NEODOSE

INDICATIONS

Prevention of progressive hearing loss and lessening of developmental delays in babies with symptomatic congenital cytomegalovirus infection involving the central nervous system.

PRECAUTIONS

• Hematologic:
  • Use not recommended if absolute neutrophil count less than 500 cells/mcL, hemoglobin less than 8 g/dL, or platelet count less than 25,000 cells/mcL.
  • Use caution in patients with cytopenias or in patients receiving myelosuppressive drugs or irradiation; monitoring recommended.
• Renal:
  • Use caution in patients with impaired renal function; monitoring and possible dosage reduction recommended.

ADVERSE EFFECTS

Significant neutropenia will occur in the majority of treated patients. Discontinue treatment if the neutropenia does not resolve after reducing the dosage by half.

BLACK BOX WARNING

Warning: Hematologic Toxicity, Impairment of Fertility, Fetal Toxicity, Mutagenesis and Carcinogenesis.

• Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir sodium.
• Impairment of Fertility: Based on animal data and limited human data, ganciclovir sodium may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
• Fetal Toxicity: Based on animal data, ganciclovir sodium has the potential to cause birth defects in humans.
• Mutagenesis and Carcinogenesis: Based on animal data, ganciclovir sodium has the potential to cause cancers in humans.

ADMINISTRATION

Use proper procedures for handling and disposal of chemotherapy; drug is potentially carcinogenic and mutagenic.

• Intravenous: Infuse over a period of 1 hour in compatible solution at a concentration not to exceed 10 mg/mL. Phlebitis and/or pain may occur at intravenous infusion site; infuse preferably via plastic cannula into veins with adequate blood flow, permitting rapid dilution and distribution.Do not administer by IM or subQ routes as severe tissue irritation may occur. Use proper procedures for handling and disposal of chemotherapy, drug is potentially carcinogenic and mutagenic. Avoid direct contact of the skin or mucous membranes with the IV solution. If contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. In the preparation and administration of injections, the National Institute for Occupational Safety and Health (NIOSH) recommends the use of double gloves and a protective gown. Prepare in a biological safety cabinet or a compounding aseptic containment isolator; eye/face and respiratory protection may be needed. Prepare compounds in a closed system drug transfer device. During administration, if there is a potential that the substance could splash or if the patient may resist, use eye/face protection. Administer certain dosage forms via a closed system drug transfer device.

MONITORING

CBC every 2 to 3 days during first 3 weeks of therapy, weekly thereafter if stable.