Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
VALGANCICLOVIR HYDROCHLORIDE (UNII: 4P3T9QF9NZ) (GANCICLOVIR - UNII:P9G3CKZ4P5)
AvKARE
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Lue koko asiakirja