylaxis of acute rejection
1.5 mg/kg of body weight administered daily for 4 to 7
days
Treatment of acute rejection
1.5 mg/kg of body weight administered daily for 7 to 14
days
For complete dosing instructions, see full prescribing information.
(2)
DOSAGE FORMS AND STRENGTHS
Single-dose 10 mL vial containing 25 mg of anti-thymocyte globulin
(rabbit) lyophilized, sterile powder.
(3)
CONTRAINDICATIONS
Allergy or anaphylactic reaction to rabbit proteins or to any product
excipients, or active acute or chronic
infections which contraindicate any additional immunosuppression (4)
WARNINGS AND PRECAUTIONS