HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LuciValgan safely and effectively. See full prescribing information for LuciValgan.
INDICATIONS AND USAGE
LuciValgan is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients
· 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
· Prevention of CMV disease in kidney and heart transplant patients at high risk.
DOSAGE AND ADMINISTRATION
Adult Dosage:
• 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 posttransplantation.
• Prevention of CMV disease in kidney transplant patients: 900 mg (two 450 mg tablets) once a day within 10 days of transplantation until 200 days posttransplantation.
Pediatric Dosage:
• 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 posttransplantation 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 posttransplantation according to dosage algorithm (note the calculation of creatinine clearance using a modified Schwartz formula in children)
· LuciValgan tablets should be taken with food.
· LuciValgan tablets should not be broken or crushed.
· Adults with renal impairment: Adjust dose based on creatinine clearance.
For adult patients receiving hemodialysis a dose recommendation cannot be given.
DOSAGE FORMS AND STRENGTHS
Tablets: 450 mg×60 tablets
CONTRAINDICATIONS
Hypersensitivity to valganciclovir or ganciclovir.
WARNINGS AND PRECAUTIONS
· Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function.
ADVERSE REACTIONS
• Adult patients: Most common adverse reactions and laboratory abnormalities (reported in at least one indication by greater than or equal to 20% of patients) are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting.
• Pediatric patients: Most common adverse reactions and laboratory abnormalities (reported in greater than or equal to 20% of pediatric solid organ transplant recipients) are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
DRUG INTERACTIONS
· Imipenem-cilastatin: Seizures were reported in patients receiving ganciclovir and imipenem-cilastatin. Concomitant use is not recommended unless the potential benefits outweigh the risks.
· Cyclosporine or amphotericin B: When coadministered with valganciclovir, the risk of nephrotoxicity may be increased. Monitor renal function.
· Mycophenolate mofetil (MMF): When coadministered with valganciclovir, the risk of hematological and renal toxicity may be increased. Monitor for ganciclovir and MMF toxicity.
· Other drugs associated with myelosuppression or nephrotoxicity: Due to potential for increased toxicity, consider for concomitant use with valganciclovir only if the potential benefits are judged to outweigh the risks.
· Didanosine: Ganciclovir coadministered with didanosine may increase didanosine levels. Monitor for didanosine toxicity (e.g., pancreatitis).
· Probenecid: May increase ganciclovir levels. Monitor for evidence of ganciclovir toxicity.
USE IN SPECIFIC POPULATIONS
· Lactation: Breastfeeding is not recommended with use of LuciValgan.
Storage
Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.