CYTOVENE IV- ganciclovir sodium injection, powder, lyophilized, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ganciclovir sodium (UNII: 02L083W284) (ganciclovir - UNII:P9G3CKZ4P5)

Διαθέσιμο από:

Genentech, Inc.

INN (Διεθνής Όνομα):

ganciclovir sodium

Σύνθεση:

ganciclovir 500 mg in 10 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

CYTOVENE-IV is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . CYTOVENE-IV is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)]. CYTOVENE-IV is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. Risk Summary In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a pregnant woman, no adequate human data are available

Περίληψη προϊόντος:

How Supplied CYTOVENE-IV (ganciclovir sodium) for injection is supplied in 10 mL sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. CYTOVENE-IV is supplied in cartons of 5 vials (NDC 0004-6940-04). Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CYTOVENE IV- GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYTOVENE -IV SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR CYTOVENE -IV.
CYTOVENE-IV (GANCICLOVIR SODIUM) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1989
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEMATOLOGIC TOXICITY: GRANULOCYTOPENIA, ANEMIA, THROMBOCYTOPENIA, AND
PANCYTOPENIA HAVE BEEN
REPORTED IN PATIENTS TREATED WITH CYTOVENE-IV. (5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
CYTOVENE-IV MAY CAUSE
TEMPORARY OR PERMANENT INHIBITION OF SPERMATOGENESIS IN MALES AND
SUPPRESSION OF FERTILITY IN
FEMALES. (5.3)
FETAL TOXICITY: BASED ON ANIMAL DATA, CYTOVENE-IV HAS THE POTENTIAL TO
CAUSE BIRTH DEFECTS IN
HUMANS. (5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, CYTOVENE-IV HAS
THE POTENTIAL TO CAUSE
CANCER IN HUMANS. (5.5)
RECENT MAJOR CHANGES
Boxed Warning
08/2018
Warnings and Precautions (5.3)
08/2018
INDICATIONS AND USAGE
CYTOVENE-IV is a deoxynucleoside analogue cytomegalovirus (CMV) DNA
polymerase inhibitor indicated for the:
treatment of CMV retinitis in immunocompromised adult patients,
including patients with acquired immunodeficiency
syndrome (AIDS). (1.1)
prevention of CMV disease in adult transplant recipients at risk for
CMV disease. (1.2)
DOSAGE AND ADMINISTRATION
CYTOVENE-IV is administered only intravenously. (2.1)
DOSAGE IN ADULT PATIENTS WITH NORMAL RENAL FUNCTION
Treatment of CMV retinitis (2.3)
Induction: 5 mg/kg (given intravenously at a constant rate over 1
hour)
every 12 hours for 14 to 21 days.
Maintenance: 5 mg/kg (given intravenously at a constant rate over 1
hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days
per
we e k.
Prevention of CMV disease in transplant
recipients (2.4)
In