Valganciclovir hydrochloride indications and usage

Valganciclovir Hydrochloride
VALCYTE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
Patient Counseling Information
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications and Usage

Adult Patients

Treatment of Cytomegalovirus (CMV) Retinitis: Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].

Prevention of CMV Disease: Valcyte tablets are indicated for the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)].

Pediatric Patients

Prevention of CMV Disease: Valcyte for oral solution and tablets are indicated for the prevention of CMV disease in kidney or heart transplant patients (4 months to 16 years of age) at high risk [see Clinical Studies (14.2)].

Limitations of Use

Valcyte is not indicated for use in either adult or pediatric liver transplant patients [see Clinical Studies (14.1, 14.2)].

The safety and efficacy of Valcyte have not been established for:

• Prevention of CMV disease in solid organ transplants other than those indicated [see Clinical Studies (14.1, 14.2)].
• Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age [see Clinical Studies (14.2)].
• Treatment of congenital CMV disease [see Use in Specific Populations (8.4)]

References

Adapted from the FDA Package Insert.