"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
COMMON BRAND NAME(S): Valcyte
WARNING: Valganciclovir turns into the drug ganciclovir inside your body. Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems. Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Seek immediate medical attention if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as fever, chills, cough, persistent sore throat), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds).
Ganciclovir has caused decreased sperm production in animals and may decrease the ability of men to father a baby.
Ganciclovir has caused tumors in laboratory animals. Although there is no information in humans, valganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.
USES: Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body.
Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness.
Valganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to help prevent CMV disease in patients receiving cancer chemotherapy treatment.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking valganciclovir and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with food, usually 1 to 2 times a day or as directed by your doctor. Swallow the tablets whole. Do not crush or break the tablets.
If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using the special measuring device provided. Do not use a household spoon because you may not get the correct dose.
Wash your hands well after handling this drug. Avoid contact with broken/crushed tablets and the liquid form of this medication on your skin, in your mucous membranes and eyes, and avoid breathing in the dust from the tablets. If contact should occur, wash the area thoroughly with soap and water. If this medication gets in your eyes, rinse them thoroughly with plain water.
Do not throw this medication in the garbage or down the drain. Special disposal is required for this medication. Contact your pharmacist for more information.
The dosage and length of treatment is based on your medical condition and response to treatment. In children, the dosage is calculated by your doctor using body size and kidney function. Accidental overdose can occur in a child or a teenager with a low body weight or decreased kidney function. Do not give a dose of more than 900 milligrams to a child or teenager.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.
Continue taking this medication exactly as prescribed by your doctor. Do not change your dose or stop taking it even for a short time unless directed to do so by your doctor. Changing or skipping your dose without approval from your doctor may increase the risk of side effects or make the infection worse.
Do not take ganciclovir instead of valganciclovir on your own without consulting your doctor or pharmacist. The effects and the dosages of ganciclovir and valganciclovir are not equal.
Keep all medical and laboratory appointments.
Tell your doctor if your condition worsens (such as worsening vision).
Additional Valcyte Information
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