August 3, 2015
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Valcyte

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Valcyte




Indications
Dosage
How Supplied

INDICATIONS

Adult Patients

Treatment of Cytomegalovirus (CMV) Retinitis

VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies].

Prevention of CMV Disease

VALCYTE is 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].

Pediatric Patients

Prevention of CMV Disease

VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies].

DOSAGE AND ADMINISTRATION

General Dosing Information

  • Adult patients should use VALCYTE tablets, not VALCYTE for oral solution.
  • 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 Preparation of VALCYTE for Oral Solution].

Recommended Dosage In Adult Patients With Normal Renal Function

For dosage recommendations in adult patients with renal impairment [see Dosage Recommendation for Adult Patients with Renal Impairment].

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.

Recommended Dosage In Pediatric Patients

Prevention of CMV Disease in Pediatric Kidney Transplant Patients

For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once daily mg dose (7x BSA x CrCL) should start within 10 days of post-transplantation until 200 days post-transplantation.

Prevention of CMV Disease in Pediatric Heart Transplant Patients

For pediatric heart transplant patients 1 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 VALCYTE 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. The k values used in the modified Schwartz formula are based on pediatric patient age, as shown in Table 1.

Mosteller BSA (m²)= Height (cm) x Weight (kg)
3600

Schwartz Creatinine Clearance (mL/min/ 1.73m²) = 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 used1.

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. 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. Before prescribing VALCYTE tablets, pediatric patients should be assessed for the ability to swallow tablets.

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 HOW SUPPLIED/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].

Dosage Recommendation For Adult Patients With Renal Impairment

Serum creatinine levels or creatinine clearance should be monitored regularly during treatment. Dosage recommendations for adult patients with reduced renal function are provided in Table 2. For adult patients on hemodialysis (CrCl less than 10 mL/min), a dose recommendation for VALCYTE cannot be given [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

Table 2 : Dosage Recommendations for Adult Patients with Impaired Renal Function

VALCYTE 450 mg Tablets
CrCl* (mL/min) Induction Dose Maintenance/ Prevention Dose
≥ 60 900 mg twice daily 900 mg once daily
40 - 59 450 mg twice daily 450 mg once daily
25 - 39 450 mg once daily 450 mg every 2 days
10 - 24 450 mg every 2 days 450 mg twice weekly
< 10 (on hemodialysis) not recommended not recommended

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

For males = (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
For females = (0.85) x (above value)

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

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.

Handle and dispose VALCYTE according to guidelines for antineoplastic drugs because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity)2.

HOW SUPPLIED

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 per 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.

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 Preparation of VALCYTE for Oral Solution].

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: April 2015

Last reviewed on RxList: 5/13/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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