ADMINISTRATION ROUTES:
IV
ALTERNATIVE NAMES:
Cymevene
ICU INDICATIONS:
- Treatment of life-threatening or sight-threatening cytomegalovirus (CMV) infection
PRESENTATION AND ADMINISTRATION:
IV Use:
Warning: Gancicolovir is a cytotoxic drug. Cytotoxic precautions apply
Each vial contains 500 mg of powder
Reconstitute each vial with 10 mL of water for injection (giving a concentration of 50 mg/ mL). Shake well to dissolve powder. Add to 50-100 mL of compatible IV fluid and administer over at least 1 hour
Prepare immediately before use; reconstituted solution is stable at room temperature for 12 hours
Store at room temperature. Do not refrigerate
Compatible with the following IV fluids:
Normal saline, Hartmanns, 5% glucose
Do not mix with other medications
DOSAGE:
5 mg/kg BD for 14 - 21 days, followed by 5 mg/kg daily
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose in renal impairment
| GFR (ml/min) | DOSE |
|---|---|
| <10 | 1.25 mg/kg OD |
| 10-25 | 1.25 mg/kg OD |
| >25-50 | 2.5 mg/kg OD |
| >50-69 | 2.5 mg/kg BD |
Dose in renal replacement therapy
| MODALITY | DOSE |
|---|---|
| CAPD | 1.25 mg/kg OD |
| HD | 1.25 mg/kg after each dialysis session |
| CVVHDF | 2.5 mg/kg OD |
DOSAGE IN PAEDIATRICS:
5 mg/kg BD for 14 - 21 days followed by 5 mg/kg daily
CLINICAL PHARMACOLOGY:
Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV)
CONTRAINDICATIONS:
- Hypersensitivity to ganciclovir, valganciclovir, acyclovir or valacyclovir
WARNINGS:
Haematological:
Ganciclovir should not be administered if the absolute neutrophil count is less than 500 or the platelet count is less than 25,000. Granulocytopaenia (neutropaenia), anaemia and thrombocytopaenia have been observed in patients treated with ganciclovir. The frequency and severity of these events vary widely in different patient populations.
PRECAUTIONS:
General:
See WARNINGS
Laboratory Tests:
No tests are required in addition to routine ICU blood tests
Drug/Laboratory Test Interactions:
None reported
IMPORTANT DRUG INTERACTIONS IN ICU:
Since both zidovudine and ganciclovir have the potential to cause neutropaenia and anaemia, some patients may not tolerate concomitant therapy with these drugs at full dosage.
Generalised seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. These drugs should not be used concomitantly; use meropenem instead of imipenem in this situation.
ADVERSE REACTIONS:
Body as a Whole:
Fever, infection, chills, sepsis
Digestive System:
Diarrhoea, anorexia, vomiting
Haematological System:
Leukopaenia, anaemia, thrombocytopaenia
Nervous System:
Neuropathy
Other"
Sweating, Pruritus