Valcyte

Cytomegalovirus Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome + 4 more
Treatment
10 FDA approvals
20 Active Studies for Valcyte

What is Valcyte

ValganciclovirThe Generic name of this drug
Treatment SummaryValganciclovir hydrochloride is a medication manufactured by Roche that is used to treat cytomegalovirus infections. It is an antiviral drug that is converted to ganciclovir after it is taken orally. This conversion happens in the intestines and liver.
Valcyteis the brand name
image of different drug pills on a surface
Valcyte Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Valcyte
Valganciclovir
2001
31

Approved as Treatment by the FDA

Valganciclovir, also called Valcyte, is approved by the FDA for 10 uses like prophylaxis of Cytomegalovirus infection and Cytomegalovirus (CMV) Infection .
prophylaxis of Cytomegalovirus infection
Cytomegalovirus (CMV) Infection
Acquired Immune Deficiency Syndrome (AIDS)
Cytomegalovirus Retinitis
Cytomegalovirus Infections
Lung Transplant
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Cardiac Transplant
Kidney Transplant

Effectiveness

How Valcyte Affects PatientsValganciclovir is an antiviral medication used to treat cytomegalovirus infections. It works by being converted into ganciclovir in the body, which then gets incorporated into the DNA of the virus and prevents it from replicating. This stops the virus from spreading and eventually causes it to die off.
How Valcyte works in the bodyValganciclovir is converted to ganciclovir in the body. Ganciclovir then binds to DNA in virus-infected cells, making it harder for the virus to replicate. This stops the virus from making copies of itself, and eventually it dies off. Ganciclovir works better on viruses than normal cells, so it can stop the virus without harming the body's cells.

When to interrupt dosage

The measure of Valcyte is contingent upon the determined illness, including Cardiac Transplant, Cytomegalovirus Infections and Cytomegalovirus Infections. Dosage can be found in the table below, corresponding to the procedure of application.
Condition
Dosage
Administration
Cytomegalovirus Infections
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Acquired Immunodeficiency Syndrome
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Kidney Transplant
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Cytomegalovirus Infections
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Lung Transplant
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Cardiac Transplant
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral
Cytomegalovirus Retinitis
, 450.0 mg, 50.0 mg/mL
, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution, For solution - Oral

Warnings

There are 20 known major drug interactions with Valcyte.
Common Valcyte Drug Interactions
Drug Name
Risk Level
Description
Aclidinium
Minor
Valganciclovir may decrease the excretion rate of Aclidinium which could result in a higher serum level.
Acrivastine
Minor
Valganciclovir may decrease the excretion rate of Acrivastine which could result in a higher serum level.
Albutrepenonacog alfa
Minor
Valganciclovir may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Almasilate
Minor
Valganciclovir may decrease the excretion rate of Almasilate which could result in a higher serum level.
Alogliptin
Minor
Valganciclovir may decrease the excretion rate of Alogliptin which could result in a higher serum level.
Valcyte Toxicity & Overdose RiskAn overdose of valganciclovir could cause increased kidney damage.
image of a doctor in a lab doing drug, clinical research

Valcyte Novel Uses: Which Conditions Have a Clinical Trial Featuring Valcyte?

Currently, 68 active studies are assessing the potential of Valcyte to treat Cardiac Transplantation, Acquired Immunodeficiency Syndrome and Cytomegalovirus Infections.
Condition
Clinical Trials
Trial Phases
Cytomegalovirus Retinitis
0 Actively Recruiting
Cytomegalovirus Infections
3 Actively Recruiting
Phase 2
Kidney Transplant
36 Actively Recruiting
Phase 2, Phase 1, Not Applicable, Phase 4, Phase 3
Cytomegalovirus Infections
0 Actively Recruiting
Cardiac Transplant
10 Actively Recruiting
Not Applicable, Phase 2, Phase 3, Phase 4
Acquired Immunodeficiency Syndrome
4 Actively Recruiting
Phase 1, Phase 2, Not Applicable
Lung Transplant
16 Actively Recruiting
Not Applicable, Phase 2, Phase 3, Phase 1

Valcyte Reviews: What are patients saying about Valcyte?

5Patient Review
4/4/2008
Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients
I am a single lung transplant recipient and have been on this medication for a while. It is very costly, over $3300 per month, but it has been effective. I may have to stop taking it because I cannot afford it.
5Patient Review
7/4/2009
Valcyte for Treatment to Prevent Cytomegalovirus Disease
I used this medication for about six weeks after my transplant, but then I started vomiting and developed a rash, so I had to stop.
5Patient Review
5/21/2009
Valcyte for Prevention of CMV Infection Post Kidney Transplant
I had this treatment after an organ transplant. It was very effective in boosting my immune system.
5Patient Review
6/19/2010
Valcyte for Treatment to Prevent Cytomegalovirus Disease
So far, this treatment has been effective. I'm hoping it will be a long-term solution.
4.7Patient Review
12/27/2016
Valcyte for Treatment to Prevent Cytomegalovirus Disease
Valcyte has been great for me. I was worried about the fatigue, but it's manageable and the drug is really effective. No side effects whatsoever- would definitely recommend.
4.7Patient Review
4/28/2009
Valcyte for Prevention of CMV Infection Post Kidney Transplant
I was diagnosed with CMV retinitus 10 years ago and have been HIV+ for 20 years. The virus has been controlled since then, but I am now blind in one eye. Valcyte has had few serious side effects so far, but the idea of having to take this medication for the rest of my life is depressing.
4.3Patient Review
10/13/2009
Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients
I've only been taking this medication for a little while, and I've already lost twenty-three pounds. I also had an esophageal ulcer, gastritis, heartburn, reflux, and an ulcer on my ankle before starting this treatment - none of which I have now.
4Patient Review
7/8/2011
Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients
I'm seeing results already and my vision is returning. Not sure how long the treatment will take, but so far so good!
4Patient Review
6/26/2013
Valcyte for Prevention of CMV Infection Post Kidney Transplant
I can't afford this medication, but it's really effective.
3.3Patient Review
10/19/2016
Valcyte for Prevention of CMV Infection After Heart Transplant
I've been prescribed this for a few months now and, all things considered, it's working well since my heart transplant. It is very costly, even with insurance coverage, because of copays and other expenses. I hope and pray that we can all find a way to afford this medication.
3Patient Review
3/3/2011
Valcyte for Prevention of Cytomegalovirus Disease After Kidney-Pancreas Transplantation
I took this medication in high doses after a liver transplant and the development of CMV. This permanently affected the nerves in my legs and feet, causing intolerable pain. I considered suicide but my doctor ignored this. If you experience any nerve pain at all while taking this medication, please demand an alternate from your doctor!
2.7Patient Review
6/8/2009
Valcyte for Prevention of CMV Infection Post Kidney Transplant
Even with insurance, this medication is quite expensive. Without coverage, it would be unaffordable for most people. I am lucky that my insurance covers such a large portion of the cost.
2.3Patient Review
1/25/2008
Valcyte for Prevention of CMV Infection Post Kidney Transplant
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about valcyte

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of Valcyte?

"nausea, or vomiting

The possible side effects of the medication are: diarrhea, upset stomach, dizziness, loss of balance or coordination, drowsiness, unsteadiness, shaking (tremors), diarrhea, nausea, or vomiting."

Answered by AI

What is Valcyte used for?

"VALCYTE is used to treat CMV retinitis in people with AIDS. CMV retinitis is an infection of the eyes caused by the CMV virus."

Answered by AI

Is Valcyte an immunosuppressant?

"Valcyte is not an immunosuppressant, though it is often prescribed to people taking immunosuppressants after a transplant to prevent a CMV infection."

Answered by AI

How long can you take Valcyte?

"The recommended dose of Valcyte is two tablets taken twice a day for 21 days. Taking this medication for more than 21 days may increase your risk of developing side effects."

Answered by AI

Clinical Trials for Valcyte

Image of New York University Langone Health in New York, United States.

GGTA1 KO Thymokidney for Kidney Failure

40 - 70
All Sexes
New York, NY
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.
Phase 1 & 2
Recruiting
New York University Langone HealthUnited Therapeutics
Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA
This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.
Waitlist Available
Has No Placebo
Los Angeles General Medical CenterHayoun Lee, PhD
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Trimethoprim-Sulfamethoxazole for Urinary Tract Infections

13 - 29
All Sexes
San Francisco, CA
The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months. The main questions this study is asking are: * Does TMP-SMX lower the number of UTIs in the first year after transplant? * What side effects or problems do participants have while taking TMP-SMX? Researchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs. Participants will: * Take either TMP-SMX or a placebo pill by mouth every day for 6 months * Have three visits to touch base with the study team about any issues * Complete short monthly online surveys about any symptoms or side effects * Share blood and urine test results from their regular transplant clinic visits
Phase 4
Waitlist Available
University of California, San FranciscoAlexandra Bicki, MD
Image of Johns Hopkins University School of Medicine in Baltimore, United States.

Fostamatinib for Lung Transplant Rejection

18 - 99
All Sexes
Baltimore, MD
Background: People who have lung transplants often survive 6 or 7 years. But some people develop donor-specific antibodies (DSA) after their transplants; antibodies are proteins that attack foreign invaders in the body. Antibodies typically kill viruses and other agents that can cause disease. But when the antibodies attack a transplanted organ, they can cause the body to reject the new tissues. People who develop DSA after a transplant have a higher risk of death within 1 year. Objective: To test a drug called fostamatinib in people who develop DSA after a lung transplant. Eligibility: Adults aged 18 and older who developed DSA after a lung transplant. Design: Participants will continue with their standard care after a transplant. Fostamatinib is a pill taken by mouth. Some participants will take the study drug along with their standard care; others will take a placebo. A placebo is a pill that looks just like the real drug but contains no medicine. All participants will take 1 pill per day for 2 weeks. Then they will take 2 pills per day for the next 6 weeks. Participants will have clinic visits every 2 weeks while taking their pills. They will have a physical exam, with blood and urine tests, during each visit. If participants have fluid samples collected from their airways during their standard treatment, some extra fluid may be collected for this study. Participants will have a follow-up visit 4 weeks after they stop taking their pills.
Phase 1
Waitlist Available
Johns Hopkins University School of Medicine (+4 Sites)Sean T Agbor-Enoh, M.D.
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Image of New York University Langone Health in New York, United States.

Xenokidney for Kidney Failure

55 - 70
All Sexes
New York, NY
The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.
Phase 1 & 2
Recruiting
New York University Langone HealthUnited Therapeutics
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Maraviroc for Primary Graft Dysfunction

18+
All Sexes
San Francisco, CA
Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1/3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD. The goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are: To address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body. This will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives. Participants will: Take drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.
Phase 2
Waitlist Available
University of California, San FranciscoDaniel Calabrese, MD
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