Valcyte can cause serious and sometimes life-threatening blood and bone marrow problems, such as low blood cells, low platelet counts, or low white blood cell counts.
It may also affect your fertility, which may lead to being unable to get pregnant or have a child.
Animal studies have shown the potential for Valcyte to cause fetal harm. Women who can get pregnant should use contraception during treatment and for 30 days following treatment. Men should use barrier contraception during and for at least 90 days after treatment.
Animal data has also indicated that this medication may cause cancer.
It is considered a prodrug of ganciclovir. This means that once processed in the body, valganciclovir is converted into ganciclovir. Ganciclovir has antiviral effects, which prevent the viral cells from growing.
Valcyte is available in tablet and liquid solution form.
What Is Valcyte Used For?
Valcyte prevents cytomegalovirus (CMV) in children and adults at high risk, including those who have received kidney, heart, and kidney-pancreas transplants. It also treats CMV retinitis (inflammation of the retina in the eye) in immunocompromised adults.
Brand Name(s): Valcyte
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Antiviral
Available Generically: Yes
Controlled Substance: N/A
Active Ingredient: Valganciclovir hydrochloride
Dosage Form(s): Tablet, liquid solution
CMV can affect multiple areas of the body, from the ears and eyes to the stomach and intestines. CMV is from the family of herpesvirus, and for most people with a functioning immune system, it will usually show little to no signs or symptoms.
You risk developing more severe complications from CMV if you have a weakened immune system, are on immunosuppressive therapies, have a recent organ transplant, or were a premature or low birth weight infant that contracted it through delivery or breast milk.
How to Take Valcyte
Always take Valcyte with food. This helps maximize the body’s absorption of the drug.
If you are prescribed the tablet formulation, be sure to swallow the tablet whole. Don’t break or crush tablets. The oral solution is prepared from a powder mix. Before dispensing it to you, a pharmacist will prepare the powder for you to use as a liquid.
For children with recent heart or kidney transplants using Valcyte for cytomegalovirus (CMV) prevention, the dosage is calculated by your healthcare provider and should be followed as prescribed.
Storage
The oral tablet formulation of Valcyte should be stored at room temperature (between 68 F and 77 F).
The powder for the solution formulation can be kept at room temperature. Once it is in liquid form, it can be refrigerated for up to 49 days (seven weeks). It cannot be frozen.
Off-Label Uses
Healthcare providers may prescribe valganciclovir for off-label uses, meaning for conditions not specifically indicated or approved by the U.S. Food and Drug Administration (FDA).
Off-label uses may include:
Congenital CMV treatment in infants Primary prevention of CMV in adults and children older than four months with human immunodeficiency virus (HIV) Prevention of Epstein-Barr virus (EBV) in post-transplant lymphoproliferative disorder (PTLD), a condition in which white blood cells multiply at an abnormally high rate and may even lead to cancers like lymphoma
What Are the Side Effects of Valcyte?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider or a pharmacist. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
The most common side effects of Valcyte are:
Diarrhea Fever Tremors Nausea Vomiting Headache Anemia (lack of red blood cells) Neutropenia (low neutrophil—a type of white blood cell—count) Leukopenia (low white blood cell count) Thrombocytopenia (low blood platelet count) Insomnia Urinary tract infection (UTI)
Severe Side Effects
Call your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life-threatening or you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
Retinal detachment: This occurs when the retina separates from its position in the eye. Symptoms can include blurred vision and/or seeing floaters or flashing lights. Life-threatening thrombocytopenia: Symptoms include nosebleeds, bleeding gums, blood in urine or stool, blood blisters, easy bruising, and petechiae (small, red dots on the skin). Severe leukopenia: Symptoms may include fever, sore throat or congestion, fatigue, slow-healing sores, gastrointestinal discomfort, enlarged lymph nodes, enlarged liver or spleen, and infected wounds. Neutropenia: Symptoms may include fatigue, fevers, sweats or chills, muscle aches, and abscesses (pus build-up often due to infection). Severe infections can result in difficulty breathing or changes in consciousness. Myelosuppression: This occurs when cell production is reduced in the body. Symptoms can depend on the underlying cause, such as low red blood cell, white blood cell, and platelet counts. Seizures
Long-Term Side Effects
Long-term use of Valcyte can cause some health complications, including:
InfertilityAcute kidney failureCancer (based on animal data)
Dosage: How Much Valcyte Should I Take?
Modifications
Adjusted dosing is based on your kidney’s ability to filter medications properly. Your healthcare provider will determine this. Your dose will be adjusted if you have poor kidney function.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage forms (solution and tablets): For treatment of CMV infection in the eyes: Adults—At first, 900 milligrams (mg) (two 450 mg tablets) two times a day for 21 days. Then, your doctor may adjust your dose to 900 mg once a day. Children—Use and dose must be determined by your doctor. For prevention of CMV disease in transplant patients: Adults who have received heart or kidney-pancreas transplant—900 milligrams (mg) (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days after transplantation. Adults who have received kidney transplant—900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days after transplantation. Children 4 months to 16 years of age who have received a kidney transplant—Dose given once a day starting within 10 days of transplantation until 200 days after transplantation is based on body size and creatinine clearance which must be determined by your doctor. However, the dose is usually not more than 900 mg once a day. Children 1 month to 16 years of age who have received a heart transplant—Dose given once a day starting within 10 days of transplantation until 100 days after transplantation is based on body size and creatinine clearance which must be determined by your doctor. However, the dose is usually not more than 900 mg once a day. Children younger than 4 months old who have received a kidney transplant—Use and dose must be determined by your doctor. Children younger than 1 month old who have received a heart transplant—Use and dose must be determined by your doctor.
Dosing may vary when used in children. Follow your healthcare provider’s instructions for how much to give your child.
Missed Dose
If you miss a dose of Valcyte, take the missed dose as soon as you remember. However, do not take the missed dose if it is closer to the time of your next dose. Instead, take the regularly scheduled dose as directed.
Make sure you do not run out of Valcyte and get your refills on time. A missed dose can increase the amount of virus in your blood.
Overdose: What Happens If I Take Too Much Valcyte?
Overdosing on Valcyte can cause life-threatening complications. Symptoms can include:
Damage to your eyes or permanent vision lossAbdominal painVomitingDiarrheaTremorsSeizure
An overdose can also potentially cause toxicity in your kidneys, irreversible pancytopenia, and persistent bone marrow suppression, which can lower the number of healthy cells your body makes to fight infection. To remedy an overdose of Valycte, dialysis might be used to reduce the amount of the drug in your body.
Precautions
What Are Reasons I Shouldn’t Take Valcyte?
Valcyte should not be used in:
If someone collapses or isn’t breathing after taking Valcyte, call 911 immediately.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for at least 1 month after stopping it. Also, men should use a condom during treatment with this medicine and for at least 90 days after treatment has been completed. If you think you have become pregnant while using the medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
Valganciclovir can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause kidney failure, especially in elderly patients with kidney problems. Check with your doctor right away if you have the following symptoms: agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, or swelling of the face, ankles, or hands.
This medicine may cause confusion, seizures, dizziness, drowsiness, or trouble in controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Pregnant or nursing people: Valcyte can cause harm to the fetus if used during pregnancy or cause unwanted side effects in breastfed infants. Children under four monthsPeople with low neutrophil, platelet, or hemoglobin counts (as determined by a healthcare provider)People who have had a significant allergic reaction (e. g. , anaphylaxis) to valganciclovir, ganciclovir, or any ingredient in Valcyte.
Your kidney function may need to be tested before taking Valcyte if you are currently on other medications that affect the kidneys.
What Other Medications Interact With Valcyte?
Valcyte can interact with other medications. Before starting treatment, you must tell your healthcare provider about all your medications, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements.
The following drugs can interact with Valcyte:
Drugs associated with myelosuppression or kidney toxicity, such as Retrovir (zidovudine) or Prograf (tacrolimus): Combined use can cause neutropenia and anemia. Probalan (probenecid): Using this drug with Valcyte can cause an increase in ganciclovir levels (the active drug in Valcyte) in the body. Your healthcare provider may reduce your Valcyte dose if you take this drug. Cellcept (mycophenolate mofetil): Taking Valcyte with mycophenolate mofetil can increase concentrations of ganciclovir.
This is not a complete list of potential drug interactions, and others may occur. Ask your healthcare provider or pharmacist what drugs or substances you should avoid while taking Valcyte.
What Medications Are Similar?
Medications that are similar to Valcyte include:
Ganciclovir: Not to be confused with valganciclovir, ganciclovir capsules are the active form of Valcyte. This means that when valganciclovir is broken down in your body, it converts to ganciclovir. Although they have the same drug ingredient, they are different medications and should not be mixed. Valtrex (valacyclovir): Valtrex is an antiviral used to treat cold sores and herpes. Zovirax (acyclovir): Zovirax is an antiviral used to treat herpes.
How Can I Stay Healthy While Taking Valcyte?
During your treatment, make sure to follow up with your healthcare provider for all recommended screenings. This includes eye exams, kidney function tests, and blood monitoring.
Use effective contraception during treatment and for 30 days (if you’re a female) or 90 days (if you’re a male) after treatment. Valcyte may potentially be harmful to the fetus if used during pregnancy. Immediately contact your healthcare provider if you become pregnant while taking Valcyte.
For Valcyte to work as best as possible, make sure you take your prescribed dose and try not to miss any doses. Additionally, don’t hesitate to reach out to your healthcare provider if you notice any side effects.
The author would like to recognize and thank Jon Candelaria for contributing to this article.
