Dosing and uses of Cytovene (ganciclovir)
Adult dosage forms and strengths
capsule
- 250mg
- 500mg
powder for injection
- 500mg
oral solution
- 25mg/mL
- 100mg/mL
CMV Retinitis
Initial: 5 mg/kg IV q12hr, over 1 hr x14-21d
Maintenance
- 5 mg/kg IV qD OR
- 6 mg/kg IV qD for 5 d/week OR
- 1000 mg PO TID
CMV Prevention in Transplant Recipients
Induction: 10 mg/kg/d div q12hr IV x7-14 d
Maintenance
- 5 mg/kg IV qD x100-120 d after transplant OR
- 6 mg/kg IV qD for 5 d/week x100-120 d after transplant OR
- 1000 mg PO TID
CMV Prevention in HIV Infected
1000 mg PO TID (primary/recurrence)
5-6 mg/kg 5-7x/week IV (recurrence)
Renal Impairment (IV Induction)
CrCl 50-69 mL/min: 2.5 mg/kg IV q12hr
CrCl 25-49 mL/min: 2.5 mg/kg IV qd
CrCl <25 mL/min: 1.25 mg/kg IV qd
For IV maint or PO, see detailes in Mfr's Package Insert
Other Information
Administration: PO: take with food
Monitor: CBCs
Other Indications & Uses
CMV retinitis in AIDS patients
Pediatric dosage forms and strengths
capsule
- 250mg
- 500mg
powder for injection
- 500mg
oral solution
- 25mg/mL
- 100mg/mL
CMV Retinitis (>3 months old)
Induction: as adult
Maint
- IV: as adult
- PO: 6 months old-16 years old: 30 mg/kg PO q8hr
CMV Prevention in HIV-infected (off-label)
30 mg/kg PO q8hr (primary)
5 mg/kg qD IV (recurrence)
Other Information
CMV prevention in transplant recipients: as adult
Administration: PO: take with food
Monitor: CBCs
Cytovene (ganciclovir) adverse (side) effects
>10%
Neutropenia w/ ANC <1000/cu.mm (25-50%)
Thrombocytopenia (20%)
1-10%
Abnl LFTs
Anemia
Confusion
Headache
Nausea/vomiting
Neuropathy
Paresthesia
Pruritus
Retinal detachment,
Rash
Sepsis
Weakness
Warnings
Black box warnings
Granulocytopenia, anemia, and thrombocytopenia reported
Animal studies showed cidofovir was carcinogenic, teratogenic, and caused hypospermia
Indicated only for prevention of cytomegalovirus (CMV) disease in advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients
The capsules are associated with a more rapid rate of CMV retinitis progression and should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily IV infusions
IV form indicated for use only in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and for prevention of CMV disease in transplant recipients at risk for CMV disease
Contraindications
Hypersensitivity to acyclovir or ganciclovir
Zidovudine: incr hematological toxicity
Not to be used if ANC <500/cu.mm or Plts <25,000/cu.mm
Cautions
Provide adequate hydration
Preexisting cytopenias, history of cytopenic reactions
Renal impairment
Perform ophthalmologic examinations q6wk
Use contraception during Tx & 90 d after ceasing therapy (men: barrier method)
Primary prophylaxis not recommended for most AIDS pts
Oral absorption is poor
<12 yo
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cytovene (ganciclovir)
Distribution: widely, to all tissues including CSF & ocular tissue
Vd: 15.26 L/1.73 sq.meter
Protein Bound: 1-2%
Bioavailability: oral: fasting: 5%; following food: 6-9%; following fatty meal: 28-31%
Half-life, elimination: 1.7-5.8 hr; prolonged with renal impairment; end-stage renal disease: 5-28 hr
Excretion: urine (80-99% as unchanged drug)
Mechanism of action
Inhibits of viral DNA polymerases resulting in chain termination
Administration
IV Compatibilities
Solution: compatible w/ most common solvents
Y-site (partial list): allopurinol, fluconazole, linezolid, propofoL
IV Incompatibilities
Y-site: aldesleukin, amifostine, amsacrine, aztreonam, cefepime, cisatracurium(?), cytarabine, doxorubicin, fludarabine, foscarnet, gemcitabine, ondansetron, piperacillin/tazobactam, sargramostim, tacrolimus, vinorelbine
IV Preparation
Prepare in a vertical flow hood using the same precautions as antineoplastic agents
Reconstitute immediately before use; discard any unused portion appropriately
Reconstitute powder with SWI, not bacteriostatic water; parabens may cause precipitation
IV Administration
Same precautions as antineoplastic agents should be followed with ganciclovir
Do not administer IM, SC, rapid infusion or IVp
Administer by slow IV infusion over at least 1 hr at a final concentration not to exceed 10 mg/mL
Too rapid infusion can cause increased toxicity & excessive plasma levels
Storage
Store intact vials at RT & protect from temperatures >40°C
