VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE- valganciclovir hydrochloride tablet
McKesson Corporation

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS

Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia and aplastic anemia have been reported in patients treated with valganciclovir hydrochloride [see Warnings and Precautions (5.1)].
Impairment of Fertility: Based on animal data, valganciclovir hydrochloride may cause temporary or permanent inhibition of spermatogenesis [see Warnings and Precautions (5.2)].
Fetal Toxicity: Based on animal data, valganciclovir hydrochloride has the potential to cause birth defects in humans [see Warnings and Precautions (5.3)].
Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir hydrochloride has the potential to cause cancers in humans [see Warnings and Precautions (5.4)].

1 INDICATIONS AND USAGE

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)].
Prevention of CMV Disease: Valganciclovir tablets 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 are indicated for the prevention of CMV disease in heart transplant patients (4 months 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 and oral solution. However, due to Roche Palo Alto LLC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Adult patients should use valganciclovir tablets, not valganciclovir for oral solution.
Valganciclovir for oral solution and 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 months 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 tablets are 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
(click image for full-size original)

Table 1. k Values According to Pediatric Patient Age*

Table 1. k Values According to Pediatric Patient Age*
*The k values provided are based on the Jaffe method of measuring serum creatinine, and may require correction when enzymatic methods are used1.

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

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 and oral solution. However, due to Roche Palo Alto LLC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.5 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 valganciclovir tablets cannot be given [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].

Table 2 Dosage Recommendations for Adult Patients with Impaired Renal Function
Valganciclovir Tablets 450 mg
CrCl* (mL/min) Induction Dose Maintenance/Prevention Dose
*An estimated creatinine clearance in adults is calculated from serum creatinine by the following formulas:

≥ 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

(140 – age [years]) x (body weight [kg])

For males = –––––––––––––––––––––––––––––––––

(72) x (serum creatinine [mg/dL])

For females = 0.85 x male value
Dosing in pediatric patients with renal impairment can be done using the recommended equations because CrCl is a component in the calculation [see Dosage and Administration (2.3)].

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