Adult patients: Valcyte® (valganciclovir hydrochloride) tablets are an antiviral prescription medication given to patients who have a high chance of developing cytomegalovirus (CMV) disease after receiving a heart, kidney, or kidney-pancreas transplant. Valcyte helps prevent CMV disease in these patients.
Pediatric patients: Valcyte tablets or oral solution is prescribed for the prevention of CMV disease in patients that are 4 months to 16 years of age who have received a kidney transplant or in patients that are 1 month to 16 years of age who have received a heart transplant and have a high chance of developing CMV disease.
Valcyte can affect blood cells and bone marrow causing serious and life-threatening problems. Patients’ doctors may do regular blood tests to check blood cells and may change the dose or tell patients to stop taking Valcyte. Patients must tell their doctor right away if they have any unexpected bruising or bleeding, unusual tiredness, fever, lack of energy, dizziness, or fainting.
Valcyte may cause cancer. Valcyte causes cancer in animals. It is not known if Valcyte causes cancer in people.
Valcyte may cause birth defects. Pregnant women who take Valcyte have a higher chance of having a baby with birth defects. Valcyte should not be used during pregnancy.
Women who can get pregnant must use a reliable method of birth control during treatment with Valcyte and continue birth control for at least 30 days after they stop taking Valcyte. Women must tell their doctor right away if they get pregnant or plan to become pregnant while taking Valcyte.
Men must use a condom during treatment with Valcyte, and for at least 90 days after treatment, if their partner can get pregnant. Patients should talk to their doctor if they have questions about birth control.
Valcyte may lower the amount of sperm in a man’s body and cause fertility problems. Valcyte may also cause fertility problems in women.
Patients should not take Cytovene-IV if they are taking Valcyte. Patients could overdose and become very sick if Valcyte is taken with Cytovene-IV. Patients should talk to their doctor or pharmacist if they have questions about their medicine.
Patients should not receive Valcyte if they are allergic to any of its ingredients or if they have ever had a serious reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte may include cold, sudden trouble breathing, wheezing, hives all over the body, swelling around the mouth, or feeling anxious.
Valcyte can affect the kidneys, including serious problems such as kidney failure. Patients’ doctors may do regular blood tests to check kidney function while patients are taking Valcyte. The doctor may adjust the dose based on these tests.
Patients must not take Valcyte tablets if they are receiving hemodialysis. Patients should talk to their doctor if they are receiving hemodialysis.
Before starting Valcyte, patients should tell their doctor if they:
Valcyte can cause seizures, sleepiness, dizziness, and confusion. Patients should not drive a car or operate other dangerous machinery until they know how Valcyte affects them.
Patients must take Valcyte exactly as their doctor prescribes it. Adult patients should use Valcyte tablets, not Valcyte for oral solution. Valcyte must be taken with food. Do not break or crush tablets.
Common side effects of Valcyte in adults and children include: diarrhea, nausea, vomiting, fever, shaky movements (tremors), low blood cell counts in a blood test, and rejection of the transplanted organ (graft).
Other common side effects in children include: headache, upper respiratory tract infection, and urinary tract infection.
Patients should tell their doctor if they have any side effect that bothers them or that does not go away.
Patients should call their doctor for medical advice about side effects. Consumers may report side effects to the FDA at 1-800-FDA-1088 or to Genentech at 1-888-835-2555.
Please see full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.
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By using the Valcyte® $15 Co-pay Card Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.
This co-pay card is valid only for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing government coverage during their enrollment period will no longer be eligible for the program.
This Co-pay Card Program is not health insurance or a benefit plan. Distribution or use of the co-pay card does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all Co-pay Card Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-pay Card Program, as may be required.
The co-pay card is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other healthcare or pharmaceutical assistance programs (such as Genentech® Access to Care Foundation (GATCF) or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the co-pay card agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer.
The co-pay card will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Co-pay Card Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this Co-pay Card Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This co-pay card is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this co-pay card must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the co-pay card as provided for under the applicable insurance or as otherwise required by contract or law. The co-pay card may not be sold, purchased, traded, or offered for sale, purchase, or trade. The co-pay card is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient’s ability to meet and maintain all requirements as set forth by the program. Genentech will periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law, and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (e.g. MA, CA).
The patient or their guardian must be 18 years or older to receive Co-pay Card Program assistance. This Co-pay Card Program is (1) void if the card is reproduced; (2) void where prohibited by law; (3) only valid in the United States and Puerto Rico; and (4) only valid for Genentech products. Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or Genentech’s products to patients. Genentech reserves the right to rescind, revoke, or amend the program without notice at any time.