万赛维注意事项

It is an antiviral drug used to treat patients with acquired immunodeficiency syndrome (AIDS) combined with cytomegalovirus (CMV) retinitis, and to prevent CMV infection in high-risk solid organ transplant patients. So what precautions should be taken during treatment with Vancevi?

1. Warning:

(1) Ganciclovir has been found to be mutagenic, teratogenic, deficient in spermatogenesis and carcinogenic in animal experiments. Therefore, Vancevir is considered to have potential teratogenic and carcinogenic effects on humans and may cause birth defects and cancer. Vancevir is also thought to cause temporary or permanent suppression of spermatogenesis. Cases of severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, myelosuppression and aplastic anemia have been observed in patients treated with Vancevir (or cyclovir). Treatment with Vancevir should not be initiated if the absolute neutrophil count is less than 500/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL.

(2) Since the safety and effectiveness of Vancevir in Chinese pediatric patients have not been established, Vancevir is not recommended for use in children.

2. The absolute bioavailability of Vansevir measured with ganciclovir is 10 times higher than that of ganciclovir capsules. Vancevir cannot replace ganciclovir capsules in a 1:1 ratio. Patients who were previously taking ganciclovir capsules and are switching to Vancevir tablets should be informed that there is a risk of overdose if they take Vancevir in excess of the prescribed dose.

3. It is recommended to monitor complete blood count and platelet count during treatment. For patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, it is recommended to use blood cell growth factor therapy and/or consider suspending medication.

4. For patients with renal insufficiency, the dose needs to be adjusted according to the creatinine clearance rate.

5. For patients undergoing hemodialysis (CrCl<10ml/min), no recommended dosage can be given. Therefore, Vancevir cannot be used in such patients.

6. Convulsions, sedation, dizziness, ataxia, and/or confusion have been reported after the use of Vancevir and/or cyclovir. If these conditions occur, they may affect activities that require concentration, including the patient's ability to drive a car and operate machinery.

7. Convulsions have been reported in patients taking imipenem-cilastatin and ganciclovir together. Vancevir should not be used together with Tylena unless the potential benefit outweighs the potential risk.

8. Both zidovudine and Vancevir may cause neutropenia and anemia when used alone. Some patients may not tolerate the full dose of these two drugs.

9. When combined with Vancevir, the plasma concentration of didanosine may increase; therefore, patients should be closely monitored for didanosine toxicity.

10. Combining Vancevir with other drugs known to have bone marrow suppression or to be associated with renal insufficiency may lead to increased toxicity.

11. Medication for pregnant and lactating women:

(1) Due to the rapid and large-scale conversion of valganciclovir into ganciclovir, studies on its reproductive toxicity have not been repeated. In animal experiments, ganciclovir caused reduced fertility and teratogenic effects.

(2) It is recommended that women of childbearing age use effective contraceptive measures during treatment. Male patients are advised to use barrier contraception during treatment with Vancevir and for at least 90 days after discontinuation of treatment. There are no safety data on Vancevir during human pregnancy. Pregnant women should avoid taking Vancevir unless the benefits to the mother outweigh the potential harm to the fetus.

(3) The effects of valganciclovir or cyclovir on perinatal and postpartum infant development have not been studied, but it must be considered that ganciclovir may be secreted into breast milk and cause serious adverse reactions in nursing infants. Therefore, when considering the possible benefits of Vancevir to nursing mothers, a decision should be made whether to discontinue medication or discontinue breastfeeding.

12. Medication for children:

Since the safety and effectiveness of Vancevir in Chinese pediatric patients have not been established, Vancevir is not recommended for use in children.

13. Medication for the elderly: There is no safety and effectiveness data for such patients.

14. Drug overdose:

(1) Valganciclovir overdose experience: An adult with renal insufficiency developed fatal bone marrow suppression (myeloid aplastic anemia) for several days after taking at least 10 times the recommended dose corresponding to the patient's degree of renal impairment (reduced creatinine clearance). It is speculated that excessive amounts of valganciclovir may also lead to increased nephrotoxicity. In patients with valganciclovir overdose, hemodialysis and hydration may help reduce plasma concentrations.

(2) Experience with intravenous ganciclovir overdose:

Overdoses with intravenous ganciclovir have been reported both in clinical trials and in postmarketing use. Some of these cases had no reported adverse events, but the vast majority of patients had one or more of the following adverse events:

① Hematological toxicity: pancytopenia, bone marrow suppression, myeloid aplastic anemia, leukopenia, neutropenia, and granulocytopenia.

②Hepatotoxicity: hepatitis, abnormal liver function.

③ Renal toxicity: Patients with original renal insufficiency may experience worsening of hematuria, acute renal failure, and increased creatinine.

④Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting.

⑤ Neurotoxicity: widespread tremors and convulsions.

15. Pay special attention to:

(1) Storage and handling: Tablets cannot be broken or crushed. Given the potential teratogenic and carcinogenic effects of Vancevir in humans, extreme caution should be used when handling broken tablets (see Warnings). Avoid direct contact with skin or mucous membranes with broken or crushed tablets. In the event of contact, flush skin thoroughly with soap and water and eyes with plenty of water.

(2) Stability: It cannot be applied after the expiration date (EXP) shown on the packaging. See outer packaging for storage precautions.