ganciclovir (Rx)

Brand and Other Names:Cytovene
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Dosing & Uses

AdultPediatric

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)

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Interactions

Interaction Checker

and ganciclovir

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            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

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            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

            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
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            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)

            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.

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            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)

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            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

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.