valganciclovir (Rx)

Brand and Other Names:Valcyte
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 450mg

powder for oral solution

  • 50mg/mL when reconstituted

Cytomegalovirus Retinitis

Indicated for treatment of CMV retinitis in patients with AIDS

Induction dose: 900 mg PO q12hr for 21 days

Maintenance dose: Following induction treatment, or in adults with inactive CMV retinitis, 900 mg PO qDay

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

CMV Prevention in Solid Organ Transplant

Indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])

Kidney transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 200 days post-transplant

Kidney-pancreas transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 100 days post-transplant

Heart transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 100 days post-transplant

Dosage Modifications

Hepatic impairment: Safety and efficacy not established

Renal impairment

  • CrCl 40-59 mL/min: 450 mg PO q12hr (induction), THEN 450 mg qDay
  • CrCl 25-39 mL/min: 450 mg PO qDay (induction), THEN 450 mg q2days
  • CrCl 10-24 mL/min: 450 mg PO q2days (induction), THEN 450 mg 2 times/week
  • <10 mL/min (on hemodialysis): Not recommended

Dosing Considerations

Adults should use tablets, not oral solution

Lymphoproliferative Disorder (Orphan)

Orphan designation for treatment of post-transplant lymphoproliferative disorder in combination with nanatinostat

Orphan sponsor

  • Viracta Therapeutics, Inc; 2533 South Coast Highway, Suite 210; Carlsbad, California 92007

Dosage Forms & Strengths

tablet

  • 450mg

powder for oral solution

  • 50mg/mL when reconstituted

CMV Prevention in Kidney & Heart Transplant

Kidney transplantation

  • <4 months: Safety and efficacy not established
  • 4 months to 16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day
  • Begin within 10 days of transplant and continue until 200 days post-transplant

Heart transplantation

  • <1 month: Safety and efficacy not established
  • 1 month to 16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day
  • Begin within 10 days of transplant and continue until 100 days post-transplant

Dosing Considerations

Calculation of creatinine clearance for the dose in children is by a modified Schwartz formula

The oral solution is the preferred formulation for children since it provides the ability to administer a dose calculated according to the Schwartz formula

Tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg)

For example, if the calculated dose is between 405 mg and 495 mg, one 450 mg tablet may be taken

Assess children for the ability to swallow tablets

Calculate BSA by Mosteller equation

  • BSA (m²) = height (cm) X weight (kg) divided by 3600  

Calculate CrCl by Schwartz equation

  • CrCl (mL/min/1.73 m²) = K x height (cm) divided by serum Cr (mg/dL)
  • If CrCl exceeds 150 mL/min/1.73 m², then use maximum value of 150 mL/min/1.73 m²; an upper limit of 150 mL/min/1.73 m² helps prevent the potential for over dosing
  • If the calculated pediatric dose exceeds 900 mg, a dose of 900 mg should be given to the child
  • Where K =
    • 0.33 for infants aged <1 yr with low birth weight for gestational age
    • 0.45 for infants aged <1 yr with birth weight appropriate for gestational age
    • 0.45 for aged 4 months to <1-2 yr
    • 0.55 for boys aged 2 to <13 yr and girls aged 2 to <16 yr
    • 0.7 for boys aged 13-16 yr
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Interactions

Interaction Checker

and valganciclovir

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • abacavir

                valganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.

              • talimogene laherparepvec

                valganciclovir 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.

              • zidovudine

                valganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.

              Monitor Closely (14)

              • dichlorphenamide

                dichlorphenamide and valganciclovir both decrease serum potassium. Use Caution/Monitor.

              • didanosine

                valganciclovir, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

              • doxorubicin

                valganciclovir increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • doxorubicin liposomal

                valganciclovir increases toxicity of doxorubicin liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                valganciclovir, 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 .

                valganciclovir and elvitegravir/cobicistat/emtricitabine/tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • emtricitabine

                valganciclovir, emtricitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

                valganciclovir 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.

              • lamivudine

                valganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

              • mycophenolate

                mycophenolate will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • pivmecillinam

                pivmecillinam, valganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • probenecid

                probenecid will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • temocillin

                temocillin, valganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • tenofovir DF

                valganciclovir 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, valganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • voclosporin

                voclosporin, valganciclovir. 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 (64)

              • aceclofenac

                aceclofenac will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acemetacin

                acemetacin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acyclovir

                acyclovir will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aminohippurate sodium

                aminohippurate sodium will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • amphotericin B deoxycholate

                valganciclovir increases toxicity of amphotericin B deoxycholate by pharmacodynamic synergism. Minor/Significance Unknown.

              • aspirin

                aspirin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin rectal

                aspirin rectal will increase the level or effect of valganciclovir 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 valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • balsalazide

                balsalazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • bendroflumethiazide

                bendroflumethiazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefadroxil

                cefadroxil will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefamandole

                cefamandole will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefpirome

                cefpirome will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ceftibuten

                ceftibuten will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • celecoxib

                celecoxib will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cephalexin

                cephalexin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorothiazide

                chlorothiazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorpropamide

                chlorpropamide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorthalidone

                chlorthalidone will increase the level or effect of valganciclovir 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 valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cyclopenthiazide

                cyclopenthiazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • dapsone

                valganciclovir increases toxicity of dapsone by pharmacodynamic synergism. Minor/Significance Unknown.

              • diclofenac

                diclofenac will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • didanosine

                valganciclovir increases levels of didanosine by decreasing renal clearance. Minor/Significance Unknown.

              • diflunisal

                diflunisal will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • entecavir

                valganciclovir, 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 valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fenoprofen

                fenoprofen will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • flucytosine

                valganciclovir increases toxicity of flucytosine by pharmacodynamic synergism. Minor/Significance Unknown.

              • flurbiprofen

                flurbiprofen will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ganciclovir

                ganciclovir will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • hydrochlorothiazide

                hydrochlorothiazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen

                ibuprofen will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen IV

                ibuprofen IV will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indapamide

                indapamide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indomethacin

                indomethacin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketoprofen

                ketoprofen will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac

                ketorolac will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac intranasal

                ketorolac intranasal will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • lornoxicam

                lornoxicam will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meclofenamate

                meclofenamate will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mefenamic acid

                mefenamic acid will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meloxicam

                meloxicam will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mesalamine

                mesalamine will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methyclothiazide

                methyclothiazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • metolazone

                metolazone will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • nabumetone

                nabumetone will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • naproxen

                naproxen will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • oxaprozin

                oxaprozin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • parecoxib

                parecoxib will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • pentamidine

                valganciclovir increases toxicity of pentamidine by pharmacodynamic synergism. Minor/Significance Unknown.

              • piroxicam

                piroxicam will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • rose hips

                rose hips will increase the level or effect of valganciclovir 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 valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salsalate

                salsalate will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulfamethoxazole

                valganciclovir increases toxicity of sulfamethoxazole by pharmacodynamic synergism. Minor/Significance Unknown.

              • sulfasalazine

                sulfasalazine will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulindac

                sulindac will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolfenamic acid

                tolfenamic acid will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolmetin

                tolmetin will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • vinblastine

                valganciclovir increases toxicity of vinblastine by pharmacodynamic synergism. Minor/Significance Unknown.

              • vincristine

                valganciclovir increases toxicity of vincristine by pharmacodynamic synergism. Minor/Significance Unknown.

              • vincristine liposomal

                valganciclovir increases toxicity of vincristine liposomal by pharmacodynamic synergism. Minor/Significance Unknown.

              • willow bark

                willow bark will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Abdominal pain (15%)

              Anemia (8-26%)

              Diarrhea (16-41%)

              Fever (31%)

              Granulocytopenia (11-27%)

              Headache (9-22%)

              Insomnia (16%)

              Nausea (8-30%)

              Retinal detachment (15%)

              Vomiting (21%)

              1-10%

              Peripheral neuropathy (9%)

              Paresthesia (8%)

              Thrombocytopenia (8%)

              <5%

              • Retinal detachment, eye pain
              • Dyspepsia, constipation, abdominal distention, mouth ulceration
              • Fatigue, pain, malaise, asthenia, chills, peripheral edema
              • Abnormal hepatic function
              • Candida infections including oral candidiasis, upper respiratory tract infection, influenza, urinary tract infection, pharyngitis/nasopharyngitis, postoperative wound infection
              • Postoperative complications, wound secretion
              • Decreased appetite, hyperkalemia, hypophosphatemia, weight decreased
              • Back pain, myalgia, arthralgia, muscle spasms
              • Insomnia, neuropathy peripheral, dizziness
              • Depression, anxiety
              • Renal impairment, creatinine clearance renal decreased, blood creatinine increased, hematuria
              • Cough, dyspnea
              • Dermatitis, night sweats, pruritus
              • Hypotension

              Postmarketing Reports

              Pyrexia, fatigue, tremor, neutropenia, anemia, leukopenia, urinary tract infection, anaphylactic reactions, agranulocytosis

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              Warnings

              Black Box Warnings

              Hematologic toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic reported

              Impaired fertility: Based on animal data and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females

              Fetal toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans

              Mutagenesis and carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans

              Contraindications

              Contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation

              Cautions

              Also see Black Box Warnings

              Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have reported; use with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation; in patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered

              Complete blood counts with differential and platelet counts should be performed frequently, especially in patients with renal impairment and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia

              May be teratogenic or embryotoxic, avoid pregnancy; male patients advised to use barrier method during and for 90 days after treatment (see Pregnancy)

              Risk of: hematologic toxicity, female infertility; aspermatogenesis

              Females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment because of potential risk to fetus; similarly, males should be advised to use condoms during and for at least 90 days following treatment

              Maintain adequate hydration

              Acute renal failure may occur in the following: Elderly patients with or without reduced renal function; exercise caution when administering to geriatric patients, and dosage reduction is recommended for those with impaired renal function, patients receiving potential nephrotoxic drugs, patients without adequate hydration

              Drug interactions overview

              • Imipenem-cilastatin: Seizures were reported in patients receiving ganciclovir and imipenem-cilastatin; concomitant use is not recommended unless the potential benefits outweigh the risks
              • Cyclosporine or amphotericin B: Coadministration may increase the risk of nephrotoxicity; monitor renal function
              • Mycophenolate mofetil (MMF): Coadministration with valganciclovir may increase the risk of hematological and renal toxicity; monitor for ganciclovir and MMF toxicity
              • Other drugs associated with myelosuppression or nephrotoxicity: Due to potential for increased toxicity, consider concomitant use with valganciclovir only if the potential benefits are judged to outweigh the risks
              • Didanosine: Ganciclovir coadministered with didanosine may increase didanosine levels; monitor for didanosine toxicity (eg, pancreatitis)
              • Probenecid: May increase ganciclovir levels; monitor for evidence of ganciclovir toxicity
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              Pregnancy & Lactation

              Pregnancy

              After oral administration, valganciclovir (prodrug) converts to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity

              Clinical considerations

              • Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome; however, in immunocompromised patients (i.e., transplant patients or patients with AIDS)
              • CMV infections may be symptomatic and may result in significant maternal morbidity and mortality; transmission of CMV to the fetus is a result of maternal viremia and transplacental infection; perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract; approximately 10% of children with congenital CMV infection are symptomatic at birth; mortality in these infants is about 10% and approximately 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
              • Females of reproductive potential should undergo pregnancy testing before initiation of therapy

              Contraception

              • Females: Because of mutagenic and teratogenic potential, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment
              • Males: Because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment

              Infertility

              • Recommended doses may cause temporary or permanent female and male infertility

              Lactation

              No data available regarding presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, effects on breastfed infant or on milk production; animal data indicate that ganciclovir is excreted in milk of lactating rats

              The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV; advise nursing mothers that breastfeeding is not recommended during treatment because of potential for serious adverse events in nursing infants and because of potential for transmission of HIV

              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

              Prodrug, converted to ganciclovir in intestine and liver

              Inhibits viral DNA polymerases resulting in chain termination

              Absorption

              AUC: 29.1 mcg⋅h/mL (healthy subjects); 40.2 mcg⋅h/mL (heart transplant recipients); 46 mcg⋅h/mL (liver transplant recipients); 48.2 mcg⋅h/mL (kidney transplant recipients)

              Peak plasma concentration: 5.61 mcg/mL (healthy subjects); 4.9 mcg/mL (heart transplant recipients); 5.4 mcg/mL (liver transplant recipients); 5.3 mcg/mL (kidney transplant recipients)

              Distribution

              Oral bioavailability: 59.4% (healthy subjects)

              Protein bound: Unknown (valganciclovir); 1-2% (ganciclovir over 0.5-51 mcg/mL)

              CSF fluid penetration: Unknown (valganciclovir); yes (ganciclovir)

              Metabolism

              Hydrolyzed by intestinal and liver esterases

              Metabolized to ganciclovir

              Elimination

              Half-life: 4.08 hr (healthy subjects); 6.58 hr (heart transplant recipients); 6.18 hr (liver transplant recipients); 6.77 hr (kidney transplant recipients)

              Clearance: 3.21 mL/min/kg (healthy subjects)

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              Administration

              Oral Solution Preparation

              Wear disposable gloves during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution

              Prior to dispensing, oral solution must be prepared by the pharmacist as follows

              Measure 91 mL of purified water in a graduated cylinder

              Shake bottle to loosen the powder; remove child resistant bottle cap and add approximately half the total amount of water for constitution to the bottle and shake the closed bottle well for about 1 minute

              Add the remainder of water and shake the closed bottle well for about 1 minute; prepared solution contains 50 mg/mL

              Remove the child resistant bottle cap and push the bottle adapter into the neck of the bottle

              The patient package insert, which includes the dosing instructions for patients, and 2 oral dispensers should be dispensed to the patient

              Avoid contact with your skin or eyes

              If you come in contact with the contents of the oral solution, wash your skin well with soap and water or rinse your eyes well with plain water

              Oral Administration

              Take with food (improved bioavailability)

              Handle and dispose according to guidelines for antineoplastic drugs because ganciclovir (active metabolite) shares some of the properties of antitumor agents (ie, carcinogenicity and mutagenicity)

              Storage

              Store tablets and undiluted oral solution at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F)

              Reconstituted oral solution

              • Refrigerate at 2-8°C (36-46°F) for no longer than 49 days
              • Do not freeze
              • Write the date of expiration of the constituted oral solution on the bottle label
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              450 mg tablet
              valganciclovir oral
              -
              50 mg/mL solution
              Valcyte oral
              -
              450 mg tablet
              Valcyte oral
              -
              50 mg/mL solution

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              valganciclovir oral

              VALGANCICLOVIR- ORAL

              (val-gan-SIGH-klow-veer)

              COMMON BRAND NAME(S): Valcyte

              WARNING: Valganciclovir turns into the drug ganciclovir inside your body. Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems. Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Seek immediate medical attention if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as fever, chills, cough, persistent sore throat), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds).Ganciclovir may reduce fertility in men and women. It may also harm an unborn baby. Talk to your doctor for more details.Ganciclovir has caused tumors in laboratory animals. Although there is no information in humans, valganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.

              USES: Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body.Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness.Valganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. It is important to have your eyes checked regularly by your doctor.

              HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking valganciclovir and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with food, usually 1 to 2 times a day or as directed by your doctor. Swallow the tablets whole. Do not crush or break the tablets.If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using the special measuring device provided. Do not use a household spoon because you may not get the correct dose.Wash your hands well after handling this drug. Avoid contact with broken/crushed tablets and the liquid form of this medication on your skin, in your mucous membranes and eyes, and avoid breathing in the dust from the tablets. If contact should occur, wash the area thoroughly with soap and water. If this medication gets in your eyes, rinse them thoroughly with plain water.The dosage and length of treatment is based on your medical condition (especially kidney function). In children, the dosage is also based on their body size. The doctor should keep track of your child's height and weight to make sure that the dose is right for them.This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.Continue taking this medication exactly as prescribed by your doctor. Do not change your dose or stop taking it even for a short time unless directed to do so by your doctor. Changing or skipping your dose without approval from your doctor may increase the risk of side effects or make the infection worse.Do not take ganciclovir instead of valganciclovir on your own without consulting your doctor or pharmacist. The effects and the dosages of ganciclovir and valganciclovir are not equal.Keep all medical and laboratory appointments.Tell your doctor if your condition worsens (such as worsening vision).

              SIDE EFFECTS: See also Warning section.Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, or shaking (tremors) may occur. If any of these effects persist or worsen, 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.Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), signs of kidney problems (such as change in the amount of urine), seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 taking valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; 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, especially of: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be at greater risk for kidney problems while using this drug.Women who are pregnant or who may become pregnant should not handle this medication.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women of child-bearing age should have a pregnancy test before starting this medication. To prevent pregnancy, men with female partners should always use effective barrier protection (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age who are taking valganciclovir should use reliable forms of birth control (such as birth control pills and condoms) during treatment and for at least 30 days after stopping the medication. Consult your doctor for more details.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.

              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.Some products that may interact with this drug include: didanosine, imipenem/cilastatin.You may be taking other drugs that decrease bone marrow function and lower your number of blood cells (such as cancer chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other drugs that may cause kidney problems (such as cyclosporine). Your doctor or pharmacist will monitor you closely and adjust your medications to decrease your risk of serious side effects.Valganciclovir is very similar to ganciclovir. Do not use medications containing ganciclovir while using valganciclovir.

              OVERDOSE: 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.Laboratory and/or medical tests (such as complete blood count, kidney function, eye exams) should be performed often to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store the tablets at room temperature away from light and moisture. Do not store in the bathroom.Store the liquid form of this medication in the refrigerator. Do not freeze. The medication expires 49 days after it was prepared by the pharmacy.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 August 2021. Copyright(c) 2021 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.

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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.