VALGANCICLOVIR HYDROCHLORIDE FOR ORAL- valganciclovir hydrochloride powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

VALGANCICLOVIR HYDROCHLORIDE (UNII: 4P3T9QF9NZ) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Tilgjengelig fra:

AvKARE

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Prevention of CMV Disease: Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2)] . Valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions ( 6.1)]. Risk Summary After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir. 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 human exposure. There are no available human data on use of valganciclovir or ganciclo

Produkt oppsummering:

Valganciclovir for oral solution: Supplied as a white to off-white powder blend for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution. Available in glass bottles containing approximately 100 mL of solution after constitution. Each bottle can deliver up to a total of 88 mL of solution.Each bottle is supplied with a bottle adapter and 2 oral dispensers (NDC 42291-972-01). Prior to dispensing to the patient, valganciclovir for oral solution must be prepared by the pharmacist [see Dosage and Administration ( 2.4)]. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VALGANCICLOVIR HYDROCHLORIDE FOR ORAL- VALGANCICLOVIR
HYDROCHLORIDE POWDER, FOR SOLUTION
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
VALGANCICLOVIR FOR ORAL SOLUTION
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALGANCICLOVIR FOR
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
VALGANCICLOVIR FOR ORAL SOLUTION.
INITIAL U.S. APPROVAL: 2001
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
HEMATOLOGIC TOXICITY: SEVERE LEUKOPENIA, NEUTROPENIA, ANEMIA,
THROMBOCYTOPENIA,
PANCYTOPENIA, AND BONE MARROW FAILURE INCLUDING APLASTIC ANEMIA HAVE
BEEN
REPORTED IN PATIENTS TREATED WITH VALGANCICLOVIR. ( 5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
VALGANCICLOVIR MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF
SPERMATOGENESIS IN
MALES AND SUPPRESSION OF FERTILITY IN FEMALES.(5.3)
FETAL TOXICITY: BASED ON ANIMAL DATA, VALGANCICLOVIR HAS THE POTENTIAL
TO CAUSE BIRTH
DEFECTS IN HUMANS. ( 5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, VALGANCICLOVIR
HAS THE
POTENTIAL TO CAUSE CANCERS IN HUMANS. ( 5.5)
INDICATIONS AND USAGE
Valganciclovir for oral solution is a deoxynucleoside analogue
cytomegalovirus (CMV) DNA polymerase
inhibitor indicated for:
Pediatric Patients( 1.2)
Prevention of CMV disease in kidney and heart transplant patients at
high risk.
DOSAGE AND ADMINISTRATION
PEDIATRIC DOSAGE ( 2.3)
Prevention of CMV disease in
kidney transplant patients 4
months to 16 years of age
Dose once a day within 10 days of transplantation until 200 days post-
transplantation according to dosage algorithm (note the calculation of
creatinine clearance using a modified Schwartz formula in children)
Prevention of CMV disease in
heart transplant patients 1
month to 16 years of age
Dose once a day within 10 days of transplantation until 100 days post-
transplantation according to dosage algorithm (note the calculation of
creat