Valcyte® (valganciclovir hydrochloride) is indicated for the treatment of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
Valcyte is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Adult patients should use Valcyte tablets, not Valcyte for oral solution. Valcyte for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient.
Valcyte is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation.
Adult Patients: The most common adverse reactions and laboratory abnormalities reported in at least one indication by ≥20% of adult patients are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.
Pediatric Patients: The most common adverse reactions and laboratory abnormalities reported in ≥20% of pediatric solid organ transplant recipients are diarrhea, pyrexia, hypertension, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
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.