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:

Ajanta Pharma USA Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets, USP are indicated for the treatment of  CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . Prevention of CMV Disease : Valganciclovir tablets, USP are indicated for the prevention of  CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)] . Prevention of CMV Disease: Valganciclovir for oral solution 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)].

Produkt oppsummering:

Valganciclovir   for oral solution: Supplied as a white to slightly yellow powder blend for constitution, forming a colorless to brownish yellow fruity 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 enclosed in a gusset pouch individually packed in a carton and supplied with a bottle adapter and 2 oral dispensers with child-resistant closure (NDC 27241-159-19). Prior  to dispensing to the patient, valganciclovir for oral solution must be prepared by the pharmacist [see Dosage and Administration (2.4)]. Pharmacist: Do not open the gusset pouch before dispensing.                        Discard the gusset pouch after constitution. Store dry powder at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VALGANCICLOVIR HYDROCHLORIDE - VALGANCICLOVIR HYDROCHLORIDE POWDER,
FOR
SOLUTION
AJANTA PHARMA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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.
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 is a deoxynucleoside analogue cytomegalovirus (CMV) DNA
polymerase inhibitor indicated
for:
Adult Patients (1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency
syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas
transplant patients at high risk.
Pediatric Patients (1.2)
Prevention of CMV disease in kidney and heart transplant patients at
high risk.
DOSAGE AND ADMINISTRATION
ADULT DOSAGE (2.2)
Treatment of CMV retinitis
Induction: 900 mg (two 450 mg tablets) twice a day for 21 days
Maintenance: 900 mg (two 450 mg tablets) once a day
Prevention of CMV disease in heart
or kidney-pancreas transplant
patients
900 mg (two 450 mg tablets) once a day within 10 days of
transplantation until 100 days post- transplantation
Prevention of CMV