New FDA Approved Generic: Valcyte

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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After a long wait, generic Valcyte (valganciclovir) has been approved and will be available soon! For more information on why the generic was delayed, see our previous post here.

Valcyte is used for the prevention and treatment of cytomegalovirus (CMV). CMV is a common virus related to the family of viruses that cause chickenpox, herpes simplex, and mono.

There is no cure for CMV—once you have been infected, the virus will be in your body for life. However, it is not always active, and medications like valganciclovir can help treat CMV in children or anyone with a weakened immune system.

How are Valcyte and valganciclovir available?

Brand name Valcyte is available both as a 450 mg tablet and a 50 mg/ml oral solution (which will be mixed by the pharmacist before you receive it).

At the moment, only the 450 mg tablet has generic approval.

How is valganciclovir usually taken, and who is it for?

For adults, valganciclovir is indicated for prevention of CMV in kidney, heart, and kidney-pancreas adult transplant patients at high risk. For heart or kidney-pancreas transplant patients, the usual maintenance dose is two tablets per day for 100 days post-transplantation; for kidney transplant patients it’s 200 days.

Valganciclovir is indicated for the treatment of CMV of the eye (retinitis) in adults with AIDS. The usual maintenance dose is also two tablets taken once daily.

For children four months to 16 years of age, valganciclovir is indicated for the prevention of CMV in kidney and heart transplant patients at high risk. The maintenance dose is calculated and based on body surface area for children.

What type of medication is valganciclovir?
Valganciclovir is a CMV nucleoside analogue DNA polymerase inhibitor. This is basically a fancy term for an antiviral.

It works by interfering with the production of a particular virus within the body. This stops the development and spreading of the virus throughout the body and gives your immune system a chance to recover and fight back.

What are the most common side effects?

The most common side effects of this medication for both children and adults include but are not limited to: diarrhea, nausea, vomiting, fever, shaky movement, low blood cell counts, and rejection of the transplanted organ.

Valganciclovir can also make you feel sleepy, dizzy, unsteady, confused, or cause seizures. You shouldn’t operate heavy machinery, drive, or participate in dangerous activities while taking it until you know how it may affect you.

Why is the generic approval of Valcyte so exciting?

After receiving an organ transplant of any kind the pill burden can be tremendous. Patients and their caregivers are often sent home with several medications, which can run up a large pharmacy bill, and Valcyte is no exception.

The cost for 60 tablets of Valcyte is around $4000 if you do not have prescription insurance, and for expensive medications like Valcyte, insurance companies often require prior authorization. For more info on prior authorizations and specialty pharmacies, see our previous post here.

Specialty pharmacies will often assist transplant patients with their costly medications, and some manufacturers offer assistance programs as well, but costs can still be significant.

The approval of generic Valcyte will hopefully decrease the initial cost for your prescription insurance which in turn will result in a cost savings for you. Generic availability may also decrease the prior authorizations required by insurance.

What if my doctor wants to keep me on brand-name Valcyte?

The manufacturer, Genentech, has a patient assistance program that can help reduce the cost of the medication. Genentech Transplant Access Services (GTAS) offers various assistance programs for Valcyte patients who are insured, uninsured, or have Medicare.

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