Frequently Asked Questions

valganciclovir solution

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Valcyte

Purine nucleosides


Valganciclovir solution is changed into another medicine, ganciclovir, in the body. It may cause severe blood side effects (eg, low platelet levels, low white blood cell counts, anemia). Contact your doctor right away if you develop unusual tiredness or weakness, easy bruising or bleeding, or symptoms of an infection (eg, fever, chills, persistent sore throat).

Valganciclovir solution has caused cancer, birth defects, and a lack of sperm production in animals. Discuss any questions or concerns with your doctor.


Valganciclovir solution is used for:

Preventing cytomegalovirus (CMV) disease in high-risk kidney and heart transplant patients who are 4 months to 16 years old. It may also be used for other conditions as determined by your doctor.

Valganciclovir solution is an antiviral agent. It works by stopping the growth and reproduction of the virus.

Do NOT use valganciclovir solution if:

  • you are allergic to any ingredient in valganciclovir solution or to ganciclovir
  • you have very low blood levels of red blood cells, certain white blood cells (neutrophils), or platelets
  • you are on dialysis
  • you are an adult; adult patients should use the tablet form of valganciclovir solution
  • you are taking ganciclovir

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Vaccination Safety: Your Questions Answered

Before using valganciclovir solution:

Some medical conditions may interact with valganciclovir solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are dehydrated or have kidney problems
  • if you have congenital CMV disease, blood cell or platelet problems, or a history of bone marrow problems
  • if you have had a transplant other than a kidney or heart transplant
  • if you have recently received or are receiving chemotherapy or radiation treatment
  • if you have taken other medicines that may cause bone marrow problems or weaken your immune system. Ask your doctor if you are unsure if any of your medicines may cause bone marrow problems or weaken your immune system

Some MEDICINES MAY INTERACT with valganciclovir solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Zidovudine because the risk of low white blood cell levels or anemia may be increased
  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
  • Mycophenolate mofetil, mycophenolic acid, or probenecid because they may increase the risk of valganciclovir solution's side effects
  • Didanosine because the risk of its side effects may be increased by valganciclovir solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if valganciclovir solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use valganciclovir solution:

Use valganciclovir solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with valganciclovir solution. Talk to your pharmacist if you have questions about this information.
  • Take valganciclovir solution by mouth with food.
  • Shake well for about 5 seconds before each use.
  • Use the measuring device that comes with valganciclovir solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Do not get valganciclovir solution on your skin or in your eyes or nose. If contact occurs, wash your skin thoroughly with soap and water and rinse your eyes with plenty of clear water.
  • Check with your pharmacist about how you should dispose of any unused medicine.
  • Take valganciclovir solution on a regular schedule to get the most benefit from it.
  • Continue to take valganciclovir solution even if you feel well. Do not miss any doses.
  • If you miss a dose of valganciclovir solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use valganciclovir solution.

Important safety information:

  • Valganciclovir solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use valganciclovir solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Valganciclovir solution is not a cure for CMV infection. Remain under the care of your doctor.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • The dose of valganciclovir solution may be different from the dose of ganciclovir. If you are switching to valganciclovir solution from ganciclovir, be sure you know how much of valganciclovir solution to take. Check with your doctor or pharmacist if you are not sure.
  • You should be careful not to become dehydrated while you are taking valganciclovir solution. The risk of kidney problems may be increased. Check with your doctor about whether you should drink extra fluids while you are taking valganciclovir solution.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Valganciclovir solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Valganciclovir solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Use of valganciclovir solution may increase your risk of developing cancer. Discuss any questions or concerns with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking valganciclovir solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Some patients have had rejection of their transplanted organ while taking valganciclovir solution. Discuss any questions or concerns with your doctor.
  • Valganciclovir solution may cause decreased sperm production. This may be temporary or permanent. Discuss any questions or concerns with your doctor.
  • Valganciclovir solution may cause decreased fertility in women. Discuss any questions or concerns with your doctor.
  • Men who take valganciclovir solution should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take valganciclovir solution and for at least 90 days after you stop taking it.
  • Women who take valganciclovir solution and who may become pregnant should always use effective birth control during sex. Do this for as long as you take valganciclovir solution and for at least 30 days after you stop taking it.
  • Lab tests, including eye exams, complete blood cell and platelet counts, and kidney function, may be performed while you use valganciclovir solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use valganciclovir solution with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems.
  • Caution is advised when using valganciclovir solution in CHILDREN; they may be more sensitive to its effects, especially fever, upper respiratory tract infection, anemia, and low white blood cell levels.
  • Valganciclovir solution should be used with extreme caution in CHILDREN younger than 4 months old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Valganciclovir solution may cause harm to the fetus. Do not become pregnant while you are using it. Use effective contraception to prevent pregnancy while you are taking valganciclovir solution. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using valganciclovir solution while you are pregnant. It is not known if valganciclovir solution is found in breast milk. Do not breast-feed while taking valganciclovir solution.

Possible side effects of valganciclovir solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cough; diarrhea; dizziness; drowsiness; headache; nausea; stomach pain; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; confusion; dark urine; decreased coordination; hallucinations; irregular heartbeat; mental or mood changes (eg, depression); muscle weakness; numbness or tingling of the skin, hands, or feet; seizures; severe or persistent headache, dizziness, or drowsiness; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremors; unsteady movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blood in the urine; change in the amount of urine produced; dark urine; fever, chills, or sore throat; seizures; severe or persistent diarrhea, vomiting, or stomach pain; tremors; unusual bruising or bleeding; yellowing of the skin or eyes.

Proper storage of valganciclovir solution:

Store valganciclovir solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep the container tightly closed. Throw away any unused medicine after 49 days. Do not use valganciclovir solution if the expiration date on the bottle has passed. Keep valganciclovir solution out of the reach of children and away from pets.

General information:

  • If you have any questions about valganciclovir solution, please talk with your doctor, pharmacist, or other health care provider.
  • Valganciclovir solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take valganciclovir solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about valganciclovir solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to valganciclovir solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using valganciclovir solution.

Issue Date: February 4, 2015
Database Edition 15.1.1.002
Copyright © 2015 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

It is possible that some side effects of valganciclovir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to valganciclovir: oral powder for solution, oral tablet

As well as its needed effects, valganciclovir may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking valganciclovir, check with your doctor immediately:

More common
  • Black, tarry stools
  • blood in the urine or stools
  • blurred vision
  • chills
  • cough
  • dizziness
  • fever
  • headache
  • hoarseness
  • lower back or side pain
  • nervousness
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • slow or fast heartbeat
  • sore throat
  • trembling or shaking of the hands or feet
  • troubled breathing
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • veil or curtain appearing across part of vision
Less common
  • Changes in facial skin color
  • confusion
  • false beliefs
  • fast or irregular breathing
  • feeling, hearing, or seeing things that are not there
  • hives, itching, and skin rash
  • large, hive-like swellings on the eyelids, face, lips, mouth, or tongue
  • puffiness or swelling of the eyelids or around the eyes
  • runny or stuffy nose
  • seizures
  • tightness in the chest or wheezing
  • trouble thinking

Some valganciclovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Abdominal or stomach pain
  • diarrhea
  • headache
  • nausea and vomiting
  • numbness, tingling, pain, or weakness of the hands or feet
  • sleeplessness
  • tingling, burning, or prickly sensations
  • trouble with sleeping
  • unsteadiness or awkwardness
Less common
  • Agitation

For Healthcare Professionals

Applies to valganciclovir: oral powder for reconstitution, oral tablet

General

After oral administration, valganciclovir is rapidly converted to ganciclovir. Therefore, side effects that are known to be associated with ganciclovir administration can be expected to occur with the administration of valganciclovir.

The most common side effects reported in at least one indication by greater than or equal to 20% of patients treated with valganciclovir tablets are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 41%), nausea (up to 30%), vomiting (up to 21%), and abdominal pain (up to 15%). Constipation, dyspepsia, abdominal distention, and ascites have been reported.[Ref]

Hematologic

Hematologic side effects have included neutropenia (absolute neutrophil count [ANC] less than 500/mcL: up to 19%; ANC 500 to less than 750/mcL: up to 17%; ANC 750 to less than 1000/mcL: up to 17%), anemia (hemoglobin [Hgb] less than 8 g/dL: up to 8%; Hgb less than 6.5 g/dL: up to 7%; Hgb 6.5 to less than 8 g/dL: up to 13%; Hgb 8 to less than 9.5 g/dL: up to 31%), and thrombocytopenia (less than 25,000 platelets/mcL: up to 4%; 25,000 to less than 50,000 platelets/mcL: up to 6%; 50,000 to less than 100,000 platelets/mcL: up to 22%). Leukopenia, pancytopenia, bone marrow depression, aplastic anemia, and potentially life-threatening bleeding associated with thrombocytopenia have been reported. Neutrophil dysplasia with evidence of bone marrow hypoplasia has also been reported.[Ref]

Immunologic

Immunologic side effects have included graft rejection in transplant patients (up to 24%).[Ref]

Ocular

Ocular side effects have included retinal detachment (15%).[Ref]

Nervous system

Nervous system side effects have included headache (up to 22%), tremors (up to 28%), insomnia (up to 20%), peripheral neuropathy (9%), and paresthesia (up to 8%). Neurotoxicity, dizziness (excluding vertigo), and convulsions have also been reported.[Ref]

Renal

Renal side effects have included elevated serum creatinine (greater than 2.5 mg/dL: up to 17%; greater than 1.5 to 2.5 mg/dL: up to 50%), acute renal failure, renal impairment, dysuria, and decreased creatinine clearance.[Ref]

Oncologic

Oncologic side effects have included the potential to cause cancers; therefore, valganciclovir is considered a potential carcinogen in humans. In animal studies, ganciclovir was found to be carcinogenic.[Ref]

Psychiatric

Psychiatric side effects have included psychosis, depression, hallucinations, confusion, and agitation.[Ref]

Other

Other side effects have included pyrexia (up to 31%), catheter-related infections (3%), fatigue, pain, edema, peripheral edema, and weakness. Local and systemic infections, sepsis, pharyngitis/nasopharyngitis, upper respiratory tract infection, urinary tract infection, postoperative wound infection, postoperative complications, postoperative pain, increased wound drainage, and wound dehiscence have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have included valganciclovir hypersensitivity.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension (up to 18%) and hypotension.[Ref]

Hepatic

Hepatic side effects have included abnormal hepatic function.[Ref]

Metabolic

Metabolic side effects have included hyperkalemia, hypokalemia, hypomagnesemia, hyperglycemia, decreased appetite, dehydration, hypophosphatemia, and hypocalcemia.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, arthralgia, muscle cramps, and limb pain.[Ref]

Respiratory

Respiratory side effects have included cough, dyspnea, rhinorrhea, and pleural effusion.[Ref]

Dermatologic

Dermatologic side effects have included dermatitis, pruritus, and acne.[Ref]

References

1. "Product Information. Valcyte (valganciclovir)" Roche Laboratories, Nutley, NJ.

2. "Oral prodrug of ganciclovir for CMV retinitis." Am J Health Syst Pharm 58 (2001): 946-8

3. Cvetkovic RS, Wellington K "Valganciclovir: a review of its use in the management of CMV infection and disease in immunocompromised patients." Drugs 65 (2005): 859-78

4. Segarra-Newnham M, Salazar MI "Valganciclovir: A new oral alternative for cytomegalovirus retinitis in human immunodeficiency virus-seropositive individuals." Pharmacotherapy 22 (2002): 1124-8

5. Curran M, Noble S "Valganciclovir." Drugs 61 (2001): 1145-50

6. Babel N, Gabdrakhmanova L, Juergensen JS, et al. "Treatment of cytomegalovirus disease with valganciclovir in renal transplant recipients: a single center experience." Transplantation 78 (2004): 283-5

7. Gabardi S, Magee CC, Baroletti SA, Powelson JA, Cina JL, Chandraker AK "Efficacy and safety of low-dose valganciclovir for prevention of cytomegalovirus disease in renal transplant recipients: a single-center, retrospective analysis." Pharmacotherapy 24 (2004): 1323-30

8. Wang TJ, Lin CP, Yang CM, Lin LL "Valgancyclovir as maintenance therapy for cytomegalovirus retinitis in a lung transplant patient-a case report." Transplant Proc 36 (2004): 2826-9

9. Ayala E, Greene J, Sandin R, et al. "Valganciclovir is safe and effective as pre-emptive therapy for CMV infection in allogeneic hematopoietic stem cell transplantation." Bone Marrow Transplant 37 (2006): 851-6

10. Diaz-Pedroche C, Lumbreras C, San Juan R, et al. "Valganciclovir Preemptive Therapy for the Prevention of Cytomegalovirus Disease in High-Risk Seropositive Solid-Organ Transplant Recipients." Transplantation 82 (2006): 30-35

11. Molina Perez E, Fernandez Castroagudin J, Seijo Rios S, et al. "Valganciclovir-induced leukopenia in liver transplant recipients: influence of concomitant use of mycophenolate mofetil." Transplant Proc 41 (2009): 1047-9

12. "Agranulocytosis in kidney transplant recipients receiving tacrolimus, mycophenolate mofetil and valganciclovir." Transplantation 82(1 Suppl 2) (2006): 952

13. Brum S, Nolasco F, Sousa J, et al. "Leukopenia in kidney transplant patients with the association of valganciclovir and mycophenolate mofetil." Transplant Proc 40 (2008): 752-4

14. Humar A, Siegal D, Moussa G, Kumar D "A prospective assessment of valganciclovir for the treatment of cytomegalovirus infection and disease in transplant recipients." J Infect Dis 192 (2005): 1154-7

15. Keven K, Basu A, Tan HP, et al. "Cytomegalovirus prophylaxis using oral ganciclovir or valganciclovir in kidney and pancreas-kidney transplantation under antibody preconditioning." Transplant Proc 36 (2004): 3107-12

16. Said T, Nampoory MR, Pacsa AS, et al. "Oral valgancyclovir versus intravenous gancyclovir for cytomegalovirus prophylaxis in kidney transplant recipients." Transplant Proc 39 (2007): 997-9

17. Taegtmeyer AB, Halil O, Bell AD, Carby M, Cummins D, Banner NR "Neutrophil dysplasia (acquired pseudo-pelger anomaly) caused by ganciclovir." Transplantation 80 (2005): 127-30

18. "Pharmacokinetics of low and maintenance dose valganciclovir in kidney transplant recipients." Transplantation 82(1 Suppl 2) (2006): 266-7

19. Czock D, Scholle C, Rasche FM, Schaarschmidt D, Keller F "Pharmacokinetics of valganciclovir and ganciclovir in renal impairment." Clin Pharmacol Ther 72 (2002): 142-150

20. Wiltshire H, Paya CV, Pescovitz MD, et al. "Pharmacodynamics of Oral Ganciclovir and Valganciclovir in Solid Organ Transplant Recipients." Transplantation 79 (2005): 1477-1483

21. "Efficacy and safety of CMV prophylaxis with valganciclovir 900 mg/day for 100 days versus 450 mg/day for 6 months post-renal transplantation." Transplantation 82(1 Suppl 2) (2006): 585

22. Fellay J, Venetz JP, Aubert JD, Seydoux C, Pascual M, Meylan PR "Treatment of cytomegalovirus infection or disease in solid organ transplant recipients with valganciclovir." Transplant Proc 37 (2005): 949-51

23. Dupuis R, Harris M, Gillis K, et al. "Experience with low-dose valganciclovir prophylaxis in adult liver transplant recipients." Transplant Proc 39 (2007): 3266-70

24. Cochrane AB "Antiviral dosing and efficacy for prophylaxis of cytomegalovirus disease in solid organ transplant recipients." Am J Health Syst Pharm 63(19 Suppl 5) (2006): S17-21

25. Pescovitz MD, Jain A, Robson R, Mulgaonkar S, Freeman R, Bouw MR "Establishing pharmacokinetic bioequivalence of valganciclovir oral solution versus the tablet formulation." Transplant Proc 39 (2007): 3111-6

More about valganciclovir

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Consumer resources

  • Valganciclovir
  • Valganciclovir solution
  • Valganciclovir (Advanced Reading)
  • Other brands: Valcyte

Professional resources

  • Valganciclovir Hydrochloride (AHFS Monograph)
  • Valganciclovir (Wolters Kluwer)

Related treatment guides

  • CMV Retinitis
  • Cytomegalovirus Infection

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