Valganciclovir Hydrochloride For Oral (Page 8 of 9)

14.2 Pediatric Patients

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 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.

15 REFERENCES

  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 [2014]. 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).

16 HOW SUPPLIED/STORAGE AND HANDLING

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 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 0591-2579-20)

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.

17 PATIENT COUNSELING INFORMATION

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)].

Carcinogenicity

Advise patients that valganciclovir is considered a potential carcinogen [see Nonclinical Toxicity (13.1)].

Lactation

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)].

Infertility

Advise patients that valganciclovir may cause temporary or permanent female and male infertility [see Warnings and Precautions (5.3), Use in Specific Populations (8.3)].

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.

Administration

Inform adult patients that they should use valganciclovir hydrochloride 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:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 1/2019

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:

  • Blood and bone marrow problems. Valganciclovir can affect the bone marrow lowering the amount of your white blood cells, red blood cells, and platelets and may cause serious and life-threatening problems.

  • Kidney failure. Kidney failure may happen in people who are elderly, people who take valganciclovir with certain other medicines, or people who are not adequately hydrated.

  • Fertility problems. Valganciclovir may lower sperm count in males and cause fertility problems. Valganciclovir may also cause fertility problems in women. Talk to your healthcare provider if this is a concern for you.

  • Birth defects. Valganciclovir causes birth defects in animals. It is not known if valganciclovir causes birth defects in people. If you are a female who can become pregnant, you should use effective birth control during treatment with valganciclovir and for at least 30 days after treatment. If you are pregnant, talk to your healthcare provider before starting treatment with valganciclovir. If you are a female who can become pregnant, you should have a pregnancy test done before starting valganciclovir.

  • Tell your healthcare provider right away if you become pregnant during treatment with valganciclovir.
  • Males should use condoms during treatment with valganciclovir, and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your healthcare provider if you have questions about birth control.
  • Cancer. Valganciclovir causes cancer in animals and may potentially cause cancer in people.

    Your healthcare provider will do regular blood test during treatment with valganciclovir to check you for side effects. Your healthcare provider may change your dose or stop treatment with valganciclovir if you have serious side effects.

What is valganciclovir?

Valganciclovir is a prescription antiviral medicine.

Valganciclovir does not cure CMV retinitis. You may still get retinitis or worsening of retinitis during or after treatment with valganciclovir It is important to stay under a healthcare provider’s care and have your eyes checked at least every 4 to 6 weeks during treatment with valganciclovir.

In children, valganciclovir hydrochloride for oral solution is used:

  • to prevent CMV disease in children 4 months to 16 years of age who have received a kidney transplant and have a high risk for getting CMV disease.

  • to prevent CMV disease in children 1 month to 16 years of age who have received a heart transplant and have a high risk for getting CMV disease.

It is not known if valganciclovir is safe and effective in children for prevention of CMV disease in liver transplant, in kidney transplant in infants less than 4 months of age, in heart transplant in infants less than 1 month of age, in children with AIDS who have CMV retinitis, and in infants with congenital CMV infection.

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:

  • have low blood cell counts

  • have kidney problems

  • are receiving hemodialysis

  • are receiving radiation treatment

  • are pregnant or plan to become pregnant. See “What is the most important information I should know about valganciclovir?”

  • are breastfeeding or plan to breastfeed. It is not known if valganciclovir passes into your breast milk. You should not breastfeed if you take valganciclovir.

    • You should not breastfeed if you have Human Immunodeficiency Virus (HIV-1) because of the risk of passing HIV-1 to your baby.

    • Talk to your healthcare provider about the best way to feed your baby.

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.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with valganciclovir.

  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take valganciclovir with other medicines.

How should I take v alganciclovir?

  • Take valganciclovir exactly as your healthcare provider tells you. Your dose of valganciclovir will depend on your medical condition.

  • Adults should only take valganciclovir hydrochloride tablets. Children may take valganciclovir hydrochloride oral solution.

  • Take valganciclovir with food.

  • Avoid contact with your skin or eyes. If you come in contact with the contents of the oral solution, wash your skin well with soap and water or rinse your eyes well with plain water.

  • If your child is prescribed valganciclovir hydrochloride for oral solution, your pharmacist will give you oral dosing dispensers to measure your child’s dose of valganciclovir hydrochloride for oral solution. To be sure you receive the prescribed dose, it is important to use the dispenser provided to you. See the detailed Instructions for Use below for information about how to take valganciclovir hydrochloride for oral solution. Ask your pharmacist if you have any questions. If you lose or damage your oral dispensers and cannot use them, contact your pharmacist.

  • If you take too much valganciclovir, call your healthcare provider or go to the nearest hospital emergency room right away.

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:

  • diarrhea

  • fever

  • fatigue

  • nausea

  • shaky movements (tremors)

  • low white cell, red cell and platelet cell counts in blood tests

  • headache

  • sleeplessness

  • urinary tract infection

  • vomiting

The most common side effects of valganciclovir in children include:

  • diarrhea

  • fever

  • upper respiratory tract infection

  • urinary tract infection

  • vomiting

  • low white blood cell counts in blood tests

  • headache

These are not all the possible side effects of valganciclovir.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store valganciclovir?

  • Store valganciclovir hydrochloride for oral solution in the refrigerator between 36° to 46°F (2° to 8°C), for no longer than 49 days.

  • Do not freeze.

  • Do not keep valganciclovir that is out of date or that you no longer need.

    Keep valganciclovir and all medicines out of the reach of children.

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 hydrochloride
Inactive ingredients for Oral Solution: mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring.

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.Parsippany, NJ 07054 USA

Rev. A 1/2019

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