NEODOSE

INDICATIONS

• Symptomatic congenital CMV infections: There was no difference between a duration of 6 weeks or 6 months of valGANciclovir in hearing in the better ear from baseline to the 6-month follow-up in neonates (32 weeks or more gestational age weighing at least 1800 g) with symptomatic congenital CMV disease. However, secondary outcomes (hearing at 12 months and 24 months and neurodevelopmental scores) were modestly better with 6 months versus 6 weeks of therapy. There was no difference in grade 3 or 4 neutropenia between the two treatment durations

PRECAUTIONS

• Hematologic:
  • Absolute neutrophil count less than 500 cells/mcL, hemoglobin less than 8 g/dL, or platelet count less than 25,000/mcL; do not use
  • Increased risk for hematologic toxicity in patients receiving myelosuppressive drugs or irradiation; with a preexisting cytopenia, previous leukopenia with ganciclovir or other nucleoside analogues, renal impairment, or baseline neutrophil count less than 1,000 cells/mcL; or infants. Monitoring recommended. Consider hematopoietic growth factor treatment in patients with severe leukopenia, neutropenia, anemia, or thrombocytopenia
• Renal:
  • Acute renal failure may occur in patients receiving concomitant nephrotoxic drugs or in patients with dehydration.
  • Renal impairment; dosage reduction recommended.

ADMINISTRATION

Administer with food.Do not break or crush tablets.

• Handle and dispose of according to guidelines for antineoplastic drugs; drug is potentially carcinogenic and mutagenic.
• Avoid direct contact of broken or crushed tablets, the powder for oral solution, and the reconstituted oral solution with the skin or mucous membranes.
• The National Institute for Occupational Safety and Health (NIOSH) recommends the use of single gloves by anyone handling intact tablets or capsules or administering from a unit-dose package.
• NIOSH recommends the use of double gloves and a protective gown by anyone handling a hazardous oral liquid or any hazardous drug via a feeding tube. Prepare in a control device, if possible. Use respiratory, eye, and face protection if not done in a control device. During administration, eye/face protection is needed if the patient may resist, or if there is potential to vomit or spit up.

BLACK BOX 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.
• Impairment of Fertility: Based on animal data and limited human data, valGANciclovir hydrochloride may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
• Fetal Toxicity: Based on animal data, valGANciclovir hydrochloride has the potential to cause birth defects in humans.
• Mutagenesis and Carcinogenesis: Based on animal data, valGANciclovir hydrochloride has the potential to cause cancers in humans.

MONITORING

CBC, including differential, and platelet counts should be monitor frequently, especially in patients with a history of leukopenia resulting from ganciclovir or other nucleoside analogue use, in infants, in patients with renal impairment, and in those with neutrophil counts less than 1000 cells/mcL at the beginning of treatment. Increase monitoring for cytopenias if therapy with oral ganciclovir is changed to valGANciclovir due to increased plasma concentrations of ganciclovir after valGANciclovir administration. Monitor renal function during therapy. Adjust the dose as appropriate for changes in height and body weight.A