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What is Valcyte?
VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.
VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink.
VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring.
Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of CHNO∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6.
The chemical structure of valganciclovir HCl is:
All doses in this insert are specified in terms of valganciclovir.
What does Valcyte look like?
What are the available doses of Valcyte?
What should I talk to my health care provider before I take Valcyte?
How should I use Valcyte?
VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
VALCYTE for oral solution and tablets should be taken with food (, ).
VALCYTE tablets should not be broken or crushed ().
Adult patients should use VALCYTE tablets, not VALCYTE for oral solution ().
Adults with renal impairment: Adjust dose based on creatinine clearance. For adult patients receiving hemodialysis a dose recommendation cannot be given (, , ).
What interacts with Valcyte?
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What are the warnings of Valcyte?
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What are the precautions of Valcyte?
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What are the side effects of Valcyte?
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What should I look out for while using Valcyte?
VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation
What might happen if I take too much Valcyte?
How should I store and handle Valcyte?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Product: 50436-0922NDC: 50436-0922-1 30 CAPSULE in a BOTTLENDC: 50436-0922-3 90 CAPSULE in a BOTTLEProduct: 50436-0922NDC: 50436-0922-1 30 CAPSULE in a BOTTLENDC: 50436-0922-3 90 CAPSULE in a BOTTLEProduct: 50436-0922NDC: 50436-0922-1 30 CAPSULE in a BOTTLENDC: 50436-0922-3 90 CAPSULE in a BOTTLE
Chemical StructureNo Image found
Valganciclovir is an antiviral drug with activity against CMV .
Non-Clinical ToxicologyVALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation
Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.
Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including 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. VALCYTE should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered.
Due to the frequency of neutropenia, anemia, and thrombocytopenia in patients receiving VALCYTE , complete blood counts with differential and platelet counts should be performed frequently, especially in patients with renal impairment and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment. Increased monitoring for cytopenias may be warranted if therapy with oral ganciclovir is changed to VALCYTE, because of increased plasma concentrations of ganciclovir after VALCYTE administration .
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with VALCYTE tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with VALCYTE for oral solution or tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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