The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent (for patients who received 100 days of treatment) to 16.8 percent (for patients who received treatment for 200 days) at one year after receiving a transplanted kidney (p<0.0001).1,2 The overall safety profile of Valcyte did not change with the extension of prophylaxis in high-risk kidney transplant patients.

 

"Among the different risks people face after a kidney transplant, CMV is one that may be prevented through prophylactic treatment with Valcyte," said Investigator, Dr. Atul Humar, Director, Transplant Infectious Diseases and Associate Professor, Department of Medicine, University of Alberta, Canada. "Data now demonstrate that we may further reduce the risk of CMV infection by increasing the duration of preventative treatment from 100 to 200 days."

 

CMV is a major cause of illness and disease during the first six months following transplantation. It is estimated that 50-80 percent of all adults are infected with the CMV virus,[i] which most often lies dormant in the body throughout life. The virus can be activated at times when the immune system is weakened such as after organ transplantation. CMV infection may cause complications in the lungs, kidneys, nervous system, liver, and gastrointestinal tract.[ii]

 

"Despite advances in the management of CMV, studies have shown that more than a third of patients still develop CMV infection even after 100 days of prophylaxis," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "This approval provides important information for physicians treating high-risk adult patients during the critical period after kidney transplant."

Why is Valganciclovir prescribed?

Valcyte is also used to prevent CMV disease in people who've had a kidney, heart, or kidney-pancreas transplant. Valcyte is not approved for use in liver transplant patients.

Valcyte is very similar to the CMV medication Cytovene (ganciclovir).

Most important fact about Valganciclovir

To avoid an overdose, it is essential to take only the prescribed number of Valcyte tablets each day. These tablets are more potent than Cytovene capsules, and cannot be substituted on a one-for-one basis.

How should you take Valganciclovir?

Valcyte is usually taken twice a day for the first three weeks, then once a day. It should be taken with food.

Be careful to avoid breaking Valcyte tablets. If a tablet does break, keep the pieces out of direct contact with skin, eyes, and mouth. If contact is unavoidable, wash thoroughly with soap and water and rinse the eyes with plain water.

• If you miss a dose...
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule.

• Storage instructions...
  Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Valcyte.

• Side effects may include:
  Abdominal pain, anemia and other blood abnormalities, burning or prickling feeling, diarrhea, fever, graft rejection, headache, high blood pressure, insomnia, mental changes, nausea, retinal detachment, tremors, vision problems, vomiting

Why should Valganciclovir not be prescribed?

If Valcyte gives you an allergic reaction, or you've had an allergic reaction to Cytovene, you will not be able to use Valganciclovir.

You will not be able to use Valcyte if you are receiving hemodialysis.

Special warnings about Valganciclovir

Valcyte may cause low blood counts. You will need to have frequent blood tests to monitor for abnormalities. Your doctor will be especially cautious if you have pre-existing blood problems or if you are taking other medications that can reduce blood counts.

Valcyte can also affect the kidneys, so your doctor will check them frequently. You should be aware that Valcyte is also considered a potential cancer-causing agent, although this possible effect has not been studied.

Valcyte can diminish fertility in both men and women. It may also prove harmful to a developing baby. Women should use birth control while taking Valcyte, and men should use condoms during treatment and for 90 days thereafter.

Convulsions, sedation, dizziness, weakness, and confusion have been reported with the use of Valcyte tablets. If any of these symptoms occur, do not drive, operate machinery, or perform any other task that requires you to be alert.

Valcyte is not a cure for CMV retinitis and your disease may worsen during or following treatment. You should have an eye exam at least every 4 to 6 weeks while being treated with Valcyte tablets.

Possible food and drug interactions when taking Valganciclovir

If Valcyte is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Valcyte with the following:

Special information if you are pregnant or breastfeeding

Valcyte may cause birth defects and should not be used during pregnancy. It's not certain whether Valcyte appears in breast milk, but it would cause serious side effects if it did. Breastfeeding is not recommended for women taking Valcyte—or for any woman with AIDS, since the disease can be passed to the infant through breast milk.

Recommended dosage for Valganciclovir

ADULTS

For the Treatment of CMV Retinitis

For active CMV retinitis, the recommended starting dosage is 900 milligrams (two 450-milligram tablets) twice a day for 21 days. The dose can then be decreased to 900 milligrams (two 450-milligram tablets) once a day. Take each dose with food.

Patients who have inactive CMV retinitis can start out at 900 milligrams once daily with food.

For the Prevention of CMV Disease in Heart, Kidney, and Kidney-pancreas Transplants

The recommended starting dosage is 900 milligrams (two 450-milligram tablets) once a day with food starting within 10 days of transplantation until 100 days posttransplantation.

If you have poor kidney function, your dose will be decreased. If you need hemodialysis, Valcyte cannot be used at all.

Overdosage

Any medication taken in excess can have serious consequences. A overdose of Valcyte can cause blood abnormalities, kidney failure, and liver disorders. If you suspect an overdose, seek medical attention immediately.

抗病毒药缬更昔洛韦(valganciclovir，Valcyte)延长治疗时间获临床研究支持

日前，罗氏公司公布了一项有关抗病毒药缬更昔洛韦(valganciclovir，Valcyte)的晚期临床研究结果：高风险肾移植患者术后服用本品的时间从100天延长至200天将进一步降低巨细胞病毒(CMV)感染的发病率。

CMV属于疱疹病毒科。该病毒在有正常免疫功能的个体中处于静息状态，但当如AIDS患者，器官移植后接受免疫抑制剂的患者等，其免疫功能受损时，该病毒就会引起病症。HIV/AIDS患者中CMV最常见的病症为CMV视网膜炎，这是一种可导致失明的眼部感染。

抗病毒药缬更昔洛韦(valganciclovir)是瑞士罗氏公司研制开发，2001年3月获准美国FDA许可，2001年5月首次在美国上市。 用于获得性免疫缺陷综合征(AIDS)患者巨细胞病毒(CMV)性视网膜炎。目前缬更昔洛韦是预防CMV感染的标准治疗药物。