Valganciclovir

Valganciclovir is a prescription medication used for the treatment of cytomegalovirus retinitis and for preventing cytomegalovirus infection after a solid organ transplant, especially kidney and heart transplant.

• Valganciclovir is available under the following different brand names: Valcyte

Adult and pediatric dosage

Tablet

• 450mg

Powder for oral solution

• 50mg/mL when reconstituted

Cytomegalovirus Retinitis

Adult dosage

• Induction dose: 900 mg orally every 12 hours for 21 days
• Maintenance dose: Following induction treatment, or in adults with inactive CMV retinitis, 900 mg orally every day

CMV Prevention in Solid Organ Transplant

Adult dosage

Kidney transplantation

• 900 mg orally every day
• Begin within 10 days of transplant until 200 days post-transplant

Kidney-pancreas transplantation

• 900 mg orally every day
• Begin within 10 days of transplant until 100 days post-transplant

Heart transplantation

• 900 mg orally every day
• Begin within 10 days of transplant until 100 days post-transplant

Pediatric dosage

Kidney transplantation

• Children below 4 months: Safety and efficacy not established
• Children between 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

• Children below 1 month: Safety and efficacy not established
• Children between 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Valganciclovir include:

• fever,
• nausea,
• vomiting,
• diarrhea,
• headache,
• tremors,
• loss of balance or coordination,
• sleep problems (insomnia), and
• cold symptoms (stuffy nose, sneezing, sore throat).

Serious side effects of Valganciclovir include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• tiredness,
• flu-like symptoms,
• lightheadedness,
• shortness of breath,
• mouth sores,
• skin sores,
• pale skin,
• cold hands and feet,
• easy bruising,
• unusual bleeding (nose, mouth, vagina, or rectum),
• seizure,
• pain or burning while urinating,
• pain or swelling near the transplanted organ,
• little or no urination, and
• swelling in the feet or ankles

Rare side effects of Valganciclovir include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Valganciclovir has severe interactions with no other drugs.
• Valganciclovir has serious interactions with the following drugs:
  • abacavir
  • talimogene laherparepvec
  • zidovudine
• Valganciclovir has moderate interactions with the following drugs:
  • dichlorphenamide
  • didanosine
  • doxorubicin
  • doxorubicin liposomal
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • emtricitabine
  • lamivudine
  • mycophenolate
  • pivmecillinam
  • probenecid
  • temocillin
  • tenofovir DF
  • ticarcillin
  • voclosporin
• Valganciclovir has minor interactions with at least 64 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• History of clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Valganciclovir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Valganciclovir?”

Cautions

• Maybe teratogenic or embryotoxic, avoid pregnancy; male patients are advised to use a 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 the potential risk to the 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 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 less than 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

Pregnancy and Lactation

• 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
• Lactation
  • No data available regarding the presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, effects on the breastfed infants, or milk production; animal data indicate that ganciclovir is excreted in the 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 the potential for serious adverse events in nursing infants and because of potential for transmission of HIV.