Valganciclovir

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 )]. …

• 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 post-transplantation 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 post-transplantation 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 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 creatinine clearance using a modified Schwartz formula in children) • Valganciclovir tablets should be taken with food. • Valganciclovir tablets should not be broken or crushed. • Adult patients should use valganciclovir tablets, not valganciclovir for oral solution. • Adults with renal impairment: Adjust dose based on creatinine clearance
• For adult patients receiving hemodialysis a dose recommendation cannot be given. …

Valganciclovir tablets USP: 450 mg, pink, oval, biconvex, film-coated tablets, debossed with 'J' on one side and '156' on the other side. • Tablets: 450 mg. (3)

• Valganciclovir tablets are indicated for the prevention of CMV disease
• In pediatric kidney transplant patients 4 months to 16 years of age and in pediatric heart transplant patients 1 month to 16 years of age at risk for developing CMV disease [see Indications and Usage , Dosage and Administration ]
• The use of valganciclovir for oral solution and tablets for the prevention of CMV disease
• In pediatric kidney transplant patients 4 months to 16 years of age is based on two single-arm, open-label, non-comparative studies in patients 4 months to 16 years of age. …

Studies of valganciclovir tablets have not been conducted in adults older than 65 years of age. Clinical studies of valganciclovir tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. …

• 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 ]
• Pregnancy and Contraception Inform females of reproductive potential that valganciclovir tablets causes birth defects in animals. …

• 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 ]
• Hypersensitivity to valganciclovir or ganciclovir

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 may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug. …

• 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. ( 2.5 , 5.2 , 8.5 , 8.6 ) 5.1 Hematologic Toxicity Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir tablets or ganciclovir. …

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 )]. …

8.1 Pregnancy 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. …

Experience with Valganciclovir Tablets: An overdose of valganciclovir could possibly result in increased renal toxicity [see Dosage and Administration ( 2.5 ), Use in Specific Populations ( 8.6 )]. Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of valganciclovir [see Clinical Pharmacology ( 12.3 )]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )]. …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.