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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

H2-Pharma, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

How Supplied CYTOVENE-IV (ganciclovir) for injection is supplied in 10 mL sterile single-dose vials, each containing 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. The concentration of ganciclovir in the reconstituted solution is 50 mg/mL. Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. CYTOVENE-IV is supplied in cartons of 5 single-dose vials (NDC 61269-450-50 for 5-vial carton, NDC 61269-450-20 for single-dose vial). 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. Discard any unused portion of the reconstituted solution. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.

Autorisasjon status:

New Drug Application

Preparatomtale

CYTOVENE IV- GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
H2-PHARMA, LLC
----------
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) 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)
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 week.
Prevention of CMV disease in transplant
recipients (2.4)
Induction: 5 mg/kg (given intravenously at a constant rate over
1 hour) every 12 hours for 7 t