Generic Name: valganciclovir ( val gan SYE kloe veer)Brand Names: Valcyte
Valganciclovir is an antiviral drug. It works by preventing viral cells from multiplying in your body. Valganciclovir will not cure CMV but it can help control the infection.
Valganciclovir treats cytomegalovirus (CMV) infection of the eye in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir also prevents CMV infection in patients who have received an organ transplant (kidney, heart, or kidney-pancreas).
Valganciclovir may also be used for purposes other than those listed in this medication guide.
Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). Be aware that the strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed. An overdose of this medication can cause serious illness.
Valganciclovir can lower the blood cells in your body that control bleeding and help you fight infection. Your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. Contact your doctor right away if you have any bleeding or signs of infection (fever, chills, body aches, or flu symptoms).
Before taking this medication, tell your doctor if you have:
liver disease, or
a blood cell disorder (such as anemia).
Tell your doctor if you are on hemodialysis or if you have recently had a radiation treatment.Valganciclovir is in the FDA pregnancy category C. This means that it is not known if it will be harmful to an unborn baby. A similar drug called ganciclovir (Cytovene) did cause birth defects in animal studies. Using valganciclovir while you are pregnant could also cause harm to the unborn baby. Do not use this medication without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. If a man fathers a child while using valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir.
This medication can affect fertility (your ability to have children), whether you are a man or a woman.You should not breast-feed while you are using valganciclovir. It is not known if this medication passes into breast milk. If you have HIV or AIDS, you should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.
Valganciclovir may cause cancer. Talk to your doctor about your individual risk.
Valganciclovir should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take the medication for longer than your doctor has prescribed.Take each dose with a full glass of water. Take valganciclovir with food. Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.
It is very important to take this medicine at the same time each day. To best treat your condition, you should not miss any doses.Do not crush or break a valganciclovir tablet. Do not use a tablet that has been accidentally broken. The medicine from a broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken tablet, ask your doctor or pharmacist how to dispose of the tablet safely.
You should have your eyes checked at least every 4 to 6 weeks while you are using valganciclovir. Your doctor may want you to have eye exams more often.
Valganciclovir can lower the blood cells in your body that help you fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.Store valganciclovir at room temperature away from moisture and heat.
See also: Valganciclovir dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.
Symptoms of a valganciclovir overdose may include seizure (convulsions), kidney failure (urinating more or less than usual, blood in the urine, swelling or numbness in your hands or feet, pain in your lower back or sides), or signs of liver damage (yellowing of the skin or eyes, severe and sudden stomach pain, diarrhea, vomiting).
If you have AIDS, follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles.Use birth control to prevent pregnancy while you are using valganciclovir, whether you are a man or a woman. Valganciclovir use by either parent can cause birth defects. If you are a man, use a condom to keep from causing a pregnancy while you are taking valganciclovir. Continue using condoms for at least 90 days after you stop taking valganciclovir. Valganciclovir can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
easy bruising, unusual bleeding;
numbness or tingling in a part of the body;
signs of infection (fever, chills, body aches, flu symptoms); or
Other, less serious side effects may be more likely to occur. Continue to take valganciclovir and talk to your doctor if you experience:
mild nausea, vomiting, diarrhea, stomach pain;
sleepiness or dizziness;
weakness, lack of coordination;
tremor (uncontrolled shaking); or
sleep problems (insomnia).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for CMV Retinitis:
Induction dose: 900 mg orally two times a day for 21 daysMaintenance dose: 900 mg orally once a day
Usual Adult Dose for CMV Prophylaxis:
Kidney, heart, or kidney-pancreas transplant patients: 900 mg orally once a day starting within 10 days of transplantation until 100 days posttransplantation
Usual Pediatric Dose for CMV Prophylaxis:
Kidney or heart transplant patients:4 months to 16 years: The recommended once daily oral dose of valganciclovir starting within 10 days of transplantation until 100 days posttransplantation is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the following equation:Pediatric dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula), whereMosteller BSA (m2) = the square root of (height [cm] x weight [kg] divided by 3600)Schwartz CrCl (mL/min/1.73 m2) = k x height (cm) divided by serum creatinine (mg/dL)where k =Less than 1 year: 0.451 to less than 2 years: 0.45 (note: k value is 0.45 instead of the typical value of 0.55)2 to less than 13 years (boys) and 2 to 16 years (girls): 0.5513 to 16 years (boys): 0.7All calculated doses should be rounded to the nearest 25 mg increment for actual deliverable dose, up to maximum dose of 900 mg. Valganciclovir oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, valganciclovir tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, one 450 mg tablet may be taken for calculated doses between 405 mg and 495 mg.
Before taking valganciclovir, talk to your doctor if you are using any of the following drugs:
zidovudine (Retrovir, AZT);
didanosine (Videx, ddI);
drugs that weaken your immune system (such as cancer medicine or steroids); or
probenecid (Benemid, Probalan).
If you are using any of these drugs, you may not be able to take valganciclovir, or you may require a dosage adjustment or special monitoring.
There may be other drugs not listed that can affect valganciclovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.