Prevention of CMV in Pediatric Heart, Kidney, or Liver Transplantation: Sixty-three children, 4 months to 16 years of age, who had a solid organ transplant (kidney 33, liver 17, heart 12, and kidney/liver 1) and were at risk for developing CMV disease, were enrolled in an open-label, safety, and pharmacokinetic study of oral valganciclovir (valganciclovir hydrochloride for oral solution or tablets). Patients received valganciclovir once daily within 10 days after transplant until a maximum of 100 days post- transplant. The daily doses of valganciclovir were calculated at each study visit based on body surface area and a modified creatinine clearance [see Dosage and Administration (2.3)].
The pharmacokinetics of ganciclovir were similar across organ transplant types and age ranges. The mean daily ganciclovir exposures in pediatric patients were somewhat increased relative to those observed in adult solid organ transplant patients receiving valganciclovir 900 mg once daily, but were within the range considered safe and effective in adults [see Clinical Pharmacology (12.3)]. No case of CMV syndrome or tissue-invasive CMV disease was reported within the first six months post-transplantation.
Prevention of CMV in Pediatric Kidney Transplantation: Fifty-seven children, 1 to 16 years of age, who had a renal transplant and were at risk for developing CMV disease, were enrolled in an open-label tolerability study of oral valganciclovir (valganciclovir hydrochloride for oral solution or tablets). Patients received valganciclovir once daily within 10 days after transplant until a maximum of 200 days post-transplant. The daily doses of valganciclovir were calculated at each study visit based on body surface area and a modified creatinine clearance [see Dosage and Administration (2.3)]. No case of CMV syndrome or tissue-invasive CMV disease was reported within the first 12 months post-transplantation.
1. Brion LP, Fleischman AR, McCarton C, Schwartz GJ. A simple estimate of glomerular filtration rate in low birth weight infants during the first year of life: noninvasive assessment of body composition and growth. J of Ped 1986: 109(4): 698 707.
2. NIOSH . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP, Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2014-138 (Supersedes 2012-150).
valganciclovir hydrochloride for oral solution: Supplied as a white to off-white powder blend for constitution, forming a colorless to brownish-yellow tutti-frutti flavored solution. Available in amber colored glass bottles containing approximately 100 mL of solution after constitution. Each bottle can deliver up to a total of 88 mL of solution. Each bottle is supplied with a bottle adapter and 2 oral dispensers (NDC 70069-810-01).
Prior to dispensing to the patient, valganciclovir hydrochloride for oral solution must be prepared by the pharmacist [see Dosage and Administration (2.4)].
Store dry powder at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].
Store constituted solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 49 days. Do not freeze.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Adverse Reactions
Inform patients that valganciclovir may cause granulocytopenia (neutropenia), anemia, thrombocytopenia and elevated creatinine levels and that dose modification or discontinuation of dosing may be required. Complete blood counts, platelet counts, and creatinine levels should be monitored frequently during treatment [see Warnings and Precautions (5.1)].
Pregnancy and Contraception
Inform females of reproductive potential that valganciclovir causes birth defects in animals. Advise them to use effective contraception during and for at least 30 days following treatment with valganciclovir. Similarly, advise males to use condoms during and for at least 90 days following treatment with valganciclovir [see Use in Specific Populations (8.1,8.3)].
Advise patients that valganciclovir is considered a potential carcinogen [see Nonclinical Toxicity (13.1)].
Advise mothers not to breast-feed if they are receiving valganciclovir because of the potential for hematologic toxicity and cancer in nursing infants, and because HIV can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].
Impairment of Cognitive Ability
Inform patients that tasks requiring alertness may be affected including the patient’s ability to drive and operate machinery as seizures, dizziness, and/or confusion have been reported with the use of valganciclovir [see Adverse Reactions (6.1)].
Use in Patients with CMV Retinitis
Inform patients that valganciclovir is not a cure for CMV retinitis, and they may continue to experience progression of retinitis during or following treatment. Advise patients to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with valganciclovir. Some patients will require more frequent follow-up.
Inform adult patients that they should use valganciclovir tablets, not valganciclovir hydrochloride for oral solution [see Dosage and Administration (2.1)].
Inform patients to take valganciclovir with food to maximize bioavailability.
Brands listed are the trademarks of their respective owners.
Manufactured By: Manufactured for:
Granules Pharmaceuticals Inc. Somerset Therapeutics, LLC
Chantilly, VA 20151 Hollywood, FL 33024
|PATIENT INFORMATION Valganciclovir (val-gan-SYE-kloe-ver) hydrochloride for oral solution|
| What is the most important information I should know about valganciclovir? Valganciclovir can cause serious side effects, including: |
|What is valganciclovir? Valganciclovir is a prescription antiviral medicine.In adults, valganciclovir tablets are used: |
|Do not take valganciclovir if you have had a serious allergic reaction to valganciclovir, ganciclovir or any of the ingredients of valganciclovir. See the end of this leaflet for a list of the ingredients in valganciclovir.|
|Before you take valganciclovir, tell your healthcare provider about all of your medical conditions, including if you: |
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Valganciclovir and other medicines may affect each other and cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist. |
|How should I take valganciclovir? |
|What should I avoid during treatment with valganciclovir? Valganciclovir can cause seizures, dizziness, and confusion. You should not drive a car or operate machinery until you know how valganciclovir affects you.|
|What are the possible side effects of valganciclovir? Valganciclovir may cause serious side effects, including: See “What is the most important information I should know about valganciclovir? ” The most common side effects of valganciclovir in adults include: |
| How should I store valganciclovir? |
|General information about the safe and effective use of valganciclovir. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valganciclovir for a condition for which it was not prescribed. Do not give valganciclovir to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about valganciclovir that is written for health professionals.|
|What are the ingredients in valganciclovir? Active ingredient: valganciclovir hydrochlorideInactive ingredients for oral solution: are mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring.|
Brands listed are the trademarks of their respective owners.
Granules Pharmaceuticals Inc., Chantilly, VA 20151
For more information about valganciclovir, please contact Granules Pharmaceuticals Inc. at 1-877-770-3183.
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