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].

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].

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].

Limitations of Use

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

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].
• Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age [see Clinical Studies].
• Treatment of congenital CMV disease [see Use in Specific Populations]

General Dosing Information

• Valcyte for oral solution and tablets should be taken with food [see CLINICAL PHARMACOLOGY].
• Valcyte for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient [see below].
• The bioavailability of ganciclovir from Valcyte is significantly higher than from ganciclovir capsules. Therefore, Valcyte tablets cannot be substituted for ganciclovir capsules on a one-to-one basis [see CLINICAL PHARMACOLOGY].
• Adult patients should use Valcyte tablets, not Valcyte for oral solution.

Adult Patients With Normal Renal Function

For dosage recommendations in adult patients with renal impairment see below.

Treatment of CMV Retinitis

• Induction: The recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days.
• Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once a day.

Prevention of CMV Disease

• For adult patients who have received a heart or kidney-pancreas transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days posttransplantation.
• For adult patients who have received a kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post-transplantation.

Pediatric Patients

Prevention of CMV Disease

For pediatric patients 4 months to 16 years of age who have received a kidney or heart transplant, the recommended once daily dose of Valcyte starting within 10 days of transplantation until 100 days post-transplantation 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/1.73m², then a maximum value of 150 mL/min/1.73m² should be used in the equation.

Mosteller BSA (m² ) = √Height (cm) xWeight (kg)/ 3600

Schwartz Creatinine Clearance mL/min/1.73m²) = k x Height (cm)/ Serum Creatinine (mg/ dL)

where k =

0.45 for patients aged 4 months to < 1 year,
0.45 for patients aged 1 to < 2 years (note k value is 0.45 instead of the typical value of 0.55),
0.55 for boys aged 2 to < 13 years and girls aged 2 to 16 years, and
0.7 for boys aged 13 to 16 years.

All calculated doses should be rounded to the nearest 25 mg increment for the actual deliverable dose. If the calculated dose exceeds 900 mg, a maximum dose of 900 mg should be administered. Valcyte for oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, Valcyte 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.

Preparation of Valcyte for Oral Solution

Prior to dispensing to the patient, Valcyte for oral solution must be prepared by the pharmacist as follows [see Storage and Handling]:

• Measure 91 mL of purified water in a graduated cylinder.
• Shake the Valcyte bottle to loosen the powder. Remove the child resistant bottle cap and add approximately half the total amount of water for constitution to the bottle and shake the closed bottle well for about 1 minute. Add the remainder of water and shake the closed bottle well for about 1 minute. This prepared solution contains 50 mg of valganciclovir free base per 1 mL.
• Remove the child resistant bottle cap and push the bottle adapter into the neck of the bottle.
• Close bottle with child resistant bottle cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child resistant status of the cap.
• Store constituted oral solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze.
• Write the date of expiration of the constituted oral solution on the bottle label.

The patient package insert, which includes the dosing instructions for patients, and 2 oral dispensers should be dispensed to the patient [see PATIENT INFORMATION].

Renal Impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1. For adult patients on hemodialysis (CrCl < 10 mL/min), a dose recommendation for Valcyte cannot be given [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

Table 1 : Dosage Recommendations forAdult Patients With Impaired Renal Function

*An estimated creatinine clearance is calculated from serum creatinine by the following formulas:

Dosing in pediatric patients with renal impairment can be done using the recommended equations because CrCl is a component in the calculation [see above].

Handling and Disposal

Caution should be exercised in the handling of Valcyte tablets and Valcyte for oral solution. Tablets should not be broken or crushed. Because valganciclovir is considered a potential teratogen and carcinogen in humans, caution should be observed in handling broken tablets, the powder for oral solution, and the constituted oral solution [see WARNINGS AND PRECAUTIONS]. Avoid direct contact with broken or crushed tablets, the powder for oral solution, and the constituted oral solution with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with plain water.

Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. Several guidelines on this subject have been published. However, there is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate [see REFERENCES].

Dosage Forms And Strengths

Valcyte Tablets

• 450 mg, pink, convex oval tablets with “VGC” on one side and “450” on the other side.

Valcyte for Oral Solution

• 50 mg/mL, supplied as a white to slightly yellow powder for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution. Available in glass bottles containing approximately 100 mL of solution after constitution. Valcyte for oral solution must be constituted by the pharmacist prior to dispensing to the patient [see DOSAGE AND ADMINISTRATION].

Storage And Handling

Valcyte Tablets

Supplied as 450 mg, pink, convex oval tablets with “VGC” on one side and “450” on the other side. Each tablet contains valganciclovir HCl equivalent to 450 mg valganciclovir. Valcyte is supplied in bottles of 60 tablets (NDC 0004-0038-22).

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Valcyte for Oral Solution

Supplied as a white to slightly yellow powder blend for constitution, forming a colorless to brownish yellow tutti-frutti flavored solution. Available in glass bottles containing approximately 100 mL of solution after constitution. Each bottle can deliver up to a total of 88 mL of solution. Each bottle is supplied with a bottle adapter and 2 oral dispensers (NDC 0004-0039-09).

Prior to dispensing to the patient, Valcyte for oral solution must be prepared by the pharmacist [see DOSAGE AND ADMINISTRATION].

Store dry powder at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze.

Distributed by: Genentech USA, Inc, A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: March 2013

Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.