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VALCYTE (VALGANCICLOVIR HCL)
- CMV retinitis in AIDS patients
- Prevention of CMV disease after cardiac transplantation
- Prevention of CMV disease after kidney transplantation
- Prevention of CMV disease in kidney-pancreas transplant
- Valganciclovir Tablet
- Valganciclovir Oral Solution
- Valcyte Tablet
- Valcyte Oral Solution
- By Indication
valganciclovir 450 mg tablet
- 2 tablets (900 mg) by oral route once daily with food
valganciclovir 50 mg/mL oral solution
- Dosage information is not available
450 mg tablet
- 2 tablets (900 mg) by oral route once daily with food
50 mg/mL oral solution
- Dosage information is not available
CMV retinitis in AIDS patients
- 2 tablets (900 mg) by oral route once daily with food
Prevention of CMV disease after cardiac transplantation
- 2 tablets (900 mg) by oral route once daily with food
Prevention of CMV disease after kidney transplantation
- 2 tablets (900 mg) by oral route once daily with food
Prevention of CMV disease in kidney-pancreas transplant
- 2 tablets (900 mg) by oral route once daily with food
- None
Contraindicated
- abacavir-lamivudine-zidovudine
- clozapine
- Clozaril
- Combivir
- deferiprone
- Fazaclo
- Ferriprox
- imipenem-cilastatin
- lamivudine-zidovudine
- Primaxin Iv
- Retrovir
- Trizivir
- Versacloz
- zidovudine
Severe
Moderate
- Atripla
- Complera
- efavirenz-emtricitabin-tenofov
- elvitegr-cobicist-emtric-tenof
- emtricitab-rilpivirine-tenofov
- emtricitabine-tenofovir
- Stribild
- tenofovir disoproxil fumarate
- Truvada
- Viread
- Aplastic anemia
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Lactating mother
- Severe bone marrow depression
Contraindicated
- Acute renal failure
- Anemia
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Dehydration
- Granulocytopenic disorder
- Neutropenic disorder
- Pregnancy
- Thrombocytopenic disorder
Severe
Moderate
- None
VALCYTE (VALGANCICLOVIR HCL)
- CMV retinitis in AIDS patients
- Prevention of CMV disease after cardiac transplantation
- Prevention of CMV disease after kidney transplantation
- Prevention of CMV disease in kidney-pancreas transplant
- Anemia
- Fever
- Neutropenic disorder
- Retinal detachment
- Thrombocytopenic disorder
- Acute abdominal pain
- Diarrhea
- Headache disorder
- Insomnia
- Nausea
- Paresthesia
- Peripheral neuropathy
- Tremor
- Urinary tract infection
- Vomiting
More Frequent
Severe
Less Severe
- Hallucinations
- Hemorrhage
- Hyperkalemia
- Hypersensitivity drug reaction
- Hypophosphatemia
- Kidney disease with reduction in GFR
- Pancytopenia
- Seizure disorder
- Acute confusion
- Agitation
- Candidiasis
- Hematuria
- Night sweats
- Ocular pain
- Peripheral edema
- Symptoms of anxiety
- Weight loss
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute renal failure
- Agranulocytosis
- Anaphylaxis
- Aplastic anemia
- Ascites
- Drug-induced psychosis
- Dyspnea
- Granulocytopenic disorder
- Hypertension
- Leukopenia
- Pleural effusions
Less Severe
- Abdominal distension
- Acne vulgaris
- Anorexia
- Arthralgias
- Back pain
- Constipation
- Cough
- Cramps
- Depression
- Dizziness
- Dyspepsia
- Dysuria
- Edema
- Fatigue
- Female infertility
- General weakness
- Oligospermia
- Pain
- Pharyngitis
- Pruritus of skin
- Skin inflammation
- Upper respiratory infection
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Valganciclovir
Safety and efficacy not established age < 1 month.
Adhere to dosing guidelines and monitor for neutropenia, infection and signs of overdose; abdominal pain, vomiting, diarrhea, tremor, or seizure.
- 1 Day – 29 Days
- Safety and efficacy not established age < 1 month.
- Adhere to dosing guidelines and monitor for neutropenia, infection and signs of overdose; abdominal pain, vomiting, diarrhea, tremor, or seizure.
- 30 Days – 18 Years
- Safety and efficacy not established age < 1 month.
- Adhere to dosing guidelines and monitor for neutropenia, infection and signs of overdose; abdominal pain, vomiting, diarrhea, tremor, or seizure.
Valganciclovir
- Severity Level:
D
- Additional Notes: Insufficient human data; teratogenic in animals at 2 times the mrhd
Contraindicated
Valganciclovir
None
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | None |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Valganciclovir
Renal-Decrease dosage for CrCL<60 mL/min. Acute renal failure may occur with or without renal failure in the elderly. Insure adequate hydration.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | N | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- 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.<br /><br />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).<br /><br /> Ganciclovir may reduce fertility in men and women. It may also harm an unborn baby. Talk to your doctor for more details.<br /><br /> 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.
| CMV retinitis in AIDS patients | |
| B25.9 | Cytomegaloviral disease, unspecified |
| H32 | Chorioretinal disorders in diseases classified elsewhere |
| Prevention of CMV disease after cardiac transplantation | |
| Z94.1 | Heart transplant status |
| Z94.3 | Heart and lungs transplant status |
| Prevention of CMV disease after kidney transplantation | |
| Z94.0 | Kidney transplant status |
| Prevention of CMV disease in kidney-pancreas transplant | |
| Z94.0 | Kidney transplant status |
| Z94.83 | Pancreas transplant status |
| 0-9 | A-Z |
|---|---|
| B25.9 | Cytomegaloviral disease, unspecified |
| H32 | Chorioretinal disorders in diseases classified elsewhere |
| Z94.0 | Kidney transplant status |
| Z94.0 | Kidney transplant status |
| Z94.1 | Heart transplant status |
| Z94.3 | Heart and lungs transplant status |
| Z94.83 | Pancreas transplant status |
Formulary Reference Tool