GANCICLOVIR- ganciclovir sodium injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GANCICLOVIR SODIUM (UNII: 02L083W284) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

GANCICLOVIR SODIUM

Composition:

GANCICLOVIR SODIUM 500 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ganciclovir for Injection 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)] . Ganciclovir for Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)]. Ganciclovir for Injection 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

Product summary:

Ganciclovir for Injection, USP is supplied as follows: 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. The container closure is not made with natural rubber latex. Storage Store vials at 20° to 25°C (68° to 77°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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GANCICLOVIR - GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GANCICLOVIR FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GANCICLOVIR FOR
INJECTION.
GANCICLOVIR FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1989
RX ONLY
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 GANCICLOVIR
FOR INJECTION.
(5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
GANCICLOVIR
FOR INJECTION MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF
SPERMATOGENESIS IN
MALES AND SUPPRESSION OF FERTILITY IN FEMALES. (5.3)
FETAL TOXICITY: BASED ON ANIMAL DATA, GANCICLOVIR FOR INJECTION HAS
THE POTENTIAL TO
CAUSE BIRTH DEFECTS IN HUMANS. (5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, GANCICLOVIR FOR
INJECTION HAS
THE POTENTIAL TO CAUSE CANCER IN HUMANS. (5.5)
INDICATIONS AND USAGE
Ganciclovir for Injection 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
Ganciclovir for Injection is administered only intravenously. (2.1)
DOSAGE IN ADULT PATIENTS WITH NORMAL RENAL FUNCTION
Treatment of CMV
Induction: 5 mg/kg (given intravenously at a
retinitis (2.3)
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
Induction: 5 mg/kg