Valganciclovir

VALGANCICLOVIR- valganciclovir hydrochloride tablet, film coated
AvPAK

1 INDICATIONS & USAGE

1.1 Adult Patients

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)].

1.2 Pediatric Patients

Prevention of CMV Disease: Valganciclovir tablets, USP are indicated for the prevention of CMV disease in heart transplant patients (4 month to 16 years of age) at high risk [see Clinical Studies ( 14.2)].
Pediatric use information for pediatric kidney transplant patients ages 4 months to 16 years and for pediatric heart transplant patients ages 1 to less than 4 months is approved for Roche
Palo Alto LLC’ s VALCYTE (valganciclovir hydrochloride) tablets. However, due to Roche Palo Alto LLC’ s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE & ADMINISTRATION

2.1 General Dosing Information

• Adult patients should use valganciclovir tablets, not valganciclovir for oral solution.
• Valganciclovir tablets should be taken with food [see Clinical Pharmacology ( 12.3)].

2.2 Recommended Dosage in Adult Patients with Normal Renal Function

For dosage recommendations in adult patients with renal impairment [see Dosage and Administration ( 2.5)].
Treatment of CMV Retinitis:
• Induction: The recommended dosage is 900 mg (two 450 mg tablets) taken orally twice a day for 21 days.
• Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day.
Prevention of CMV Disease:
• For adult patients who have received a heart or kidney-pancreas transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days
of transplantation until 100 days post-transplantation.
• For adult patients who have received a kidney transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days of transplantation until 200
days post-transplantation.

2.3 Recommended Dosage in Pediatric Patients

Prevention of CMV Disease in Pediatric Heart Transplant Patients: For pediatric heart transplant patients 4 month to 16 years of age, the recommended once daily mg dose (7x BSA x CrCL) should start within 10 days of transplantation until 100 days post-transplantation.
The recommended once daily dosage of valganciclovir is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the equation below:
Pediatric Dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73m ² , then a maximum value of 150 mL/min/1.73m ² should be used in the equation. The k values used in the modified Schwartz formula are based on pediatric patient age, as shown in Table 1.

Mosteller BSA (m ²) = √ Height (cm) x weight (kg)
3600
Schwartz Creatinine Clearance (mL/min/1.73m ²) = K x Height (cm)
Serum Creatinine (mg/dL) Table 1. k Values According to Pediatric Patient Age*

k value	Pediatric Patient Age
0.33	Infants less than 1 year of age with low birth weight for gestational age
0.45	Infants less than 1 year of age with birth weight appropriate for gestational age
0.45	Children aged 1 to less than 2 years
0.55	Boys aged 2 to less than 13 years Girls aged 2 to less than 16 years
0.7	Boys aged 13 to 16 years

^* The k values provided are based on the Jaffe method of measuring serum creatinine, and may require correction when enzymatic methods are used ¹
Monitor serum creatinine levels regularly and consider changes in height and body weight and adapt the dose as appropriate during prophylaxis period. All calculated doses should be rounded to the nearest 10 mg increment for the actual deliverable dose. If the calculated dose exceeds 900 mg, a maximum dose of 900 mg should be administered. Valganciclovir for oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, valganciclovir tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, if the calculated dose is between 405 mg and 495 mg, one 450 mg tablet may be taken. Before prescribing valganciclovir tablets, pediatric patients should be assessed for the ability to swallow tablets. Pediatric use information for pediatric kidney transplant patients ages 4 months to 16 years and for pediatric heart transplant patients ages 1 to less than 4 months is approved for Roche Palo Alto LLC’ s VALCYTE (valganciclovir hydrochloride) tablets. However, due to Roche Palo Alto LLC’ s marketing exclusivity rights, this drug product is not labeled with that pediatric information.