Generic equivalent of Valganciclovir
1 SKUs available · Available to order · NABP accredited · DSCSA compliant
Valganciclovir is the generic equivalent of the brand-name drug Valganciclovir. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Valganciclovir through Premier Pharma with same-day fulfillment on in-stock SKUs.
BOXED WARNING WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY,FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS • Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir tablets [see Warnings and Precautions ( 5.1 )]. • Impairment of Fertility: Based on animal data and limited human data, valganciclovir tablets may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )]. • Fetal Toxicity: Based on animal data, valganciclovir tablets have the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )]. • Mutagenesis and Carcinogene…
Source: FDA prescribing information. For licensed professionals only.
1 INDICATIONS AND USAGE Valganciclovir tablets are 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 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1 )]. Prevention…
12.1 Mechanism of Action Valganciclovir is an antiviral drug with activity against CMV [see Microbiology ( 12.4 )].
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Valganciclovir is an antiviral drug with activity against CMV [see Microbiology ( 12.4 )]. 12.3 Pharmacokinetics Valganciclovir is a prodrug of ganciclovir. Valganciclovir Cmax and AUC are approximately 1% and 3% of those of ganciclovir, respectively. Pharmacokinetics in Adults: The pharmacokinetics of ganciclovir after administration of valganciclovir tablets have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis, and in solid organ transplant patients (Table 10). Table 10 Ganciclovir Pharmacokinetics* in Healthy Volunteers and HIV-positive/CMV-positive Adults Administered Valganciclovir Tablets 900 m…
4 CONTRAINDICATIONS Valganciclovir tablets are 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 )]. Hypersensitivity to valganciclovir or ganciclovir. ( 4 )
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic Toxicity [see Warnings and Precautions ( 5.1 )]. • Acute Renal Failure [see Warnings and Precautions ( 5.2 )]. • Impairment of Fertility [see Warnings and Precautions ( 5.3 )]. • Fetal Toxicity [see Warnings and Precautions ( 5.4 )]. • Mutagenesis and Carcinogenesis [see Warnings and Precautions ( 5.5 )]. The most common adverse reactions and laboratory abn…
7 DRUG INTERACTIONS In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of valganciclovir and other renally excreted drugs, patients with impaired renal function…
2 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 disease in kidney transplant patients 900 mg (two 450 mg tablets) once a day within 10 days of transplantation…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Adverse Reaction Inform patients that valganciclovir tablets may cause granulocytopenia (neutropenia), anemia, thrombocytopenia and elevated creatinine levels and that dose modification or discontinuation of dosing may be required. Complete blood counts, platelet counts, and creatinine levels should be monitored frequently during treatment [see Warnings and Precautions ( 5.1 )]. Pregnancy and Contraception Inform females of reproductive potentia…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| VALGANCICLOVIR TABS 450 MG 60CT | 2-Day |
Premier Pharma stocks 1 Valganciclovir SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Valganciclovir is the generic equivalent of Valganciclovir. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Valganciclovir in 450 mg/1 and TABLET, FILM COATED.
12.1 Mechanism of Action Valganciclovir is an antiviral drug with activity against CMV [see Microbiology ( 12.4 )].
Create a free Premier Pharma account to unlock live wholesale pricing, place orders, and track shipments — approval typically takes minutes for licensed pharmacies, clinics, doctor's offices, and veterinary practices.