VALGANCICLOVIR HYDROCHLORIDE FOR ORAL- valganciclovir hydrochloride powder, for solution
Actavis Pharma, Inc.
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir hydrochloride for oral solution [see Warnings and Precautions. (5.1)].
Impairment of Fertility: Based on animal data and limited human data, valganciclovir hydrochloride for oral solution may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions. (5.3)]
Fetal Toxicity: Based on animal data, valganciclovir hydrochloride for oral solution has the potential to cause birth defects in humans [see Warnings and Precautions. (5.4)]
- Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir hydrochloride for oral solution has the potential to cause cancers in humans [see Warnings and Precautions. (5.5)]
Prevention of CMV Disease: Valganciclovir hydrochloride 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 (14.2)].
Valganciclovir hydrochloride for oral solution should be taken with food [see Clinical Pharmacology (12.3)].
Valganciclovir hydrochloride for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient [see Dosage and Administration (2.4)].
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 (7 x 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 (7 x BSA x CrCl) should start within 10 days of transplantation until 100 days post-transplantation.
The recommended once daily dosage of valganciclovir hydrochloride for oral solution 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.
Pediatric Patient Age
Infants less than 1 year of age with low birth weight for gestational age
Infants less than 1 year of age with birth weight appropriate for gestational age
Children aged 1 to less than 2 years
Boys aged 2 to less than 13 years
Girls aged 2 to less than 16 years
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. Valganciclovir hydrochloride for oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above.
Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist as follows [see How Supplied/Storage and Handling (16)]:
Measure 91 mL of purified water in a graduated cylinder.
Shake the valganciclovir 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 Counseling Information (17)].
Caution should be exercised in the handling of valganciclovir hydrochloride for oral solution. Because valganciclovir is considered a potential teratogen and carcinogen in humans, caution should be observed in handling, the powder for oral solution, and the constituted oral solution [see Warnings and Precautions (5.4,5.5)]. Avoid direct contact with 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 valganciclovir hydrochloride for oral solution according to guidelines for antineoplastic drugs because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity).2
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