Dosing & Uses
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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
History of clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or excipients
Cautions
May be teratogenic or embryotoxic, avoid pregnancy; male patients advised to use barrier method during and for 90 days after treatment (see Pregnancy)
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
Acute renal failure may occur in elderly patients with or without reduced renal function; exercise caution when administering to geriatric patients; dosage reduction is recommended for those with impaired renal function, patients receiving potential nephrotoxic drugs, and patients without adequate hydration
Hematologic toxicity
- Cytopenia may occur at any time during treatment and may worsen with continued dosing; cell counts usually begin to recover within 3 To 7 days after discontinuing the drug
- Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia 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 analogs have previously resulted in leukopenia, or in whom neutrophil counts are < 1000 cells/μL at beginning of treatment
- Increased monitoring for cytopenias may be warranted if therapy with oral ganciclovir is changed to this drug because of increased plasma concentrations of ganciclovir after administering therapy
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
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
- Based on animal data and limited human data, at recommended human doses the drug may cause temporary or permanent inhibition of spermatogenesis in males and may cause suppression of fertility in females; advise patients that fertility may be impaired with therapy
Animal data
- When given to pregnant rabbits at dosages resulting in 2 times the human exposure (based on AUC), ganciclovir caused malformations in multiple organs of the fetuses; maternal and fetal toxicity also observed in pregnant mice and rabbits
- Therapy has the potential to cause birth defects; pregnancy should be avoided in female patients taking this drug and in females with male partners taking the drug; females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment because of the Impairment of 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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Valcyte oral - | 50 mg/mL solution |  | |
| Valcyte 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 |  | |
| valganciclovir oral - | 450 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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. Get medical help right away if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as sore throat that doesn't go away, fever, chills, cough), 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 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.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).Valganciclovir can make you more likely to get infections or may worsen any current infections. 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.Tell your health care professional that you are using valganciclovir before having any immunizations/vaccinations. 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 childbearing 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 childbearing 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 March 2022. Copyright(c) 2022 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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