VALGANCICLOVIR

COMMON BRAND NAME(S): Valcyte

GENERIC NAME(S): VALGANCICLOVIR HCL

 

Description: Valganciclovir is an antiviral drug that prevents the Cytomegalovirus cells from multiplying in your body.

Pharmacokinetics:

Absorption: Well absorbed from the GI tract. Increased absorption if taken w/ food. Bioavailability: Approx 60%. Time to peak plasma concentration: 1-3 hr.

Distribution: Widely distributed to all tissue including CSF and ocular tissue.

Metabolism: Converted to ganciclovir by rapid first-pass intestinal or hepatic metabolism.

Excretion: Via urine as ganciclovir.

Indications:

It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants.

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 drug may also be used to help prevent CMV disease in patients receiving cancer chemotherapy treatment.

Contraindications:

Should not be given to patients who have allergic reactions with the drug.

How to use valganciclovir

Dosage: Take 900 mg of 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.
  • 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.
  • This medication works best when the amount of drug in your body is kept at a constant level.
  • 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.

Anemia: 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. 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).

Decreased sperm production: Ganciclovir has caused decreased sperm production in animals and may decrease the ability of men to father a baby.

Tumors: 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.

Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Common side effects:

  • diarrhea,
  • upset stomach,
  • dizziness,
  • drowsiness,
  • unsteadiness, or
  • shaking (tremors)

Tell your doctor immediately if any of these unlikely but serious side effects occur:

  • mental/mood changes (such as confusion, hallucinations),
  • change in the amount of urine,
  • seizures

Precautions:

General:

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug.

  • Allergy: Before taking valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; or if you have any other allergies.
  • Medical History: Before using this medication, tell your doctor or pharmacist if you had: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment.
  • Immunizations: Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
  • Hematologic toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia, and aplastic anemia have been reported in patients treated with VALCYTE or ganciclovir. VALCYTE should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL.
  • Impairment of fertility: Based on animal studies, this medication may reduce fertility in men and women.

Pregnancy Risk: Category C.  During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Women of child-bearing age who are taking valganciclovir should use reliable forms of birth control (such as birth control pills and condoms) during treatment and for at least 30 days after stopping the medication.

Breastfeeding: It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.

Interactions:

  • Some products that may interact with this drug include: didanosine, imipenem/cilastatin, mycophenolate, probenecid.
  • You may be taking other drugs that decrease bone marrow function and lower your number of blood cells (such as cancer chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other drugs that may cause kidney problems (such as cyclosporine). Your doctor or pharmacist will monitor you closely and adjust your medications to decrease your risk of serious side effects.
  • Valganciclovir is very similar to ganciclovir. Do not use medications containing ganciclovir while using valganciclovir.

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, kidney function, eye exams) should be performed often to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store the tablets at room temperature away from light and moisture. Do not store in the bathroom.

Store the liquid form of this medication in the refrigerator. Do not freeze. The medication expires 49 days after it was prepared by the pharmacy.

Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Available Brands

  • Valcyte [ Roche ]

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