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USP DI Vol. II - VALGANCICLOVIR (Systemic)

VALGANCICLOVIR (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Valcyte

Category

  • Antiviral, systemic

Description

Valganciclovir (val-gan-SYE-kloh-veer)is an antiviral. It is used to treat infections caused by viruses.

Valganciclovir is used to treat the symptoms of cytomegalovirus (CMV) retinitis,an infection in the eyes of people with acquired immunodeficiency syndrome(AIDS). Valganciclovir will not cure this eye infection, but it may help tokeep the symptoms from becoming worse.

This medicine may cause some serious side effects, including anemia andother blood problems. Before you begin treatment with valganciclovir, youand your doctor should talk about the good this medicine will do as well asthe risks of using it.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

    Oral
  • Tablets (U.S.)


Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For valganciclovir, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to valganciclovir or ganciclovir. Also tell your healthcare professional if you are allergic to any other substances, such as foods,preservatives, or dyes.

Pregnancy?Valganciclovir has not been studied in pregnantwomen. However, studies in animals have shown that valganciclovir causes birthdefects and other problems. Use of valganciclovir during pregnancy shouldbe avoided whenever possible. The use of birth control is recommended duringvalganciclovir therapy. Men should use a condom while taking valganciclovir,and for at least 90 days following treatment.

Breast-feeding?It is not known whether valganciclovir passesinto the breast milk. However, valganciclovir is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of valganciclovirin children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof valganciclovir in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be used together at all, in other casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose, or other precautionsmay be necessary. When you are taking valganciclovir, it is especially importantthat your health care professional know if you are taking any of the following:

  • Amphotericin B by injection (e.g., Fungizone) or
  • Antineoplastics (cancer medicine) or
  • Antithyroid agents (medicine for overactive thyroid) or
  • Azathioprine (e.g., Imuran) or
  • Chloramphenicol (e.g., Chloromycetin) or
  • Colchicine or
  • Cyclophosphamide (e.g., Cytoxan) or
  • Flucytosine (e.g., Ancobon) or
  • Interferon (e.g., Intron A, Roferon-A) or
  • Mercaptopurine (e.g., Purinethol) or
  • Methotrexate (e.g., Mexate) or
  • Plicamycin (e.g., Mithracin) or
  • Zidovudine (e.g., AZT, Retrovir)?Caution should be used ifthese medicines and valganciclovir are used together; receiving valganciclovirwhile you are using these medicines may make anemia and other blood problemsworse
  • Didanosine (e.g., Videx) or
  • Mycophenolate (e.g., CellCept) or
  • Probenecid (e.g., Benemid)?Use of these medicines with valganciclovirmay increase the chance of side effects

Other medical problems?The presence of other medical problems may affect the use of valganciclovir.Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease?Valganciclovir may build up in the blood inpatients with kidney disease, increasing the chance of side effects
  • Low platelet count or
  • Low red blood cell count or
  • Low white blood cell count?Valganciclovir may make these blooddiseases worse

Proper Use of This Medicine

It is important that you takevalganciclovir tablets with food. This is to make sure the medicineis fully absorbed into the body and will work properly.

To get the best results, valganciclovir must be givenfor the full time of treatment. Also, this medicine works best whenthere is a constant amount in the blood. To help keep the amount constant,valganciclovir must be taken on a regular schedule.

Dosing?The doseof valganciclovir will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of valganciclovir. If your dose is different, do not change it unless your doctor tellsyou to do so.

  • For oral dosage form (tablets):
    • For treatment of CMV in the eyes:
      • Adults?To start, 900 milligrams (mg) two times a day withfood. As you improve the dose may be changed to 900 mg once a day with food.
      • Children?Use and dose must be determined by your doctor.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that yourdoctor check you at regular visits for any blood problems that maybe caused by this medicine.

It is also very important that your ophthalmologist(eye doctor) check your eyes every 4 to 6 weeks since it is still possiblethat you may have some loss of eyesight during valganciclovir treatment.

Valganciclovir can lower the number of white blood cells in your blood,increasing the chance of getting an infection. It can also lower the numberof platelets, which are necessary for proper blood clotting. If this occurs,there are certain precautions you can take to reduce the risk of infectionor bleeding:

  • If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
  • Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.

Be careful not to handle crushed or broken tablets. If you have contactwith broken or crushed tablets, wash your skin with soap and clear water.If the medicine gets into your eyes, rinse them with clear water.


Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your doctorimmediately if any of the following side effects occur:

      More common

        Black, tarry stools; blood in urineor stools; chills; cough; fever; hoarseness; lower back or side pain; painful ordifficult urination; pale skin; pinpoint red spots on skin; sore throat; seeing flashes or sparks of light; seeing floating spots before the eyes; troubled breathing; ulcers, sores, or white spots in the mouth; unusual bleeding or bruising; unusualtiredness or weakness; veil or curtain appearingacross part of vision

      Less common

        Changes in facial skin color; fast orirregular breathing; hives, itching, and skin rash; large, hive-like swellings on eyelids, face, lips,mouth, and/or tongue; puffiness or swelling of theeyelids or around the eyes; runny or stuffy nose; shortness of breath; tightness in chest and/or wheezing

    Check with your doctor as soon as possible if any of thefollowing side effects occur:

      Less common

        Confusion; false beliefs; feeling, hearing, or seeing things that are not there; illogical thinking; seizures

    Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome.

      More common

        Abdominal pain; diarrhea; headache; nausea and vomiting; numbness, tingling, pain, or weakness of hands or feet; sleeplessness; tingling, burning, orprickly sensations; trouble sleeping

      Less common

        Agitation

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Developed: 06/27/2001