HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Leucadia Pharmaceuticals

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

How Supplied Ganciclovir for injection is supplied in 15 mL sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. Ganciclovir for injection is supplied in cartons of 25 vials (NDC 24201-500-25). 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GANCICLOVIR- GANCICLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
LEUCADIA PHARMACEUTICALS
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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
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 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
r