Valganciclovir

What Is Valganciclovir?

Valganciclovir is a prescription antiviral medicine. It belongs to a group called nucleoside analog antivirals (also called guanine analogs). It is a “prodrug,” which means the body changes it into its active form, ganciclovir, after it is swallowed. It is sold under the brand name Valcyte in the United States and as generic versions. It is mainly used to treat and prevent infections caused by cytomegalovirus (CMV), especially in people with weakened immune systems.

FDA-Approved Uses

Valganciclovir is approved for the following uses:

In adults:

• Treatment of CMV retinitis (a CMV infection of the retina in the eye) in people with AIDS
• Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant recipients who are at higher risk

In children:

• Prevention of CMV disease in kidney transplant recipients 4 months of age and older, and in heart transplant recipients from birth, who are at higher risk

Other Prescribed Uses

Specialists sometimes prescribe valganciclovir for other CMV-related situations, such as treating CMV infection after other types of transplant or in newborns with certain congenital CMV infections. These decisions belong to the treating specialist and follow current clinical guidelines.

Available Forms and Strengths

• Tablets: Valganciclovir 450mg
• Oral solution: 50 mg/mL, made by the pharmacy from a powder mixed with water, for children and others who cannot swallow tablets

Available forms and strengths can vary by manufacturer and country.

What Is the Recommended Dosage of Valganciclovir?

There is no single dose that fits everyone. The prescribed dose and length of treatment depend on several factors:

• The condition being treated. Treatment of active CMV disease usually starts with a higher “induction” dose, followed by a lower “maintenance” dose. Prevention in transplant patients uses a lower daily dose for weeks to months.
• Age. Children are dosed differently from adults.
• Body weight and body surface area. These are commonly used to calculate the dose in children.
• Kidney function. Valganciclovir leaves the body through the kidneys, so people with reduced kidney function need lower or less frequent doses. Kidney tests are used to set the dose.
• Type of transplant and overall health.

Valganciclovir should be taken with food to help the body absorb it. Swallow tablets whole with water. Do not break, crush, or chew the tablets, because the medicine can be harmful if it touches the skin or is inhaled as dust. If a tablet is broken or crushed, avoid direct contact and wash any skin contact with soap and water, and rinse eyes with plain water.

Take valganciclovir exactly as your licensed medical specialist or pharmacist instructs. Do not change the dose, stop early, or extend treatment on your own. Stopping too soon can allow the virus to return or cause serious illness.

How Valganciclovir Works

After it is swallowed, valganciclovir is quickly changed in the body into ganciclovir. Inside infected cells, ganciclovir is further changed into an active form that looks similar to one of the building blocks of viral DNA. The virus mistakenly uses it while copying its genetic material. This blocks the enzyme the virus needs to make more DNA, so the virus cannot multiply well.

Valganciclovir treats and controls CMV infection by slowing viral growth. It does not cure CMV, and the virus can stay in the body in an inactive form. The immune system plays a major role in keeping the virus under control. How well the medicine works depends on the strength of the person’s immune system, the site of the infection, and how early treatment starts. It does not work against bacterial or fungal infections, and it is not used for the common cold or flu.

Is a Prescription Required to Buy Valganciclovir Online?

In the United States, valganciclovir is a prescription-only medicine. A licensed healthcare professional must evaluate you before it is prescribed. Treatment is usually started and supervised by a specialist because blood and kidney monitoring is needed.

Depending on the condition, the specialist may be:

• A transplant physician or transplant surgeon
• An infectious disease specialist
• An ophthalmologist (for CMV eye infections)
• An HIV specialist
• A pediatric specialist (for children and newborns)

Only buy valganciclovir from a licensed pharmacy that requires a valid prescription. Be careful with websites that sell it without one or that ship medicines from overseas without verification. Counterfeit, expired, or improperly stored products can be unsafe. Products labeled for animals are not approved for people and should never be used.

Side Effects of Valganciclovir

Side effects are common with this medicine, and some can be serious. Regular blood tests help catch problems early.

Common Side Effects

• Diarrhea
• Nausea or vomiting
• Fever
• Headache
• Trouble sleeping
• Tiredness or weakness
• Tremor or shakiness
• Low white blood cell counts, low red blood cell counts (anemia), or low platelet counts (found on blood tests)
• Swelling in the legs or feet
• Tingling or numbness in the hands or feet

Talk to your doctor or pharmacist if these bother you or do not go away.

Serious Side Effects

Serious reactions are possible. Get medical help right away if you notice:

• Fever, chills, sore throat, or other signs of infection (possible low white blood cells)
• Unusual bruising or bleeding, nosebleeds, bleeding gums, or black or bloody stools (possible low platelets)
• Extreme tiredness, pale skin, shortness of breath, or a fast heartbeat (possible anemia)
• Swelling of the face, lips, tongue, or throat, or trouble breathing (allergic reaction)
• Seizures, confusion, hallucinations, or unusual behavior
• Decreased urination or new swelling (possible kidney problems)
• Sudden changes in vision, new floaters, flashes of light, or a shadow or curtain over part of your vision (possible retinal detachment)
• Severe or lasting diarrhea or vomiting, especially with signs of dehydration

Call emergency services if you have trouble breathing or think you are having a life-threatening reaction.

Drug Interactions

Valganciclovir can affect blood counts and the kidneys, so many interactions involve medicines that have similar effects. Major categories include:

• Medicines that lower blood cell counts, such as zidovudine (an HIV medicine), mycophenolate mofetil, azathioprine, and some chemotherapy drugs. Combined use can raise the risk of serious blood problems.
• Medicines that can harm the kidneys or affect how the kidneys clear drugs, such as amphotericin B, cyclosporine, tacrolimus, certain antibiotics, and some anti-inflammatory drugs (NSAIDs)
• Probenecid, which can raise ganciclovir levels
• Imipenem-cilastatin, an antibiotic linked to a higher risk of seizures when combined with ganciclovir
• Didanosine and other HIV medicines, whose levels or side effects may change
• Other antivirals, including some that are cleared by the kidneys
• Live vaccines, which may not be safe or effective in people with weakened immune systems

Tell your provider about all over-the-counter medicines (including NSAIDs such as ibuprofen), vitamins, supplements, and herbal products. Also mention alcohol use.

Give your licensed medical specialist and pharmacist a complete, up-to-date list of everything you take. This list is not complete, so always check before starting or stopping any medicine.

Safety & Important Considerations

• FDA boxed warning: blood problems. Valganciclovir can cause severe low white blood cell counts, low red blood cell counts, low platelet counts, and, in some cases, bone marrow failure. Blood counts are checked regularly during treatment.
• FDA boxed warning: impaired fertility. Based on animal studies, valganciclovir may cause temporary or permanent infertility in both men and women.
• FDA boxed warning: birth defects and cancer. Based on animal studies, valganciclovir may cause birth defects and cancer in humans. Discuss these risks with your specialist before starting.
• Kidney disease: Dose changes are required for reduced kidney function. Kidney function is checked before and during treatment, and dose changes may be needed if kidney function changes.
• Blood tests: Complete blood counts and kidney tests are done at the start and regularly during treatment.
• Eye monitoring: People treated for CMV retinitis need regular eye exams. Report any vision changes right away.
• Seizures and nervous system effects: Seizures, confusion, and tremor can occur. Use caution if you have a history of seizures.
• Handling the medicine: Do not crush or break tablets. Caregivers should avoid touching broken tablets or spilled liquid with bare hands, and should wash hands well after handling the medicine.
• Pregnancy: Valganciclovir can harm an unborn baby and is generally avoided during pregnancy unless the benefit clearly outweighs the risk. Women who could become pregnant should use effective birth control during treatment and for at least 30 days after the last dose. Men with female partners who could become pregnant should use condoms during treatment and for at least 90 days afterward. Tell your provider right away if you become pregnant.
• Breastfeeding: It is not known whether valganciclovir passes into breast milk, but because of the potential for serious harm to a nursing infant, breastfeeding is generally not advised during treatment. Discuss the risks and benefits with your provider.
• Children: Valganciclovir is used in children for certain uses, with dosing based on age, body surface area, and kidney function. Safety and effectiveness have not been established for all uses in children.
• Older adults: Kidney function often declines with age, so dose adjustment may be needed. Older adults also often take multiple medicines, which raises the chance of interactions.
• Vaccines: Ask your provider before getting any vaccine, especially live vaccines.
• Driving and machinery: Dizziness, confusion, and seizures can occur. Use caution until you know how the medicine affects you.

Who This Medication Is For

Valganciclovir is prescribed for adults and children who have CMV disease or who are at high risk of developing it, within its approved indications. This most often includes people with AIDS who have CMV retinitis and people who have received a kidney, heart, or kidney-pancreas transplant. Whether it is appropriate depends on the type of infection or risk, immune status, kidney function, blood counts, medical history, and other medicines.

Who Should Not Take Valganciclovir

Valganciclovir is not suitable for everyone. Do not take it if:

• You have had an allergic reaction to valganciclovir, ganciclovir, or any ingredient in the product. Tell your provider if you have reacted to acyclovir or valacyclovir, since cross-reactions can occur.
• You have severely low blood cell counts, unless your specialist decides the benefit outweighs the risk.

Use extra caution and discuss risks with your provider if you have:

• Kidney disease or are on dialysis (a different form of ganciclovir may be needed)
• Low white blood cell, red blood cell, or platelet counts, or a history of blood disorders
• A history of seizures
• A history of radiation therapy or cancer treatment that affected the bone marrow
• Pregnancy, plans for pregnancy, or breastfeeding
• Plans to have children in the future

What to Do If You Miss a Dose

• Take the missed dose as soon as you remember, and take it with food.
• If it is almost time for your next dose, skip the missed one and go back to your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, or you miss several doses, contact your licensed medical specialist or pharmacist. Missed doses can affect how well the infection is treated or prevented, especially in transplant recipients.

Related medications to Valganciclovir

Other medicines exist for CMV, and the right one depends on the person’s condition, kidney function, blood counts, and other treatments. Only a licensed specialist can decide whether a different medicine is appropriate.

Same medicine in another form:

• Ganciclovir, given by IV in a hospital or clinic (valganciclovir is the oral form of this medicine)

Other antivirals used for CMV:

• Letermovir, used to prevent CMV in certain stem cell and kidney transplant recipients
• Maribavir, used for CMV that has not responded to other treatments after transplant
• Foscarnet, given by IV, used for resistant CMV or when blood counts are too low for ganciclovir
• Cidofovir, given by IV, used in some situations when other options are not suitable

Related antivirals (not typically used for CMV treatment):

• Acyclovir and valacyclovir, used for herpes simplex and varicella-zoster (shingles) infections. These are sometimes used at high doses to help prevent CMV in some settings under specialist direction, but are not equivalent to valganciclovir.

Do not switch or stop valganciclovir without talking to your licensed medical specialist.

Storage Instructions

• Tablets: Store at room temperature, generally between 59°F and 86°F (15°C and 30°C), in the original container. Keep them dry and protected from moisture and light. Avoid storing them in a bathroom.
• Oral solution: Before mixing, store the powder at room temperature. After the pharmacy mixes it, the solution is usually kept in a refrigerator at 36°F to 46°F (2°C to 8°C) and discarded after about 49 days. Do not freeze it. Shake well before each use, and use only the dosing device provided. Follow the pharmacy label.
• Handling: Do not crush or break tablets. Wash hands after handling.
• Child safety: Keep all medicines out of reach and sight of children and pets, preferably in a locked or high cabinet.
• Do not use medicine past its expiration date. Ask your pharmacist about safe disposal of unused or expired medicine.

Disclaimer:

This page is for educational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Patients must consult a licensed medical specialist, such as a transplant physician, infectious disease specialist, ophthalmologist, or HIV specialist, depending on the condition, before starting, changing, or stopping treatment. Treatment decisions must be based on a full clinical evaluation by a qualified specialist. Information about dosing, strengths, and safety may change, so always follow the guidance of your prescriber and the current product labeling.