REMS
Absorption: IV administration results in complete bioavailability.
Distribution: Widely distributed; enters CSF.
Protein Binding: 12%.
Half-Life: Adults: 2.9 hr; Children 9 mo12 yr: 2.4 ±0.7 hr; Neonates: 2.4 hr (↑ in renal impairment).
Contraindicated in:
Bone marrow depression or immunosuppression or thrombocytopenia (do not administer if absolute neutrophil count [ANC] <500/mm3, hemoglobin <8 g/dL, or platelet count <25,000/mm3)
;Ganciclovir is not the preferred systemic therapy during pregnancy
;Use Cautiously in:
CV: arrhythmias, edema, hypertension, hypotension
Derm: alopecia, photosensitivity, pruritus, rash, urticaria
Endo: hypoglycemia
GI: ↑liver enzymes, abdominal pain, GI BLEEDING, nausea, vomiting
GU:
↓fertility
,gonadal suppression
, hematuria, renal impairmentHemat:
, THROMBOCYTOPENIA, ANEMIA, eosinophiliaLocal: pain/phlebitis at IV site
Neuro: abnormal dreams, ataxia, confusion, dizziness, drowsiness, headache, malaise, nervousness, SEIZURES, tremor
Resp: dyspnea
Misc: fever
Drug-drug:
Renal Impairment
Lab Test Considerations:
Monitor CBC with differential at least every 2 days during twice daily therapy and weekly thereafter. Granulocytopenia usually occurs during the first 2 wk of treatment but may occur anytime during therapy. Recovery begins within 37 days of discontinuation of therapy.
IV Administration:
Because ganciclovir is considered to be carcinogenic, it should be handled and disposed of based on guidelines issued for antineoplastic drugs. Use double gloves and a protective gown to prepare and administer. If possible, prepare in a biologic safety cabinet or a compounding aseptic containment isolator; eye, face, and respiratory protection may be needed. Prepare and administer 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 and face protection. Discard IV equipment in specially designated containers.
Advise patient to notify health care provider if fever; chills; sore throat; other signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
May cause fetal harm. Advise women of reproductive potential to use a nonhormonal method of contraception during therapy and for ≥30 days after last dose and to avoid breastfeeding during therapy. Advise men to use condoms during and for ≥90 days after therapy. May ↓ fertility.
NDC Code