Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 500mg
CMV Retinitis
Indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adults, including patients with acquired immunodeficiency syndrome (AIDS)
Induction: 5 mg/kg IV q12hr, infused over 1 hr for 14-21 days
Maintenance
- Following induction treatment, 5 mg/kg IV qDay OR
- 6 mg/kg IV qDay for 5 days/week
CMV Prevention in Transplant Recipients
Indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease
Induction: 5 mg/kg IV qDay infused over 1 hr for 7-14 days
Maintenance
- 5 mg/kg IV qDay for 100-120 days after transplant OR
- 6 mg/kg IV qDay for 5 day/week for 100-120 days after transplant
CMV Prevention in HIV Infected (Off-label)
1000 mg PO TID (primary/recurrence)
5-6 mg/kg 5-7x/week IV (recurrence)
CMV Colitis or Esophagitis in HIV-Infected Patients (Off-label)
Treat initially with ganciclovir 5 mg/kg/dose IV q12hr; once therapy is tolerated, change to valganciclovir 900 mg PO q12hr for 21-42 days or until signs and symptoms have resolved
Dosage Modifications
Renal impairment
Induction dose
- CrCl 50-69 mL/min: 2.5 mg/kg IV q12hr
- CrCl 25-49 mL/min: 2.5 mg/kg IV qDay
- CrCl 10-24 mL/min: 1.25 mg/kg IV qDay
- CrCl <10 mL/min: 1.25 mg/kg IV 3 x per week following hemodialysis
Maintenance dose
- CrCl 50-69 mL/min: 2.5 mg/kg IV qDay
- CrCl 25-49 mL/min: 1.25 mg/kg IV qDay
- CrCl 10-24 mL/min: 0.625 mg/kg IV qDay
- CrCl <10 mL/min: 0.625 mg/kg IV 3 x per week following hemodialysis
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 500mg
CMV Prevention in HIV-infected (off-label)
5 mg/kg IV qDay (recurrence)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (8)
- abacavir
ganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.
- bacitracin
ganciclovir and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
- imipenem/cilastatin
ganciclovir, imipenem/cilastatin. unknown mechanism. Avoid or Use Alternate Drug. Coadministration may increase risk of seizures. Avoid unless potential benefit outweighs the risk.
- imipenem/cilastatin/relebactam
ganciclovir, imipenem/cilastatin/relebactam. unknown mechanism. Avoid or Use Alternate Drug. Coadministration may increase risk of seizures. Avoid unless potential benefit outweighs the risk.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, ganciclovir. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- talimogene laherparepvec
ganciclovir decreases effects of talimogene laherparepvec by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Although no drug interactions studies have been performed, antiherpetic viral agents may interfere with the effectiveness of talimogene laherparepvec.
- trilaciclib
trilaciclib will decrease the level or effect of ganciclovir by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.
- zidovudine
ganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.
Monitor Closely (20)
- acalabrutinib
acalabrutinib, ganciclovir. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- dichlorphenamide
dichlorphenamide and ganciclovir both decrease serum potassium. Use Caution/Monitor.
dichlorphenamide, ganciclovir. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis. - didanosine
ganciclovir increases levels of didanosine by decreasing renal clearance. Use Caution/Monitor.
ganciclovir, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity. - doxorubicin
ganciclovir increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.
- doxorubicin liposomal
ganciclovir increases toxicity of doxorubicin liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
ganciclovir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Either increases toxicity of the other by decreasing renal clearance. Use Caution/Monitor. Toxicity may result from coadministration of emtricitabine and tenofovir with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion .
- emtricitabine
ganciclovir, emtricitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.
ganciclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine. - hydroxyurea
ganciclovir, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ifosfamide
ifosfamide, ganciclovir. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.
- lamivudine
ganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of hematologic toxicity.
- mycophenolate
ganciclovir will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.
- peramivir
ganciclovir increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.
- pivmecillinam
pivmecillinam, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- pretomanid
pretomanid will increase the level or effect of ganciclovir by Other (see comment). Modify Therapy/Monitor Closely. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.
- probenecid
ganciclovir will increase the level or effect of probenecid by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.
- temocillin
temocillin, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- tenofovir DF
ganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- ticarcillin
ticarcillin, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- ublituximab
ublituximab decreases effects of ganciclovir by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- voclosporin
voclosporin, ganciclovir. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
Minor (63)
- aceclofenac
aceclofenac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- acemetacin
acemetacin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- acyclovir
acyclovir will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- aminohippurate sodium
aminohippurate sodium will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- amphotericin B deoxycholate
ganciclovir increases toxicity of amphotericin B deoxycholate by pharmacodynamic synergism. Minor/Significance Unknown.
- aspirin
aspirin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- aspirin rectal
aspirin rectal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- balsalazide
balsalazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- bendroflumethiazide
bendroflumethiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- cefadroxil
cefadroxil will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- cefamandole
cefamandole will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- cefpirome
cefpirome will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ceftibuten
ceftibuten will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- celecoxib
celecoxib will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- cephalexin
cephalexin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- chlorothiazide
chlorothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- chlorpropamide
chlorpropamide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- chlorthalidone
chlorthalidone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- choline magnesium trisalicylate
choline magnesium trisalicylate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- cyclopenthiazide
cyclopenthiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- dapsone
ganciclovir increases toxicity of dapsone by pharmacodynamic synergism. Minor/Significance Unknown.
- diclofenac
diclofenac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- diflunisal
diflunisal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- entecavir
ganciclovir, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- etodolac
etodolac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- fenoprofen
fenoprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- flucytosine
ganciclovir increases toxicity of flucytosine by pharmacodynamic synergism. Minor/Significance Unknown.
- flurbiprofen
flurbiprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- hydrochlorothiazide
hydrochlorothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ibuprofen
ibuprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ibuprofen IV
ibuprofen IV will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- indapamide
indapamide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- indomethacin
indomethacin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ketoprofen
ketoprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ketorolac
ketorolac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- ketorolac intranasal
ketorolac intranasal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- lornoxicam
lornoxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- meclofenamate
meclofenamate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- mefenamic acid
mefenamic acid will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- meloxicam
meloxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- mesalamine
mesalamine will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- methyclothiazide
methyclothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- metolazone
metolazone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- nabumetone
nabumetone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- naproxen
naproxen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- oxaprozin
oxaprozin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- parecoxib
parecoxib will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- pentamidine
ganciclovir increases toxicity of pentamidine by pharmacodynamic synergism. Minor/Significance Unknown.
- piroxicam
piroxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- rose hips
rose hips will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- salicylates (non-asa)
salicylates (non-asa) will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- salsalate
salsalate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- sulfamethoxazole
ganciclovir increases toxicity of sulfamethoxazole by pharmacodynamic synergism. Minor/Significance Unknown.
- sulfasalazine
sulfasalazine will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- sulindac
sulindac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- tolfenamic acid
tolfenamic acid will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- tolmetin
tolmetin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- valganciclovir
ganciclovir will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- vinblastine
ganciclovir increases toxicity of vinblastine by pharmacodynamic synergism. Minor/Significance Unknown.
- vincristine
ganciclovir increases toxicity of vincristine by pharmacodynamic synergism. Minor/Significance Unknown.
- vincristine liposomal
ganciclovir increases toxicity of vincristine liposomal by pharmacodynamic synergism. Minor/Significance Unknown.
- willow bark
willow bark will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.
Adverse Effects
>10%
Neutropenia w/ ANC <1000/cu.mm (25-50%)
Thrombocytopenia (20%)
1-10%
Elevated LFTs
Anemia
Confusion
Headache
Nausea/vomiting
Neuropathy
Paresthesia
Pruritus
Retinal detachment,
Rash
Sepsis
Weakness
Frequency Not Defined
Blood and lymphatic disorders: Pancytopenia, bone marrow failure
Cardiac disorders: Arrhythmias
Ear and labyrinth disorders: Tinnitus, ear pain, deafness
Eye disorders: Visual impairment, vitreous disorders, eye pain, conjunctivitis, macular edema
Gastrointestinal disorders: Abdominal pain, dyspepsia, flatulence, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis, gastrointestinal perforation, eructation, dry mouth
General disorders and administration site conditions: Fatigue, injection site inflammation, edema, pain, malaise, asthenia, chest pain, multiple organ failure
Blood Immune system disorders: Hypersensitivity Infections and infestations: Candida infections including oral candidiasis, upper respiratory infection, influenza, urinary tract infections, cellulitis
Investigations: Blood alkaline phosphatase increased, hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, creatinine clearance decreased
Metabolism and nutrition disorders: Weight decreased
Musculoskeletal and connective tissue disorders: Back pain, myalgia, arthralgia, muscle spasms, leg cramps, myasthenia
Nervous system disorders: Headache, insomnia, dizziness, paresthesia, hypoaesthesia, seizures, somnolence, dysgeusia (taste disturbance), tremor
Psychiatric disorders: Depression, confusional state, anxiety, agitation, psychotic disorder, thinking abnormal, abnormal dreams
Renal and urinary disorders: Kidney failure, renal function abnormal, urinary frequency, hematuria
Respiratory, thoracic and mediastinal disorders: Cough, dyspnea
Skin and subcutaneous tissues disorders: Dermatitis, alopecia, dry skin, urticaria, rash
Vascular disorders: Hypotension, hypertension, phlebitis, vasodilation
Postmarketing Reports
Hemolytic anemia, agranulocytosis, granulocytopenia
Cardiac arrest, conduction disorder, torsade de pointes, ventricular tachycardia
Congenital anomaly
Inappropriate antidiuretic hormone secretion
Cataracts, dry eyes
Intestinal ulcer
Cholelithiasis, cholestasis, hepatic failure, hepatitis
Anaphylactic reaction, allergic reaction, vasculitis
Blood triglycerides increased
Acidosis, hypercalcemia, hyponatremia Arthritis, rhabdomyolysis
Dysesthesia, dysphasia, extrapyramidal disorder, facial paralysis, amnesia, anosmia, myelopathy, cerebrovascular accident, third cranial nerve paralysis, aphasia, encephalopathy, intracranial hypertension
Irritability, hallucinations
Renal tubular disorder, hemolytic uremic syndrome
Infertility, testicular hypotrophy
Bronchospasm, pulmonary fibrosis
Exfoliative dermatitis, Stevens Johnson syndrome Peripheral ischemia
Warnings
Black Box Warnings
Hematologic toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia reported
Impairment of fertility: Based on animal data and limited human data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females
Fetal toxicity: Based on animal data, ganciclovir has the potential to cause birth defects in humans
Mutagenesis and carcinogenesis: Based on animal data, ganciclovir has the potential to cause cancers in humans
Contraindications
Hypersensitivity reaction (eg, anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation
Cautions
Also see Black Box Warnings
Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia observed; not recommended if the absolute neutrophil count (ANC) <500 cells/mcL, hemoglobin <8 g/dL, or the platelet count <25,000 cells/mcL
Exercise caution patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation; granulocytopenia (neutropenia) usually occurs during first or second week of treatment but may occur at any time during treatment; cell counts usually begin to recover within 3-7 days after discontinuing drug Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving IV solution for treatment of CMV retinitis
Renal impairment should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of ganciclovir will be increased due to reduced renal clearance; increased serum creatinine levels have been reported in elderly patients and in transplant recipients receiving concomitant nephrotoxic medications (eg, cyclosporine and amphotericin B); monitor renal function during therapy is essential, especially for elderly patients and those patients receiving concomitant agents that may cause nephrotoxicity
Based on animal data and limited human data, recommended human dose (RHD) may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females (see Pregnancy)
Fetal toxicity may occur when administered to pregnant women based on findings in animal studies (see Pregnancy)
Animal data indicate that ganciclovir is mutagenic and carcinogenic, may potentially be carcinogenic in humans
Drug interactions overview
- Coadministration with imipenem-cilastatin is not recommended because generalized seizures reported
- Monitor renal function when coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine
- Based on increased risk, monitor for hematological and renal toxicity when concomitantly using mycophenolate mofetil with ganciclovir
- Other drugs associated with myelosuppression or nephrotoxicity: Consider only if the potential benefits outweigh the risks
- Coadministration with didanosine will potentially increase plasma levels and toxicities of didanosine; closely monitor
- Concomitant use with probenecid may increase ganciclovir levels; consider reducing dose of ganciclovir and monitor possible toxicities
Pregnancy & Lactation
Pregnancy
Placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least 1 case report in a pregnant woman; however, no adequate human data are available to establish whether ganciclovir poses a risk to pregnancy outcomes
In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures 2 times the exposure at the recommended human dose (RHD); treatment caused fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity; teratogenic changes in animals included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia
Disease-associated maternal and/or embryo-fetal risk
- Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome; however, in immunocompromised patients, CMV infections may be symptomatic and may result in significant maternal morbidity and mortality
- CMV fetal transmission results from maternal viremia and transplacental infection
- Perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract ~10% of children with congenital CMV infection are symptomatic at birth
- Mortality in symptomatic infants is ~10% and ~50-90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems
- Risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and of greater severity than that resulting from maternal reactivation of CMV infection
Contraception
- Test for pregnancy in females of reproductive potential before initiating treatment
- Females: Because of ganciclovir’s mutagenic and teratogenic potential, use effective contraception during treatment and for at least 30 days following treatment
- Males: Because of ganciclovir’s mutagenic and teratogenic potential, use barrier contraception during treatment and for at least 90 days following treatment
Infertility
- Based on animal data and limited human data, may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females at recommended human dose (RHD); advise patients that fertility may be impaired with use
Lactation
No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production
Ganciclovir was present in milk in lactating rats following administration
Breastfeeding is not recommended during treatment owing to the potential for serious adverse reactions in nursing infants
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
Mechanism of Action
Inhibits of viral DNA polymerases resulting in chain termination
Absorption
AUC: 22.1-26.8 mcg·hr/mL
Distribution
Vd (steady-state): 0.74 L/kg
Diffuses across the placenta
Protein binding: 1-2% over ganciclovir concentrations of 0.5-51 mcg/mL
Elimination
Clearance: 3.2 mL/min/kg (renal); 3.52 mL/min/kg (systemic)
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
Reconstitute vial with 10 mL of Sterile Water for Injection
Do not use bacteriostatic water for injection containing parabens; it is incompatible with ganciclovir and may cause precipitation
Gently swirl the vial in order to ensure complete wetting of the product; continue swirling until a clear reconstituted solution is obtained
Visually inspect solution for particulate matter and discoloration prior to proceeding with infusion
Discard the vial if particulate matter or discoloration is observed
IV Administration
Also see Storage
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 and excessive plasma levels
Handling and disposal
- Exercise caution in the handling and preparation of solutions
- Reconstituted solutions are alkaline (pH 11)
- Avoid direct contact of the skin or mucous membranes with solution
- If such contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water
- Wearing disposable gloves is recommended
- Because ganciclovir shares some of the properties of antitumor agents (eg, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs
Storage
Unused vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Reconstituted vials: Store at 25°C (77°F) for no longer than 12 hr; do not refrigerate or freeze
Diluted solutions: Refrigerate at 2-8°C (36-46°F) for no longer than 24 hr; do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| ganciclovir intravenous - | 500 mg/250 mL (2 mg/mL) solution |  | |
| Zirgan ophthalmic (eye) - | 0.15 % gel |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ganciclovir ophthalmic (eye)
GANCICLOVIR - OPHTHALMIC
(gan-SYE-klo-veer)
COMMON BRAND NAME(S): Zirgan
USES: Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness).Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.
HOW TO USE: Apply this medication to the affected eye as directed by your doctor, usually 5 times a day (about every 3 hours while awake) until the eye has healed, and then 3 times a day for 7 more days.To apply eye medication, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Do not wear contact lenses while you have an eye infection or while using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. Repeat these steps for your other eye if so directed. Wait several minutes for your vision to clear before driving or operating machinery.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes between applying each medication. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or if it gets worse (for example, you develop eye pain/itching/swelling).
SIDE EFFECTS: Temporary blurred vision after you apply this medication and mild eye irritation/redness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you can do it safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as eye exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Protect from freezing. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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